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VOLUME 16 ISSUE 12 DECEMBER 2011 | VOLUME 17 ISSUE 1 JANUARY 2012

RETINA


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ESCRS

EUROTIMES

december 2011/january 2012 Volume 16/17 | Issue 12/1 This month... Special Focus: Retina 4

Cover Story: Safety of various retinal treatments discussed

8 Newsmaker interview with EURETINA Board member Sebastian Wolf 10 Study shows positive results with super-dose drug 11 Biodegradable implant can improve visual acuity 12 New software could help track patients with geographic atrophy 15 Many patients still require surgery for proliferative diabetic retinopathy

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Cataract & Refractive 17 Study shows good results for laser blended vision patients 18 New acrylic IOL performs well 20 Range of secondary IOL implant options available 21 No glistenings found with hydrophobic acrylic IOL 22 Nobel prize-winning ophthalmologist remembered 23 Refractive surgery patients can have unexpected refractive surprises

Cornea 24 Ocular herpes treatments focus of 2011 EuCornea Medal Lecture 25 Corneal gene therapy may improve allograft survival 26 Detecting corneal pathology with 3-D tomography 31 Specialists positive about future of keratoprosthesis surgery

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Glaucoma 32 Microhyphema indicator for canaloplasty failure 33 Advantages and drawbacks with new drainage devices

News 35 ESASO to build on success of AMD and Retina Congress 36 ESCRS Research Committee looks at new glaucoma technologies 38 Prague looks ahead to 16th ESCRS Winter Meeting

Features

Cover Image: A retinal oximetry image showing a mild central retinal vein occlusion. Full details on page 5. Image is courtesy of Einar Stefánsson MD, PhD.

39 Practice Development 40 EU Matters 41 Ophthalmologica Highlights 43 JCRS Highlights

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46 Industry News 46 Journal Watch 47 Eye on Travel 48 Calendar

With this month’s issue... innovations in advanced technology iols & laser systems & 2012 wall planner

editorial staff

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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

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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

Contributors Devon Schuyler Eisele Stefanie Petrou-Binder Maryalicia Post

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. ISSN 1393-8983

As certified by ABC, the EuroTimes average net circulation for the 11 issues distributed between 01 January 2010 and 31 December 2010 is 32,019.

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EUROTIMES

Editorial

ESCRS

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EDITORIAL

Medical Editors

Volume 16/17 | Issue 12/1

José Güell

Ioannis Pallikaris

Clive Peckar

Paul Rosen

INNOVATION IS key

Ophthalmologists face major challenges ahead in dealing with ageing populations

by Gisbert Richard

International Editorial Board

I

n 1851, Hermann von Helmholtz presented the first ophthalmoscope, and opened the door on a new world, ie, to being able to observe the posterior part of the eye. Based on this fundamental development the “Ophthalmologische Gesellschaft” was established just a few years later in 1857 in Heidelberg. At times this society comprised more international than German members and was only later renamed the German Society of Ophthalmology (“Deutsche Ophthalmologische Gesellschaft”) – the oldest ophthalmological, and some say the oldest medical society of the world. It provided the impetus for the great development of our discipline, the foundation of eye clinics all around the world and the successful systematic treatment of eye diseases. Innovation was part of the start up. The vision of the founders has been to take up ideas and hand them over. Therefore it is a necessity to consequent further development of research. We have to make sure that research and development are supported in the future. Based on this, we have to translate new developments into pragmatic guidelines. Retinology is not the past, it is the present and the future. I would like to invite my colleagues to look forward, think constructively and positively and act according to the motto: “Use the chances, realise the potential, shape the near future”. Let us take a brief look into enormous advances in medicine over the last few decades. Life expectancy is continually increasing worldwide and today most people of 65 years and older are healthier, more active and with regard to mental and cognitive fitness, better off than earlier generations. Currently, the highest life expectancy in Japan and Sweden is already 85 years for women and 77 years for men. It is expected that the life expectancy will also increase in the future, and that by 2050 it could have reached 94 years. This will result in an enormous challenge for ophthalmology. We are a field that particularly deals with diseases associated with ageing, so we will be affected by the longevity revolution.

