Vol 18 - Issue 3

VOLUME 18 ISSUE 3 MARCH 2013

ENDOPHTHALMITIS UPDATE

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march 2013 Volume 18 | Issue 3 This ISSUE...

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9 22

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Special Focus: Endophthalmitis

Glaucoma

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27 Early results show outflow device effective in lowering IOP 28 Is a cure for glaucoma within reach?

29 Glaucoma stents can help long-term reduction of IOP, studies show

Cover Story: Experts discuss the future of endophthalmitis prophylaxis 8 A Californian surgery centre is convinced of positive effects from use of IC antibiotics 9 Sterile conditions crucial to help prevent endophthalmitis 10 New single-dose preparation is important step in battle against endophthalmitis 11 Comparing ocular cefuroxime levels after various routes of administration

Cataract & Refractive

12 New technologies help make cataract surgery outcomes more predictable 13 Young ophthalmologists listen to discussion on lens and laser options 14 Refining older approaches and using new techniques can improve visual outcomes 15 Laser can provide better visual outcomes for patients 16 New optical designs give patients greater choice in IOLs 17 Error in IOL calculation can lead to refractive surprises 18 Numerical simulation could improve refractive outcomes in femtosecond cataract surgery

Cornea

20 Corneal crosslinking could improve vision in children 21 Three devices are compared for measuring central corneal thickness 22 New approaches for corneal transplantation discussed

17th ESCRS Winter Meeting in Warsaw

Retina 30 EURETINA Winter Meeting focuses on future trends 31 Study results confirm anti-VEGF safety in Asian patients 32 Management of retinoblastoma 33 Intraoperative OCT for vitreoretinal surgery could prevent repeat surgeries

Ocular 34 New innovations help with drug delivery to ocular structures 35 Running a cosmetic surgery office vs. a general ophthalmology practice

Paediatric Ophthalmology 36 Keynote speaker outlines experiences of treating amblyopia and strabismus 37 Evidence-based guidelines for treating amblyopia 38 Refractive surgery in children

News 39 Presenters discuss how EUREQUO has helped improve their surgical results

Features 40 EU Matters 41 Ophthalmologica 42 Industry News 43 Book Review 46 JCRS Highlights 48 Calendar

23 News and reviews from the meeting Cover images taken from ESCRS Guidelines on prevention, investigation and management of post-operative endophthalmitis, Version 2, August 2007.

Left image (courtesy of Suleyman Kaynak) shows early presentation of acute endophthalmitis due to Streptococcus mitis; right image (courtesy of Uwe Pleyer) shows presentation of acute endophthalmitis due to Staphylococcus aureus.

With this issue... 13th Euretina congress, epos/wSpos Paediatric SUB Specialty day,

4th eucornea congress & xxxI congress of the escrs preliminary programmes

editorial staff

ESCRS

EUROTIMES

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Published by The European Society of Cataract and Refractive Surgeons Publisher Carol Fitzpatrick

Managing Editor Caroline Brick

Executive Editor Colin Kerr

Production Editor Angela Sweetman

Editors Sean Henahan Paul McGinn

Senior Designer Paddy Dunne

Assistant Designer Janice Robb Circulation Manager Angela Morrissey Contributing Editors Howard Larkin Dermot McGrath Roibeard Ó hÉineacháin Contributors Devon Schuyler Eisele Stefanie Petrou-Binder Maryalicia Post

Leigh Spielberg Pippa Wysong Gearóid Tuohy Colour and Print W&G Baird Printers Advertising Sales ESCRS, Temple House, Temple Road Blackrock, Co. Dublin, Ireland Tel: 353 1 209 1100 Fax: 353 1 209 1112 email: escrs@escrs.org

Published by the European Society of Cataract and Refractive Surgeons Temple House, Temple Road, Blackrock, Co Dublin, Ireland.

No part of this publication may be reproduced without the permission of the managing editor. Letters to the editor and other unsolicited contributions are assumed intended for this publication and are subject to editorial review and acceptance.

ESCRS EuroTimes is not responsible for statements made by any contributor. These contributions are presented for review and comment and not as a statement on the standard of care. Although all advertising material is expected to conform to ethical medical standards, acceptance does not imply endorsement by ESCRS EuroTimes.

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As certified by ABC, the EuroTimes average net circulation for the 11 issues distributed between 01 January 2011 and 31 December 2011 is 32,332.

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EUROTIMES

Editorial

ESCRS

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EDITORIAL

Medical Editors

Volume 18 | Issue 3

José Güell

Ioannis Pallikaris

Clive Peckar

Paul Rosen

A HOT TOPIC

Every surgeon has a responsibility to submit their endophthalmitis cases to the new European Registry of Endophthalmitis

by Peter Barry

International Editorial Board

Emanuel Rosen Chairman ESCRS Publications Committee

Noel Alpins australia Bekir Aslan TURKEY Bill Aylward UK Peter Barry IRELAND Roberto Bellucci ITALY

E

ndophthalmitis prophylaxis for cataract surgery has become a hot topic again. In the January edition of JCRS the latest figures from the Swedish cataract registry show an incidence down to 0.029 per cent in the period 20052010.1 The non-use of intracameral cefuroxime was the greatest single risk factor. Add-on pre-, per- or postoperative antibiotic drops conferred little, if any, extra benefit. In this same issue of JCRS is the first systematic assessment of intracameral cefuroxime in the US.2 The results of this study coincide remarkably with the results of the ESCRS Endophthalmitis Study (16,000 patients in each) in terms of background rate, (0.3 per cent) benefit of intracameral cefuroxime, numbers of streptococcal and staphylococcal infections and visual outcome from these main organisms.

Subsequent to publishing the results of the ESCRS study, others have confirmed the benefits of switching to the intracameral route of administration. The Spanish study of 13,652 patients between 19992008 showed a ten-fold reduction.3 A French Study of 5,115 patients4 all with uncomplicated surgery showed an even greater reduction as did an Asian study5 of 50,000 patients including both phaco and ECCE and using intracameral cefazolin. In a more recent report from South Africa6 8,190 patients showed a reduction by a factor of seven.

Nonetheless, the lack hitherto of an approved product has resulted in catastrophic errors in dilution7 and contamination.8 This lack is perhaps the major cause of surgeons’ reluctance to convert to the intracameral route. This may now change with the European Medicines Agency (EMA) approval of Aprokam from Thea Laboratories (France).

Given recent disasters from compounding pharmacies in the US, it is to be hoped the demonstrated benefits of the intracameral approach worldwide and now in the US will encourage the FDA to approve a product in the US. EUROTIMES | Volume 18 | Issue 3

Hiroko Bissen-Miyajima JAPAN As the number of endophthalmitis cases in Europe is now very small, the ESCRS is planning a European Registry of endophthalmitis following cataract surgery. This will serve to track breakthrough organisms and changes in bacterial resistance and antibiotic susceptibilities. I consider every surgeon has a responsibility to submit their endophthalmitis cases to this registry: www.escrs.org.

References 1. Friling E et al, J Cataract Refract Surg 2013; 39:15-21.

2. Shorstein N et al, J Cataract Refract Surg 2103; 39:8-14.

3. Garcia-Saenz MC, J Cataract Refract Surg 2010; 36:203-207.

4. Barreau G et al J Cataract Refract Surg, in press.

5. Tan C et al J Cataract Refract Surg 2012; 38:425-430.

6. Van der Merwe J Cataract Refract Surg 2012; 38:2054.

7. Olavi P. Letter to Editor Acta Ophthalmologica 2011; April 6:1-2 8. Çakir M. et al Curr Eye Res 2009; 34:988-95.

John Chang CHINA Joseph Colin FRANCE Alaa El Danasoury SAUDI ARABIA Oliver Findl AUSTRIA I Howard Fine USA Jack Holladay USA Vikentia Katsanevaki GREECE Thomas Kohnen GERMANY Anastasios Konstas GREECE Dennis Lam HONG KONG Boris Malyugin RUSSIA Marguerite McDonald USA Cyres Mehta INDIA Thomas Neuhann GERMANY Rudy Nuijts THE NETHERLANDS Gisbert Richard GERMANY Robert Stegmann SOUTH AFRICA Ulf Stenevi SWEDEN Emrullah Tasindi TURKEY Marie-Jose Tassignon BELGIUM Manfred Tetz GERMANY Carlo Enrico Traverso ITALY Roberto Zaldivar ARGENTINA

Peter Barry FRCS is president of the ESCRS

Oliver Zeitz germany

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Cover Story

endophthalmitis

ESCRS ENDOPHTHALMITIS STUDY UPDATE

Additional studies confirm intracameral cefuroxime reduces incidence of endophthalmitis after cataract surgery

by Roibeard O’hEineachain

“

The resistant bacteria we see in Sweden have been resistant all along and we don’t appear to have really induced any resistance to bacteria by using the antibiotic prophylaxis Anders Behndig MD

“

Intracameral cefuroxime has been proven in postcataract patients and is shown to reduce the incidence of endophthalmitis fivefold and even tenfold in other studies and more than 10 studies support the use of cefuroxime Jorge Alio MD, PhD

EUROTIMES | Volume 18 | Issue 3

S

ince Ignaz Semmelweis first proposed that obstetricians wash their hands before attending to women in childbirth, hygiene protocols in a clinical setting have been a recurring source of controversy. In cataract surgery, there is now general agreement regarding sterile technique, but somewhat less of a consensus regarding endophthalmitis prophylaxis. However, following publication of the ESCRS Endophthalmitis Study in 2006 an increasing number of surgeons, particularly in Western Europe, have adopted the practice of injecting antibiotics intracamerally at the conclusion of surgery.

The ESCRS initiated the ESCRS Endophthalmitis Prophylaxis Study in 2003.

The study’s investigators, chaired by Peter Barry FRCS, Dublin Ireland, originally designed the trial to include 35,000 cataract patients who were to be randomised to receive intracameral cefuroxime or no intracameral antibiotic. However, in a dramatic turn of events, by the time 16,000 patients had been recruited the data showed that those receiving the intracameral antibiotic had a five-fold reduction in endophthalmitis.

Following the publication of the ESCRS study, the ESCRS adopted new guidelines for cataract surgery advising the use of intracameral cefuroxime. The American Academy of Ophthalmology (AAO), for their part, also state in their preferred practice guidelines for cataract surgery that “only intracameral antibiotics at the end of the case guarantees suprathreshold antibiotic levels for an extended period of time”.

However, until very recently, there has been no product approved for use in that way anywhere in the world, and there remains some disagreement about which antibiotic would be the safest and most effective. As a consequence, cataract surgeons in many parts of the world have been slow to adopt the use of intracameral antibiotics, although in Western Europe the majority of practices appear to have done so.

Picture taken from EuroTimes November 2006 vol 11 issue 11

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Peter Barry giving the Ridley Medal Lecture at the XXIV ESCRS Congress in London, September 2006

A survey of ASCRS and ESCRS members which David Leaming MD carried out in 2011 showed that 60 per cent of ESCRS respondents used intracameral antibiotics, compared to only 20 per cent of American respondents.

The evidence The inspiration for the ESCRS Endophthalmitis Study came from a report on the results achieved with intracameral cefuroxime in Sweden, as reported by Per Montan MD of St Erik's Eye Hospital in Stockholm, Sweden in the June 2002 issue of the Journal of Cataract and Refractive Surgery.

“The Swedish registry data provided strong evidence of its efficacy and the safety but it was nonetheless anecdotal in statistical terms. So the ESCRS study aimed at proving the efficacy and safety of cefuroxime in a randomised trial,” Dr Barry told EuroTimes in an interview.

The Swedish retrospective study showed that the incidence of endophthalmitis occurring in patients included in the Swedish Cataract registry fell from 0.48 per cent to 0.06 per cent after the Swedish ophthalmologists adopted the use of intracameral cefuroxime in 1996.

That is, from 1990 through 1995 there were 18 cases of postoperative endophthalmitis among 3,742 eyes that underwent cataract procedures, compared to only 11 cases in 12,245 procedures performed during the years 1996 to 2000 (p <0 .001). The Swedish Registry patients included virtually all cataract procedures performed during the years under study.

The use of intracameral antibiotics

by Swedish cataract surgeons was in turn inspired by a study by Howard Gimbel MD, who reported achieving a very low incidence of endophthalmitis after he adopted the use of intracameral

Courtesy of Uwe Pleyer

Courtesy of Suleyman Kaynak

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Early presentation of acute endophthalmitis due to Streptococcus mitis

vancomycin (Gimbel et al. Eur J Implant Refract Surg. 1994;6:280–285).

Cataract surgeons in Sweden chose to use cefuroxime instead of vancomycin, because it is active against most of the bacteria that had caused endophthalmitis in cataract patients in the Swedish Cataract Registry during previous years and because of a general feeling they had that vancomycin should be reserved for treatment rather than prophylaxis.

Cefuroxime is a second-generation cephalosporin antibiotic. It was FDAapproved for oral and parenteral use in 1983. It is effective against most staphylococcus and streptococcus species, many Gram-negative organisms, p. acne and the diptheroids. Its use in endophthalmitis prophylaxis has been solely on an off-label basis until last year, when a new single-dose preparation of cefuroxime (Aprokam®, Thea) for intracameral use received approval in several European countries.

Study mirrors registry results The ESCRS Endophthalmitis Study adopted the Swedish protocol for their randomised controlled study. They randomised patients into four groups, two groups received intracameral cefuroxime and two groups received no intracameral antibiotics. As an additional measure, one group each of the intracameral antibiotic and no intracameral antibiotic also received postoperative topical treatment with the third-generation antibiotic levofloxacin.

The trial commenced on September 15, 2003 in 24 centres in eight European countries. It was planned to include a total of 35,000 cataract patients undergoing phaco cataract surgery. However, the ESCRS Endophthalmitis Study’s investigators terminated the trial early, on January 13, 2006, when they detected a trend in favour of intracameral antibiotics.

By that time 15,971 patients had been recruited into the study. Among the 8,244 patients in the two groups that did not receive intracameral cefuroxime there were 23 (0.28 per cent) presumed cases of endophthalmitis, 16 (0.15 per cent) of which were proven. By comparison, among the 7,997 patients in the two groups that did receive intracameral cefuroxime there were only five (0.06 per cent) presumed cases, EUROTIMES | Volume 18 | Issue 3

three (0.038 per cent) of which were proven (p =0.002).

Another finding of the study was that the use of a third-generation fluoroquinolone at the end of surgery did not appear to have any significant prophylactic effect, whether or not patients also received intracameral cefuroxime.

Findings continue to gain support

Further studies are continuing to bear out the results of the ESCRS prophylaxis study.

For example, the latest findings of the Swedish cataract registry indicate that not only has the incidence of cataract surgery continued to remain lower than it was before the routine use of intracameral cefuroxime, it has continued to decrease even further.

The registry findings showed that during the years 2005 to 2010 the rate of endophthalmitis following cataract surgery among 464,996 operated eyes was only 0.029 per cent. That compares to an incidence of 0.048 per cent during the years 2002 through 2004 (P<.001). (Friling et al, Journal of Cataract & Refractive Surgery 2013: 39:15-21.)

“That has probably been due to improvements in surgical technique, such as smaller incisions, shorter operating times and the fact that patients in Sweden now undergo cataract surgery when they are healthier and at a younger age than was previously the case,” said Anders Behndig MD, Umeå University, Umeå, Sweden.

Gram-positive species accounted for 70 per cent of cases. The numbers of endophthalmitis cases caused by strains resistant to intracameral had not increased in Sweden over the years although such strains now account for a higher proportion of cases.

“The resistant bacteria we see in Sweden have been resistant all along and we don’t appear to have really induced any resistance to bacteria by using the antibiotic prophylaxis,” Dr Behndig said.

He noted that in a few rare instances patients did not receive intracameral cefuroxime, generally for fear of an allergic reaction. In those cases the rate of endophthalmitis was seven times higher.

Centres outside of Sweden which participated in or adopted the protocol of the ESCRS Endophthalmitis Study have also reported a sustained reduction in the incidence of endophthalmitis.

Presentation of acute endophthalmitis due to Staphylococcus aureus (Images taken from the ESCRS Guidelines on prevention, investigation and management of post-operative endophthalmitis)

A study conducted at a University Hospital in Madrid, Spain showed that among 13,652 patients who underwent cataract surgery from 1999 to December 2008, the rate of endophthalmitis fell from 0.59 per cent during the years 1999 to 2005 to 0.043 per cent after surgeons at the centre adopted the routine use of cefuroxime in 2006. (García-Sáenz et al, J Cataract, Refract Surg 2010; 36: 203-207.)

Jorge Alio MD, PhD, Alicante Spain, who participated in the ESCRS Endophthalmitis Study said that his centre has continued to have a low incidence of endophthalmitis following the study’s completion.

“Intracameral cefuroxime has been proven in post-cataract patients and is shown to reduce the incidence of endophthalmitis five-fold and even tenfold in other studies and more than 10 studies support the use of cefuroxime.

No randomised clinical study has been published that could demonstrate the efficacy of any other antibiotic in preventing endophthalmitis,” Dr Alio said.

The moxifloxacin alternative On the other hand, many cataract surgeons have chosen not to adopt the prophylactic use of intracameral cefuroxime. They include some who accept the findings of the ESCRS Endophthalmitis Study but maintain that other agents might be more suitable.

“I think that the ESCRS Endophthalmitis study is one of the seminal studies in our field. Its findings really extended and solidified the work that had come out of earlier investigations, particularly in Sweden, suggesting that intracameral antibiotics would be a huge step forward in reducing the incidence of endophthalmitis,” said Douglas Koch MD, Cullen Eye Institute, Baylor College of Medicine, Texas, US. However, he noted that he has been using the fourth-generation fluoroquinolone, moxifloxacin, rather than cefuroxime, as his intracameral antibiotic. He added that he prefers the agent to cefuroxime because it has a longer half-life and unlike cefuroxime, intracameral administration achieves levels that are effective against MRSA, if only for a few hours.

He noted that moxifloxacin is also easier to use than cefuroxime and possibly less risky as well. Since it can be used without dilution its use does not entail any risk of

“

I think that the ESCRS Endophthalmitis Study is one of the seminal studies in our field

Douglas Koch MD

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The ESCRS Endophthalmitis Study has made a revolutionary change not only in my practice, but also many practices in India Keiki Mehta MD

contacts

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Cover Story

endophthalmitis

“

The survey has not been repeated, but since that time, I think that more American surgeons are using intracameral antibiotics following publication of the study, compared to before David Chang MD

“

In my country almost nobody has any doubts with regard to the cefuroxime efficiency in endophthalmitis prophylaxis Boris Malyugin MD

dilution errors. On the other hand, like cefuroxime, until very recently, and vancomycin, it is not available in single dose units and must be prepared in batches.

“The issue in the United States is the lack of availability of antibiotics that are premixed at the dosages that are required for intracameral use, particularly antibiotics such as cefuroxime and vancomycin. That means you have to rely on a compounding pharmacy or your own pharmacy in order to prepare these intracameral injections,” Dr Koch noted.

He added that the availability of an approved product such as Aprokam, the new cefuroxime preparation, would

certainly increase the adoption of intracameral antibiotics by cataract surgeons in the United States. “Any delay in the availability of a product such as this in the US is inexcusable,” he added.

Keiki Mehta MD in India told EuroTimes that he has had a similar experience with moxifloxacin.

“The ESCRS Endophthalmitis Study has made a revolutionary change not only in my practice, but also many practices in India.

The use of intracameral moxifloxacin has become routine,” he said in an interview.

He noted that he and his associates at his centre have been using intracameral moxifloxacin for close to 16 months and during that time they have encountered only one case of endophthalmitis out of around 6,000 cases. In previous years they had about two cases per year out of 4,500 cases of cataract surgery, he said.

“The changes are most dramatic in eye camps where infection was previously quite a problem but now that we use moxifloxacin the incidence has plummeted to almost zero,” he added.

With regard to cefuroxime, Dr Mehta expressed concern that the agent might leak into the vitreous, particularly in older eyes where the zonules may have lost some of their integrity. The effect of cefuroxime on the retina has yet to be fully elucidated, he said. Moxifloxacin, on the other hand has a proven track record of retinal safety, since it is frequently used intravitreally for the treatment of endophthalmitis.

However, Dr Behndig told EuroTimes that Swedish cataract surgeons currently use cefuroxime in eyes with posterior capsule ruptures and it has so far proved completely safe in such cases.

Vancomycin as first resort Some cataract surgeons meanwhile have adhered to the use of intracameral vancomycin as originally suggested by Howard Gimbel MD. Vancomycin, a glycopeptides antibiotic, is generally reserved as an antibiotic of last resort.

COMING SOON IN APRIL EUROTIMES...

Corneal Crosslinking at the crossroads Our April Cover Story will focus on the future of corneal crosslinking.

Corneal crosslinking, in which corneal stroma fibres are strengthened by exposure to ultraviolet-A (UVA) light in the presence of riboflavin as a photosensitizer, is a successful treatment for keratoconus and post-LASIK ectasia in adults. Recent studies suggest it may also be suitable for other applications.

This article will examine the status of emerging indications, including paediatric treatment, combined ablation

EUROTIMES | Volume 18 | Issue 3

and crosslinking for ectatic conditions, ectasia prophylaxis with primary LASIK and as a broad-spectrum anti-microbial for infectious keratitis. Also examined will be technical advances that could make the treatment safer and less burdensome for patients. These include higher-dose UVA that could shorten treatment times and technologies that might help riboflavin penetrate the epithelium, eliminating the pain and complication risk of removing it.

“Prior to the ESCRS Endophthalmitis Study, I had been using intracameral vancomycin based on Howard Gimbel’s reported outcomes in more than 20,000 cases. Because of the success and safety of using 1.0mg of vancomycin in 0.1ml for my own patients, I have continued this practice ever since,” said ASCRS president, David Chang MD. “We have the increasing threat of methicillin resistant staph aureus (MRSA) in the US, and vancomycin is one of the few agents that multi-drug resistant organisms are sensitive to. Unlike with systemic vancomycin administration, I do not believe that direct injection of 0.2ml into the sterile anterior chamber poses any risk of inducing vancomycin drug resistance.

Finally, an important British study has validated the pharmacokinetic rationale of using a single intracameral injection of 1mg of vancomycin.”1 He noted that in a survey of ASCRS members conducted in 2007, approximately one year after the ESCRS Endophthalmitis Study, around three-fourths of the more than 1,300 respondents were still not injecting intracameral antibiotics. However, 82 per cent said that they would do so if a reasonably priced commercial preparation were available.

“The survey has not been repeated, but since that time, I think that more American surgeons are using intracameral antibiotics following publication of the study, compared to before,” he added.

He noted that the ESCRS study did not compare intracameral cefuroxime to the most common American practice pattern for endophthalmitis prophylaxis, namely, the prophylactic use of pre- and postoperative topical 4th generation fluoroquinolone antibiotics. In addition, the ASCRS survey indicated that the lack of a commercially available antibiotic for intracameral injection in the US raised significant concerns over the risks of mixing “homemade” antibiotic solutions.

“In light of these perceived risks, I suspect that many American surgeons won’t switch unless IC antibiotics are shown to be superior to what they are already doing,” Dr Chang said.

In some parts of the world, previously established protocols stand in the way of wider use of intracameral antibiotics.

“In my country almost nobody has any doubts with regard to the cefuroxime efficiency in endophthalmitis prophylaxis.

But there is some difference between the private and state-owned clinics. The latter are slow adopters of intracameral cefuroxime. This is because in state hospitals and ophthalmology departments they are very strict in following the protocols and practice patterns approved by the Ministry of Health. The arrival of the commercially single-dose intracameral antibiotic injection is going to change the situation dramatically,” said Boris Malyugin MD, Moscow.

Peter Barry – peterbarryfrcs@theeyeclinic.ie Anders Behndig – anders.behndig@ophthal.umu.se Jorge Alio – jlalio@vissum.com Douglas D Koch – dkoch@bcm.edu Keiki Mehta – drkeiki@mehtaeyeinstitute.com David F Chang – dceye@earthlink.net Boris Malyugin – boris.malyugin@gmail.com

“

...I think that the reluctance, the overwhelming reluctance, surgeons have against using intracameral cefuroxime all relate to the unavailability of a product that is approved in a single unit dose for cataract surgery Peter Barry FRCS

The future of endophthalmitis prophylaxis Last year’s annual congress

of the ESCRS in Milan saw the launch of Aprokam, which has been approved in several EU countries for the prophylaxis of postoperative endophthalmitis after cataract surgery. After reconstitution of Aprokam, no further dilution is required and each vial is only indicated for single-patient use; this has the potential to reduce the risk of dilution errors and contamination.

“I have argued over the years defending the ESCRS Endophthalmitis Study's results in the four corners of the globe, most particularly in North America, and I think that the reluctance, the overwhelming reluctance, surgeons have against using intracameral cefuroxime all relate to the unavailability of a product that is approved in a single unit dose for cataract surgery," said Dr Barry.

Another initiative on the way is the establishment by the ESCRS of an Endophthalmitis Registry based in the Dublin ESCRS office and open to all.

This could, similar to TRUST (Tracking Resistance in the US Today) help identify bacterial resistance and breakthrough organisms causing endophthalmitis after cataract surgery.

“Because the numbers are going down so much we want some way to flag the ones that occur in order to determine patterns in terms of emerging bacteria resistance,” Dr Barry said.

He added that the registry’s remit will extend not only to endophthalmitis after cataract surgery but also after intravitreal injections, working in conjunction with EURETINA who have expressed great interest in participating. Current estimates are that endophthalmitis occurs in about one out of every 1,000 injections and in as many as one out of 100 patients.