Great opportunities What does age actually mean? Goethe finished writing Faust when he was 82 years of age. Michelangelo designed the dome of St Peter’s Basilica when he was 90. Seen in this light, one could think that at 65 the best of one’s life is still to come. There are some essential aspects that are prerequisites for this, and these could be combined in a motto: "age healthily". The blessing of our field is that in a certain way, more than any other area, we are increasingly better able to treat geriatric diseases. Previously it was just cataracts, today it is also the “wet” form of macular degeneration. The challenges are great. The opportunities in scientific ophthalmology are much better than generally assumed. There are still important positions in the whole of ophthalmology, including industry, available for people who are scientifically qualified. This is due to the fact that scientists have to delve deeply into topics and so are compelled to approach the core of the problem. It is also partly due to the fact that new discoveries in pharmacology, molecular and cellular biology, neurophysiology EUROTIMES | Volume 16/17 | Issue 12/1

Emanuel Rosen Chairman ESCRS Publications Committee

Noel Alpins australia Bekir Aslan TURKEY Bill Aylward UK Peter Barry IRELAND Roberto Bellucci ITALY and immunology have a wide range of applications, which are on the verge of being clinically implemented. Because of the special situation in the subretinal area, new possibilities for transplantation have been opened up. For this reason gene therapy approaches for hereditary, degenerative retinal diseases will be available very much earlier than diseases of other less reachable organs. Because blindness or severe visual defects create a heavy burden on the social budget, financial support of research in all these areas is both economically interesting and meaningful. We need to urge the political decision makers to orientate strongly on what is feasible and worthwhile in research. With regard to rewarding scientific projects, ophthalmology stands at the top. Naturally we have to provide the highest performance in patient care. Nevertheless, to achieve successful, internationally competitive scientific research, we have to succeed in establishing the necessary framework conditions for gifted and enthusiastic scientists. The growth in the clinic will in future be based on advances in research and the implementation of these findings in clinical practice. Finally, I would like to wish you all a successful winter meeting of EURETINA which takes place in Rome, Italy, on January 28, 2012.

Hiroko Bissen-Miyajima JAPAN 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 Oliver Zeitz germany

* Gisbert Richard is president of EURETINA


Symptomatic VMA A Disease That’s Gaining Traction

Symptomatic vitreomacular adhesion (VMA) is an increasingly recognized sight-threatening disease of the vitreoretinal interface 1

VMA: » May lead to symptoms such as metamorphopsia, decreased visual acuity, and central visual field defect2 » Can cause traction resulting in anatomical damage, which may lead to severe visual consequences, including3,4 • •

Macular hole3 Retinal tear/detachment4

RefeRences 1. Schneider EW, Johnson MW. Emerging nonsurgical methods for the treatment of vitreomacular adhesion: a review. Clin Ophthalmol. 2011;5:1151-65. 2. Steidl SM, Hartnett ME. Clinical pathways in vitreoretinal disease. New York: Thieme Medical Publishers; 2003. Chapter 17; 263-86. 3. Gallemore RP, Jumper JM, McCuen BW 2nd, Jaffe GJ, Postel EA, Toth CA. Diagnosis of vitreoretinal adhesions in macular disease with optical coherence tomography. Retina. 2000;20(2):115-20. 4. Mitry D, Fleck BW, Wright AF, Campbell H, Charteris DG. Pathogenesis of Rhegmatogenous Retinal Detachment: Predisposing Anatomy and Cell Biology. Retina. 2010 Nov–Dec;30(10):1561–72. 11/11

ThromboGenics, Inc. | 1560 Broadway, 10th Floor, New York, NY 10036 - U.S.A. | ©2011 ThromboGenics, Inc. | All rights reserved.