Reference 1 Murphy et al, Br J Ophthalmol, 2007 October; 91(10): 13501353. Published online 2007 March 27.

Amsterdam

2013

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XXXI congress of the escrs ONLINE from 15 march:

Registration and hotel bookings

WWW.ESCRS.ORG

endophthalmitis

contact

Special Focus

Neal Shorstein – neal.shorstein@gmail.com

study shows dramatic results

US centre sees 22-fold drop in post-cataract endophthalmitis after adopting IC injections

by Howard Larkin

W

hile some American surgeons remain skeptical of the landmark ESCRS study demonstrating that intracameral (IC) cefuroxime reduces post-cataract surgery endophthalmitis risk, one large California surgery centre is convinced.

Over a five-year period during which 14 surgeons increased their use of IC antibiotics from 11 per cent to 100 per cent of cataract cases, their endophthalmitis rate dropped 22-fold, according to a recent study (J Cataract Refract Surg 2013; 39:8–14).

The ecological time-trend study strongly suggests that IC antibiotics reduce endophthalmitis risk, and may be particularly effective in cases involving posterior capsule rupture. Previously, no US centre has demonstrated such an association.

The study also suggests that IC antibiotics may be more effective than topical fourth-generation fluoroquinolones, and there may be little or no additional benefit from adding drops to IC antibiotics, though additional research is needed.

If confirmed, the financial impact could be substantial.

Substituting IC cefuroxime, or even moxifloxacin, for topical gatifloxacin saves about €55 per case, which could amount to more than €100m in savings annually for the US Medicare public insurance program, the study estimated.

Lead investigator Neal H Shorstein MD acknowledged that the study cannot conclusively rule out that factors beyond the centre’s changes in antibiotic prophylaxis practices may have helped reduce endophthalmitis rates. However, he pointed out that the drop in endophthalmitis associated with using IC antibiotics was an order of magnitude greater than that associated with switching from topical tobramycin to topical gatifloxacin, and was statistically significant whereas the drop associated with increasing use of the topical fluoroquinolone was not.

From a clinical perspective, Dr Shorstein has no doubt that IC antibiotics are the way to go. “In the end the results were quite stark. In 2010 and 2011 we had one case of endophthalmitis out of more than 7,000 cataract surgeries.

Not only did intracameral antibiotics work better, they seemed to work a whole lot better.”

The study involved 16,264 consecutive phacoemulsification procedures at Kaiser Permanente Diablo Service Area from 2007 through 2011. Patient data were collected through Kaiser Permanente’s electronic medical records system, with followup obtained for all but one of the cataract patients operated, Dr Shorstein said. In total, 19 cases of endophthalmitis were observed. Rates per 1,000 cases were calculated for three time periods during which surgeons operated under three different prophylactic antibiotic protocols.

Dr Shorstein initiated the study in 2007 after observing that his department’s endophthalmitis rate rose to nine cases in 2,878 patients, or 3.13 cases per 1,000, from about one per 1,000 in the early 2000s. At that time, surgeons chose their own antibiotic regimen. In 2007, most patients received postoperative antibiotic drops only, though 11 per cent received IC antibiotics.

EUROTIMES | Volume 18 | Issue 3

Courtesy of Neal H Shorstein MD

8

On a recent trip to Tibet, Dr Shorstein demonstrated some phacoemulsification techniques to Dr Yong in the operating theatre at the Shangri-La People’s Hospital

“In the end the results were quite stark. In 2010 and 2011 we had one case of endophthalmitis out of more than 7,000 cataract surgeries” Finding no association by surgeon or change in procedures to explain the increase, Dr Shorstein looked for new methods to reduce infection risk. The ESCRS study caught his attention.

“This was the first large randomised clinical trial that tried to answer what could be done to reduce endophthalmitis. It was an opportunity to put evidence-based medicine to work.”

Working with Kaiser Permanente’s in-house compounding pharmacy, the department changed its protocol beginning in 2008 to inject intracameral cefuroxime for all cataract patients without penicillin/cephalosporin allergies or posterior capsule ruptures. As a result, in 2008 and 2009, about 80 per cent of patients received IC antibiotics plus each surgeon’s usual post-op drops. Of 6,278 cases, nine developed endophthalmitis, dropping the rate by more than half to 1.43 per 1,000. However, the decline was not statistically significant (p=0.09), Dr Shorstein noted.

Further confounding the results was a shift from topical tobramycin to gatifloxacin, which nearly doubled from 42 per cent of cases in 2007 to 75 per cent in 2008, and 80 per cent in 2009.

Seeking more improvement, Dr Shorstein and colleagues added IC antibiotics in PCR cases, which he noted have about a five-to 10-fold higher risk of endophthalmitis than uncomplicated cases. For penicillin-allergic patients, moxifloxacin and vancomycin were added as second- and third-line IC antibiotics. Beginning in 2010, all cataract patients received IC injections, plus surgeons’ preferred post-op drops.

The results were dramatic. In 2010 and 2011, just one of 7,108 cataract patients developed endophthalmitis, resulting in a significant drop in rate to 0.14 per 1,000 (p<0.01).

Dr Shorstein pointed out that this sharp drop occurred while topical gatifloxacin use remained stable, suggesting that IC antibiotics may be the key change that reduced endophthalmitis risk.

Overall, infection rates were much lower in IC injected cases for the entire five years. Of 12,609 cases, just four developed endophthalmitis for a rate of 0.32 per 1,000. By contrast, of the 3,655 cases not receiving IC antibiotics, 15 developed endophthalmitis for a rate of 4.20 per 1,000, or more than 13 times the IC antibiotic rate. In addition, of 2,038 cases that received IC antibiotics but no drops, one case of endophthalmitis developed for a rate of 0.49 per 1,000. This is close to the Swedish registry rate of 0.45, Dr Shorstein noted.

“I am convinced that the benefits of intracameral injections are indisputable and remarkable.”

IC antibiotics are now standard of practice at Dr Shorstein’s centre and are being considered throughout the Kaiser Permanente system, which serves nearly nine million members. He noted, however, that his centre’s on-site compounding pharmacy makes it easy and safe to dilute cefuroxime for IC injection. For surgeons without such access, moxifloxacin may be a better choice since it can be drawn up without dilution, and can be nearly as economical as cefuroxime when used for multiple doses prepared under appropriate sterile conditions, he said.

Dr Shorstein (right) and Dr Yong with the Shangri-La Tibetan monastery in the background

9

Special Focus

endophthalmitis

Arita Meibomian GLAND COMPRESSOR

danish OUTBREAK

Bacillus endophthalmitis caused by use of contaminated viscoelastic material in otherwise uncomplicated cataract surgery

by Roibeard O’hEineachain in Milan

A

Courtesy of Maria Voss Kyhn MD, PhD

recent outbreak of endophthalmitis in Denmark highlights the degree to which cataract surgeons are dependent on sterile conditions in the manufacturing of viscoelastics, according to Maria Voss Kyhn MD, PhD, Copenhagen Denmark.

The endophthalmitis outbreak occurred in patients who had undergone uncomplicated cataract surgery with a new viscoelastic material, Visco Supreme (CLR Medicals), Dr Voss Kyhn told the XXX Congress of the ESCRS. “The only common denominator out of all these patients was the use of Visco Supreme during otherwise uncomplicated routine cataract surgery,” she reported.

The Danish distributor of the product had provided free samples of its new product to several ophthalmic surgeons in Denmark in the autumn of 2011, Dr Voss Kyhn noted.

Surgeons at these centres used the CE-marked viscoelastic in 93 patients undergoing cataract surgery. Of these, 43 developed severe intraocular reactions within 24 hours.

Eight of the cases were referred to Glostrup Hospital in Copenhagen within 72 hours, she noted. All presented with severe intraocular fibrinoid reaction and hypopyon and flare in the anterior and posterior chamber. Their visual acuity ranged from hand movements to 0.8. Two patients also presented with retinal haemorrhages.

Two cases with milder symptoms and visual acuities of 0.6 and 0.8 received only local treatment with nepafenac, dexamethasone and ciloxan. Five of the remaining six patients underwent pars plana vitrectomy. One patient had a degree of intraocular reaction and corneal oedema that made vitrectomy impossible, and therefore only underwent vitreous tap. All six received intravitreal injections of vancomycin and ceftazidime.

One patient with a retinal detachment required additional surgery. Another patient, with positive bacterial growth of Bacillus Cereus, required several additional surgical interventions because of recurrent intraocular inflammation with hypopyon after the tapering of local

K5-5900

Colony forming units of different bacillus species found on culturing of sterile samples of the viscoelastic

treatment. The patient eventually underwent the removal of both the IOL and the lens capsule. The patient also received weekly injections of ceftazidime for four weeks, in order to control intraocular reaction.

Direct microscopy of vitreous biopsies revealed the presence of many leukocytes, and in two specimens showed a few Gram positive rod-shaped bacteria, Dr Voss Kyhn said. Microbiological culture resulted in the growth of Bacillus Cereus in one of the two specimens examined with positive direct microscopy, she added.

Examination of the extracted IOL and lens capsule showed no signs of microorganisms. However, microbiological culturing of samples of the viscoelastic material showed growth of several different Bacillus species in one-third of the samples.

Following the outbreak, Dr Voss Kyhn and colleagues reported their findings regarding the contaminated viscoelastic to the Danish health and medicines authority and the health authorities of other EU countries. They in turn immediately suspended the use of Visco Supreme.

Dr Voss Kyhn noted that surgeons in five other countries have used Visco Supreme without any reports of severe intraocular reactions. An investigation of the production facility in the US did not reveal the source of the contamination.

“Intraocular infection with Bacillus species is a rare cause of postoperative endophthalmitis. However, in posttraumatic endophthalmitis it causes as much as 39 per cent of all cases. The present series of bacillus endophthalmitis was caused by the use of contaminated viscoelastic material in otherwise uncomplicated cataract surgery,” Dr Voss Kyhn concluded.

This new instrument has been designed to gently express meibum from dysfunctional meibomian glands (MGD). The special angles of the forceps allow the surgeon to easily insert and position the tips over the eyelid parallel to the lid margin. The broad, smoothly polished jaws are then used to atraumatically compress the glands – relieving any occlusions with minimal pain to the patient.

Designed by Dr. Reiko Arita of Saitama City, Japan

®

973-989-1600 • 800-225-1195 • www.katena.com Slit-lamp photo of patient at presentation: hyperemia, hypopyon and fibrinoid reaction in the anterior chamber

EUROTIMES | Volume 18 | Issue 3

contact Maria Voss Kyhn – mariavoss@gmail.com

contacts

10

Special Focus

endophthalmitis

an important step

New cefuroxime preparation to provide approved means of endophthalmitis prophylaxis

by Roibeard O’hEineachain in Dublin

A

long- awaited commercial singledose preparation of cefuroxime for intracameral injection after surgery has become available in several European countries and looks set to be launched throughout most of Europe very soon.

The new formulation is called Aprokam® (Laboratories Théa) and is provided in a vial that contains 50mg anhydrous cefuroxime powder which can be reconstituted with saline solution in a single dilution. It therefore reduces of the chances of batch contamination and dilution errors that can occur with so-called kitchen pharmacy.

“The launch of Aprokam unequivocally represents an important step in the battle against endophthalmitis, it also represents the achievement of one of the ESCRS Endophthalmitis Study Group's principal objectives, said Peter Barry FRCS, Dublin Ireland, who chaired the ESCRS Endophthalmitis Study.

“The ESCRS study was designed to prove the efficacy and safety of intracameral cefuroxime in a randomised trial. But then having done that, we wanted to encourage industry to come up with an approved commercial product to overcome everyone's anxiety about the risks of using an unapproved product,” he told EuroTimes.

In the ESCRS study, patients who received intracameral cefuroxime at the conclusion of cataract surgery had a fivefold reduction in the rate of postoperative endophthalmitis compared to those who did

“

The launch of Aprokam unequivocally represents an important step in the battle against endophthalmitis, it also represents the achievement of one of the ESCRS Endophthalmitis Study Group’s principal objectives Peter Barry FRCS

EUROTIMES | Volume 18 | Issue 3

“

The big problems with cefuroxime have been that you need to carry out two dilutions from one bottle, and from that, prepare five syringes and that would last one week Beatrice Cochener MD

not receive the antibiotic (0.05 per cent vs 0.35 per cent) (Barry et al, J Cataract Refract Surg. 2006 Mar;32(3):396-406).

Many centres of the world have since that time adopted the use of intracameral cefuroxime in their cataract surgeries and have reported similar reductions in their rates of endophthalmitis.

However, there are many surgeons who are unwilling to use an off-label product and there are many who have criticised the kitchen pharmacy method of preparation, which could itself lead to dilution errors and outbreaks of endophthalmitis from contamination.

Easier preparation At present in most countries cefuroxime is prepared for intracameral use in hospital pharmacies or in the operating theatre and requires two dilutions, instead of just one dilution as in the case of Aprokam. Moreover, since cefuroxime is often prepared in batches for later use, one case of contamination or one dilution error can affect multiple patients.

“The big problems with cefuroxime have been that you need to carry out two dilutions from one bottle, and from that, prepare five syringes and that would last one week. All of this requires a lot of organisation and quality monitoring of the storage organisation,” said Beatrice Cochener MD, CHU Brest, Brest, France.

There have been reports in the literature of dilution errors and batch contamination.

In one hospital an incorrect dilution resulted in a series of patients receiving intracameral cefuroxime at 10 times its recommended concentration. At another

hospital, a contaminated batch of diluted cefuroxime resulted in eight patients developing fungal endophthalmitis.

Preparing Aprokam involves the injection 5.0ml of 0.9 per cent sodium chloride solution into the vial containing cefuroxime with a sterile needle, then shaking the vial until the solution is free of particles. The next step is to aspire at least 0.1ml of the solution into a 1.0ml syringe then replacing the needle with an anterior chamber cannula and expelling all the air from the syringe. Sterile technique is necessary throughout the reconstruction procedure and the vial and all the remaining solution in the vial must be discarded.

“Aprokam gives us the security of being obtained in an approved formulation directly from the manufacturer, it also saves time because it only requires one reconstruction.

There is also the added safety of having one vial for one patient,” Dr Cochener noted.

Good track record The inspiration behind the ESCRS Endophthalmitis Study was the findings obtained from the Swedish cataract surgery registry. The registry records nearly all cases of cataract surgery performed in Sweden and an analysis by Per Montan MD showed that the incidence of endophthalmitis fell dramatically following the adoption of intracameral cefuroxime by most surgeons in 1998. The incidence of endophthalmitis remains very low in Sweden with the latest registry showing an incidence of just below 0.02 per cent.

“When a few clinics first started using it word quickly spread that it appeared to be effective in reducing endophthalmitis rates, so essentially all clinics in Sweden have been using this regimen for many years now,” said Anders Behndig MD, Umeå University, Umeå, Sweden.

He noted that the numbers of endophthalmitis cases caused by strains resistant to intracameral cefuroxime have not increased in Sweden over the years.

Moreover, the resistant species were those that had already been resistant to cefuroxime. There is no indication that species sensitive to the antibiotic are developing a resistance to it.

In addition, endophthalmitis rates have continued to decline in a slow but sure fashion. That has probably been due to improvements in surgery, such as smaller

Peter Barry – peterbarryfrcs@theeyeclinic.ie Beatrice Cochener – beatrice.cochenerlamard@chu-brest.fr Anders Behndig – anders.behndig@ophthal.umu.se Jorge Alio – jlalio@vissum.com

“

When a few clinics first started using it word quickly spread that it appeared to be effective in reducing endophthalmitis rates, so essentially all clinics in Sweden have been using this regimen for many years now Anders Behndig MD

“

The great reductions in endophthalmitis in many centres around the world after the introduction of intracameral cefuroxime is something that should be acknowledged Jorge Alio MD, PhD

incisions, shorter operating times and the fact that patients now undergo cataract surgery in Sweden at a younger age than they used to.

He noted that once it has been approved cataract surgeons in Sweden will adopt the use of Aprokam for its safety advantage and approved status. Eye surgeons in Sweden currently use cefuroxime in surgeries involving the anterior segment, including glaucoma surgery, penetrating and posterior lamellar transplants and vitrectomy, when combined with cataract surgery.

Jorge Alio MD PhD, Vissum, Alicante, Spain, a member of the ESCRS Endophthalmitis Study Group, noted that the incidence of endophthalmitis among patients in the study at his centre who received intracameral cefuroxime had the same low incidence of endophthalmitis.

Another centre in Spain has reported similar reductions in the rate of the complication when patients received the intracameral antibiotic.

“The great reductions in endophthalmitis in many centres around the world after the introduction of intracameral cefuroxime is something that should be acknowledged.

But up to now all the cefuroxime preparations have been off-label, so Théa deserves congratulation for providing a better way of using prophylactic antibiotics,” he told EuroTimes.

contacts

Susanne Gardner – susanne.gardner@gmail.com Luis Cordoves – luis.cordoves@hotmail.es Ejaz Ansari – ansari712@googlemail.com

Special Focus

endophthalmitis

INTRACAMERAL CEFUROXIME

Despite increases in dose administered, the subconjunctival injection does not achieve aqueous humour antibiotic levels comparable to the intracameral injection

by Susanne Gardner D Pharm

Cefuroxime Topical drops Subconjunctival injection Intracameral injection

Moxifloxacin

Dose

AH level

Dose

a

25mg (@50mg/ml)

0.18-2.16

0.5% (@5mg/ml)d

2.28

50 mg/ml

25mga

2.31-5.65b

1 mge

3.03e

20 mgg

125 mga

20.23c

1 mgh

3300h

b

AH level d

Dose

2.04

f

24.8g

Susanne Gardner D Pharm

Mean AH antibiotic levels (μg/ml) after various routes of administration

"H

Comparing ocular cefuroxime levels after various routes of administration In 1996, Jenkins

and associates3 measured anterior chamber cefuroxime concentrations after administration routes that included subconjunctival injection and frequent topical drops. Mean aqueous humour (AH) cefuroxime levels 120-160 minutes after a EUROTIMES | Volume 18 | Issue 3

High antibiotic levels are achieved instantaneously after intracameral injection, without delays due to drug diffusion

AH level f

(a) Adapted from reference 3. (b) Ref. 3: AH sampling times (12-24 minutes) - (120-160 minutes) after dose. (c) Ref. 3: AH sample at 12-24 minutes after dose. (d) Ref. 5: following Q2h topical drop dosing. (e) Ref. 4: Mean peak level measured at one hour post-dose. (f) Ref. 7: Two drops (one each about 20’ and 30’ before surgery). (g) Ref. 6: Measured at five hours post-dose. (h) Approximate AH concentration, extrapolated from intracameral 1mg dose, using anterior chamber volume of 0.3 ml

ow does subconjunctival injection compare with intracameral injection or topical drops in terms of pharmacokinetics?"

This question is timely in the wake of recent developments surrounding intracameral cefuroxime discussed throughout this issue. The available data allow direct comparison of drug levels achieved after subconjunctival vs. intracameral injection.

The subconjunctival injection places the drug near the anterior surface of the eye, forming a depot beneath the conjunctival barrier adjacent to the sclera. Drug diffuses into adjacent ocular structures, but the injection port itself is thought to facilitate leakage back into the conjunctival sac1,2 bathing the external cornea with injected solution. Penetration through corneal layers to the aqueous humour is dependent on drug lipophilicity, hydrophilicity, and molecular size, among other factors. In contrast to topical drops that introduce interpatient variability in retained dose, subconjunctival and intracameral injections deliver a known finite dose.

“

Vancomycin

“...we strive to deliver the highest, safe, single antibiotic dose whenever possible, so that meaningful intraocular antibiotic levels are sustained for as long a period of time as possible” 25mg subconjunctival dose reached 5.65 μg/ml, but only 2.16 μg/ml after a similar topical drop dose (see table). Increasing the subconjunctival dose to 125mg raised AH levels to 20.23 μg/ml at 12-24 minutes, with levels still rising at the last sampling time. In study eyes with a 10mm corneal wound, topical 12.5mg cefuroxime produced AH peaks of 9.34 μg/ml at 12-24 minutes, whereas the same dose to a normal cornea produced lower levels of 0.05 μg/ml.

The authors concluded that, in an intact eye, only the subconjunctival route of administration produced AH levels > 1 μg/ ml at 12-24 minutes post-dose, with levels rising slowly over time after either drops or subconjunctival injection. Nevertheless, the table shows that AH cefuroxime levels after an intracameral injection exceed levels after subconjunctival injection, or after drops, even in the presence of a corneal wound.

A more recent study examined AH moxifloxacin levels after a 1.0mg

subconjunctival injection given at various times prior to cataract surgery.4 AH levels reached 3.03 μg/ml one hour after injection (see table), dropping to 1.91 μg/ ml at three hours; 0.53 μg/ml at five hours; and 0.3 μg/ml at six hours post-dose. In comparison, topical drops given Q2h before surgery produced AH levels of 2.28 μg/ml.5 Subconjunctival vancomycin resulted in substantially higher AH concentrations than did topical drops, despite the use of a higher drop concentration (see table).6,7 By direct injection into the anterior chamber, the intracameral injection bypasses corneal and external ocular barriers, and reduces interpatient variability in the delivered dose. High antibiotic levels are achieved instantaneously after intracameral injection, without delays due to drug diffusion. The cefuroxime 1.0mg intracameral injection delivers AH levels at least 100 times greater than the highest subconjunctival dose (see table).

Nevertheless, Ejaz Ansari FRCOphth, MD points out that some centres continue use of postoperative subconjunctival antibiotics because endophthalmitis rates are perceived as relatively low and subconjunctival corticosteroids are also given. Luis Cordoves MD, of the Hospital Universitario de Canarias, Spain, however, finds that subconjunctival injection is often painful with current modes of topical anaesthesia, and emphasises that one study reported a three-fold reduction in postoperative endophthalmitis rates after 50mg subconjunctival cefuroxime was discontinued, and replaced with 1.0mg

intracameral cefuroxime at the end of cataract surgery.8 It is important to recall that any discussion of measured ocular antibiotic levels implies correlation with bacterial MICs and anticipated bactericidal effects over time. These “drug-bug” interactions vary considerably with bacterial strain and antibiotic. However, because the eye does not lend itself to multiple intraocular entries, and corneal layers are an intended barrier to the environment, we strive to deliver the highest, safe, single antibiotic dose whenever possible, so that meaningful intraocular antibiotic levels are sustained for as long a period of time as possible. To date, the intracameral injection remains the method of drug delivery that best accomplishes this goal.

References 1. Wine NA, Gornall AG, Basu PK. The ocular uptake of subconjunctivally injected C14 hydrocortisone. I. Time and major route of penetration in a normal eye. Am J Ophthalmol 1964;58:362-366.

2. Gardner SK. Ocular Drug Penetration and Pharmacokinetic Principles. In: Lamberts DW, Potter DE, eds. Clinical Ophthalmic Pharmacology. Boston: Little Brown & Co; 1987:1-52.

3. Jenkins CDG, Tuft SJ, Sheraidah G, et al. Comparative intraocular penetration of topical and injected cefuroxime.

Br J Ophthalmol 1996;80:685-688.

4. Matsuura K. Pharmacokinetics of subconjunctival injection of moxifloxacin in humans. Graefes Arch Clin Exp Ophthalmol 2012.

5. Hariprasad SM, Blinder KJ, Shah GK et al. Penetration pharmacokinetics of topically administered 0.5% moxifloxacin ophthalmic solution in human aqueous and vitreous. Arch Ophthalmol 2005; 123:39-44.

6. Souli M, Kopsinis G, Kavouklis E, et al. Vancomycin levels in human aqueous humour after intravenous and subconjunctival administration. Int J Antimicrob Agents 2001;18:239-43.

7. Alster Y, Herlin L, Lazar M, Loewenstein A. Intraocular penetration of vancomycin eye drops after application to the medial canthus with closed lids. Br J Ophthalmol 2000;84:300-302.

8. Yu-Wai-Man P, Morgan SJ, Hildreth AJ, et al. Efficacy of intracameral and subconjunctival cefuroxime in preventing endophthalmitis after cataract surgery. J Cataract Refract Surg 2008;34:447-451.

11

Update

Cataract & refractive

contacts

12

Stephen S Lane – sslane@associatedeyecare.com Paul-Rolf Preussner – pr.preussner@uni-mainz.de

ELIMINATING REFRACTIVE SURPRISES

Modern preoperative and intraoperative aberrometry makes cataract surgery outcomes more predictable

by Roibeard O’hEineachain in Milan

N

ew technologies that enable intraoperative aberrometry in eyes undergoing cataract surgery may provide better visual outcomes than surgery performed with conventional preoperative aberrometry alone, but new preoperative optical measurement techniques may produce equally accurate results, according to participants in a debate held at the JCRS session of the XXX Congress of the ESCRS. Stephen Lane MD opened the discussion by stating that intraoperative aberrometry can bring the refractive results of cataract surgery closer to those commonly achieved with LASIK. “Greater than 95 per cent of LASIK surgery outcomes are within half a dioptre of their nomogram-predicted refractive target and 90 per cent of eyes achieve an uncorrected distance visual acuity of 20/20 or better and the enhancement rate of less than three per cent. If we could do that in our present day cataract surgery we would certainly be doing our patients a tremendous service,” said Dr Lane, University of Minnesota, St Paul, US. He noted that data from the Swedish national cataract registry showed that among 17,000 eyes undergoing cataract surgery procedures aiming for emmetropia, only 55 per cent had a spherical equivalent within half a dioptre of emmetropia and had less than one dioptre of astigmatism (Behndig et al, J Cat Refract Surg 2012 ; 38: 1181-1186).