OCRVMA004


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Cover Story

retina

Medical Retina

Some experts in the field look at the safety of treatments by Roibeard O’hEineachain

It is important to realise that you can count the risk either per injection (typically around one per 1,000 as in cataract surgery), or per patient, in which case you would multiply the risk because the treatment is repeated for 24 times or more Jan van Meurs MD

Regarding the great efficacy of the intravitreal injection of anti-VEGF, the relevance of local and systemic side effects is remarkably low Gisbert Richard MD

EUROTIMES | Volume 16/17 | Issue 12/1

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ver the past decade retinal medicine has entered a new era in which neovascular agerelated macular degeneration (AMD) – a previously untreatable chronic and progressive condition – cannot only be stabilised but can even be reversed. However, with this potential for improved vision comes a small but not insignificant risk of total vision loss in the treated eye due to endophthalmitis. As a procedure, intravitreal injections appear to be about as safe as a cataract extraction procedure in terms of the endophthalmitis rate. In prospective clinical trials the incidence of the complication per injection has ranged from 0.05 per cent, in the Marina trial, to 0.16 per cent, in the Vision trial. However, it is because patients must receive repeated injections, generally about one a month, the risk per patient is generally much higher, ranging from 0.7 per cent, in the ANCHOR study, to 2.7 per cent in the FOCUS study. “It is important to realise that you can count the risk either per injection (typically around one per 1,000 as in cataract surgery), or per patient, in which case you would multiply the risk because the treatment is repeated for 24 times or more,” said Jan van Meurs MD, The Rotterdam Eye Hospital and Erasmus University, Rotterdam, The Netherlands. On the other hand the risks involved in not treating patients are also very considerable, noted EURETINA president, Gisbert Richard MD, University Medical Centre, Hamburg, Germany. The principal diseases treated by anti-VEGF injections – the wet form of AMD, diabetic macular oedema and vein occlusion – are also the main reasons for legal blindness in developed countries, he told EuroTimes. He noted that in a recent meta-analysis published in the journal Retina, the overall rate of endophthalmitis following intravitreal injections of ranibizumab

and bevacizumab was 0.05 per cent per injection or less, and the rate of other complications like retinal detachment was even lower (0.01 per cent). “Regarding the great efficacy of the intravitreal injection of anti-VEGF, the relevance of local and systemic side effects is remarkably low. Therefore, the intraocular injection justifies the small risk of postoperative complications, even considering that the drug requires repeated injection into the eye,” Dr Richard added. He noted that in his experience, antiVEGF agents have a cumulative and residual effect, such that each treatment results in a better and longer lasting effect and over time the need for retreatment becomes less and less. Moreover, a new anti-VEGF agent called VEGF trap (Regeneron) may reduce the need for repeated injections in the future.

Avastin vs Lucentis Currently the most frequently administered intravitreal agents are the anti-VEGF agents, bevacizumab (Avastin, Genentech) and related compound ranibizumab (Lucentis). The main indication currently is for choroidal neovascularisation resulting from AMD, but the future is likely to see an increasing use of the agents for diabetic retinopathy. Of the two agents only ranibizumab has received FDA approval for intravitreal use in the treatment of CNV. However, many patients cannot afford the 40-fold higher price of ranibizumab, and as a result must decide between off-label treatment with bevacizumab or gradually going blind. In fact, Avastin injections account for 60 per cent of patients receiving intravitreal antiVEGF agents in the US. Until recently, the arguments in favour of ranibizumab over bevacizumab have been largely theoretical. Proponents of Lucentis had originally argued that because Avastin is a much larger molecule it would not penetrate the retinal tissues as