In contrast, of 1,314 patients who underwent cataract surgery with intraoperative aberrometry, 80 per cent achieved a postoperative refraction within half a dioptre of target values.

The intraoperative aberrometry technology used in the patients was the Optiwave™ refractive analysis system or ORA system™ by WaveTec. “This was not quite the 94 per cent that we were aiming for with LASIK, but it’s certainly a lot better than what we see with standard preoperative biometry,” Dr Lane said.

The ORA system attaches to the base of most surgical microscopes and enables

Don’t miss Industry News, see page 42 EUROTIMES | Volume 18 | Issue 3

“

The refractive surprises that we sometimes see in these very difficult to manage patients disappear with the use of this technology Stephen Lane MD

a real-time evaluation of true refractive power of the eye in each case. In addition, every ORA system is connected live to the Wavetec servers in order to continually update the IOL calculation algorithms based on the results achieved, Dr Lane said.

He pointed out that, in 72 per cent of cases, surgeons changed the power in conventional IOLs and the power and/ or cylinder axis rotation in toric IOLs based on the findings of intraoperative aberrometry. Preoperative biometry alone would have resulted in at most around 70 per cent of eyes being within half a dioptre of target refraction.

Furthermore, the intraoperative refractive information and potential for surgical course correction the ORA system provides makes it particularly useful with toric IOLs, he said. The intraoperative prediction error was less than one half of a dioptre in 82 per cent of patients. The system is also very effective in patients that have undergone previous myopic LASIK, among whom 72 per cent were within half a dioptre of intended refraction.

“The refractive surprises that we sometimes see in these very difficult to manage patients disappear with the use of this technology.

Preoperative aberrometry improving in accuracy

Intraoperative aberrometry shares some inherent limitations with preoperative aberrometry and it cannot be used in all patients, countered Paul-Rolf Preussner

MD, PhD, University Clinic Mainz, Germany.

The optical characteristics of the eye can change after surgery. The shrinkage of the capsular bag can change the defocus and centration of the IOL, and can cause toric IOLs to rotate, he said.

In addition, intraoperative hydration of corneal incisions can result in corneal thickness variations, which in turn cause an asymmetry of the cornea.

In addition, since the patient needs to fixate in order to align the measurement with the visual axis, intraoperative aberrometry is only possible when using topical anaesthesia. It cannot be used in eyes requiring peribulbar or general anaesthesia.

Furthermore, true state-of-the-art technology in preoperative aberrometry can produce refractive results with a refractive predictability very close to that of spectacle prescription.

To illustrate his point, he presented the results he and his associates achieved in 115 eyes that underwent cataract surgery with IOL calculations performed using OKULIX ray tracing software (Tedics) and the Lenstar® optical biometer (Haag-Streit).

The patients in the study were part of a larger trial and were selected for the analysis because they had achieved best corrected visual acuity of 20/20 or better and were implanted with aspheric IOLs (Hoffmann et al, J Refract Surg 2012; 28:650-655).

In all eyes, Dr Preussner and his associates measured axial length, corneal radii and the position and thickness of the crystalline lens with the Lenstar system and entered the data into the OKULIX ray tracing program.

At a follow-up of at least one month the standard deviation of the prediction error was 0.29 D, the mean absolute error was 0.21 D and the median absolute error was 0.17 D. One hundred per cent were within 1.0 D and 91 per cent were within 0.5 D. The said prediction errors are approximately a factor of two smaller than the corresponding errors obtained after re-digitising the data of Chen M,

“

The problem of biometry in postmyopic LASIK eyes is a solved problem when we use a physical rather than a statistical approach. That means we have to measure the whole cornea, both the anterior and posterior corneal surface

Paul-Rolf Preussner MD, PhD Clin Ophthalmol 2011; 5:197-198 who compared measurements of intraoperative aberrometry with post-surgery refraction.

The same ray tracing approach also produced highly accurate results in 80 eyes with toric IOLs, where the mean and median cylinder vector prediction errors were 0.51 D and 0.41D, Dr Preussner said (data presented by P Hoffmann on the meeting in Milan).

Furthermore, the ray tracing and optical biometry approach to preoperative aberrometry largely solves the problem of biometry in patients who have previously undergone myopic LASIK, he said. As an illustration, he presented his findings in 12 eyes with a history of myopic LASIK all of which had a prediction error of less than 0.5 D. “The problem of biometry in postmyopic LASIK eyes is a solved problem when we use a physical rather than a statistical approach. That means we have to measure the whole cornea, both the anterior and posterior corneal surface.

When we submit that data to the ray tracing software we end up with the same accuracy as in virgin eyes,” he added.

Update

13

Cataract & refractive

LENS OR LASER

Young ophthalmologists hear debate on which procedures are best in specific circumstances

by Leigh Spielberg in Milan

A

young adult asks you about procedures available for correcting his high myopia, how do you decide which way to go - lens or cornea? This question was explored by two senior ophthalmic surgeons during a debate held at the Young Ophthalmologists’ Programme at the XXX Meeting of the ESCRS. “We must remember that these are not patients in the traditional sense, but young people undergoing elective surgery.

Complications due to refractive surgery can be a disaster,” Vikentia Katsanevaki MD reminded her audience.

Dr Katsanevaki, who is head of the Refractive Department, Orasis Eye Centre, Athens, was arguing for the corneal approach to refractive surgery.

The protagonist for the intraocular approach was Tobias Neuhann MD of the Marienplatz Eye Clinic, Munich, Germany.

Dr Neuhann pointed out that laser treatment of the cornea has its own potential problems.

“Generally speaking, laser refractive surgery induces trauma, which is subject to

“

We must remember that these are not patients in the traditional sense, but young people undergoing elective surgery Vikentia Katsanevaki MD

healing. Further, laser treatment can lead to high-order aberrations, which generally do not occur with implantable collamer lenses such as the Visian ICL (Staar).”

These lenses, sometimes referred to as implantable contact lenses (ICL), are implanted in the posterior chamber, between the iris and lens. They are an alternative to corneal laser refractive surgery, iris-fixated anterior chamber lenses and clear lens exchange with implantation of an IOL in the capsular bag.

THE SWISS TR OCAR SYSTEM AL FE VITREO-RETIN SA D AN E IS EC PR FOR

No refractive regression “With an ICL, the cornea remains undisturbed, dryeye complications do not occur and visual recovery is rapid. I love the optical quality of the ICL. And it is very predictable, and IOL calculation later in the patient’s life remains unchanged. There is no refractive regression, like we sometimes see after laser surgery,” said Dr Neuhann.

Dr Katsanevaki countered that there could be a chance for induced cataract with an ICL since the lens vaults over the crystalline lens.

“That’s true, that is indeed a potential risk, but remember, early cataracts after excimer laser treatment have also been reported,” replied Dr Neuhann.

He added that corneal stability is excellent with the ICL, with negligible chance of corneal ectasia. Fifteen-year follow-ups have reported stable endothelial cell counts, just like with LASIK. And the shape and biomechanics of the cornea remain untouched.

Laser less expensive Dr Katsanevaki responded that laser treatment is less expensive, since there’s no specialised lens to buy. LASIK could be more acceptable to the patient, since it has been around for so long.

“I find that it’s important not to try to convince the patient to change his mind, unless the patient is ineligible for the modality requested. Also, it’s important to know something about the patient in daily life. What is the profession, and what are the hobbies and activities of the patient? What are the expectations after treatment?”

SURGERY

with MVR blade 23G and 25G models 1-step techniques and self-sealing cap for

EUROTIMES | Volume 18 | Issue 3

Courtesy of Tobias Neuhann MD

contacts

Vikentia Katsanevaki – vikentia_katsanevaki@yahoo.gr Tobias Neuhann – dr.neuhann@email.de

New Toric ICL version V4c one-week post-op

“

With an ICL, the cornea remains undisturbed, dry-eye complications do not occur and visual recovery is rapid Tobias Neuhann MD

Dr Neuhann conceded that laser refractive surgery is still the dominant refractive surgery modality. But he noted that no single technique will be able to solve every refractive problem. For example, in a patient with thin corneas, laser surgery is not an option. In the end, anatomical qualification, potential side-effects and predicted long-term results are the dominant criteria for decisionmaking. But combining both techniques is possible and sometimes helpful, like in cases in which bioptics is employed.

14

Update

The moment innovation and passion lead to the best vision for your patient.

This is the moment we work for.

Cataract & refractive

reverting back

Everything old in refractive surgery may be new again, Grabner tells AAO in Barraquer Lecture

by Howard Larkin in Chicago

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There’s a lot of unfinished business in the field of refractive surgery

www.meditec.zeiss.com Günther Grabner MD EUROTIMES | Volume 18 | Issue 3

Courtesy of Günther Grabner MD

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s refractive surgery enters its fourth decade, visual outcomes will continue to improve thanks to both new technologies and refinements of older approaches, predicted Günther Grabner MD, Salzburg, Austria.

Even presbyopia, the “last frontier” of refractive surgery, is being crossed as new corneal and lens options emerge and assessment tools improve.

“There’s a lot of unfinished business in the field of refractive surgery,” said Dr Grabner, who gave the Barraquer Lecture at the joint meeting of the American Academy of Ophthalmology and the Asia-Pacific Academy of Ophthalmology. He noted that for every technique that has succeeded, such as LASIK, others have faded away, such as radial keratotomy, or never really caught on, such as conductive keratoplasty.

However, technological advances may bring back some less popular techniques, he noted.

For example, the precision of femtosecond laser technology may make astigmatic keratotomy more predictable and less technically challenging, Dr Grabner said. Intrastromal astigmatic keratotomy also shows promise, and would leave the epithelium intact. As a result, he expects astigmatic incisional procedures of all types to gain popularity.

While phakic intraocular lenses have had their share of complications, with many pulled from the market due to endothelial damage, some newer angle-supported and iris-supported designs reduce the risks, Dr Grabner noted. Iris-claw toric lenses offer significant refractive advantages with low risk, he noted.

Similarly, new hydrogel and biosynthetic materials and lens designs may make corneal onlays viable for refractive surgery,

Dr Grabner said. Tests have shown these materials produce better visual outcomes and fewer complications than epikeratophakia using earlier hydrogels or donor grafts.

A range of new approaches is emerging for presbyopia correction, including hydrogel corneal implants and the pin-hole implants. Unlike laser corneal procedures, these implants are reversible, and they do not carry the risk of intraocular procedures, Dr Grabner noted. He considers the KAMRA pin-hole device to be a top choice for presbyopia in patients who do not need cataract surgery.

Development of technologies that assess the outcomes of presbyopia treatment in more meaningful, functional ways also helps improve outcomes. Devices such as the Salzburg Reading Desk, developed by Dr Grabner and colleagues, more accurately measure reading speed and acuity than Jaeger charts and stopwatches. These assessment tools should be used in clinical practice to quantify outcomes and help determine how the various presbyopia correction options compare.

Dr Grabner was chosen for the Barraquer Award, which honours a physician who has made significant contributions in the field of refractive surgery, in part for his work on the Salzburg Reading Desk. The lecture and award are named for refractive surgery pioneer Jose I Barraquer MD. Dr Grabner founded the first eye bank in Austria in 1977, and founded cornea and uveitis clinics, and a centre for refractive corneal surgery at the Second University Eye Clinic in Vienna. Since 1993 he has been director and full professor at the Paracelsus Medical University in Salzburg.

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Gunther Grabner – G.Grabner@salk.at

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Frank A Bucci Jr – buccivision@aol.com

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Cataract & refractive

better vision

Femtosecond laser can detect and compensate for lens tilt when performing capsulorhexes

by Roibeard O’hEineachain in Milan

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cataract surgeries over the last four years at the Eye Institute of the Sacred Heart, a charity eye centre in Lima, Peru. Hundreds of cases were performed with the LensAR laser in Lima during 2012.

One of the most frequently cited advantages of femtosecond laser cataract surgery is the precision it affords in the creation of the capsulorhexis, he noted. The rate at which he and his associates achieve free-floating capsulorhexis with the LensAR system has been greater than 98 per cent.

Their results are similar to those achieved in the Asian Eye Institute in Makati city, Philippines, where the surgeons achieved

piece no-touch fluid-filled device that does not distort the cornea. Its non-OCT 3-D biometry imaging system includes a highresolution Scheimpflug infrared camera on a rotating platform.

Visualising surgery Other features of the LensAR system include a scanning illumination beam that is confocal with the treatment laser, a down-the-pipe camera, which allows the surgeon to visualise the surgery as if through a surgical microscope, and calibration software which links all of the elements together into a single threedimensional system.

The imaging system can detect and compensate for lens tilt when performing capsulorhexes. The laser also has several nucleus fragmentation patterns, including cubes, spheres and pies.

However, removing the cortex takes practise, because the remnants do not present the usual leaflets that are easily accessed, but instead is thin with sticky properties and is often concealed behind the iris and capsular edge.

Photo: Cees van Roeden/Wonderful Copenhagen

xperience to date suggests that the LensAR femtosecond laser system can provide greater precision in surgery than conventional phaco, which can translate into better visual outcomes for patients, Frank A Bucci Jr MD, Wilkes-Barre Pennsylvania, US told the XXX Congress of the ESCRS. “I think that the LensAR system, with its ergonomic design and imaging system, has made a significant contribution to femtosecond laser cataract surgery technology,” Dr Bucci said.

Dr Bucci noted that he and his associates have performed more than 6,000 free

free-floating caps with the LensAR system in over 90 per cent of cases. The manifest refraction spherical equivalent at six months' follow-up was -0.21 D in 249 eyes that underwent capsulotomies with the femtosecond laser compared to +0.55 D in 123 eyes that underwent manual capsulotomies (P< 0.001).

The Philippines team also reported that procedures using femtosecond lasers involved less cumulative dissipated energy than those performed with conventional phacoemulsification, and that held true for all grades of cataract, Dr Bucci said.

The same group also reported lower corneal endothelial cell loss after the femtosecond laser procedure than after conventional phaco, although it did not reach statistical significance (p > 0.09).

Dr Bucci noted that the LensAR system is relatively small and compact and has a very ergonomic design. Its retractable laser head can rotate 90 degrees, allowing the surgeon the choice of performing the procedure from the temporal or superior position.

The LensAR docking system is a three-

Photo: Nowstockphoto

Welcome to the SOE 2013 Congress in Copenhagen

EUROTIMES | Volume 18 | Issue 3

Please register before 29 April 2013 to take advantage of the Mid registration fee Please stay updated on the SOE 2013 Congress Website

www.soe2013.org

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Cataract & refractive

NEW OPTIONS

Innovations in optical design are offering patients greater choice in multifocal IOLs

by Roibeard O’hEineachain in Milan

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nnovations in optical design are increasing the number of patients in whom multifocal IOLs could achieve their desired effect, according to a series of presentations at the XXX Congress of the ESCRS. “New options out there give us a broader range of patients to whom we can offer these lenses. And patients now have the choice of close-reading vision or intermediate vision, and we also now have the ability to correct astigmatism with multifocal toric lenses as well,” said Andrea Y Ang MD, MBBS, MPH, cornea fellow, Cincinnati Eye Institute, Cincinnati, Ohio, US. She noted, for example, that AcrySof® ReSTOR (Alcon) is now available in four different designs covering a broad range of visual requirements. Patients now have a choice of a toric or non-toric version with near adds of 2.5 D or +3.0 D. Patients who

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All patients also said that, given the choice, they would again opt for the AT LISA toric multifocal IOL and that the surgery did provide them with result in achieving spectacle freedom Roberto Zaldivar MD

require good intermediate vision are likely to benefit from the newer, 2.5 D version.

The ReSTOR lens has an apodised diffractive structure consisting essentially of nine or seven concentric diffractive rings

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of different widths. The width between the steps determines the power of each ringsector and the step height that controls the lens’ light distribution, Dr Ang said.

The new 2.5 D near add version of the ReSTOR lens differs from the +3 D in having only seven diffractive rings instead of nine. In addition, 100 per cent of the central zone of the new lens focuses light from distance object, compared to only 40 per cent in the older lens. The optic’s outer, distance-focusing area has been increased by six per cent and the apodised diffractive area has been decreased by 18 per cent.

“The early users of the ReSTOR +2.5 D add multifocals believe that it performs better for their patients in activities involving distance vision. The +3 D lens is better for reading a book or for reading small print and other near activities like that, and the 2.5 D lens is better for watching television or using the computer,” Dr Ang added.

The toric versions of the ReSTOR have the same basic design as the non-toric lenses but have a posterior toric surface with posterior toric axis marks like those of non-multifocal AcrySof toric IOLs. They are available in cylinder powers of 0.68 D to 2.05 D at the corneal plane, 1.0 D to 3.0 D at the IOL plane.

Small incision toric multifocal

Another toric multifocal, the AT LISA® (Carl Zeiss Meditec), is especially designed for small incision cataract surgery and has produced good results for near and distance vision, said Roberto Zaldivar MD, Buenos Aires, Argentina.

The IOL has a diffractive aspheric back surface and an aspheric toric front surface.

The lens provides a theoretical addition of +3.75 D at the IOL plane. It is available in cylinder powers of 1.0 to 12.0 D in 0.50 D increments.

In a study involving 22 eyes with 1.0 D to 4.0 D of astigmatism, the distance visual acuity was 20/20 or better in 70 per cent of eyes and 20/25 in remaining 30 per cent of eyes at six months' follow-up.

In addition, the near visual acuity at a distance of 40cm was 20/20 in 75 per cent of eyes, 20/25 in eight per cent of eyes and 20/50 in the remaining 17 per cent.

Intermediate vision was on average 20/40 or 20/50 at distances of 60cm to 80cm.

Furthermore, of 12 patients who received a questionnaire about their quality of vision, eight said they had no problems with night vision and only four said they had moderate difficulties. On the other hand, eight reported moderate difficulties with glare at night.

“All said they were satisfied with the surgical results. All patients also said that,

contacts

Update

ESCRS

16

Andrea Y Ang – C/O: eholland@fuse.net Jorge L Alió – jlalio@vissum.com Roberto Zaldivar – Zaldivar@zaldivar.com

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The potential advantages of having radial sectors instead of concentric rings include better contrast sensitivity, less haloes and less glare Jorge L Alió MD

given the choice, they would again opt for the AT LISA toric multifocal IOL and that the surgery did provide them with the result in achieving spectacle freedom,” Dr Zaldivar said.

Radial sectors Another of the new IOLs, the Lentis MPlus (Oculentis), Like the AcrySof ReSTOR, has one version suitable for those who want to read small print and another version for those to whom intermediate and distance vision is more important, said Prof Jorge L Alió MD, PhD, VISSUM, Instituto Oftalmológico de Alicante, Alicante, Spain.

The Lentis Mplus is based on the concept of rotational asymmetry. Instead of the concentric sections providing different foci, the lens is divided into two different radial sectors, the largest sector and the central zone focus light from distant objects and the smaller sector focuses light from near or intermediate objects, depending on whether the lens has a +3.0 D add or + 1.5 D add.

“The potential advantages of having radial sectors instead of concentric rings include better contrast sensitivity, less haloes and less glare,” Dr Alio said.

He noted that he and his associates have been implanting the new multifocal lenses in patients for the past three years and the results achieved to date suggest that the lenses provide good spectacle independence, with contrast sensitivity close to that achieved with monofocal IOLs. Around 50 per cent of eyes implanted with the new lenses have achieved an uncorrected distance visual acuity of 20/20 or better and around 60 per cent of those with the +3.0 D add version have achieved an uncorrected visual acuity of J2 or better.

In addition, 83 per cent of eyes with the + 3.0 D lens achieved both a distance visual acuity of 20/32 or better and an uncorrected near visual acuity of J3. Among patients with the +1.5 D lens, 54 per cent achieved an uncorrected distance visual acuity of 20/32 or better, and an uncorrected intermediate visual acuity of J3 or better.

Don’t miss EUREQUO update, see page 39 EUROTIMES | Volume 18 | Issue 3

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Update

Cataract & refractive

IOL CALCULATION There are several possible types of error in IOL calculation that can lead to refractive surprises

by Roibeard O’hEineachain in Milan

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OL calculation in LASIK or PRKtreated patients must be based on the cornea’s current dimensions and must be free of assumptions based on a standard model of the eye, Wolfgang Haigis MS, PhD, University Eye Hospital, Wuerzburg, Germany told the XXX Congress of the ESCRS. In cataract patients who have undergone previous corneal refractive surgery there are several possible types of error in IOL calculation that can lead to refractive surprises. Chief among them are those resulting from the use of inappropriate keratometry calibrations (keratometer index) and those that result from the false assumptions that some IOL power formulas make regarding the internal dimensions of such eyes, noted Dr Haigis.

Keratometry instruments measure the height of a reflected image on a presumed convex spherical surface and derive from it the anterior cornea’s radius of curvature.

However, following LASIK or PRK there are differences in curvature between that of the untreated peripheral cornea and that of the central optical zone. The result is that in eyes that have small optical zones after refractive surgery the standard keratometry instrumentation may give the radius for the untreated cornea, Dr Haigis said.

“If you measure a steeper radius, as would be the case in a patient who had undergone myopic LASIK, it is then equivalent to a stronger corneal power, which then translates into a weaker IOL power, which finally translates into a hyperopic error," Dr Haigis said.

Another type of error is the keratometry index error. That results from the derivation of the total corneal power from the anterior radius alone, based on the assumption that the cornea’s posterior radius will have the same correspondence to the anterior radius as it did before refractive surgery.

A third type of error is the IOL formula error, wherein the flattening of the cornea causes the formula to yield erroneous values for the effective lens positions. In eyes treated for myopia the formula will assume a more anterior lens position than would actually be the case. With some formulas, that in itself can result in hyperopic refractive shifts of around +2.0 D. IOL calculation methods that use the patient’s treatment history are impractical

EUROTIMES | Volume 18 | Issue 3

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If you measure a steeper radius, as would be the case in a patient who had undergone myopic LASIK, it is then equivalent to a stronger corneal power...

The power of one

Wolfgang Haigis MS, PhD because in most cases the data is not available. Methods using only current data include the R-factor method, the Shammas no-history method, the BESSt formula, which uses Pentacam (Oculus) measurements, and the Haigis-L formula, which uses measurements obtained with the IOLMaster (Carl Zeiss Meditec).

Dr Haigis presented the results obtained with the Haigis-L formula in 226 eyes that had undergone LASIK for myopia and 57 eyes that had undergone hyperopic LASIK. The study involved 82 surgeons who implanted 50 different types of IOL. At final refraction the median absolute prediction error was 0.37 D for the myopic eyes and 0.4 D for the hyperopic eyes.

Furthermore, in both the hyperopic and myopic LASIK groups around 82 per cent of eyes were within one dioptre and around 60 per cent were within half-a-dioptre of predicted refraction Dr Haigis said.

He added that the refractive results achieved with the Haigis-L formula in patients with previous surgery are close to the current standard benchmark for normal eyes, which is 85 per cent of eyes within 1.00 D and 55 per cent within 0.50 D of the predicted values.

Dr Haigis added that the IOLMaster comes with the Haigis L formula already implemented in its software from version 4.x onward. The Haigis-L formula is also available at: www.ascrs.org.

The one FeMTo plaTForM for cornea, presbyopia and cataract.

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Dr Haigis is a consultant to Carl Zeiss Meditec.

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The Ziemer FEMTO LDV Z Models are FDA cleared and CE marked and available for immediate delivery. For some countries, availability may be restricted due to local regulatory requirements; please contact Ziemer for details. The creation of a corneal pocket is part of a presbyopia intervention. Availability of related corneal inlays and implants according to policy of the individual manufacturers and regulatory status in the individual countries. Cataract procedures with the FEMTO LDV Z2, Z4 and Z6 models are not cleared in the United States and in all other countries. An upgrade possibility for these devices is planned once cataract options are available and cleared by the responsible regulatory bodies.

Wolfgang Haigis – w.haigis@augenklinik.uni-wuerzburg.de eurotimes_feb2013_FEMTO_LDV_Z_Models_Ad_120x300mm.indd 1

30.01.13 08:53

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Update

Cataract & refractive

Harald Studer – harald.studer@istb.unibe.ch

Cataract surgery planning Patient-specific numerical simulations may help reduce astigmatism

by Howard Larkin in Milan

Courtesy of Harald P Studer PhD

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An example incision opening in the numerical finite element simulation model

The Optimeyes project (Integrated Scientific Services, Port, Switzerland) combines sophisticated simulation technology with clinical information, to provide surgical outcome prediction for refractive surgery

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umerical simulations that take into account individual patients’ specific corneal characteristics could improve refractive outcomes in femtosecond cataract surgery, suggests a preliminary clinical study presented at the XXX Congress of the ESCRS. “We are convinced that patient-specific numerical simulations have the potential to become an essential tool for planning in femtosecond cataract surgery,” said Harald P Studer PhD, University of Bern, Switzerland.

The prospective clinical study was limited to assessing how well a standardised biomechanical cornea model customised with individual topography data could predict refractive and topographic outcomes in manual cataract surgery. However, the simulation methodology, produced on behalf of Integrated Scientific Services AG, Port, Switzerland might eventually take advantage of the precision of femtosecondassisted surgery and advanced topographic, tomographic and even corneal

Don’t miss EU Matters, see page 40 EUROTIMES | Volume 18 | Issue 3

biomechanical measurements to plan and execute a wide range of incisions to reliably correct astigmatism and other aberrations.

Clinical study Dr Studer started with the question of whether it is possible to create patient-specific surgical planning aids with numerical simulations. He designed a clinical study involving 13 cataract patients without previous eye surgery who were able to undergo topography. The goal was to see how well a numerical model based on known biomechanical properties and modified with patient-specific topographic data could predict outcomes based on specific cataract incision characteristics.