well as Lucentis and would therefore be less effective and it would also be more immunogenic. Subsequent research has suggested that there may be only slight or negligible differences between the two agents in terms of safety or efficacy. For example, in the Comparison of AMD Treatments Trials (CATT) both agents produced virtually identical results in terms of visual acuity throughout at all time points during one year of follow-up. There was a slightly higher incidence of serious adverse events in the bevacizumab group (24 per cent vs. 19 per cent, p=0.040), mainly hospitalisations. However, the authors point out that the bevacizumab group had a higher rate of risk factors for hospitalisation, such as smoking, diabetes and a history of cardiovascular disease (The CATT Research Group, N Engl J Med 2011; 364:1897-1908). At the same time, the incidence of endophthalmitis per patient was fairly high in both treatment groups in the CATT study. Among 600 patients randomised to receive ranibizumab, the incidence was one in 300 patients, and among 600 patients randomised to receive bevacizumab the incidence was one in 150 patients. The microorganisms identified included coagulase negative staphylococcus in two cases and alpha haemolytic streptococcus in two cases. Two cases were culturenegative. Visual acuity upon resolution of the infection ranged from 20/25 to 20/60 in four cases, in one case it was 20/125, and in another it was counting fingers. Despite there being little differences between the two agents in the context of the trial, proponents of ranibizumab maintain that the situation could be very different in the context of vast numbers of compounding pharmacists using a range of different repackaging techniques. In fact, there have been several recent reports of outbreaks of endophthalmitis following intravitreal injections of


Endophthalmitis prophylaxis Even when intravitreal agents are packaged in the ideal way, there is still an inherent risk with such approaches because they involve repeated penetrations of the globe, said ESCRS president-elect Peter Barry FRCS, Dublin, Ireland, St Vincent’s University Hospital and Royal Victoria Eye and Ear Hospital, and chairman of the ESCRS Endophthalmitis Study Group. “The cumulative risk of endophthalmitis is higher than would be acceptable for modern cataract surgery. You have to face that fact,” he told EuroTimes.
Dr Barry noted that antibiotic prophylaxis has proved very successful in reducing the risk of endophthalmitis following cataract surgery. However, since intravitreal treatment for retinal disease involves repeated injections, antibiotic prophylaxis in such patients could actually increase the risk by turning the eye into a breeding ground for resistant bacteria. “You have to be very careful about the overuse of antibiotic drops. It could be the very worst thing because it might select out the resistant organisms and increase the patient's risk from being inoculated from their own flora at the time of injection with EUROTIMES | Volume 16/17 | Issue 12/1

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Courtesy of Einar Stefánsson MD, PhD

bevacizumab, including one outbreak involving 12 patients treated at a centre in Florida, another involving four patients treated at a Veterans’ Administration system in Nashville, and another five patients treated at a veterans’ administration Hospital in Los Angeles, California. The cases prompted an alert from the FDA in which they said: “Healthcare professionals should be aware that repackaging sterile drugs without proper aseptic technique can compromise product sterility, potentially putting the patient at risk for microbial infections. Healthcare professionals should ensure that drug products are obtained from appropriate, reliable sources and properly administered.” As a result of the problems encountered, the administration of the Veterans' Hospital System in the United States has since withdrawn bevacizumab from use in the treatment of macular degeneration. Meanwhile, the product’s manufacturers seem unlikely to make it available in appropriately prepared dosages. In fact, bevacizumab’s manufacturers are so vehemently opposed to the intravitreal use of the product that in 2007 they announced they would halt sales of bevacizumab to compounding pharmacies that have been dividing it into the smaller quantities. However, following intense pressure from the AAO and other ophthalmological organisations, Genentech later cancelled that plan. “Although I would not support pressurising Avastin’s manufacturers to produce an intravitreal packaging of their product, I would like Lucentis supporters to put their energy in to finding better drugs, not to try and enforce the use of an expensive equivalent,” said Dr van Meurs. Dr Richard noted that at his clinic he administers both ranibizumab and bevacizumab depending on the patients’ preference and financial considerations. He added, however, that in some countries regulations require physicians to use the approved agent for an indication when one is available.