All patients underwent standard cataract surgery. During surgery, parameters of the main incision, including distance from the limbus, length, width and angular orientation, were recorded by the surgeon using callipers. Patients also underwent three topography measurements with a Pentacam (Oculus), one before surgery, a second immediately after surgery and a third one month after surgery.

The numerical simulation was based on corneal biomechanical features previously identified by Dr Studer and other researchers. They included incompressibility, which is influenced by water content; isotropic tissue matrix, which includes proteoglycans, glycosaminoglycans and keratocytes; major collagen fibres with a realistic distribution based on x-ray scatter investigations; and collagen cross-links (Studer H. J Biotech 43 (2010) 836-842). The resulting mesh was warped to individual topography measurements to create a patient-specific finite element model.

Data from the incisions was entered in the model and the refractive and topographic results were simulated. The simulations were then compared with the actual surgical outcomes to determine the validity of the prediction model.

Predicting outcomes Surgically induced astigmatism, including both changes in sphere and cylinder, were mostly within 0.25 dioptre. This means the outcome can be predicted almost within the precision of the measurement device, Dr Studer said. Comparing differences in predicted vs. actual post-op topography elevation, the majority were below 5.0 microns, which also is close to the precision of the measuring device, he added.

Dr Studer was encouraged by the results.

“The simulations were not tuned by any means to match the clinical results.

This shows us that the material definition

“

The simulations were not tuned by any means to match the clinical results.

This shows us that the material definition we have is pretty close to reality, and we have the potential to predict other types of surgery...

Harald P Studer PhD

we have is pretty close to reality, and we have the potential to predict other types of surgery, such as femtosecond cataract surgery.”

A clinical trial of femtosecond-assisted cataract surgery is planned, he said.

So far, the model applies to cataract surgery only. But Dr Studer believes models could also be developed for limbal relaxing incisions. With the advent of devices for measuring corneal biomechanical properties in vivo, such as the Corves ST (Oculus), the model could be further individualised, he noted.

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E R IP FR EA SH ES 3 Y BER INE A EM R M RT FO

ESCRS

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Update

Cornea

Beatrice Frueh – beatrice.frueh@insel.ch Denise Wajnsztajn – denisewaj@gmail.com Hemlata Gupta – hemlatagupta@rediffmail.com

CROSSLINKING

Treatment is effective in arresting keratoconus and often improves vision in children

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orneal crosslinking is effective in arresting progressive keratoconus and improving or stabilising vision in children for three years or more, presenters told the XXX Congress of the

Continuous improvement Similar results were observed in a 36-month retrospective study by Denise Wajnsztajn MD, Joseph Frucht-Pery MD and colleagues at Hadassah-Hebrew University Medical Center, Jerusalem, Israel. In 42 eyes of 36 keratoconus patients with a mean age of 16 ranging from 11 to 18, of whom five were female, best corrected visual acuity improved for 62 per cent, remained the same for 30 per cent and declined for eight per cent. Two eyes lost one line of vision while one eye, in a Down’s syndrome patient, lost two lines. Gains were statistically significant at 12, 24 and 36 months.

Other topographic and refractive parameters also suggested crosslinking arrested keratoconus progression.

Kmax improved or was stable in 94.5 per cent of eyes overall, falling from a mean of 55 to 52.6 in 25 eyes at 12 months (p<0.0001), Dr Wajnsztajn reported. Kmax continued to decline in the second year and levelled off in the third, but the difference was not statistically significant, possibly due to a small sample. Topographic cylinder was

Courtesy of Hemlata Gupta MD

ESCRS. Though it is less successful in reducing astigmatism than in adults, the procedure appears to be as safe for children as it is for adults, and may help reduce the need for corneal transplants due to keratoconus.

“Keratoconus in children is more severe at diagnosis and progresses faster than in adults. It is one of the most common causes of corneal transplantation in children, after congenital corneal opacities, accounting for 15 per cent to 20 per cent of all corneal transplants in children,” noted Hemlata Gupta MD, Centre for Sight, New Delhi, India.

Children also have a higher risk of transplant rejection.

Early identification is crucial, and crosslinking in these patients might prevent many transplants, she added.

In a prospective study involving 33 eyes in 25 progressive keratoconus patients under age 18, progression was arrested in every eye, reported Beatrice Frueh MD, of the University of Bern, Switzerland. Mean patient age was 14.8 years, ranging from five to 17. Four were girls, three had previous penetrating keratoplasty in the fellow eye and two had Down’s syndrome. All were treated with the Dresden protocol, receiving epithelial abrasion followed by 30 minute riboflavin application and 30 minutes UVA irradiation.

Topical anaesthesia was used in all but the two Down’s syndrome patients, who received general anaesthesia.

Intraoperative pachymetry was used in all cases.

At the last follow-up, which ranged from 12 months to 36 months after surgery with a mean of 26.2 months, eight eyes had gained two lines or more of best corrected visual acuity, 25 eyes were unchanged and none lost two or more lines, Dr Frueh said. Topographic indices, including average K, surface activity index and surface regularity index, did not change significantly and cylinder and

spherical equivalent remained stable out to three years.

Corneas thinned significantly during the first year and then stabilised, while Kmax flattened from a mean of 55.5 D preoperative to 53.9 D at 12 months and 52.9 D at 24 months, findings consistent with other studies, Dr Frueh added.

However, Kmax increased at 12 months in two eyes, boys aged 11 and 8. These apparent progressions both were due to acute keratoconjunctivitis, and regressed when treated. One other eye also underwent lamellar keratoplasty, though this was a very advanced case with poor vision, she said.

“Be aware of pseudoprogression in case of active vernal keratoconjunctivitis,” Dr Frueh said.

And as with adults, corneal crosslinking should not be performed in children with advanced keratoconus cases, such as those with scarring, she cautioned.

IMAGE 1 - Pre – C3R pentacam K1 - 47.1; K2 – 54.4; Thinnest pachymetry – 419

EUROTIMES | Volume 18 | Issue 3

IMAGE 2 - Post – C3R pentacam (2 years post-op) K1 - 44.8; K2 – 47.2; Thinnest pachymetry - 444

Courtesy of Beatrice Frueh MD

by Howard Larkin in Milan

The topography of a 12-year-old child. Upper left first visit, upper right progression before CXL, lower left one year after CXL and lower right two years after CXL

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In the paediatric age and adolescents, crosslinking is a safe and efficacious procedure to stop or delay keratoconus progression. Further studies are required to confirm our findings Denise Wajnsztajn MD

improved or stable in 91.4 per cent, refractive cylinder in 73.3 per cent and refractive spherical equivalent in 65.6 per cent.

Four ocular surface complications were observed. These were a hypertrophic epithelium eight weeks after surgery which progressed to a culture-negative microbial keratitis two weeks later, contact lens-induced sub-epithelial infiltrates four days after surgery and a non-healing epithelial defect for seven weeks after crosslinking that progressed to severe stromal oedema. Three eyes also experienced corneal haze with no loss of visual acuity.

“In the paediatric age and adolescents, crosslinking is a safe and efficacious procedure to stop or delay keratoconus progression. Further studies are required to confirm our findings,” Dr Wajnsztajn said.

Dr Gupta also reported a retrospective corneal crosslinking study involving 20 eyes of 15 children aged nine to 16. All had documented ectasia progression with no active surface inflammation. Eight of the 15 had vernal keratoconjunctivitis-associated keratoconus. All were treated with 0.1 per cent with one drop every 2.5 minutes for 30 minutes before irradiation. Mean follow-up was 18.5 months, ranging from 12 to 25 months.

At the last follow-up, improvement of one line or more in best corrected visual acuity was observed in all eyes, with six, or about 30 per cent, gaining more than three lines, Dr Gupta said. Kmax fell from a mean of 59.64 preoperative to 56.53, sim K fell from 51.96 to 48.73, and thinnest pachymetry from 455 microns to 400 microns. Mean preoperative aberrations also fell from 2.6 to 2.42 after treatment. Postoperative complications were limited to mild corneal haze and corneal scarring.

“The results show a stabilisation and improvement in keratoconus in terms of corrected visual acuity and corneal curvature after collagen crosslinking in children,” Dr Gupta concluded. Larger cohort studies with longer follow-up are needed to derive stronger conclusions, she said.

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Update

Cornea

CORNEAL THICKNESS

High-speed Scheimpflug tonometer CCT readings lower than other technologies

by Howard Larkin in Milan

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entral corneal thickness (CCT) measurements taken with the Corvis ST (Oculus) non-contact tonometer are significantly lower than readings obtained with the Orbscan IIz (Bausch & Lomb) and Pentacam (Oculus) devices, Mukesh Kumar, senior optometrist, Narayana Nethralaya Eye Hospital, Bengalaru, India, told the XXX Congress of the ESCRS. While readings from the Corvis correlate well with the other two devices, the numerical differences are large enough that they may not be interchangeable in clinical practice, he cautioned.

Mr Kumar examined 104 keratoconic eyes in 52 patients using all three devices and compared the results. Mean age was 24, ranging from 14 to 32 and mean refractive error was -4.0 D cylinder, ranging from -3.0 to -8.0. Patients with previous corneal surgery or acute hydrops were excluded.

The Corvis ST incorporates a highspeed Scheimpflug camera that captures horizontal images of the cornea at a rate of 4,300 frames per second to record corneal deformation produced by an air puff. This enables measurement of corneal thickness as well as corneal stiffness and viscosity.

However, in Mr Kumar’s study Corvis consistently underestimated CCT in keratoconus eyes compared with Orbscan IIz, which makes multiple slit-lamp images of the anterior chamber using a camera moving horizontally, and Pentacam, which creates a 3 D model of the anterior chamber using a rotating Scheimpflug camera. Mean Corvis measurements were 429.4 +/- 50.4 microns, about six per cent lower than the 456.4 +/- 54.3 measured by Orbscan and about five per cent lower than the 452.0 +/- 57.0 measured by Pentacam.

There was significant linear correlation among measurements from all the devices, Mr Kumar reported. Between Pentacam and Orbscan, the correlation r-value was 0.782; between Pentacam and Corvis 0.807; and between Corvis and Orbscan 0.921, all significant at p<0.01.

Non-contact advantages Mr Kumar emphasised the usefulness of measurement of CCT in keratoconus, noting that it is used for diagnosis, follow-up and planning for surgical procedures. Accurate thickness EUROTIMES | Volume 18 | Issue 3

“Contact ultrasound is the most common method of measuring corneal thickness” measures are essential for implanting Intacs and planning corneal surgery.

“Contact ultrasound is the most common method of measuring corneal thickness,” Mr Kumar said. But it has drawbacks including infection risk, making non-contact measurement attractive.

While Corvis CCT data may not be interchangeable with measurements by other devices, the instrument generates other data that may be highly useful for assessing and following ocular conditions.

These include deformation amplitude, length and velocity, which correlate with corneal biomechanical properties of stiffness and viscosity.

For glaucoma, the dynamic information on corneal deformation and recovery it provides enables accurate calculation of intraocular pressure that takes into account differences in corneal dimensions and biomechanical properties. This removes the uncertainties inherent in Goldmann applanation tonometry, which assumes all corneas respond similarly to external pressure.

Combined with topographic and tomographic data, Corvis may also increase the sensitivity and specificity of screening for patients at risk of ectasia (Renato A et al. Int Ophthalmol Clin. 2011;51:11-38).

Overlaying images from weakened corneas deforming over those from normal corneas can help spot early keratoconus even in eyes with normal topography.

The device, introduced in 2010, also may be useful for objectively measuring the results of corneal cross-linking on corneal biomechanical properties. Its potential for enabling customised crosslinking and refractive procedures has also been discussed.

® EYEFILL S.C. SUPREME COHESIVE

® EYEFILL D.C. DISPERSIVE COHESIVE

contact Mukesh Kumar – mukesh.opt@gmail.com ad EYEFILL 1-2hoch ENG 1301v1 pva RZ.indd 1

08.02.13 11:19

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22

Update

Cornea

Donald Tan – donald.tan.t.h@snec.com.sg Choun-Ki Joo – ckjoo@catholic.ac.kr Jodhbir Mehta – jodmehta@gmail.com Ray Tsai – raytsai@ms4.hinet.net Shigeru Kinoshita – naruse@koto.kpu-m.ac.jp

CORNEAL TRANSPLANTATION New approaches suggest bright future

Courtesy of Ray Tsai

Human corneal endothelial cell on donor disk

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Particularly exciting are the new technologies for endothelial reconstruction now on the horizon Donald Tan MD

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lthough traditional penetrating keratoplasty (PK) is still very useful for full-thickness pathology, selective lamellar keratoplasty is now proving increasingly useful for treating specific diseases, reported Donald Tan MD at the 3rd EUCORNEA Congress.

“Particularly exciting are the new technologies for endothelial reconstruction now on the horizon,” said Dr Tan who chaired a session entitled “Endothelial Cell-Based Therapies for Corneal Reconstruction,” organised by the Asia Cornea Society.

He highlighted the three major advances that have been made recently. First, better donor tissue inserters have been developed for Descemet’s stripping automated endothelial keratoplasty (DSAEK).

“These tissue inserters may be similar to IOL shooters in terms of how they are used, or use the glide or pull-through principle, which affords better surgical control of the donor during donor insertion and tissue manipulation in the AC, as compared to standard taco folding techniques. The ultimate goal is to decrease endothelial cell loss, which is currently around 30 per cent and the studies on the most recent inserters such as the EndoGlide, are beginning to show even lower cell loss rates in the region of about 15 per cent cell loss at one year. This represents a major improvement when compared to PK, in which endothelial cell loss is around 40 per cent at one year.”

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Second, ultrathin DSAEK donor tissue preparation has been becoming more precise.

“I think we’re reaching the limits of microkeratome technology. The goal is to equal the results of DMEK, which is the most anatomically pure form of endothelial cell replacement. But the greatest challenge in DMEK is transplanting a monolayer of cells without significant endothelial cell damage. Scrolling of the donor tissue remains a problem, as it remains highly challenging to unscroll the donor in the eye without damaging endothelial cells,” he noted.

With that in mind, Dr Tan and his team developed a disposable mat (D-Mat) which, when used with the EndoGlide Ultrathin donor insertion device, offers surgeons enhanced control within the anterior chamber. The D-mat is a flexible, circular, disposable 15-micron-thick polymer mat designed to prevent scrolling of donor Descemet’s membrane, and essentially mimics the stromal layer in a DSAEK donor, thus allowing the newer DSAEK techniques to be utilised in DMEK surgery.

“The D-Mat for DMEK allows us to avoid touching the tissue between stripping and insertion into the anterior chamber,” said Dr Tan. Instead, the D-Mat is grasped as it is inserted into the EndoGlide donor insertion device. Once inserted into the anterior chamber, the surgeon pulls in just the donor DM tissue, leaving the D-Mat inside the EndoGlide chamber, and this prevents inadvertent donor inversion and also makes it easier to manipulate the donor into position in the AC. “The next step might involve femtosecond laser technology coupled with real-time, high-resolution corneal imaging, to perform ultrathin DSAEK donor preparation, which may further enhance lamellar corneal surgery, but this is still some way off.”

On the less distant horizon, human endothelial cell culture might soon make endothelial cell reconstruction a reality, reported Dr Choun-Ki Joo of the Catholic University of Korea in Seoul, during the same session.

“A major problem for the surgical treatment of posterior corneal pathology is the current shortage of donor tissue.

We are working on a solution for this problem via tissue engineering,” said Dr Joo. Dr Joo discussed the advances he and his team made in developing a “real artificial cornea.” This was a combination of a scaffold constructed from recombinant human collagen and cultured corneal endothelial cells.

“We need to develop a tissue-engineered layer so that we can move beyond conventionally processed human donor corneas,” Dr Joo concluded.

Dr Jodhbir Mehta, a colleague of Dr Tan’s at the Singapore National Eye Centre, continued on a similar topic with his talk on the effect of nano-printing on human endothelial cell culture. Getting corneal endothelial cells to grow is tricky.

Their environment is crucial, he noted.

“Cultured cells are like children. They will observe their environment to see how they should behave, so we have

Courtesy of Shigeru Kinoshita

by Sean Henahan in Milan

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We have injected cultured human corneal endothelium, in combination with ROCK inhibitor, into monkey eyes, with good results

Shigeru Kinoshita to provide them with the ideal environment in which to proliferate,” said Dr Mehta.

This involves creating a functional reconstruction of corneal endothelium using nano-topography.

“We are able to use soft lithography to create patterns on a nanoscale. This is necessary because endothelial cells are very sensitive to surface morphological cues. They are able to detect the difference between micro- and nano-sized features.” The work has led to endothelial cell cultures with good intercellular interdigitation and tight junctions as well as significant adhesion of the cells to the surface structure.

Dr Ray Tsai, of Taipei Eye Center in Taiwan, raised the question of whether human corneal endothelial cells could be harvested, allowed to undergo ex vivo expansion and then be transplanted back into the human eye. The goal would be to set up a system for human corneal endothelial cell (HCEC) banking, similar to that now in place for whole human corneas.

“Our work has shown that HCECs could be viably transplanted onto a denuded human cornea,” said Dr Tsai, taking us a big step closer to this goal.

In a related presentation Dr Shigeru Kinoshita, of the Kyoto Prefectural University in Japan took this one step further.

“The ultimate goal of surgeries like DSAEK and DMEK is to obtain a high endothelial cell density with good physiological function using donor corneal endothelial cells.

But what if we could simply inject cultured endothelial cells into the anterior chamber?”

This is precisely what he and his team have done, albeit in animal models.

“We have injected cultured human corneal endothelium, in combination with ROCK inhibitor, into monkey eyes, with good results,” said Dr Kinoshita.

After injection, a face-down position is maintained for three hours, after which they observed good adhesion of the cells to Descemet’s membrane. Some delegates wondered whether the cells might simply disappear into the trabecular meshwork, but Dr Kinoshita responded that this was not the case. Indeed, human trials are tentatively planned for 2013.

Highlights from

17th ESCRS Winter Meeting

Polish hosts offer a warm welcome to ESCRS

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he ESCRS president Peter Barry said the warm welcome given to the society by its Polish hosts for the ESCRS Congress exceeded all expectations.

“We knew that when we decided to hold the meeting in Poland for the first time that we could look forward to the friendship and hospitality of Wojciech Omulecki and the Polish Society of Cataract & Refractive Surgery, but they have surpassed themselves and have made this meeting an outstanding success,” said Dr Barry.

Dr Barry said that the large amount of Polish ophthalmologists attending the meeting was particularly encouraging with 600 registered. He also welcomed the delegates from other countries outside Poland who attended the meeting.

“This is our 17th Winter Meeting and thanks to the excellent work of our Programme Committee, it continues to go from strength to strength. We are continuing to include an extended didactic programme with courses in basic optics, cataract, refractive and cornea and I am especially pleased that for the first time we are offering our young ophthalmologists their own dedicated programme. “ Dr Barry also thanked Dr José Güell, president of EuCornea and Dr Rudy Nuijts, chairperson of the ESCRS Cornea Committee, for organising Cornea Day. “Cornea Day continues to be a very important part of the Winter Meeting and

once again we had an excellent programme with presentations from some of our leading corneal surgeons.”

Dr Barry also said he was delighted to announce that, almost €1,000 had been raised for ORBIS and Oxfam through contributions from delegates at registration.

“The work of ORBIS and Oxfam is very important,” he said, “and this generous donation will help both charities to continue their excellent work. I would urge delegates to visit the ESCRS website at: www.escrs.org to find out more about the specific projects their donations are helping to support.”

Programme highlights On Saturday, there was didactic courses on cataract surgery, refractive surgery and cornea, free paper sessions on cataract and two symposia. The first symposium discussed, “Measuring Success in Cataract Surgery and the second, “Strategies for Treating Keratoconus”.

The Polish Society of Cataract & Refractive Surgery hosted Live Surgery which was transmitted from the Department of Ophthalmology at the Medical University of Warsaw.

The Winter Meeting concluded on Sunday with a symposium on Capsular Complications, a Polish Society Symposium and cornea and refractive free paper sessions.

Wojciech Omulecki, president of the Polish Society of Ophthalmology pictured with ESCRS president Peter Barry

Cornea Day highlights the treatment of corneal disease

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his year’s Cornea Day once again proved to be a popular event, fulfilling a role as a format for the presentation of new concepts in the treatment of corneal disease, Jose Güell MD, past-president of the ESCRS and president of EuCornea told ET Today, in an interview.

“The idea of Cornea Day is based on what we were doing at our own cornea meeting in Spain for a number of years.

The concept is to have a day of work covering all aspects of cornea and ocular surface disease but selecting four key topics. Each session has a keynote lecture main topic and a series of case reports with an opportunity for discussion in each case,” Dr Guell said.

The Cornea Day sessions highlighted headline issues as well as topics pertaining to more common problems.

This year’s Cornea Day sessions included one devoted to corneal grafts, another to infectious keratitis, another to keratoconus and other ectasias, and a special EuCornea session devoted to the ocular surface.

“There are certain areas that are hotter than others.

Research into the use of stem cells in ocular surface

Rudy Nuijts, chairperson of ESCRS Cornea Committee pictured with EuCornea president José Güell

reconstruction, or used to create an artificial cornea, all of this kind of research worldwide is a really hot topic.

But there is also continuing research into more common problems such as infectious keratitis,” Dr Guell noted.

The session devoted to keratoconus included some presentations concerning collagen cross-linking, a technology that is now increasingly adopted for the treatment of ectasias but for which the indications have yet to be fully fine-tuned.

“One of the goals I hope to achieve during my tenure as president over the next two years is the establishment of a standard of care in the treatment of keratoconus and other ectasias, and to define the actual status of this new technology and determine its limits.”

Dr Güell noted that this year’s EuCornea meeting, to be held in conjunction with the XXXI Congress of the ESCRS in Amsterdam next October, will cover the same range of topics but in much greater depth. Over two days it will include 15 free paper sessions, 12 symposia and seven courses.

“Our goal is to maintain this interest in the treatment of the ocular surface among young European ophthalmologists and to encourage them to participate in the meetings and cooperate with the society in the projects we undertake,” he added.

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Warsaw, Poland 15 – 17 February 2013

Light-adjustable lens provides stable and predictable outcomes

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wo-year results with the lightadjustable IOL show that it can provide highly predictable refractive results, even in eyes that have undergone previous refractive surgery, said Tobias Neuhann MD, Munich, Germany at this year’s ESCRS Winter Meeting.

The study included 65 eyes of patients with a mean age of 63 years, 24 of whom had undergone previous corneal refractive surgery. All underwent implantation of a Light-Adjustable Lens (Calhoun Vision, Pasadena, CA) during routine cataract surgery. Dr Neuhann and his associates assessed the patients’ visual acuity and refraction approximately two weeks after

surgery, and adjusted the IOL’s refraction with a UV device (Light Delivery Device, Calhoun Vision) following any necessary refractive adjustments; the final lock-in was performed, making the IOL power permanent.

The patients’ mean preoperative refractive error was -1.87 D and by one year it was 0.13 D. Furthermore, 94 per cent of eyes were ±0.50 D from the intended preoperative target. The LAL also demonstrated good stability following the final lock-in treatment. Moreover, the 24 eyes had previous corneal refractive procedures such as LASIK, PRK, radial keratotomy or corneal rings, all had results which were equal in terms of refractive

predictability and stability as eyes that had never undergone surgery.

Dr Neuhann noted that based on his findings to date the light-adjustable lens appears to be living up to its promise of providing predictable outcomes more similar to those commonly achieved in refractive surgery “Light Adjustable Lens implantation during refractive cataract surgery together with postoperative IOL power adjustment demonstrated stable and effective results in achieving the targeted refraction. Even eyes with previous corneal refractive surgery, such as post-LASIK, demonstrated the same very good refractive and visual outcomes,” he concluded.

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Even eyes with previous corneal refractive surgery, such as post-LASIK, demonstrated the same very good refractive and visual outcomes Tobias Neuhann MD

Phaco may be be preferable to phacotrabeculectomy

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hacoemulsification may be preferable to phacotrabeculectomy as first-line treatment for eyes with medically controlled angle-closure glaucoma and coexisting cataract since it provides comparable IOP control and entails fewer complications and additional surgical interventions, according to the results of a randomised trial presented at this year’s meeting by Ahmed Saeed MD, Benha University hospital, Benha, Egypt.

The study involved 48 eyes of 38 patients with angleclosure glaucoma and cataract. Half of the eyes underwent phacoemulsification alone and half underwent combined phacotrabeculectomy with mitomycin C. All underwent a thorough examination at one month and at three, six, 12, 18 and 24 months postoperatively.

At each examination Dr Saeed and associates recorded documentation of the IOP, number of IOP-lowering drugs, BCVA, gonioscopy, complications, additional manoeuvres required to maintain filtration or to handle complications and

any additional surgical intervention. They also performed visual field testing at 12 and 24 months.

Both groups succeeded in achieving lower mean IOP values with statistically significantly less anti-glaucoma drugs. The mean IOP showed no statistically significant differences between both groups preoperatively and postoperatively, although IOP was lower in the phacotrabeculetomy group by 0.96 mmHg than in the group that underwent phacoemulsification alone. In addition, the reduction in the number of anti-glaucoma drugs needed was greater by 0.21 by phacotrabeculectomy, but the difference between the groups was not statistically significant.

In addition, ultrasound biomicroscopy imaging showed statistically significant increases in all anterior chamber parameters postoperatively in both groups. However, the mean anterior chamber depth was statistically significantly higher in the group that underwent phacoemulsification alone. The phacotrabeculectomy group had significantly more intra- and postoperative complications and additional interventions.

Ahmed Saeed

Femtocataract - so far, so good

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Roberto Bellucci

oncerns that femtosecond cataract surgery could induce miosis and increased intraocular pressure (IOP) are not borne out in the clinical setting, reported Roberto Bellucci MD, University of Verona, Italy, at the meeting.

“There are a number of potential advantages to femtosecond laser cataract surgery, including the ability to create well-placed capsulotomies and reduced phaco time.

However, there have been some concerns about the potential for miosis associated with miogenic compounds released from the iris, as well as potential risk of IOP increases associated with gas bubbles released during the procedure,” said Dr Bellucci.

Dr Bellucci reported a study involving 50 eyes operated consecutively with the Victus femtosecond laser. No corneal incisions were made by the femtosecond laser in this study.

Total employed energy including lens fragmentation was 14.415 ± 0.067μJ, with minimal variation across eyes.

A comparison of pupil diameter measurements through

the cornea before and after surgery showed no change whatsoever. Horizontal pupil diameter was 7.39 ± 0.77mm before femtosecond laser application, 7.37 ± 0.8mm during laser treatment, and 7.33 ± 0.72mm before the beginning of phaco surgery.

IOP measurements taken with the iCare tonometer before and after surgery also showed no statistically significant change. IOP was 15.25 ± 1.9 mmHg before docking, and was 15.0 ± 1.5 after femtolaser application.

“Intralenticular fluidics are a new issue raised by femtosecond cataract surgery. Our study results indicate that this treatment does not affect pupil diameter or intraocular pressure. This technique allows us to produce a well-centred, perfectly shaped capsulorhexis, along with more precise postoperative keratometry.”

He noted that the low level of applied energy suggests different results may be obtained with different lasers and higher energy. He also cited a need for better docking technology for femtosecond cataract surgery in general.

Highlights from

17th ESCRS Winter Meeting

Poster prizes focus on visual outcomes

Mark Myshalov accepted the winning poster prize in the Refractive Category from Roberto Bellucci on behalf of Nika Takhchidi

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ptimum optics for LASIK ablations and blue-blocker IOLs in patients with retinitis pigmentosa were the topics of the refractive and cataract poster prize winners at the 17th ESCRS Winter Meeting in Warsaw.

The poster of Nika Takhchidi MD, of the S. Fyodorov Eye Microsurgery Institution, Moscow, winner in the Refractive Category, described a study which compared visual acuity and visual quality outcomes in 64 myopic patients who underwent either Q-value guided Femtosecond laser-assisted LASIK or conventional Femtosecond laser-assisted LASIK. The study showed that at one year after surgery those

who underwent the Q-value guided procedure had a mean spherical equivalent of 0.12 and a mean uncorrected visual acuity of 1.1. That compared to mean spherical equivalent of 0.26 and a mean uncorrected visual acuity of 0.87 in the control group.

Furthermore, under mesopic conditions visual acuity was twice as good as preoperative values at all spatial frequencies in the Q-value guide LASIK group, but only increased slightly in low and moderate spatial frequencies in the conventional femto-LASIK group.

The winning poster in the Cataract Category was presented to Balász Varsányi MD, Semmelweis University,

Balász Varsányi accepted the winning prize in the Cataract Category

Budapest, Hungary. It described a retrospective study involving 30 patients with autosomal recessive/sporadic retinitis pigmentosa who underwent implantation of a blueblocker IOL, a conventional IOL or no IOL. The researchers found that at one year there was no significant difference between the two surgery groups. In the blue filter IOL group vision improved by -0.08 logMAR compared to preoperative values, while in the normal IOL group it improved by -0.09 logMAR. In the control group, the mean annual change in the BCVA was 0.02 logMAR. All patients who underwent cataract surgery claimed subjectively ‘improved vision’ one year after the operation.

Young ophthalmologists’ programme was a major success

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he first Young Ophthalmologists’ Programme held at an ESCRS Winter Meeting was a major success.

The session was moderated by Oliver Findl, Austria; Simone Morselli, Italy; and Kaarina Vannas, Finland and included video cases presented by young ophthalmologists.

Dr Peter Barry, president of the ESCRS, said he was very impressed by the attendance with more than 160 young ophthalmologists at the session. “There was also very good audience participation,” he said, “and fantastic credit is due to the young ophthalmologists who brought along their videos and showed practical difficulties they had encountered in their earlier surgery cases in order to help them

“Fantastic credit is due to the young ophthalmologists who brought along their videos and showed practical difficulties...”

Peter Barry, president of ESCRS

become better by not repeating their mistakes again and again. It is humbling to show your surgical problems in public.”

Dr Barry, speaking to ET Today after the meeting, said it had been a superb session and the ESCRS would certainly repeat it in 2014.

Oliver Findl, Simone Morselli and Paul Ursell at the Young Ophthalmologists’ Programme

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Highlights from

Picture Gallery from Warsaw 2013

17th ESCRS Winter Meeting

contact

Inga Kersten-Gomez – inga.kersten-gomez@ kk-bochum.de

Update

GLAUCOMA

OPEN-ANGLE GLAUCOMA

New outflow device targets subconjunctival space

by Dermot McGrath in Milan

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he ab-interno gelantine microdevice with subconjunctival drainage (AqueSys Inc.) offers a safe, effective and non-invasive means of lowering intraocular pressure in primary open-angle glaucoma patients, suggest the early results from the first clinical trials.

“The initial results have been very encouraging. The implant (XEN) offers a minimally invasive procedure that is potentially interesting for treating all stages of glaucoma, especially mild to moderate glaucoma and especially in combination with cataract. The mechanism of action is well understood and accepted, with an average IOP reduction of 26 per cent in our study,” Inga Kersten-Gomez MD told delegates attending the XXX Congress of the ESCRS. Dr Kersten-Gomez, University Eye Hospital, Bochum, Germany noted that the implant is the first ab interno device which works by creating aqueous outflow from the anterior chamber into the non-dissected tissue of the subconjunctival space.

The procedure uses a collagen-derived,

“

The procedure is straightforward and can be performed as a primary procedure or in conjunction with cataract surgery Inga Kersten-Gomez MD

gelatin implant that is soft and flexible when hydrated and which has been designed to mitigate traditional implant problems such as migration and erosion. Its gelatin material is biocompatible and is very well tolerated by the ocular tissues, she added.

Implanting the device is not particularly difficult and demands only a short learning curve, said Dr Kersten-Gomez. The implant is placed through a small, clear corneal incision using a preloaded inserter similar to those used for intraocular lenses. Using an ab interno approach, the surgeon places the implant with the inserter in the anterior

chamber angle through the trabecular meshwork to the desired subconjunctival location.

“The procedure is straightforward and can be performed as a primary procedure or in conjunction with cataract surgery,” she said.

Dr Kersten-Gomez’s prospective, openlabel, non-randomised pilot study included 23 patients with or without medications.

Patients included non-refractory and refractory cases, with 10 patients receiving the implant in combination with cataract surgery.

Full ophthalmological examinations were performed including clinical assessments of IOP, anterior chamber OCT imaging, visual acuity, visual field and assessment of complications at regular follow-up intervals.

Safety parameters were evaluated using IOP, visual acuity and visual field examinations.

To assess the clinical efficacy of the device, the investigators compared the mean IOP changes and the reduction in medication use from baseline to postoperatively. Dr Kersten-Gomez presented the one-year follow-up data,

although she stressed that the study is ongoing and follow-up is scheduled for up to three years and that the heterogenous population is a limiting factor.

In terms of results, the mean preoperative IOP of 21.0 mmHg was reduced to 16.0 mmHg at one month (-23 per cent), 15.2 mmHg at six months (-27 per cent) and 15.9 mmHg at one year (-26 per cent). The glaucoma medications were reduced from a mean of 2.2 eye drops preoperatively to 0.5 eye drops postoperatively at the 12-month follow-up point.

Dr Kersten-Gomez added that the results from Bochum University Eye-Hospital were very much in line with those reported in the ongoing worldwide multicentre clinical trial at 12 other centres, with 107 patients at the starting point and follow-ups for three years, recruitment still ongoing.

Longer follow-ups are needed as well as a larger number of patients and a more homogenous population to fully assess the safety and efficacy of the implant over time, Dr Kersten-Gomez said. This method may be interesting for a broad range of surgeons performing minimal-invasive surgery, especially for mild and moderate glaucoma with or without cataract.

“One obvious advantage of the ab interno to subconjunctival approach is that it bypasses potential aqueous outflow obstructions. A single implant delivers desired effectiveness using a clinical proven outflow pathway,” she said.

The fact that the approach is conjunctivasparing also means that alternative surgical options (except canaloplasty) are not compromised.

Glaucoma Day ESCRS

Friday, 4th October 2013 Amsterdam, The Netherlands Available Online: Registration and Hotel Bookings

Scientific Programme organised by

www.escrs.org EUROTIMES | Volume 18 | Issue 3

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contacts

Update

GLAUCOMA

GLAUCOMA CURE?

microbiological and neurobiological rejuvenation are greatly reduced.”

The largest cup Dr Stegmann has seen turn around in an adult was 0.7, though it was not very deep. The patient’s pressure dropped from 59 mmHg to 14 mmHg on the table, and was stable at 12 mmHg with a completely normal disc at 12 months, he said.

Disc cupping reversal, RNFL thickening observed after early viscocanalostomy and canaloplasty

by Howard Larkin in Milan

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hen treated early with viscocanalostomy or canaloplasty, glaucomatous disc cupping and thinning of the retinal nerve fibre layer are often reversed in children and sometimes in adults, Robert C Stegmann MD, Pretoria, South Africa, told the XXX Congress of the ESCRS. The treatment is long lasting, too, Dr Stegmann said. Indeed, some of his earliest viscocanalostomy patients have remained stable for 21 years and counting. Many with preoperative intraocular pressures (IOPs) above 30 mmHg have maintained pressures in the 12 to 14 mmHg range with no progression of visual field loss for five to 10 years or more, with complication rates of about two per cent. Children with open collector channels in the canal of Schlemm treated in the past few years with canaloplasty typically see pressures drop 60 to 70 per cent, from above 30 mmHg to 9 to 12 mmHg. “The children are not howling all day long due to corneal oedema, pain and tearing, their mothers are not throwing their hands up, and you see the cupping turn around.… The time has come, as far as I am concerned, to talk about our capability to cure this disease,” Dr Stegmann said.

Early intervention Both viscocanalostomy, which Dr Stegmann developed more than two decades ago, and canaloplasty, which he began about seven years ago and is considered an outgrowth of the earlier procedure, reduce IOP by restoring the physiological aqueous outflow mechanism through the trabecular meshwork, into Schlemm’s canal and out the collector channels at the outer edge of

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The time has come, as far as I am concerned, to talk about our capability to cure this disease Robert C Stegmann MD

the canal. A parabolic scleral flap about 250 microns deep is cut, followed by a deeper flap exposing the choroid, and with it Schlemm’s canal.

In viscocanalostomy, high viscosity sodium hyaluronate is pumped in slowly to open the canal as well as pores in the trabecular meshwork. This step is also diagnostic, as it shows if the blockage is due to canal collapse, or trabecular meshwork disease, or both; and if the outflow channels are open, Dr Stegmann said.

In canaloplasty, a lighted microcatheter is inserted to open 360 degrees of the channel before dilating it with viscoelastic, and a suture or, more recently, a stent (Stegmann Canal Expander®, Ophthalmos GmbH, Switzerland) about twice the diameter of a human hair, may be inserted to keep it open.

“If you had open collector channels very shortly after surgery the results were phenomenal, with a drop of 60 to 70 per cent on average,” Dr Stegmann said of the viscocanalostomy procedure.

He achieved mean IOP of 17 mmHg for extended periods in a population with a mean preoperative IOP of 47 mmHg. Adding a suture with canaloplasty lowered pressure even more, but proper tensioning

Robert Stegmann – eyeclinic@ul.ac.za Manfred Tetz – manfred.tetz@charite.de

“

With non-penetrating approaches, complications go down Manfred Tetz MD

was a problem. Inserting the Stegmann Canal Expander® makes the outcome more predictable, with postoperative pressures from 9-12 mmHg typical for patients with 30 mmHg or more before surgery, he said.

In infants, Dr Stegmann routinely sees not only a pressure drop, but a reduction in cupping after surgery. He has even documented thickening of the retinal fibre layer with OCT. He emphasised, however, that surgery must be done early, before the disease can cause permanent damage to the optic nerve and even outflow channels. Dr Stegmann operates on infants as soon as an anaesthesiologist will clear them for surgery, often at three or four weeks of age.

“Every single one of them turns around.

But if you wait three years and the cup is 0.9 or 1.0, forget it.”

Cupping also reverses in some adults, though he does not have a large enough sample to predict with any precision when it is likely, Dr Stegmann said. He believes that once he has 1,000 adult cases analysed, he will be able to develop reliable guidelines.

However, success is more likely with shallower cups.

“Once you see the ominous sign of the lamina cribrosa, the chances of

Target pressure Dr Stegmann believes that very low pressures are not necessary for most glaucoma patients to benefit.

“If you can drop pressure by 50 per cent you basically can cure the disease. I have many patients with pressures that have gone from over 60 mmHg to between 19 and 29 mmHg, and over 21 years have had no visual field progression.”

As long as the IOP is close to episcleral venous pressure, the physiological outflow mechanism will work, he added.

Manfred Tetz MD, Berlin, Germany, advised sticking with studies in selecting target IOP. That means lower teens in advanced glaucoma cases.

“With more pressure the optic nerve does get worse.”

One criticism of viscocanalostomy and canaloplasty is that while they lower pressure, they may not lower it enough, Dr Tetz said. He reported achieving IOPs of 13.5 mmHg on average with combined phaco and canaloplasty, and 15 to 15.5 mmHg using canaloplasty alone (publication accepted by J. of Glaucoma 2013).

“We can get to 15, but we cannot get to 12. Whether that will be enough remains to be seen.”

However, the safety of canaloplasty compared with trabeculectomy makes it very attractive. In about 5,000 cases he has had one case of persisting hypotony and no cases requiring corneal transplant. He worries about that one case, even though such a safety record is virtually unheard of for trabeculectomy or tube implants.

“With non-penetrating approaches, complications go down,” Dr Tetz noted.

He suggested that long-term outcomes studies on canaloplasty continue, and that guidelines be developed for what kind of complications are acceptable for glaucoma surgery in general.

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Update

GLAUCOMA

GLAUCOMA STENTS

MIGS offers viable long-term IOP control in mild to moderate glaucoma

by Dermot McGrath in Milan

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icro-invasive glaucoma surgery (MIGS) involving ab interno implantation of a trabecular micro-bypass stent (iStent, Glaukos Corp.) during cataract surgery is a safe and effective means of controlling intraocular pressure (IOP) over the long term in primary open-angle glaucoma (POAG) patients, according to a study presented at the XXX Congress of the ESCRS. “Our data shows sustained long-term reduced IOP and medication use following iStent implantation and cataract surgery. In this series, implantation of a single iStent with cataract surgery resulted in long-term IOP control four years after surgery with a reduced medication burden. It is significantly more effective than cataract surgery alone while maintaining a safety profile that is similar to cataract surgery alone,” said Antonio Maria Fea MD, PhD. Dr Fea described the iStent as an FDA-approved heparincoated titanium tube that is 1.0mm in length with a microscopic opening of just 120 microns in diameter. The device is inserted ab interno through a small temporal clear corneal incision, bypassing the trabecular meshwork and placed in Schlemm's canal without disrupting the scleral surface. It improves outflow by allowing aqueous humour to drain directly from the anterior chamber into Schlemm’s canal bypassing the obstructed trabecular meshwork.

A number of recent studies in the scientific literature with up to two years' follow-up suggest that the device is effective at controlling IOP over this time period and is well tolerated by the ocular structures, said Dr Fea. “There is accumulating evidence from recent studies that this device combined with cataract surgery is able to significantly reduce the intraocular pressure in patients with early to moderate open-angle glaucoma. A recent study by our Spanish colleagues Arriola-Villalobos et al. shows nice control of the IOP in 19 patients with a mean follow-up of 53 months. No anti-glaucoma medications were used at the end of follow-up in 42 per cent of patients,” he said.

Turning to his own clinical experience with the iStent, Dr Fea said that in 2010 his group published the outcomes of a prospective double-masked randomised clinical trial of patients with phacoemulsification alone or phacoemulsification with iStent implantation. Primary outcomes were IOP and reduction in medication use over 15 months and IOP after a one-month washout of ocular hypotensive agents at 16 months postoperatively.

The study included 36 eyes with cataract and mild to moderate OAG, IOP greater than 18 mmHg on one ocular hypertensive medication or any IOP reading if the patient was on more than one ocular hypertensive medication.

Exclusion criteria were a glaucoma diagnosis other than POAG, peripheral anterior synechiae, cloudy corneas likely to inhibit gonioscopic view of the angle, previous ocular surgery, history of trauma or ocular surface disease, preproliferative or proliferative diabetic retinopathy, and age-related macular degeneration with macular scar or large macular atrophy that would inhibit potential visual acuity.

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NEW

FRONTIERS The ESCRS is awarding 40 grants of €1000

“

Our data shows sustained long-term reduced IOP and medication use following iStent implantation and cataract surgery Antonio Maria Fea MD, PhD

“The main results of the study showed that implantation of the micro-bypass stent combined with cataract extraction resulted in significantly lower IOP and a significant reduction in the use of ocular hypotensive medications 15 months postoperatively compared with cataract surgery alone. The mean decrease in the combined surgery group was 3.2 mmHg compared with 1.6 mmHg in the control group. At the final follow-up at 15 months, 67 per cent of patients in the combined treatment group were medication-free compared with 24 per cent in the control group,” Dr Fea said.

To try to determine the long-term effect of the iStent on IOP, Dr Fea decided to recall his patients for a follow-up visit.

Of the 12 eyes originally enrolled in the combined iStent and phacoemulsification group, one patient was lost to followup and one refused the wash-out procedure. Of the original control group of 24 eyes, five patients had subsequently died, four were lost to follow-up, and one was unable to attend.

Looking at the mean medicated IOP over time, Dr Fea said the lower IOP in the treatment group carried through to month 55 of the follow-up, with a mean of 15.9 mmHg for combined group compared to 17.0 mmHg for control.

A slight difference was also found in the mean use of ocular hypotensive medications, with sustained lower medication use in the treatment group, although this was not statistically significant. However, after washout of ocular hypotensive medications the IOP at month 56 decreased 0.3 mmHg in the treatment group versus an increase of 3.6 mmHg in the control group, said Dr Fea. In terms of safety, both groups recorded excellent longterm best-corrected visual acuity, with no secondary surgeries or adverse events in the treatment group, and one case of macular drusen in the control group, he said.

Summing up, Dr Fea said that most patients sustained long-term reduced IOP and medication use following iStent implantation and cataract surgery.

“The IOP-lowering effect of phacoemulsification alone is not as consistent and as predictable as ophthalmologists would like, which is why the iStent will probably become a commonly used adjunctive device for many patients with mild to moderate glaucoma,” he concluded.

contact Antonio Maria Fea – antoniofea@interfree.it

to young ophthalmologists who want to travel abroad to improve their skills

Visit www.escrs.org to apply

Update

30 Scan this QR code to gain access to EuroTimes podcasts

RETINA

quality over quantity

Retina specialists discuss diagnostics and treatments for retinological diseases at EURETINA Winter Meeting

by Dermot McGrath

R

EYE CHAT Exclusive interviews Up to date information Problem solving

Toric IOL power Calculating the correct toric IOL power for your patient poses a number of challenges, and current calculation formulas may not provide accurate answers.

Dr Oliver Findl discusses the ins and outs of toric IOL biometry with Dr Jaime Aramberri, of San Sebastian, Spain, who addressed this question recently at the ESCRS Congress in Milan.

podcast

www.eurotimes.org

Also available on iTunes

EUROTIMES | Volume 18 | Issue 3

esearchers and clinicians from Europe and further afield took full advantage of the opportunity to take stock of recent progress in the field of retina studies at a lively and highly stimulating 3rd EURETINA Winter meeting in Rome, Italy.

“It was a great success and the feedback from participants was very positive indeed,” Gisbert Richard, president of EURETINA told EuroTimes. “The international guests were very enthusiastic about the meeting, with renowned scientists presenting their findings in the fields of diagnostics and treatments for retinological diseases. At the same time there were a great number of posters, giving young scientists the opportunity to present their projects and results,” he said.

As Dr Richard noted, the aim of the winter meeting is rather different than the main EURETINA Congress and affords delegates the opportunity to exchange and debate in a slightly less charged atmosphere than the main congress.

“The EURETINA Congress is designed to provide a forum for clinicians to learn about the latest developments in the fields of diagnostics and vitreoretinal treatment. The winter meeting, however, focuses more on future trends. That future is created in the laboratories of scientists undertaking basic research who frequently do not work in eye clinics but in basic research laboratories, in neurology, and so forth. So the aim of the meeting is to bring basic researchers and clinicians together. This was done in Rome and both the clinicians and the basic scientists were very satisfied,” he said.

With the ophthalmic meeting calendar increasingly crowded, Dr Richard said that it was important to have clearly-defined aims in order to give the winter meeting a distinctive feel and character.

“We deliberately chose not to have an industrial exhibition or industrial support to maintain the independent character of the event. The goal of the meeting is to offer a rather limited congress of high scientific standard with invited speakers and a lot of discussion time. This is only possible if the meeting is not too large. Quality is more important than quantity,” he said.

Developments in artificial vision and retinal chips, the latest in imaging technologies and treatments for degenerative diseases were among some of the key topics under the spotlight at the meeting, said Dr Richard.

“In many of the specific topics important developments are knocking on the door. This is true for imaging diagnostics, for retinal chips and electrostimulation, for the prevention and treatment of degeneration and for the interaction of degeneration and inflammation of the eye,” he said.

The pace of technological advances in recent years continues to drive forward diagnostic and therapeutic possibilities, said Dr Richard.

“The speed and resolution of imaging methods have vastly improved over the last few years. Today they yield information about the behaviour of individual cells, and in the near future it may be possible to gain insights into the metabolic processes inside the cells. The retinal chip is already in use clinically and we saw some interesting

“

It was a great success and the feedback from participants was very positive indeed

Gisbert Richard, EURETINA president results presented in Rome. However, the limitations of this technique were also discussed in one paper. There have also been important advances in electrostimulation for degenerative diseases, for which astonishing results were reported, also from the neurological viewpoint. These will have to be investigated in controlled ophthalmological studies,” he said.

Researchers are also continuing to shed light on the complex processes underlying degenerative retinal diseases and are thus moving closer to the goal of preventing them or inducing regeneration, added Dr Richard.

“The great potential of stem cells was illustrated by various speakers. Looking at degeneration and inflammation at the molecular level reveals astonishing cross-links that were surprising to some,” he said.

Looking ahead to this year’s EURETINA Congress in Hamburg in September, Dr Richard said that the organisers anticipate another successful meeting to build on the momentum achieved in recent years.

“The EURETINA congress has developed into the biggest international retinological meeting worldwide, and has a distinguished reputation. It has therefore become important for clinicians and for the industry. This year we are going to organise a World Retina Day, which will make the international and worldwide focus of the congress more obvious than previously. The majority of the vitreoretinal societies from Europe, Asia, North and South America and the Middle East will take part with their own symposia,” he said.

As Dr Richard sees it, the important point to remember is that organisations like EURETINA are ultimately there to further the cause of the millions of patients worldwide afflicted with potentially blinding and debilitating retinal and macular diseases.

“Vitreoretinal diagnostics and treatment have experienced an enormous boom in the last few years, which has also marked the whole of medicine. This development serves the well-being of patients, and has also taught us that with a better understanding of many diseases, we are better able to treat them. We believe that this dynamic trend will continue as the pipeline is well filled with new developments, giving us high hopes, in the interests of our patients,” he concluded.

Update

31

RETINA

good results

Phase III REVEAL trial confirms anti-VEGF agent’s efficacy and safety in Asian patients

by Cheryl Guttman Krader in Milan

R

esults from the Phase III REVEAL study establish that Intravitreal ranibizumab (Lucentis, Genentech) is safe and effective for improving vision and reducing central retinal thickness in Asian patients with diabetic macular oedema (DME), reported Adrian Koh MD, at the 12th EURETINA Congress, citing results of the Phase III REVEAL study.

Conducted at centres in China, Hong Kong, Taiwan, Republic of Korea, Japan and Singapore, REVEAL randomised 396 patients equally into three arms to receive ranibizumab 0.5mg + sham focal grid laser, ranibizumab 0.5mg + active laser, or sham injection + active laser. Injections (ranibizumab or sham) were given to all patients monthly for three months and as needed thereafter based on ETDRS BCVA stability and DME progression. Laser photocoagulation (active or sham) was performed based on ETDRS guidelines and was repeated no more than once every three months. Almost 90 per cent of patients completed the 12-month study.

Significant differences Both the ranibizumab monotherapy and laser combined arms were significantly superior to laser alone in the primary endpoint analysis of mean average change in BCVA from baseline to month one to 12 (+5.9 and +5.7 vs. +1.7 letters). In addition, there were significant differences favouring both the ranibizumab monotherapy and combined laser arms compared with laser alone in analyses of mean change from baseline to month 12 in BCVA (+6.6 and +6.4 vs. +1.8 letters) and CRT (-132 and -164 vs. -58.6 microns).

Safety data showed the most common ocular and non-ocular adverse events were minor. Rates of serious adverse events were generally similar across all study groups.