A retinal oximetry image showing a mild central retinal vein occlusion. The pseudocolour scale on the right side shows the oxygen saturation percentage. The arterioles are red indicating near full oxygen saturation of hemoglobin. The venules indicate low oxygen saturation, ie, hypoxia

a bug that is resistant to the antibiotic being used for prophylaxis,” he said. There are studies on the literature that seem to support the theory that antibiotic prophylaxis may confer little additional protection when combined with good sterile technique. For example, in a study involving patients receiving a total of 3,838 intravitreal injections of ranibizumab or preservative-free triamcinolone, there were no statistically significant differences in the rates of endophthalmitis among those receiving no topical antibiotics, those receiving topical antibiotics on the day of surgery, and those receiving topical antibiotics for several postoperative days. In fact, the three cases of endophthalmitis occurring in the study all occurred in the group receiving antibiotics for several postoperative days. The injection protocol in the study required the application of topical povidone-iodine to the conjunctival surface and the use of a sterile lid speculum (Bhavsaret al, Arch Ophthalmol. 2009; 127(12):1581-1583). Another study demonstrated the possible dangers of routine use of topical antibiotics. The randomised study involved 24 patients who received antibiotic prophylaxis while treated with intravitreal agents. Cultures taken from those receiving fluoroquinolones showed a significantly increased resistance to both older and newer fluoroquinolones, while those taken from eyes receiving azithromycin showed an increased resistance to macrolides, and up to 80 per cent of cultures had evidence of multi-resistant organisms (Kim et al, Arch Ophthalmol. 2011;129(9):1180-1188). Dr Richard noted that he currently uses perioperative topical antibiotics, prescribing Gentamycin eye drops three times per day for one week.

“We see little downsides in using topical antibiotics perioperatively, so we continue with this and have an extremely low incidence of intra-ocular infection,” he said. Dr van Meurs said he only uses the topical antibiotics just before but not after intravitreal injections. “I don’t use antibiotics after injection, as reflux is not a likely mechanism of infection and post-injection drops create resistant bacteria for the next injections. Infection prophylaxis works best when started close to the infection risk, as we would like to reduce the bacterial load without selecting resistant bacteria. Therefore, repeated antibiotic drops one hour before injection, thorough skin, and lid margin cleaning with povidone iodine one per cent or five per cent one minute before injection, and rinsing of the conjunctival sac with one per cent or 0.25 per cent povidone iodine, makes sense,” he said.

Good sterile technique Although there is as yet no consensus as to the role of antibiotic prophylaxis when administering anti-VEGF agents, there is a general agreement as to what constitutes good sterile technique, Dr Richard said. “According to the guidelines of the American Academy of Ophthalmology and the German Ophthalmological Society several measures should be performed before the injection. It is necessary to exclude patients with active infection, such as those with conjunctivitis, blepharitis, keratitis or lacrimal passage infections. The conjunctiva should be irrigated with five per cent povidone iodine, the periorbital skin should be cleaned with 10 per cent povidone iodine swabs. The perioperative setting should include sterile surrounding, gloves, surgical drape, cannula and syringe, hand disinfection, usage of a lid speculum,

You have to be very careful about the overuse of antibiotic drops. It could be the very worst thing because it might select out the resistant organisms... Peter Barry FRCS

Clearly from a standpoint of safety we need to look at ways of eliminating or at least reducing the need for intravitreal injections

Einar Stefánsson MD, PhD


Cover Story

retina

Gene therapy is another technology that is beginning to bear fruit in the treatment of retinal disease, notably in the treatment of Leber’s congenital amaurosis. Clinical studies are under way employing gene therapy in the treatment of retinitis pigmentosa the medication has to be sterile as well,” Dr Richard said. Dr Van Meurs told EuroTimes that useful additional measures might include making sure only the patient and injector are in the room; using a controlled air flow system; cap, mask and gloves for the injector, drape that separates nose, mouth and hair from the eye for the patient. He added that if research shows that outbreaks of endophthalmitis really are more common after Avastin (prepared in batches), injection through a bacterial filter at the price of €2.00 extra per injection would then be an inexpensive option of reducing the excess risk. "This could be done either in the office, although you would need larger aliquots, because the filter has a considerable dead space, or in the pharmacy for each prepared vial, to further minimise batch contamination,” he said.

implant’s polymer, polylactic glycolic acid, biodegrades to lactic acid glycolic acid, water, and carbon dioxide. In the PLACID trial, only 15 per cent of eyes required IOP-lowering medication. The only specific adverse event to occur significantly more often in the implant group was increased IOP, which occurred in 20 per cent, compared to 1.6 per cent of the laser alone group. Another, completely different approach, now under development by a French Company called Novogali, is to inject dexamethasone in a pro-drug form. The pro-drug’s chemical structure, dexamethasone palmitate, is relatively inert in the aqueous and the vitreous and is therefore less likely to affect the lens or the trabecular meshwork. However, in the retina it breaks down and becomes active. A Phase I, Open-Label, Dose-Escalation Clinical Study is now under way.

New delivery routes Intravitreal steroids carry about the same risk of endophthalmitis as intravitreal anti-VEGF agents and also have some additional risks. However, steroids have also been the focus of the development of a number of other methods to deliver medicine to the retina, in the form of slow-release implants, such as Ozurdex, and most recently a dexamethasone preparation designed for topical administration. The earliest steroid implant was Retisert (Bausch + Lomb), which used fluocinolone acetonide. The implant is sutured to the eye wall using a 3.5mm pars plana incision designed to last up to three years. In the FDA clinical trial all phakic patients receiving the implant have developed cataracts and 40 per cent of eyes needed filtration surgery to control the IOP. The Iluvien (Alimera) implant also uses fluocinolone acetonide but appears to have a less severe effect on IOP. In the Fluocinolone for Macular Edema (FAME) study, 75 per cent of patients developed cataracts, but only five per cent requires filtering surgery. There is also a biodegradable dexamethasone implant, Ozurdex (Allergan). Unlike the Retisert and the Iluvien implants, it does not leave an empty husk behind once the drug is used up. Instead, as the drug is released, the

Non–invasive options However, even these approaches remain invasive procedures. A better alternative might be the development of agents that can be applied topically, said Einar Stefánsson MD, PhD, University of Iceland, Reykjavik, Iceland. “Clearly from a standpoint of safety we need to look at ways of eliminating or at least reducing the need for intravitreal injections. The complications like endophthalmitis and intraocular inflammation seen with intravitreal injections show we need to focus on developing non-invasive ways of delivering drugs into the eye,” Dr Stefánsson told EuroTimes. He noted that in a recently published phase II study a topical 1.5 per cent dexamethasone aqueous solution prepared by cyclodextrin nanoparticle technology produced significant reductions in mean macular thickness and significant improvements in mean visual acuity in 19 eyes of 19 patients with chronic diabetic macular oedema (Tanito et al, Invest Ophthalmol Vis Sci. 2011;52(11):7944-7948). Dr Stefánsson said that so far patients have had a fairly low incidence of elevated IOP. Moreover, should a patient be a steroid responder and develop a high IOP, the treatment is very easily reduced simply by withdrawing the medication.

Don’t miss Research update, see page 36 EUROTIMES | Volume 16/17 | Issue 12/1

Courtesy of Peter Barry FRCS

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Vitrectomy for endophthalmitis post anti-VEGF injection