“REVEAL is the first randomised, clinical trial designed to assess the efficacy and safety of ranibizumab in Asian patients with DME, and the results are consistent with those observed in RESTORE, one of the pivotal studies that led to approval of ranibizumab for treatment of DME in Europe and Asia,” said Dr Koh, founding partner and senior consultant, Eye & Retina Surgeons, Camden Medical Centre, Singapore.

EUROTIMES | Volume 18 | Issue 3

“

In giving anti-VEGF therapy on a regular basis, the perfusion status seems to improve for most diabetics Adrian Koh MD

“It was encouraging to see there were no new safety signals in this study, and particularly given the concern about the potential for adverse events thought to be related to systemic VEGF inhibition in patients with diabetes. Ranibizumab was well tolerated, and there was no increase in rates of cerebrovascular events or cardiovascular morbidity and mortality in this population of diabetic patients receiving repeated anti-VEGF injections.”

Analyses of treatments received showed the mean number of injections (ranibizumab or sham) was similar across all three groups (range 7.0 to 7.8) as were the mean number of laser treatments (active or sham, range 1.5 to 1.9).

“The study was initiated with the expectation that adjunctive laser would reduce the burden of ranibizumab injections. However, that has not been observed in any clinical trials, and in fact, there has even been some suggestion that applying laser too early will limit visual gains with ranibizumab,” said Dr Koh. However, he noted that clinicians should not forget that laser has an important place in management of diabetic eye disease.

“DME does not arise in isolation and it should not be the sole focus of treatment.

Very often patients have progression of diabetic retinopathy or significant peripheral nonperfusion for which laser photocoagulation plays a role,” Dr Koh said.

He added that it was also feared initially that prolonged anti-VEGF therapy might increase ischemia to the eye. Rather, the reverse appears to be true.

“In giving anti-VEGF therapy on a regular basis, the perfusion status seems to improve for most diabetics,” Dr Koh said.

contact

Adrian Koh – ahckoh@yahoo.com

contacts

32

Update

RETINA

RETINOBLASTOMA OUTCOMES

Modern approaches deliver benefits of localised chemotherapy with strategies to minimise risk

by Cheryl Guttman Krader in Milan

I

ntravitreal chemotherapy (IViC) and intra-arterial chemotherapy (IAC) represent significant advances in the management of retinoblastoma, reported clinical researchers at the 12th EURETINA Congress.

Discussing eye-targeted chemotherapy approaches during a session on ocular tumours, Francis Munier and Carol Shields MD reported their experiences with IViC and IAC. The data show excellent tumour control with improved globe salvage rates and acceptable safety.

“Vitreous seeding represents one of the biggest challenges clinicians face in the management of retinoblastoma, but IViC appears to restore an excellent prognosis for eye preservation in these desperate cases,” said Dr Munier, head, retinoblastoma clinic, Jules-Gonin Eye Hospital, Lausanne, Switzerland.

“In our experience, the ocular survival rate using IViC is around 85 per cent, which is totally unprecedented in the field. Now, a prospective, multicentre, Phase II trial, SPOG-RB2011, is under way to validate IViC as a safe and effective salvage option.”

IViC is being used in eyes with relapsed/ resistant retinoblastoma when the tumour burden is mostly vitreal with or without subretinal seeds, provided that its source is accessible to focal treatment. Careful patient selection and an improved injection technique have been crucial for addressing the risk of tumour spread after IViC, said Dr Munier.

Patients are selected for IViC based

on imaging assessment with ultrasonic biomicroscopy (UBM). Any of the following findings exclude patients from the procedure: invasion of the anterior and posterior chamber, anterior hyaloid detachment, or the presence of retinal detachment, tumour or vitreous seeds at the needle entry site.

The injection is performed with a very small, 32-gauge needle using an anti-reflux procedure and sterilisation of the needle tract. Dr Munier said he first does an anterior chamber paracentesis, removing a volume of aqueous equal to that of the injection, and sends the specimen for cytopathology to rule out tumour cells in the anterior chamber.

“If patients are correctly selected by UBM, there should be no cells in the anterior chamber, and so far all of our samples have been negative,” he said.

The needle is inserted perpendicularly, 2.5 to 3.5mm from the limbus at the desired meridian opposite to the seeds and advanced until the needle tip reaches the centre of the vitreous cavity. Dr Munier cautioned that if there is a hyaloid detachment, care must be taken to avoid injecting into the retrohyaloidal space, which would expose the retina to a toxic concentration of the chemotherapeutic agent.

After the drug is delivered and the needle withdrawn, three freeze-thaw cryoapplications are performed at the entry site, and the eye is shaken to distribute the drug.

Dr Munier recently published outcomes of IViC in a retrospective interventional case series including 23 eyes. Almost all

“

Vitreous seeding represents one of the biggest challenges clinicians face in the management of retinoblastoma...

Francis Munier MD

eyes had prior systemic intravenous and/or intra-arterial chemotherapy. They received a median of four intravitreal injections of melphalan 20-30 mcg given at intervals of seven to 10 days, and all but two eyes received intensive focal therapy to sterilise the seeding source and subretinal seeds.

After a median follow-up of 22 months (range nine to 31), the ocular survival rate was 87 per cent, and there were no cases of extraocular tumour recurrence or systemic spread.

“It is noteworthy that no eye required EBR for control of vitreous seeding,” Dr Munier said.

He noted that having performed more than 200 IViC injections, he has never observed reflux during the procedure. In the reported series, retinal toxicity was limited to peripheral salt-and-pepper retinopathy at the injection site (10 eyes, 43 per cent), and there were two cases of transient localised vitreous haemorrhage.

Courtesy of Francis Munier MD

Pictured left to right: The case of a unilateral retinoblastoma group D of the left eye (diffuse vitreous seeding) (cf photo montage prechemo; macula obscured by the seeding), successfully treated by 3 cycles of intra-arterial melphalan followed by 3 weekly intravitreal injections of melphalan (cf photo montage 7 months after chemo initiation with healthy macula)

EUROTIMES | Volume 18 | Issue 3

Carol Shields – carolshields@gmail.com Francis Munier – francis.munier@fa2.ch

Intra-arterial approach Dr Carol Shields, Oncology Service, Wills Eye Hospital, Philadelphia, US, discussed IAC. In this relatively new method for treating retinoblastoma that requires an interventional neuroradiologist or endovascular neurosurgeon, drug is delivered into the ophthalmic artery under fluoroscopy using a catheter passed after insertion through the femoralartery. IAC is considered in patients with International Classification of Retinoblastoma (ICRB) groups C, D or E retinoblastoma, including use as primary treatment in patients with unilateral disease. It is also used as a secondary treatment for those who fail other methods.

“We are cautious with patient selection for IAC, but we use it every week because it is very powerful,” said Dr Shields, noting that her group has now performed over 200 IAC procedures.

Results from a recent report of 17 eyes treated with IAC using melphalan 5.0mg explain Dr Shields’ excitement about the procedure. Complete response was achieved in 14 (88 per cent) eyes, including in nine (82 per cent) of 11 eyes with subretinal seeds and six (67 per cent) of nine eyes with vitreous seeds. Among eyes that were treated with IAC as primary therapy, the success rate was 100 per cent among groups C and D eyes and 33 per cent for group E eyes.

“The addition of topotecan has improved control in eyes with vitreous seeds and in group E,” Dr Shields said.

Another report from Dr Shields and colleagues showed high tumour control and globe salvage rates were achieved in eyes with little subretinal fluid and minimal subretinal or vitreous seeds using a minimal exposure technique involving just one or two treatment cycles. Otherwise, an IAC treatment course usually involves three cycles.

They also published their experience using IAC in eyes with retinoblastoma-induced retinal detachment and reported complete reattachment was achieved in all eyes with partial detachment and in almost half of eyes with total detachment.

Ocular complications after IAC mostly relate to vascular compromise, that can include small retinal branches or even complete obstruction of the ophthalmic artery in up to five per cent of cases.

However, these problems have been minimised over the past two years with improvement in technique, noted Dr Shields.

“On histopathology we occasionally saw chemotherapy precipitates in the arteries that we believe explains the occlusion. Now, however, we are seeing occlusive problems less often using a technique that minimises fluoroscopy time and advances the catheter tip just into the ostium of the ophthalmic artery,” Dr Shields said.

Update

33

RETINA

INTRAOPERATIVE OCT

Vitreoretinal applications could improve surgery outcomes and understanding of pathophysiology

F

our weeks after a shaken baby with epiretinal membrane was treated with a 25-gauge vitrectomy and retinal peel, optical coherence tomography (OCT) revealed a second membrane layer missed at the first surgery. Following its removal in a second procedure, the infant’s foveal contour returned and vision improved.

Many repeat surgeries such as this might be prevented with intraoperative OCT for vitreoretinal surgery, Albert J Augustin MD, professor and chairman of the Department of Ophthalmology at Klinikum Karlsruhe, Karlsruhe, Germany, told the 12th EURETINA Congress. The emerging technology “allows you to judge the different [tissue] layers and the results of your surgery immediately, and you still have access to the retina if you missed something.”

Microscope-mounted OCT systems now in development also could improve the accuracy of diagnosis and prognosis, prevent second peels and other procedures that may turn out to be unnecessary as surgery progresses, and avoid surgical mishaps such as inducing full-thickness macular holes, Prof Augustin said. Detailed 3-D imaging of how tissues respond during surgery also would advance understanding of the pathophysiology of vitreoretinal conditions, he added.

“I think we can clearly state that vitreoretinal surgery overall would benefit from real-time feedback on depth and tissue interaction,” Prof Augustin said.

Handheld OCT The use of OCT during vitreoretinal surgery began with handheld devices and dates back at least to 2009, with much of the pioneering clinical work done

by Cynthia Toth MD and colleagues at Duke Eye Centre, Durham, North Carolina, US, Prof Augustin said. Such devices provide rapid, non-contact, high-resolution, crosssectional retinal imaging that can be very useful for assessing progress intraoperatively.

For example, it can help identify surgical changes difficult to see under the surgical microscope, such as relief of macular traction around a full-thickness macular hole following internal limiting membrane peel (Dayani et al. Retina. 2009;29(10):1457-1468). It can also show development of a macular hole during a peeling procedure.

This may lead to a modification of your surgical technique and tamponade, Prof Augustin said.

Handheld intraoperative OCT also has provided insight into disease pathogenesis, such as showing a possible connection between the vitreous cavity and intraretinal fluid in optic pit-related maculopathy (Ehlers et al. Arch Ophthalmol. 2011;129(11):1483-1486).

However, handheld OCT also presents several drawbacks, Prof Augustin noted. The system must be covered by a sterile plastic bag, making it somewhat clumsier to use than in non-surgical settings, and potentially compromising the sterility of the operating field. More significantly, it requires halting surgery and does not allow imaging of live surgical manoeuvres with instruments in the eye.

The next logical step is to mount the OCT on the surgical EUROTIMES | Volume 18 | Issue 3

Courtesy of Albert J Augustin MD

by Howard Larkin in Milan

am ur 13th EURETINA Congress

26–29 September 2013 available online: registration and Hotel Bookings

www.euretina.org Figure 1 (left): OCT of an epiretinal membrane before surgery; Figure 2: OCT of the epiretinal membrane case immediately after surgery showing successful removal of the membrane and remaining retinal thickening

microscope so it can be used during surgery, Prof Augustin said. Work with spectral domain OCT in porcine eyes has shown that it can image instruments and retinal tissues in surgery (Ehlers et al. IOVS, May 2011).

“The diamond-dusted scraper can clearly be seen, which means you can judge your manoeuvres by visualising the instrument you are using in surgery.”

Integrating the OCT image with the surgical image, so that both can be seen simultaneously, will allow surgeons even greater control, Prof Augustin said.

Prototypes have been demonstrated on animal eyes and are in development at Duke and by Susanne Binder MD and colleagues at Rudolph Foundation Hospital, Vienna, Austria.

Dr Binder is collaborating with Carl Zeiss Meditec, who have mounted a Cirrus HD-OCT system running 4.5.1.11 Cirrus HD-OCT acquisition software adapted to the optical pathway of a Zeiss OPMI VISU 200 surgical microscope.

The shared pathway enables simultaneous direct and OCT visualisation of the same surgical area.

Prof Augustin presented several cases illustrating the capability of microscope-mounted OCT. In one, of a preretinal membrane, the flat membrane without anteriorposterior traction and an intact foveal contour are clearly visible at the start of surgery, as are the clean retina and foveal depression at the end of vitrectomy.

In another case, the lifting of the internal limiting membrane is clearly visible mid-procedure. A third shows how the technology can be used to identify residual membrane after the first peeling.

Intraoperative OCT is also useful for evaluating macular hole closure directly after membranectomy and can help determine how to proceed, Prof Augustin said. It can help in choosing which gas to use or if just air is an option.

Prof Augustin noted that ultrasound imaging is already used to guide placement of posterior radioactive plaque for treating choroidal melanoma. OCT can provide very high resolution images of the choroid, and so is a logical next step.

Recording OCT images during surgery also opens the door to further research in pathophysiology, Prof Augustin said.

contact Albert Augustin – albertjaugustin@googlemail.com

contacts

Update

OCULAR

New innovations

Variety of platforms show promise for safe, efficient, effective and long-lasting drug delivery

by Cheryl Guttman Krader in Fort Lauderdale

U

ntethered microbots, nanospheres and thermoresponsive hydrogels are among the many new innovation approaches being evaluated to better deliver drugs to ocular structures.

Speaking in a mini symposium during the 2012 annual meeting of the Association for Research in Vision and Ophthalmology (ARVO), Ashim Mitra PhD, School of Pharmacy, University of Missouri, Kansas City, described increasing ocular tissue bioavailability of topically applied drugs via various chemical modifications, including creating prodrugs that target influx transporters present in the cornea and using a lipid linker to enhance cellular uptake.

“Rather than using potentially cytotoxic permeation enhancers to increase transport of impermeable drugs through the cornea, the prodrug approach takes advantage of the cells own machinery. We have shown these compounds are not cytotoxic, and in animal models, acyclovir prodrugs have demonstrated excellent activity against epithelial and stromal HSV-1 keratitis,” Dr Mitra said.

Dr Mitra and colleagues are also working to develop thermo-sensitive gel technology using novel pentablock polymers to improve the residence time of drugs both

Courtesy of Bradley Nelson PhD

34

A 1mm-long microrobot docked to a chick embryo chorioallantoic membrane which serves as a retinal vein model

in front of and inside the eye. He described development of a dual phase polymeric delivery system comprised of a continuous biocompatible gel phase and a discontinuous nanoparticle phase that has been successful in avoiding the burst release phenomenon that has been a limitation of other nanoparticle formulations for ocular drug delivery.

Jennifer Kang-Mieler PhD, Department of Biomedical Engineering, Illinois Institute of Technology, Chicago, also discussed thermoresponsive hydrogels as a platform for ocular drug delivery. She pointed out that an advantage of this technology is that it allows for intraocular drug delivery through small gauge needles.

She described how her laboratory has synthesised thermo-responsive hydrogels as both degradable and nondegradable systems and encapsulating various ocular pharmacological agents. She also noted this

From the Archive New ESCRS trial in bid to cut endophthalmitis rate to 0.01%

T

he ESCRS has launched the largest multicentre controlled trial ever undertaken in ophthalmology worldwide, designed to reduce the incidence of endophthalmitis following cataract surgery to less than 0.01 per cent and precisely identify the natural history and true incidence of the disease.

The trial heralds the beginning of a new role for the ESCRS in the organisation and funding of clinical research.

"Endophthalmitis is the most feared complication in cataract surgery, but due to its

EUROTIMES | Volume 18 | Issue 3

low frequency it has been very difficult to determine the risk factors of the condition and the best means of preventing it.

"No surgeon, no single clinic will ever be able to do a trial like this. Every cataract surgeon in the world will be studying the results of this trial and it should influence the way in which every cataract operation in the world is carried out," said ESCRS president Ulf Stenevi MD.

n

From EuroTimes, Volume 8, Issue 3, March 2003

platform can be developed to deliver drug at a single release rate, or when combined with nanoparticles or microspheres, at various and multilevel rates.

So far, data from in vitro and in vivo biocompatibility studies indicate the synthesised thermo-responsive hydrogels are safe for injection in the eye. Dr KangMieler also described results from an animal study demonstrating efficacy and safety of a nanosphere-thermo-responsive hydrogel complex encapsulating dexamethasone sodium phosphate for suppressing laserinduced choroidal neovascularisation (CNV).

“We believe our thermo-responsive hydrogel has benefits as a potential drug delivery system, and we hope it will be used for various ocular pharmacological agents in the future,” she said.

Speaking at the same symposium, Peter Humphries PhD, Department of Genetics, Trinity College, Dublin, Ireland, discussed improving drug delivery to neuronal ocular tissues via barrier modulation. Explaining the rationale, he noted that about 98 per cent of systemically administered low molecular weight (LMW) anti-neovascular and neuroprotective compounds with therapeutic potential for retinal diseases do not cross an intact inner blood-retina barrier or do so with limited efficiency.

The strategy developed by Dr Humphries and colleagues enables permeability of LMW compounds (up to 1 kD) by selectively downregulating tight junctions of the inner retinal vasculature. He reviewed experiments that have been done with the development of a platform based on transient RNAimediated suppression of transcripts encoding claudin-5, which is a component of the tight junctions. In this approach, a doxycyclineinducible gene encoding claudin-5 shRNA is delivered using an adeno-associated viral vector that efficiently transduces the endothelial cells of the inner retinal vasculature. The gene is switched on in tandem with the systemically administered drug.

“So far we have shown this is a remarkably efficient way to get LMW compounds from the peripheral circulation into the eye while excluding larger, noxious molecules. In addition, all evidence from studies conducted so far indicate this is a potentially safe process for clinical use,” Dr Humphries said.

Early animal experiments demonstrated efficacy in protecting against light-induced retinal degeneration, suppressing laserinduced CNV, and preventing retinal degeneration in animal models of retinitis pigmentosa. Future research aims to apply the technology to treatment of early stage AMD to prevent progression to neovascular disease using LMW compounds directed at novel molecular targets.

Justin Hanes PhD, Center for Nanomedicine at the Wilmer Eye Institute,

Ashim Mitra – mitraa@umkc.edu Jennifer Kang-Mieler – kang-mieler@iit.edu Bradley Nelson – Bradley.nelson@iris.mavt.ethz.ch Peter Humphries – pete.humphries@tcd.ie Justin S Hanes – hanes@jhmi.edu

Johns Hopkins University, Baltimore, focused on using nanoparticles as a platform for providing local drug delivery and timed, continuous release. He explained that each nanoparticle can be packed with hundreds of thousands of LMW drug molecules, and he discussed his group’s development of a biodegradable polymer drug conjugate technology for treating ocular neovascularisation based on an investigational, potent inhibitor of hypoxia inducible factor-1a (HIF-1a).

Results from in vivo testing generated positive safety data and showed efficacy of the HIF-1a polymer nanoparticles in models of laser-induced CNV, oxygen-induced ischemic retinopathy, and neovascular AMD. In the latter experiment, which was done in a well-accepted transgenic mouse model of ocular NV, the duration of action of the HIF1a polymer particle treatment was at least 2.5 times longer than that of ranibizumab.

“These are exciting results with our firstgeneration system, and we believe a system based on larger microparticles might extend the duration of action significantly. In addition, unlike anti-VEGF agents, treatment with the single-agent HIF-1a inhibitor downregulates VEGF, PDGF, their receptors and other pro-angiogenic molecules, leading to regression of CNV,” Dr Hanes said.

He added that the nanotechnology platform has applicability to other drugs and is being investigated in a variety of projects, including cornea graft rejection studies and for neuroprotection of retinal ganglion cells and photoreceptors.

An engineering-driven approach

Bradley Nelson PhD, Institute of Robotics and Intelligent Systems, ETH-Zurich, Switzerland, reviewed the work his group has been doing developing microrobots for retinal drug delivery and surgical applications. Wireless control of these untethered microdevices is achieved using electromagnetic fields. So far, evaluations in in vitro and in vivo experiments show the systems provide force feedback and can be navigated with micron precision.

Based on initial experience, it is expected the microrobots can be introduced into the vitreous through a sutureless site and manoeuvred without the need for vitrectomy.

As a strategy for retinal drug delivery, the group is currently focusing on using the steerable microrobots to precisely place drugloaded implants at the site of pathology.

“Using the microrobot to overcome diffusion limits would dramatically decrease the amount of drug that needs to be released,” Dr Nelson explained.

In addition to drug delivery, other possible applications for the technology include removing epiretinal membranes, repairing retinal tears, and hypoxia monitoring at the vitreoretinal interface.

35

Update

OCULAR

OCULUS SDI® 4 / BIOM® 5

LID SURGERY

Running an aesthetic surgery office differs from that of a general ophthalmology practice

by Pippa Wysong in Toronto

W

hen it comes to performing surgery on or around the eyelid, at what point should a subspecialist be brought in, or can a general ophthalmologist do it all?

These were among the questions debated at the annual Walter Wright Ophthalmology conference in Toronto, Canada.

"There is no question generalists can, and should perform eyelid surgery," said Patricia Teal MD. She is an ophthalmologist and chief of surgery at the Douglas Memorial Hospital in Fort Erie. She also founded the Patricia Teal MD Cosmetic Laser & Aesthetic Centre in Fort Erie, Ontario.

Ryan Eidsness MD, added that he considers all eyelid surgeries as cosmetic procedures because “all patients expect good aesthetic results.” He is an ophthalmologist who practices at Focus Eyecare Specialists in Regina Saskatchewan and is trained in oculoplastics.

However, certain complex procedures should be left to people who have additional training specifically in either oculoplastic or cosmetic surgery. These include lacrimal repairs, reconstructive surgery/cancer-related issues, orbit repairs and surgery specifically for more complex cosmetic purposes. Both debaters agreed with this.

“When it comes to eyelid surgery, you should do just what you’re comfortable doing,” Dr Eidsness said. Generalists should be able to perform common procedures like lid laceration repair, ectropion, entropion and blepharoplasty. These are within the capabilities of all graduating residents, he said.

“It’s when you get into the larger procedures and the less reproducible procedures like ptosis repair, reconstruction and canalicular repair - these should be left for surgeons with subspecialty training,” he said.

Most generalists shy away from these anyway. Generally, the reoperation rate for ptosis is between three per cent to 20 per cent, noticeably higher than for blepharoplasty, ectropion and entropion surgeries, he noted.

Successful eyelid surgery means knowing the anatomy. To start with one needs to know where the eyelid is supposed to sit.

“It’s surprising how many people don’t know where it should sit. If you don’t know this, and if you don’t understand the gender and racial differences, you’re not going to get a good result,” Dr Eidsness said.

EUROTIMES | Volume 18 | Issue 3

Another tip for successful eyelid surgery is to understand surgical planes, with the goal to restore normal anatomy, he added.

Sometimes blepharoplasty cases come in with additional issues, which make the surgery less straightforward and these should be done by someone with more experience.

For instance, ptosis, or a drooping eyelid, can have a number of different causes which may require different approaches.

“In patients where surgery is the appropriate choice, you have to know your options. For ptosis surgery, the anterior approach is probably the most common, though there are some good posterior approaches. All of them can provide excellent results, it’s knowing when to use them and how to use them,” Dr Eidsness said.

Cosmetic surgery

Ophthalmologists wanting to perform more detailed cosmetic surgery of the eye should undergo additional training, Dr Teal said. “Cosmetic surgery is really a subtype of oculoplasty. It’s goal is to enhance the appearance of the eye toward an aesthetic ideal, or restoring normal appearance,” she said.

Not everyone is cut out to do cosmetic surgery and there are requirements beyond technical skill. “Do you have the right personality and talents? Plus, are you the type of person who likes to sit and talk to people?

You need to understand people’s lives, what they want and why they want a cosmetic procedure,” she explained.

Traits such as creativity and ingenuity are not as straightforward. Cosmetic surgeons need artistic vision and skill, along with some artistic talent. “You have to appreciate and understand what's beautiful. If you don’t, you won’t have any success in the cosmetic field,” Dr Teal said.

Being mentored is important too, but it can be tricky finding a good mentor, in part because cosmetic surgery is competitive.

Running a cosmetic surgery office is quite different from that of a general ophthalmology practice. This is largely due to the fact that cosmetic patients are healthy patients, and need to be treated differently by office staff. Don’t have well patients and sick patients in the same waiting room, she said.

contacts

5 Reasons for the new BIOM® 5 •

Reliability Titanium and stainless steel ensure highest mechanical stability

•

Function Short and long versions of the BIOM® 5 support the working distance of choice

•

Accuracy Fine focusing made easy through reduction of the thread lead

•

Time Saving Fast exchange of view of retina and anterior segment due to newly designed reduction lenses

•

Made to last Excellent resistance to today‘s rigorous sterilization methods

www.oculus.de

Ryan Eidsness – r.eidsness@gmail.com Patricia Teal – info@tealcosmeticlaser.com Eurotimes SDI5 Produkt e 120x3001 1

29.01.2013 13:05:10

36

Update

PAEDIATRIC OPHTHALMOLOGY

EPOS/ WSPOS

European Paediatric Ophthalmological Society / World Society of Paediatric Ophthalmology & Strabismus

PAEDIATRIC SUB SPECIALTY DAY WEDNESDAY 9 OCTOBER 2013 Taking place during XXXI Congress of the ESCRS 5–9 October 2013 Amsterdam RAI, Amsterdam, The Netherlands Immediately preceding The 39th Meeting of EPOS in Leiden, The Netherlands from 11–12 October 2013.