Gene therapy is another technology that is beginning to bear fruit in the treatment of retinal disease, notably in the treatment of Leber’s congenital amaurosis. Clinical studies are under way employing gene therapy in the treatment of retinitis pigmentosa. Another approach is the use of encapsulated cell technology. This approach, in effect, places a drug factory in the eye, in the form of a cluster of encapsulated cells, which secrete a therapeutic agent. In a presentation at the 11th EURETINA Congress, Weng Tao MD, US, described how, in three dose-ranging studies involving a total of 120 patients with retinitis pigmentosa or geographic atrophy, an implant employing encapsulated cell technology to secrete a neurotrophic agent was able to increase the thickness of the photoreceptor layers of the retina in the eyes with implant. In the meantime, practitioners of medical retina are to some extent flying blind in their attempts to reduce the rate

of endophthalmitis in their patients, said Dr Barry. That is because as yet there is no comprehensive epidemiological evidence on which to base prophylactic measures. “It might be a good idea to create an endophthalmitis registry like the Swedish registry, but covering all of Europe and encompassing both cataract procedures and intravitreal injections, through a combination of the efforts of EURETINA and the ESCRS,” he added.

contacts Jan van Meurs – janvanmeurs@cs.com Gisbert Richard – augenklinik@uke.uni-hamburg.de Peter Barry – peterbarryfrcs@eircom.net Einar Stefánsson – Einarste@landspitali.is


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Newsmaker Interview

EURETINA

FOCUS ON safety

Less than complete consensus regarding intravitreal anti-VEGF treatments

For this month’s special retinal issue, EuroTimes contributing editor, Roibeard O’hEineachain, spoke with EURETINA general secretary, Sebastian Wolf MD, PhD, Department of Ophthalmology, University of Bern, Bern, Switzerland about the major issues facing retinal specialists today

Q:

What are currently the major controversies regarding the treatment of retinal disease?

There are currently two major controversies in the treatment of macular disease and both involve intravitreal anti-VEGF therapy. First is the question of whether it is better to treat AMD with ranibizumab, an approved drug, or bevacizumab, a less rigorously tested offlabel drug which must be repackaged for intravitreal use. The CATT study showed that the two agents have a very similar efficacy but there is still some question about whether they are equally safe, and

this is where much of the controversy lies. Bevacizumab is much cheaper than ranibizumab but it hasn't been tested like an approved drug and there may be safety issues which will only come out after larger studies. The CATT study showed some differences but it was not powered to show differences in safety so those may have been chance findings. We also do not know if bevacizumab will have the same efficacy as ranibizumab at two years, so we'll have to wait for the two-year results. The other question regarding antiVEGF therapy is in the treatment of diabetes. Do we still need to perform macular photocoagulation, which has been the standard of care for many years? There are some who feel that there is still a place for macular photocoagulation in focal macular oedema, and there are others who think that anti-VEGF therapy is the major breakthrough and that laser photocoagulation is no longer needed. If we look at the data, anti-VEGF therapy is yielding better visual outcomes than laser photocoagulation in all studies. But there are some specialists who maintain that the differences are not so big in their hands. Therefore, it may be that you have to be very experienced in macular photocoagulation to get the same results with the techniques as you do with antiVEGF therapy.

Q:

New diagnostic technologies have become available in recent years, how are these effecting your treatment decision?

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We have had spectral domain OCT in our hands for three years. It's a relatively new diagnostic tool, and it has dramatically improved our abilities to diagnose and follow-up patients with macular oedema. It really enables us to detect small amounts of intra- or subretinal fluid which is very important for treatment decisions if we have active disease in AMD. That is how we know when to re-inject these patients. I think nowadays most people use OCT as their primary tool for followup of patients and for making decisions. Fluorescein angiography has become much less important and this holds true not only for AMD but also for diabetic macular oedema, central vein occlusion oedema and all vascular oedemas.

Q:

Do you think retinal physicians need to take a closer look at safety issues in medical retina, as regards endophthalmitis, for example?

There is an issue if we use bevacizumab if we use repackaged injections and there has been a series of outbreaks of endophthalmitis following the use of bevacizumab repackaged at compounding pharmacies. This is a real issue for using bevacizumab; we need to have quality control and we need to have better standardisation of the aliquotation of the drug. Otherwise, with respect to endophthalmitis, the risk is very low. On the other hand if we think of safety for systemic disease like cardiovascular disease or stroke it probably would be good to have more detailed data.