Available Online: Registration and Hotel Bookings

www.wspos.org

EUROTIMES | Volume 18 | Issue 3

OPTIMISING OUTCOMES

Decades of clinical experience and research studies generate a wealth of practical pearls

by Cheryl Guttman Krader in Milan

I

n a keynote address delivered at the 2nd World Congress of Paediatric Ophthalmology and Strabismus, Emilio Campos MD, professor and chief of ophthalmology, University of Bologna, Italy, highlighted his career experiences and lessons learned during 40 years of clinical strabismology. His presentation provided pearls for amblyopia detection and treatment of amblyopia and strabismus.

While screening in young children is critical to limit the burden of amblyopia-related visual impairment, achieving complete eradication of amblyopia through screening is impossible because of the presence of primary microstrabismus, noted Dr Campos.

In undertaking screening, evidence demonstrating there is good parallelism between free alternation of fixation and equal visual acuity in the two eyes until around age five indicates that fixation preference can be used for diagnosing and following amblyopia in children below the age when visual acuity can be reliably tested (<3 years).

However, fixation preference in one eye can only be reversed by treatment early, said Dr Campos, cautioning that continuing occlusion after age five with the aim of obtaining free alternation has to be avoided.

“Intractable diplopia will be its only result,” he said.

Cure of amblyopia is established by obtaining iso-acuity, free alternation, equal speed of reading and iso-accommodation. If residual amblyopia persists, hyperopic patients should receive a full cycloplegic correction to achieve their optimal acuity.

Although a variety of modalities for treating amblyopia have been proposed over the years, Dr Campos said that none is a valid alternative to occlusion. Nevertheless, there is a place for medical therapy. Recognising the role of the dopaminergic system in amblyopia, Dr Campos and colleagues began investigating the use of citicoline. Their experience showed intramuscular injection of citicoline produced stable results for at least six months without complications.

“Citicoline represents a useful adjunct to part-time occlusion in non-responding patients, and with the current availability of an oral preparation, its use is easier and more accepted,” Dr Campos said.

Research investigating botulinum toxin for strabismus treatment was initiated by Dr Campos almost three decades ago with a focus on essential infantile esotropia.

“In the early 1970s, based on the idea that a prevalence of esotonus was the underlying aetiology, use of prisms and even surgery were proposed as treatment for infantile esotropia to break the system and induce an exotropia. However, injection of botulinum toxin into both medial rectus muscles is a more acceptable and less invasive approach,” he said.

The technique involves mask narcosis and injection of botulinum toxin A five units per muscle, under direct visualisation with an open sky approach. Dr Campos noted that stable results have been achieved in about 75 per cent of cases after just one treatment if the neurotoxin is administered no later than six months of age. “The end-result is usually a small-angle esotropia, rarely orthotropia, but normal binocular vision with stereopsis has never been achieved,” he said.

Dr Campos provided four take-home messages about accommodative esotropia, the most common form of esotropia. Having found that hyperopes who develop esotropia have a reduced fusional amplitude in divergence, Dr Campos said that a full retinoscopic correction should be prescribed as prevention in these patients.

He addressed the misperception on hypo-accommodation in patients with a high accommodative convergence. Lack of accommodation is due to prolonged use of bifocals, noting that it pre-exists. Therefore, parents must be counselled that the need for near aid might remain after surgery.

Dr Campos said that a change in the AC/A ratio probably underlies esophoria that is present with full correction in teenagers with accommodative esotropia and asthenopic complaints. In this situation, surgery can be performed but will eliminate only the phoric component.

Treatment of accommodative esotropia requires full retinoscopic correction and surgery is contraindicated. Bifocals should be used for the correction and not progressive lenses.

Findings from studies by Dr Campos and colleagues also highlight issues to keep in mind when performing strabismus surgery. He cautioned colleagues to think about a lost or slipped muscle in patients who present with an excessive lid opening and a mild muscle action deficit so that they do not inadvertently operate on healthy muscles without fixing those responsible for the strabismus.

Dr Campos also underscored the need for follow-up within one week after reoperating on rectus muscles to evaluate patients for the development of corneal dellen, which occurs fairly frequently after reoperations.

Noting a shift in strabismologists’ surgical activity to include more adults with acquired ocular motility problems, Dr Campos reinforced the need to evaluate motility in both eyes when operating on adult patients with a large deviation and severe motility disorder secondary to thyroid eye disease.

“The presence of a high degree hypotropia should not detract your attention from a careful evaluation of motility in the second eye and from CT/NMR examinations. Surgery on just one eye would not solve the problem,” he said.

He further noted that involvement of the second eye can be delayed, occurring after a long period of the patient being diplopia-free. Awareness of this situation will allow proper diagnosis and intervention.

“The greatest mistake that a surgeon can make is to undo the previous surgery rather than approaching the newly affected eye,” Dr Campos said.

Also pertaining to strabismus surgery in adults, Dr Campos noted misperceptions exist about the risk of diplopia after operating on a severely amblyopic eye of adults. Based on findings from his research showing that diplopia is much more likely to occur in amblyopic than in freely alternating patients, there is no risk of postoperative diplopia in adults with infantile alternating strabismus. However, greater caution is needed in deep amblyopic patients.

contact

Emilio Campos – emilio.campos@unibo.it

37

Update

PAEDIATRIC OPHTHALMOLOGY

AMBLYOPIA

Evidence-based guidelines for amblyopia treatment, but more data needed to determine certain predictive factors

by Cheryl Guttman Krader in Milan

T

he large, prospective multicentre trials conducted by the Paediatric Eye Disease Investigator Group (PEDIG) have changed his practices for managing amblyopia secondary to anisometropia, strabismus or both, in patients ages three to 17 years, Jonathan Holmes MD, told a session of the 2nd World Congress of Paediatric Ophthalmology and Strabismus.

Dr Holmes said that prior to the PEDIG studies he would initiate treatment with spectacle correction based on the cycloplegic refraction plus patching of the sound eye for six hours/day. “Now I begin treatment with spectacles alone, even when there is strabismus and even in older children, based on PEDIG observational studies showing that amblyopia resolved completely in at least 25 per cent of cases using spectacles alone,” said Dr Holmes, Joseph E and Rose Marie Green Professor of Visual Sciences, Mayo Clinic, Rochester, MN, US. If spectacles alone are insufficient, options for achieving further visual acuity (VA) improvement include patching the sound eye, atropine to the sound eye or fogging the sound eye with a Bangerter filter. For patching, Dr Holmes said he initially prescribes just two hours a day, even for severe anisometropic/strabismic amblyopia. Use of this low-dose regimen is based on results of randomised clinical trials comparing different patching regimens in children ages three to less than seven. In a trial enrolling patients with severe amblyopia, children were randomised to patching prescribed full-time or six hours/day. A moderate amblyopia trial compared patching prescribed six versus two hours/day.

In each study, the two patching regimens resulted in similar mean VA improvement. In a follow-up randomised clinical trial of two hours of daily patching with or without near activities, some cases of severe anisometropic or strabismic amblyopia also improved with the low-dose twohour-a-day regimen. Another randomised study by Stewart et al, in England, also reported similar outcomes for patching six versus 12 hours/ day. “Using an occlusion dose monitor to determine compliance, Stewart et al found patching time averaged six hours for those in the 12-hour group and four hours in the six-hour group, which may partly explain the similar mean visual acuity improvements with the different regimens,” Dr Holmes said.

However, he added that a review of individual outcomes in the Stewart study showed some patients achieved complete resolution of amblyopia when patched for just one or two hours/day and others had little improvement despite actually patching for more than 10 hours/day.

“Currently we do not have enough data to determine potential predictive factors for a child being an extremely poor responder or a super-responder. The inability to identify these children prior to starting patching remains a challenge for clinicians,” Dr Holmes said.

He added, “If VA improvement plateaus with two hours of patching, treatment can be switched or the patching time can be increased. Patching two hours a day is very reasonable for starting treatment, but will not be enough for everybody.”

EUROTIMES | Volume 18 | Issue 3

The efficacy of atropine one per cent for treatment of amblyopia was demonstrated first in a PEDIG study of moderate amblyopes randomised to atropine one drop every morning or part-time occlusion at least six hours a day. A follow-up PEDIG study in moderate amblyopes showed outcomes were similar using atropine on weekend mornings only, compared with daily use. A third study compared weekend atropine alone or with a plano lens. The addition of the plano lens (increasing the blurring effect of the atropine) as initial treatment for amblyopia did not enhance mean VA improvement over weekend atropine alone, but it increased by fourfold the percentage of children temporarily losing VA in the sound eye.

“Clinicians using a plano lens to enhance the atropine effect need to follow children carefully for reverse amblyopia. VA usually returns to baseline after treatment stops, but some children may require treatment for reverse amblyopia,” Dr Holmes said.

He added that findings from the latter study, which included 60 children with severe amblyopia, support weekend only atropine as a reasonable option even for severe amblyopia.

Results of a trial enrolling children ages seven to 17 years led Dr Holmes to offer treatment for amblyopia to older children, especially those seven to 12 years of age.

In this PEDIG study, children were randomised to optical correction only or augmented with patching (two to six hours/day) plus near activities. Children in the augmented treatment arm aged <13 years also received atropine.

Among children ages 13 to 17, responder rates were similar in the augmented regimen and optical treatment alone groups. However, the responder rate was more than doubled by augmented treatment in children ages seven to 12. When the children in each age group were further divided based on history of previous treatment for amblyopia, there was a benefit of the augmented regimen among treatment-naïve older children (≥13 years). In the younger subgroup (<13 years), there was a significant benefit of augmented treatment (patching plus atropine) regardless of prior treatment history, but the proportion of responders to augmented treatment was much higher in the treatmentnaïve subgroup.

“The individual data from this study also highlight significant individual variability in response and identified some children ages 14 to 15 who had a marked improvement in VA,” Dr Holmes observed.

“Unfortunately, as clinicians, we can’t yet predict who will be a super-responder, and so it is very reasonable to offer treatment of patching two hours/day to even teenagers with amblyopia, after a trial of spectacles, particularly if they have never had a previous trial of treatment,” he said.

contact Jonathan Holmes – holmes.jonathan@mayo.edu

CALL

FOR ENTRIES ENTER THE JOHN HENAHAN

WRITING COMPETITION for Young Ophthalmologists and WIN a €1,000 travel bursary to the XXXI Congress of the ESCRS in Amsterdam, The Netherlands, 5-9 October 2013 See www.facebook.com/ESCRSYO for details

JOHN HENAHAN PRIZE 2013

PAEDIATRIC OPHTHALMOLOGY

REFRACTIVE SURGERY

Some of the children who benefit most from refractive surgery are those least likely to respond to conventional approaches

by Roibeard O’hEineachain in Milan

EUROTIMES | Volume 18 | Issue 3

“

LASIK works well, but these implants have major advantages in paediatric ophthalmology Michael O’Keefe FRCS

L

ong-term follow-up of an increasing number of patients appears to confirm the safety and efficacy of refractive surgery in children, whether in the form of corneal ablation or phakic IOLs, according to two speakers at the JCRS session of the XXX Congress of the ESCRS. The main indications for refractive surgery in children are myopia, anisometropic amblyopia and congenital high myopia where the traditional methods of treatment are not successful. Those traditional methods include glasses, contact lenses, patching and atropine, said William F Astle MD, FRCSC, Alberta Children's Hospital, University of Calgary, Calgary, Alberta, Canada.

“There tends to be a certain subset of children who won't wear their glasses and are not progressing appropriately no matter what you do. And there are children with a range of underlying medical and neurobehavioral conditions who are not going to wear their glasses or contact lenses and in many cases they're functionally blind,” Dr Astle said.

He noted that he and his associates have performed PRK and LASEK on 446 eyes of 275 children with various amounts of hyperopia, myopia and astigmatism and their results to date show that it is very effective both early on and after 14 or more years of follow-up.

Dr Astle noted that he and his associates initially performed standard PRK on their patients but because of a few instances of dense haze they switched to performing LASEK, which they combine with mitomycin C in eyes with greater than five dioptres of myopia or hyperopia. They performed all of the procedures using general anaesthesia.

Among the 55 anisometropic amblyopes who underwent surgery, the preoperative refractive difference between the two eyes was 4.77 D preoperatively and 0.56 D postoperatively. Among the 39 patients in the myopic group, the mean difference between the two eyes went from 9.12 D to 1.18 D. In the 16 hyperopic group it went from 5.84 D to 0.0 D, he reported.

Dr Astle noted that in 80 per cent of the children the treated eye was within 3.0 D of the fellow eye at 5.5 years after their surgery.

In addition 63.6 per cent had improvements

contacts

William F Astle – william.astle@ albertahealthservices.ca Michael O’Keefe – mokeefe@materprivate.ie

Update

Courtesy of William F Astle MD, FRCSC

38

Standard anaesthesia technique with the laser

in their vision and the proportion with fine stereo vision rose from 9.09 per cent before LASEK to 43.64 per cent post-LASEK. He added that some of the children who benefit most from refractive surgery are those least likely to respond to conventional approaches. For example, in children with autism, parents reported that the surgery seemed to bring about improvements in behaviour, in their walking ability and their overall functional abilities.

“A lot of professionals and even parents of children with neurobehavioral disorders have very low expectations for them and feel that their uncorrected vision can be dismissed as good enough for a child that has multiple handicaps, but these days paediatric refractive surgery can fulfil an

important need for this complex minority of children,” Dr Astle added.

Other options Michael O’ Keefe FRCS, Mater Private Hospital, Dublin, Ireland, said that he has been performing paediatric refractive surgery for over 10 years and that he currently prefers to use Artiflex® irisfixated IOLs (Ophtec), which he said are less expensive than LASIK or PRK and offer very quick rehabilitation.

“An additional advantage of phakic IOLs is that they can be replaced if their refraction changes significantly as the child grows. Furthermore, it leaves the cornea largely untouched, leaving the option open for future corneal ablative procedures,” he said.

However, he noted that he achieved good long-term results with LASIK in a series of seven eyes of six amblyopic patients. The patients ranged from two to 12 years in age and their preoperative spherical equivalent ranged from -5.00 D to -16.0 D, and their mean preoperative visual acuity ranged from hand movements to 6/18.

After a mean follow-up of 9.5 years the mean spherical equivalent was -4.3 D, compared to -9.6 D preoperatively. In addition, their postoperative visual acuity ranged from 6/6 to 6/60 and improved by a mean 2.5 Snellen lines in six eyes.

“Ten years later we're seeing no ectasia or any long-term flap complications, and of the seven eyes we treated five had a mean regression of about two-and-a half dioptres.

But we saw 3.7 D of regression in the untreated eyes,” Dr O’Keefe said.

He and his associates have also achieved good results with the Artiflex IOLs in 11 eyes of six children. After a mean followup of 15 months the mean preoperative spherical equivalent (SE) refraction improved from -14.6 D to -2.40 D and the mean corrected distance visual acuity improved from logMAR 0.84 to 0.67 postoperative SD (p=0.005).(Ryan et al, Acta Ophthalmol 2012 ;90:458-462).

The indications for refractive surgery in the study included high anisometropia and high myopic astigmatism and high bilateral myopia in children with neurobehavioral disorders.

Dr O’Keefe noted that in their responses to a NEI VFQ-25 questionnaire, parents of the patients in his series reported significant improvements in their children’s visionrelated quality of life.

He added that there were no intraoperative or postoperative serious complications. However, he acknowledged that the risk of endothelial cell loss will entail some extra vigilance over the years to come.

“LASIK works well, but these implants have major advantages in paediatric ophthalmology. If I were to pick one single thing it would be the quick visual rehabilitation that they provide, with the lack of all the ongoing treatment that I would otherwise have to carry out,” he added.

contacts

Lampros Lamprogiannis – lamproslamprogiannis@ hotmail.com Sonia Manning – sonia.sofia1@gmail.com

News

EUREQUO

BENCHMARKING

Audits yield valuable insight for organisational and individual improvement

by Howard Larkin in Milan

C

omparative data from the nearly one million cataract cases recorded in the European Registry of Cataract and Refractive Surgery Quality Outcomes (EUREQUO) helps both surgery centres and individual surgeons assess and improve their performance, presenters told the XXX Congress of the ESCRS. From experienced consultants to resident trainees, the data help identify not only opportunities for upgrading surgical skills but also differences in populations that may influence patient needs and outcomes.

“EUREQUO provides a simple, uniform method of recording pre-operational, intra-operational and post-operational data. It allows comparison on a national and international level, and is a valuable tool in our effort to improve our surgical results,” said Lampros Lamprogiannis MD, of the 2nd Department of Ophthalmology, Aristotle University of Thessaloniki, Papageorgiou General Hospital, Greece, which is headed by Prof Stavros Dimitrakos.

The Anterior Eye Department of the clinic, headed by Assistant Prof Ioannis Tsinopoulos, joined EUREQUO in March 2012. A first analysis was presented, comparing results of the clinic with national and international data.

On average, cataract patients presenting at Papageorgiou had worse corrected visual acuity than the international figures, with 80 per cent below 0.5, or 20/40, and 21 per cent at or below 0.1, or 20/200, compared with 52 per cent and 12 per cent internationally, and 70 per cent and 24 per cent in Greece.

“It is clear that patients in our hospital choose to be operated on much, much later,” Dr Lamprogiannis said.

Rates of pseudoexfoliation were also substantially higher at Papageorgiou, 6.59 per cent, and in Greece, 7.93 per cent, than the international figure of 0.41 per cent.

“When it comes to risk factors in cataract surgery, the main problem we have to deal with is pseudoexfoliation,” said Dr Lamprogiannis, noting that the present findings are consistent with previous studies that show a high prevalence in Greece.

All Papageorgiou cataract patients received phaco and posterior chamber EUROTIMES | Volume 18 | Issue 3

IOLs, as did more than 99 per cent of patients internationally. Dr Lamprogiannis reported that acrylic hydrophobic lenses were implanted in 98 per cent of patients, compared with 64 per cent nationally, topical anaesthesia was used in 97 per cent compared with 44 per cent internationally, and 5.56 per cent of patients were admitted as inpatients, far less than the 43 per cent reported nationally.

Dr Lamprogiannis noted that the complication rate in the 2nd Department of Ophthalmology, at 6.46 per cent, was somewhat higher than for Greece, at 5.71 per cent, and much higher than internationally, at 2.15 per cent. Possible reasons for the higher rate could include the higher incidence of pseudoexfoliation and advanced cataracts, he said. The clinic also has a higher proportion of older patients, and 23 per cent of procedures are done by residents, which may also increase complications.

Despite these complications, postoperative uncorrected visual acuity results are similar to national and international outcomes, with 25 per cent of clinic patients achieving 0.8, or 20/25, or better and 71 per cent achieving 0.5 or better, compared with 24 per cent and 56 per cent nationally, and 26 per cent and 61 per cent internationally. Short-term post-surgical complication rates are also comparable. The clinic also uses premium IOLs more often, with 11 per cent of

patients receiving them, of which eight per cent were toric and three per cent multifocal. That compared with two per cent premium lenses of all types nationally and 0.5 per cent internationally.

“It makes it easy to conduct audits of surgical outcomes, and the results can improve treatment and patients’ quality of life,” Dr Lamprogiannis said of his first EUREQUO comparison. “In Greece we are sometimes accused of not counting. So we try to counteract that.”

Surgical training EUREQUO also provides valuable benchmarking information for surgeons in training, said Sonia Manning MD, of St Vincent’s University Hospital and Royal Victoria Eye and Ear Hospital, Dublin, Ireland. A senior ophthalmology trainee, she used the system to track her progress toward published performance guidelines based on EUREQUO data (Lundström M et al. J Cataract Refract Surg 2012 Jun; 38(6): 1086-93).

Dr Manning prospectively entered into EUREQUO data for 316 consecutive cataract operations over a 20-month period from January 2011 through August 2012, during which she worked at three training hospitals in Dublin. She then compared her results with those of other participants in Ireland and Europe.

Preoperatively, Dr Manning found that her patient mix had somewhat worse best corrected visual acuity and more complicating factors than in Ireland or internationally. Only 23 per cent of her patients achieved 6/12, or 20/40, compared with 37 per cent nationally, and 48 per cent internationally. Conversely, 22 per cent of her patients had corrected vision of 6/60, or 20/200, or worse, compared with 16 per cent nationally, and 12 per cent internationally.

The rate of co-existing eye disease,

including AMD, glaucoma and diabetic retinopathy, was 36 per cent, compared with 26 per cent and 30 per cent respectively nationally and internationally.

Twenty-four per cent of the patients had co-morbidity rendering surgery technically more difficult, including white cataract, pseudoexfoliation and corneal opacities.

Nine per cent of cases had small pupils, requiring mechanical dilatation, compared with five per cent nationally and three per cent internationally.

Intra-operatively, 99.7 per cent of Dr Manning’s patients received phacoemulsification, similar to national and international rates. Dr Manning had seven posterior capsule ruptures for a rate of 2.22 per cent, higher than the 1.33 per cent for Ireland and 1.17 per cent internationally.

She also reported two dropped nuclei (a rate of 0.63 per cent, also higher than the 0.28 per cent national and 0.04 per cent international rates, respectively).

With 92 per cent of all patients and 98 per cent of patients without ocular co-morbidities achieving 6/12, or 20/40, or better corrected vision, Dr Manning’s visual acuity outcomes were comparable to national and international results.

However, her postoperative complication rates were somewhat higher than acceptable published benchmark standards. She had no cases of posterior capsule opacification, endophthalmitis or elevated intraocular pressure at a mean follow-up of 20 days following surgery.

EUREQUO made ongoing self-audit easy and helped me identify areas needing improvement and focus on goals, Dr Manning said. “It proves to myself, my trainers and training body that I am on my way to achieving proposed benchmark standards. I recommend it to all trainees in cataract surgery.”

Visit: www.eurequo.org.

Journal Watch Aspirin AMD Risk?

Regular aspirin use may be associated with an increased risk of developing age-related macular degeneration (AMD), a new study suggests. Australian researchers prospectively analysed data from a population-based cohort with four examinations during a 15-year period (1992-1994 to 2007-2009). They found that regular aspirin users were more likely to have incident neovascular AMD. The 15-year cumulative incidence of AMD was 9.3 per cent in users and 3.7 per cent in nonusers. This remained true after adjustment for age, sex, smoking, history of cardiovascular disease, systolic blood pressure and body mass index. Moreover, the association showed a significant dose-response effect. The report has major implications for millions of patients who take aspirin for cardioprotection. In a related commentary, Sanjay

Kaul MD comments that the strength of evidence is not sufficiently robust to be clinically directive. He notes that these findings are, at best, hypothesisgenerating that should await validation in prospective randomised studies before guiding clinical practice or patient behaviour. n SG Liew et al., JAMA Intern Med, “The Association of Aspirin Use With Age-Related Macular Degeneration”, 2013;():1-7. doi:10.1001/jamainternmed.2013.1583 S Kaul, JAMA Intern Med, “Relationship of Aspirin Use With Age-Related Macular Degeneration Association or Causation?”,2013;():1-2. doi:10.1001/jamainternmed.2013.2530.

39

40

Feature

EU MATTERS

SPEEDIER INNOVATION

New ‘one-stop-shop’ process for EU patents should reduce delay and cost of bringing ophthalmic devices to market

by Paul McGinn

C

utting-edge medical devices will reach the hands of ophthalmic surgeons more quickly than ever with new “unitary patents”.

The patents, formally known as “European patents with unitary effect,” were approved as part of regulations adopted by the European Parliament, European Commission and European Council of Ministers in December.

The new patent regulations are expected to come into effect later this year – as soon as they are ratified by France, Germany, the UK and 10 other EU countries. The first unitary patents are expected to be granted as early as April of 2014.

EU leaders hope that the new unitary patents will attract more inventors and start-up companies to use Europe as their base for research and development and thus spur much-needed economic growth.

According to the latest statistics, the EU is lagging far behind the US and China in the patent race. In 2011, for example, the US granted 224,000 patents; China granted 172,000 patients. By contrast, the European Patent Office granted only 62,000 patents in 2011.

Legal protection

“One of the reasons for this difference is without a doubt the prohibitive cost and the complexity of obtaining patent protection throughout the single market,” said internal market and services commissioner Michel Barnier.

Under the current system, which was set up in 1973, inventors must expend significant sums and time to receive full legal protection of their inventions throughout EU and in non-EU countries.

Although inventors already can receive a European patent from the European Patent Office, they must apply to each European country separately to validate the European patent in that country and thus come within the protection of that particular country’s patent laws. In that way, the traditional European patent is more a “bundle” of national patents rather than a single patent.

The traditional European patent validation process involves also huge delays and significant fees for translating and administrative costs. For example, an inventor who validates a patent in every EU country must spend more than €36,000, about two-thirds of which is for translators, according to EU statistics. By comparison, inventors spend the equivalent of about €2,000 for a patent in the US or about €600 for a patent in China.

There are further costs under the current system. For instance, inventors now have to pay renewal fees in each country in which they have a validated patent. And if an investor wants to purchase the rights to use a patent through a licensing agreement, that agreement, too, has to be registered country by country, again for a significant fee. To make matters even more complicated, an inventor who wants to protect his or her

patent from infringement must hire teams of lawyers to bring multiple sets of legal proceedings in every affected country.

Streamlined application In addition to a streamlined application and approval process, the new patent regulations provide from a new Unified Patent Court to oversee the unitary patent procedure. The new process and court will protect inventions in 25 of the EU’s 27 countries.

Italy and Spain have, for now, declined to adopt unitary patents. Instead, they will continue to rely on the current – and more cumbersome – patent system, which included the EU’s 27 member countries and 11 other non-EU European nations: Albania, Croatia, Serbia, Iceland, Switzerland, Monaco, San Marino, Lichtenstein, Norway, Turkey and Macedonia.

Under the new procedure, a “European patent with unitary effect” will cost about €5,000, including translation fees.

An inventor will: *Apply for a unitary patent at the European Patent Office in Munich, Germany through one of three official languages – English, German or French; *Translate the terms of the approved patent into the other two official languages; *Receive patent protection for 20 years for their inventions in every EU country – except Italy and Spain – without the need to validate the patent in any country;

*Pay renewal fees to the European Patent Office; *Bring one set of legal proceedings to protect the patent in the Unified Patent Court. That court will have the exclusive jurisdiction to deal with lawsuits involving the validity of a patent and any infringement of a patent. The court will sit in a number of cities throughout the EU, including London, Paris and Munich.

Appeals of the decisions of those courts will be heard by a special appellate court, which will sit in Luxembourg.

Overcoming obstacles The new patent procedure, which is decades in the making, has overcome numerous political and legal obstacles.

Only two years ago, the EU's highest court, the European Court of Justice, ruled that a European Patent Court – as originally proposed, to adjudicate patent disputes throughout the 38 EU and nonEU countries – would be illegal because it did not allow for Court of Justice to hear any appeals from the patent court.

In that ruling, the Court of Justice stated that the creation of an independent patent court – without oversight by the Court of Justice – would deprive national courts and the Court of Justice itself from ensuring that EU law was correctly and uniformly interpreted throughout the EU. Under the new regulations, the Court of Justice can hear appeals from the Unified Patent Court, thus addressing the previous objections.

For more background about European patents, please see this column in the May and June 2011 issues of EuroTimes and the EU Commission’s website at: http://ec.europa.eu/internal_market/ indprop/patent/index_en.htm.

Journal Watch Cataract surgery reduces fracture risk

C

ataract surgery in older patients appears to carry the added benefit of reduced risk for hip fracture.

US researchers examined the association between cataract surgery and fracture incidence one year after cataract surgery in patients 65 years of age and older.

The study also included a random sample of Medicare (US public health insurance) beneficiaries with cataract who did not receive cataract surgery. The study included 1,113,640 Medicare beneficiaries 65 years and older with a diagnosis of cataract. The majority were female (60 per cent) and white (88 per cent). Of patients with cataract, 410,809 (36.9 per cent) underwent cataract surgery

EUROTIMES | Volume 18 | Issue 3

during the seven-year study period. During this period, the overall one-year fracture incidence was 1.3 per cent for hip fractures. Cataract surgery was associated with a 16 per cent decrease in the adjusted odds of hip fracture one year after surgery. The association between cataract surgery and lower odds of hip fracture was even stronger for patients with severe cataract. Those patients had a 23 per cent reduction in the adjusted odds of hip fracture.

Osteoporosis was the most common fracture-related comorbidity. The most common ocular comorbidity was glaucoma. Previous US studies have shown that cataract surgery is a cost-effective intervention for visual improvement, with an estimated cost per quality-adjusted life-year gained for cataract surgery in the first eye of

$2,023 in the US and $2,727 in the second eye. The current study buttresses previous reports linking visual impairment with an increased risk of fractures, illness and death in the elderly population. Cataracts have been found to be the most common cause of fracture-related visual impairment, with untreated cataract causing up to 49 per cent of visual impairment in patients with femoral neck fractures related to decreased vision. The researchers cite a need for further investigation of the additional potential benefit of cataract surgery as a cost-effective intervention to decrease the incidence of fractures in the elderly. n SVL Tseng et al., JAMA, “Risk of Fractures

Following Cataract Surgery in Medicare Beneficiaries”, 2012;308[5]:493-501.

Review

OPHTHALMOLOGICA

Retinal blood flow evaluation There are now several non-invasive technologies available which can measure the response of retinal blood flow to physiological and pharmacological stimuli.

That may in turn elucidate the role of altered retinal blood flow and its regulation in the pathogenesis of retinal diseases of vascular origin. The technologies include the new retinal vein analyzer and bidirectional laser Doppler velocimetry to measure retinal blood flow and blood vessel diameter in the main retinal vessels.

The addition of a scanner in such a setup enables the creation of a map of the retinal microcirculation. Other techniques include laser Doppler flowmetry and laser speckle flowgraphy, which measure the velocities of blood in discrete areas of the retinal tissue microcirculation. The blue-field simulation technique allows the quantification of the velocity, number and velocity pulsatility of

leukocytes moving in the retinal capillaries of the macular region. Colour Doppler imaging enables measurement of the peak systolic and end-diastolic values of blood velocity in the ophthalmic and central retinal artery, from which a resistivity index is obtained.

(Pournaras et al, Ophthalmologica 2012 DOI:10.1159/000338186)

Micronutrients in AMD There is a range of micronutrients that may be of value in treating or preventing AMD, according to a survey of the peer-reviewed literature on the topic. The micronutrients include vitamin C, β-carotene, vitamin E and zinc, the carotenoids, lutein and zeaxanthin and the omega-3 fatty acids.

Theories regarding the mode of action of the micronutrients include an improved filtration of short wavelength light and a

reduction in oxidative and inflammatory damage, in addition to other structural and physiological factors.

(Aslam et al, Ophthalmologica 2013 DOI:10.1159/000343708.)

Spectral domain OCT segmentation software In eyes with exudative AMD, the Spectralis optical coherence tomography (OCT) segmentation software provides a reliable representation of the inner limiting membrane, but is unreliable in its representation of the Bruch’s membrane, according to findings of a retrospective study. The study’s investigators reviewed 114 scans of 38 eyes of 38 newly diagnosed exudative AMD patients. The Spectralis OCT segmentation software drew inner limiting membrane correctly in all 114 spectral domain OCT scans, but drew the Bruch’s membrane correctly in only

59 scans (51.8 per cent). The software was significantly less reliable in locating Bruch’s membrane in cases with pigment epithelium detachment (PED), where it only drew the membrane correctly in 42.5 per cent of eyes, compared to 73.5 per cent of eyes without PED (p = 0.049).

(Tilleul et al, Ophthalmologica 2013; DOI:10.1159/000342980.)

José Cunha-Vaz EDITOR OF OPHTHALMOLOGICA, The peer-reviewed journal of EURETINA

Advanced technologies for cataract surgery The ultimate workflow

EUROTIMES | Volume 18 | Issue 3 60492 TOP Eurotimes ad workflow.indd 1

06-02-13 13:57

41

42

Feature

industry news

meet

Recent developments in the vision care industry

Maximum networking capability

The new OCULUS Floating License Key simultaneously supports the OCULUS devices such as the Pentacam®, the Keratograph 5M and the visual field perimeters in a local network.

The license key is used in a local computer network and is inserted in the USB port of the server. With the OCULUS Floating License Key, the basic software of the OCULUS devices can be used on up to 50 workstations simultaneously. Optional software can be used at any workstation in a local network according to the number of optional software purchased.

“The OCULUS Floating License Key can be customised with the optional software modules and packages from all OCULUS devices. The examinations from the OCULUS devices can be viewed at every workstation within the local network, where the OCULUS Patient Data Management

OCULUS Floating License Key

software is installed,” said a company spokeswoman.

The OCULUS Floating License Key allows the easy access to examination results on any computer within the local network.

This optimised viewing procedure enables improved patient consultation and increases the efficiency in a clinic,” she said. n

www.oculus.de

Support for Peruvian clinic

Geuder are supporting the ophthalmic clinic CEPRECE in Cusco, Peru.

“Today, up to 120 patients a day, often the poorest of the poor, are being examined and treated,” said a Geuder spokeswoman. “In September 2012, Dr CEPRECE Clinic Frilo Silva, the director of the clinic, was invited by Dr Berthold Seitz to Homburg/Saar for a three-week crash course in order to learn modern laser techniques, phacoemulsification and simpler vitrectomies under the guidance of the surgeons Anja and Arne Viestenz in the WetLab using various equipment systems,” she said.

Geuder supported Dr Silva with a combined vitrectomy and phaco machine plus OR instruments, so that now even complicated ophthalmic surgeries can be performed in Cusco. “The joint vision is now to expand CEPRECE to become a training centre for Peruvian ophthalmologists in order to convey the necessary know-how for self-help,” said the Geuder spokeswoman.

At the heart of EVA is a revolutionary fluid control system called VacuFlow VTi using Valve Timing intelligence technology. It just effortlessly delivers the precise flow and fast vacuum required by you, the surgeon.

Put simply, EVA VacuFlow VTi technology puts you in absolute control, all of the time.

www.evabydorc.com

n

Ultra-Thin DSAEK

Gebauer Medizintechnik GmbH recently launched a new series of re-usable Stainless Steel Heads for Ultra-Thin DSAEK with cutting depths of 450mµ, 500µm and 550µm.

The design incorporates a transparent applanation plate which allows cuts with consistent thickness and well-defined edges.

"The new product enables the user to achieve a precise and UT-DSAEK lamella with one pass only, thus eliminating the unpredictable process of making two subsequent microkeratome cuts on the donated cornea," said a company spokewoman." The new UT-DSAEK Heads are compatible with the existing Gebauer SLc microkeratomes which can easily be upgraded," she said. n

EUROTIMES | Volume 18 | Issue 3 109-..._ADV_Meet_EVA_tbv_Eurotimes_120x300.indd

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31-10-12 09:13

www.geuder.de

www.gebauermedical.com

Scientific advisory board

Marguerite McDonald MD, FACS, clinical professor of ophthalmology at NYU School of Medicine in Manhattan and adjunct clinical professor of ophthalmology at Tulane University Health Sciences Center in New Orleans, has joined the Scientific Advisory Board (SAB) of Orca Surgical as the chairman.

Dr McDonald will lead the clinical team investigating Orca Surgical’s new surface ablation procedure – EBK™ (Epi Bowman Keratectomy). n

www.orcasurgical.com

43

Review

Book REVIEW

AMSTERDAM 2013

4 EUCORNEA CONGRESS TH

Elegance and speed A battle still rages on one of the most interesting and controversial questions in vitreoretinal surgery: whether scleral buckling is still a powerful tool, or whether it should be relegated to the dustbin of medical history.

Given the elegance and speed that characterises modern vitrectomy, “the procedure is not practised much anymore except by a small group of enthusiasts”, laments the author. This sort of debate might seem curious to anterior segment surgeons. After all, the standard technique for cataract removal, phacoemulsification, has been the unquestionable gold standard for more than a decade. And yet the debate goes on, and will likely do so until the current senior vitreoretinal surgeons, who learned the technique as a mainstay of their treatment of retinal detachments, retire.

Dr Sandeep Saxena and his co-editors have assembled an extensive group of surgeons to help write Vitreoretinal Surgery.

Published by Jaypee Highlights, this 430page text addresses the big debates in the field and introduces the reader to the full extent of posterior segment surgery.

Section 1 is an “Introduction to the Principles, Techniques and Instrumentation of Vitrectomy.” This covers highly specific topics such as long-term intraocular tamponade with silicone oil; chromovitrectomy, or the use of vital dyes for enhanced visualisation of preretinal tissues; and an entire chapter on endophotocoagulation & safe intravitreal injection technique.

Section 2, “Retinal Detachment”, devotes a chapter to each of five broad topics: scleral buckling, pneumatic retinopexy, primary vitrectomy for retinal detachment, proliferative vitreoretinopathy and giant retinal tears. “Diabetic Retinopathy” is the topic considered in Section 3, while “Retinal Vascular Disorders and Inflammation” are covered in Section 4.

Particularly interesting is Section 5, “Macular Surgery.” For example, what are the indications and advantages of ILM peeling after ERM removal? What is the evidence? And which dyes have been shown to be advantageous for this particularly delicate surgical procedure? This section also considers VR surgery for myopic foveoschisis (“the disease is now curable”) and submacular haemorrhage removal, which is recommended within seven days of the onset of bleeding.

Sections 6, 7, 8 and 9 cover “Trauma,” EUROTIMES | Volume 18 | Issue 3

“Endophthalmitis,” “Retinopathy of Prematurity” and “Viral Retinitis” respectively.

Regarding endophthalmitis, it is sobering to be reminded that the majority (67 per cent) of endophthalmitis cases are iatrogenic, primarily after cataract surgery; the second most common cause is trauma (25 per cent). The results of the Endophthalmitis Vitrectomy Study (EVS) are reviewed here, as are the causative organisms and the antibiotics recommended to treat them.

The management of retinopathy of prematurity is referred to as “a combination of peripheral ablative treatment for the early stages of ROP and vitreous surgery for the later stages.” The section on surgical techniques in viral retinitis primarily focuses on CMV-related retinal detachment in patients with AIDS. Section 10 is entitled “Miscellaneous.”

It covers rather exotic topics such as vitreoretinal surgery for parasitic diseases, but it also reviews the management of a dislocated crystalline lens, dropped nucleus and (sub)luxation of an intraocular lens.

The last section discusses eye-conserving surgical treatment methods for intraocular tumours.

This book is written in a lucid style and is richly illustrated. Those readers who will likely derive most benefit from this text are residents doing their vitreoretinal surgery rotation, vitreoretinal fellows and earlycareer surgeons looking to brush up on their knowledge before a challenging case.

BOOKS EDITOR Leigh Spielberg PUBLICATION Vitreoretinal Surgery AUTHORS Sandeep Saxena, Carsten H Meyer, Masahito Ohji and Levent Akduman PUBLISHED BY Jaypee Highlights If you have a book you would like to have reviewed please send it to: EuroTimes, Temple House, Temple Road, Blackrock, Co Dublin, Ireland

4-5 OCTOBER 2013 Available Online: Registration and Hotel Bookings

www.eucornea.org Abstract Submission

Deadline: 22 March 2013

Symposium & Congress

April 19â&#x20AC;&#x201C;23, 2013

Register Today www.ascrs.org

OPTIO

ASOA ORK 2013 SHOPS

NAL W

Special 1-Day Programs Friday, April 19, 2013

SanFrancisco2013 American Society of Cataract and Refractive Surgery American Society of Ophthalmic Administrators

Meeting Highlights Saturday, April 20 Binkhorst Lecture

Monday, April 22 2013 Charles D. Kelman Innovator’s Lecture Humans, Happiness, and the Wonder of New

Intraocular Lens Evolution: What a Long Strange Trip It’s Been Presented by Nick Mamalis, MD, ASCRS’s 2013 Binkhorst Medal winner is highly respected in ophthalmology for his transformative work in the study and understanding of toxic anterior segment syndrome. He is among the world’s experts in cataract and refractive surgery and has made significant contributions to the science and practice of ophthalmology.

Sunday, April 21 Science and Medicine Lecture When Experts Disagree: A New Approach to Medical Decision Making Jerome Groopman, MD, and Pamela Hartzband, MD, are both well-known medical writers and members of the Harvard Medical School faculty. Dr. Groopman has written several books, two of which were New York Times bestsellers. Dr. Hartzband is a noted endocrinologist and is regularly featured among America’s Best Doctors. Most recently, Dr. Groopman and Dr. Hartzband are coauthors of Your Medical Mind, a 2011 release that explains how patients can cut through the myriad information from doctors, drug companies, and friends to arrive at positive medical decisions. They also co-author a bi-monthly column for ACP Internist, the publication of the American College of Physicians, which is read by 150,000 internal medicine physicians in the United States and Canada.

Richard Mackool, MD, is the Director of The Mackool Eye Institute, the first ambulatory surgery center in New York.

He has been granted approximately 125 patents, both in the U.S. and internationally, for inventions relating to cataract extraction, phacoemulsification and intraocular lens implant designs. He is also an experienced author, writing hundreds of medical publications.

Tuesday, April 23 Hot Off the Press Moderator: David F. Chang, MD Panelists: Reay H. Brown, MD, Bonnie An Henderson, MD, Edward J. Holland, MD, and Ronald Yeoh, MD This session will encompass a free-flowing panel discussion by the specialty section editors of EyeWorld, who will highlight and debate the Best Papers of ASCRS 2013, as selected and presented by EyeWorld editorial board members.

April 20–23

PROBE

Practice Revenue Optimization and Business Efficiency

A core selection of CME-designated business courses that provide a comprehensive analysis of your practice to maximize revenue.

The program will cover financial and investment strategies, productivity management, profit diversification, and business model analysis. www.ascrs.org/probe

46

Review

JCRS Highlights Journal of Cataract and Refractive Surgery

Residual fragments and endophthalmitis risk New laboratory research supports previous suggestions that residual lens cortex after phacoemulsification may be associated with an increased risk for the development of endophthalmitis. Chinese researchers report animal study data in which Staphylococcus aureus and Staphylococcus epidermidis were dispensed into aqueous humour or serial dilutions of lens cortex that were obtained from cataract patients during phacoemulsification. After a 24-hour incubation, the colony-forming unit (CFU) was quantified. Eighty rabbits had phacoemulsification. Complete lens cortex removal was performed in half of the rabbits, while a quarter of lens cortex was retained in the remaining animals.

Staphylococcus aureus, with an inoculum size of 32 CFU, 56.3 CFU and 108.6 CFU, was injected intracamerally at the conclusion of surgery and the production of endophthalmitis was measured 72 h later.

The researchers observed that lens cortex was associated with a significant increase in bacterial growth compared with aqueous humour. They conclude that eyes with residual lens cortex seem more prone to develop endophthalmitis if anterior chamber bacterial contamination occurs during phacoemulsification.

In a related editorial, Emanuel Rosen MD, FRCSEd, discussed the implications of these findings. He reviews the measures surgeons now take to reduce the risk of postoperative endophthalmitis, including preoperative topical antibiotics, draping and postoperative intracameral antibiotics. He then cites previous clinical reports suggesting that retained cortical fragments might enhance the ability of common bacteria to infect the anterior segment of the eye. Dr Rosen notes that although the clinical evidence is still slight, Dr Lou’s study suggests that it would be wise to ensure that all cortical material is removed as a further prophylactic manoeuvre against infection within the operated eye.

prospective double-masked parallel-group study enrolled 406 patients at 17 clinical sites in the US. Patients with anterior chamber cell (ACC) grade 2 or higher after cataract surgery were randomised to loteprednol etabonate 0.5 per cent gel or vehicle four times a day for 14 days. On day eight, 30.5 per cent of patients in the loteprednol etabonate group and 16.3 per cent of patients in the vehicle group had complete resolution of ACC, whereas 72.9 per cent and 41.9 per cent, respectively, had grade zero pain (both P<.001). Significant treatment differences for complete resolution of ACC and grade zero pain favouring loteprednol etabonate were also found on day 15 and day 18. One patient in each treatment group had a significant increase in IOP (≥10 mm Hg).

Analyses of pain, photophobia and tearing favoured loteprednol etabonate at different time points beginning on day three. More than 85 per cent of patients in each treatment group reported no discomfort on drop instillation.

A second study, also conducted in the US, compared the efficacy of loteprednol etabonate 0.5 per cent versus prednisolone acetate 1.0 per cent for the control of postoperative inflammation in patients having routine cataract surgery. The comparative case series randomised 88 patients to receive loteprednol etabonate or prednisolone acetate four times daily in addition to bromfenac 0.09 per cent and besifloxacin 0.6 per cent after surgery. At three weeks the researchers noted no significant differences in efficacy. They observed less fluctuation in IOP assessments in patients treated with loteprednol etabonate than in patients treated with prednisolone acetate, in particular one day and three days postoperatively. n R

Rajpal et al., JCRS, “Efficacy and safety of loteprednol etabonate 0.5% gel in the treatment of ocular inflammation and pain after cataract surgery”, 158-167.

S Lane t al. JCRS, “Loteprednol etabonate 0.5% versus prednisolone acetate 1.0% for the treatment of inflammation after cataract surgery”, Vol.39, No. 2. 168-173.

n B

Lou et al., JCRS, “Residual lens cortex material: Potential risk factor for endophthalmitis after phacoemulsification cataract surgery”, Vol.39, No. 2, 250-257.

E Rosen, JCRS, “Breeding ground?”, Vol.39, No. 2, 153.

Pain control after cataract surgery Two new studies report that a new gel formulation loteprednol etabonate 0.5 per cent appears to be safe and effective in the treatment of inflammation and pain after cataract surgery. The first, a large multicentre, ad ET versario 1-2hoch ENG18 1301v2 pva RZ.indd EUROTIMES | Volume | Issue 3

1

07.02.13 11:40

Thomas Kohnen associate editor of jcrs FURTHER STUDY Become a member of ESCRS to receive a copy of EuroTimes and JCRS journal

Save the Date

San Francisco 2013 Make the most of your time at the ASCRS•ASOA Symposium & Congress and attend our EyeWorld programs for additional CME and an opportunity to network with your colleagues.

Thursday, April 18 – Monday, April 22, 2013

Among the topics to be covered in these AMA PRA Category 1 CreditsTM designated sessions are: • A discussion on recent developments in anti-infective and anti-inflammatory therapeutic treatments • Updates on diagnosing and treating the ocular surface, including dry eye disease • New developments in allergy therapeutics • New considerations and continuing discussions regarding laser-assisted cataract refractive surgery • Maximizing outcomes with refractive IOLs • Update on the prevalence and alternative treatment for meibomian gland disease

These non-CME, ASCRS-authorized educational programs will provide timely and important information on: • Options and considerations in the use of premium IOLs • Advances in technologies, techniques, and outcomes in laser vision correction surgery • An interactive discussion on the applications of femtosecond and excimer lasers for ophthalmic surgery

EyeWorld Corporate Events are directly developed by industry and hosted by EyeWorld. These non-CME meetings provide valuable information on new products, procedures, and applications of existing products. Included among the topics discussed in these sessions are:

For updates and to register visit

www.EyeWorld.org

• • • • • • • •

Live surgery New developments in surgical instrumentation Surgical options for the treatment of dry eye Growing the overall size of the premium IOL lens market Considerations in the selection of a premium IOL New developments in laser vision correction Advanced IOL technology Discussion of technological advances and breakthroughs in cataract surgery • Update on crosslinking • Advances in diagnostic and imaging equipment

48

Reference

CALENDAR OF EVENTS

Dates for your Diary

March

April

April

May

EuroLam 3rd Macula and Retina Congress

4th World Congress on Controversies in Ophthalmology (COPHy)

ASCRS•ASOA Symposium and Congress

ARVO

www.ascrs.org www.asoa.org

11th SOI International Congress

2013

22-23 FLORIDA, USA www.euro-lam.org

2013

2013

4-7 BUDAPEST, HUNGARY

www.comtecmed.com/cophy/2013/

2013

19-23 SAN FRANCISCO, USA

5-9 SEATTLE, WASHINGTON, USA www.arvo.org

15-18 MILAN, ITALY

www.congressisoi.com

May

Black Sea Ophthalmology Society & ESCRS Academy Meeting

2013

June

June

July

European Society of Ophthalmology (SOE) 2013

International Meeting on Anterior segment surgery

www.soe2013.org

www.femtocongress.com

Indian Intraocular Implant & Refractive Surgery Convention

2013

24-26 TBILISI, GEORGIA

www.bs-os.org

8-11 COPENHAGEN, DENMARK

The Visions of Gullstrand – 600 year jubilee

10th Congress SEEOS and 3rd Congress of Macedonian Ophthalmologists

www.feinpat.hemsida24.se

www.zom.mk

31-2 JUNE LANDSKRONA, SWEDEN

2013

2013

22-23 VERONA, ITALY

6-7 CHENNAI, INDIA www.iirsi.com

20-23 OHRID, MACEDONIA

July

July

September

September

26th APACRS Annual Meeting

5th World Glaucoma Congress

13th EURETINA Congress

www.apacrs.org

www.worldglaucoma.org

14th International Paediatric Ophthalmology Meeting

2013

2013

11-14 SINGAPORE

2013

17-20 VANCOUVER, CANADA

12-13 DUBLIN, IRELAND

2013

26-29 HAMBURG, GERMANY www.euretina.org

Email: hmurphy@materprivate.ie

October

October

November

November

ESCRS Glaucoma Day

XXXI Congress of the ESCRS

AAO Annual Meeting

93rd SOI National Congress

www.escrs.org

www.escrs.org

www.aao.org

www.congressisoi.com

2013

4 AMSTERDAM, THE NETHERLANDS

4th EuCornea Congress

4-5 AMSTERDAM, THE NETHERLANDS www.eucornea.org

2013

5-9 AMSTERDAM, THE NETHERLANDS

2013

16-19 NEW ORLEANS, USA

2013

27-30 ROME, ITALY

EPOS/WSPOS Paediatric Sub Speciality Day 9 AMSTERDAM, THE NETHERLANDS www.wspos.org

Advertising Directory: Abbott Medical Optics: Page: IBC; Alcon Laboratories: Page: OBC; ASCRS/Eyeworld: Pages: 44-45, 47; Carl Zeiss Meditec: Page: 14; Croma-Pharma GmbH: Pages: 21, 46; D.O.R.C. International BV: Page: 42; Katena Products Inc.: Page: 9; Medicel Ag: Page: 13; Nidek: Page: 31; Oculus Optikgerate GmbH: Page: 35; Oertli Instruments AG: Page: IFC; SOE (European Society of Ophthalmology): Page: 15; Technolas Perfect Vision: Page: 3; Topcon: Page: 41; Ziemer Ophthalmic Systems: Page: 17.

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Delivering the accuracy of a femtosecond laser to Refractive Cataract Surgery, the LenSx® Laser is designed to predictably perform many of the most challenging aspects of traditional cataract surgery. Creating highly reproducible capsulotomy, lens fragmentation and all corneal incisions with image-guided surgeon control, Alcon’s LenSx® Laser is Putting the Future in Motion.

To learn more about LenSx® Laser technology for Laser Refractive Cataract Surgery, visit lensxlasers.com.

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