Q:

In the CATT study there were six cases of endophthalmitis among 1,200 patients during the first year of treatment, two of which occurred in patients receiving ranibizumab. Is an incidence of one in three hundred patients still fairly high?

Sebastian Wolf – sebastian.wolf@insel.ch

I think this may be due to a difference in health systems. In Europe the incidence of endophthalmitis has been much lower in all studies than in the US, which may be connected to the fact that there are more strict rules in how to do the injections.

Q:

Do you think ophthalmologists who are not retinal specialists should receive additional training before practising medical retina?

These injections put patients at risk and ophthalmologists need training in how to perform and monitor their effects. They at least must be able to do a thorough examination and be able to perform and read OCT and understand fluorescein angiography. I think these are the minimal requirements for general ophthalmologists going into the field of intravitreal injections.

Q:

The 2012 EURETINA Meeting will be held in combination with the ESCRS meeting. What do you think are some of the areas in which the two specialties could benefit from closer cooperation and collaboration?

Nowadays quite a few patients undergo a combination of anterior and posterior segment surgery and some anterior segment surgeons are handling the anterior complications from surgery of the posterior pole. A closer exchange of ideas will help us to improve combined surgery and a close relationship between the two specialties is very important in the assessment of the patients receiving treatments like steroids for the posterior segment, which may cause problems like glaucoma and cataract.

RuSSiAn LAnGuAGE EDiTion noW onLinE


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Special Focus

retina

SUPER DOSE RANIBIZUMAB

Potential role for improving functional outcomes in eyes with recalcitrant fluid or vascularised PED by Cheryl Guttman Krader in Fort Lauderdale

Courtesy of CA Chan Inc

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Image 1: An 86-year-old man presented with a history of blurred and distorted vision for six months due to a subfoveal vascularised PED, left eye. BCVA was RE: 20/30, LE: 20/100

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lthough anti-VEGF therapy with intravitreal ranibizumab (Lucentis, Genentech) is a major advance in the treatment of exudative age-related macular degeneration (AMD), many eyes on monthly treatment continue to have persistent disease activity. At one year in the Comparison of AgeRelated Macular Degeneration Treatments Trial (CATT), 50 per cent of eyes treated with monthly ranibizumab 0.5mg had persistent fluid on OCT. In addition, vascularised pigment epithelial detachment (vPED), which is present in about seven per cent of eyes with neovascular AMD and is a poor prognostic factor in natural history studies, has responded incompletely or inconsistently to conventional doses of antiVEGF agents. At the annual meeting of the Association for Research in Vision and Ophthalmology, results reported from investigator-initiated,

Based on these interim results, we think super dose treatment has some benefit for incomplete responders, although it is not a solution for everyone Eric Chen MD

EUROTIMES | Volume 16/17 | Issue 12/1

Image 2: Within four weeks after a single injection of a superdose of 2.0mg/0.05ml of ranibizumab (Genentech, Inc. South San Francisco, CA), there was flattening of the PED besides resolution of the subretinal fluid, LE

prospective studies suggest a potential role for a 2.0mg “super dose” ranibizumab regimen in these challenging cases. Eric Chen MD, a retinal specialist at Retina Consultants of Houston, Houston, Texas, reported interim findings from the Phase 1-2 Superdose AntiVEGF for recalcitrant AMD (SAVE) study. All patients received ranibizumab 2.0mg/0.5 cc monthly x 3 doses and were then randomised to follow-up every four or six weeks with “capped PRN” therapy in which ranibizumab 2.0mg is injected mandatorily every three months or earlier if there is clinical or imaging evidence of CNV membrane activity. Patients were eligible for the study if they had persistent fluid on OCT after receiving at least nine ranibizumab injections within the past 12 months and Snellen equivalent BCVA between 20/25 and 20/320. The two-year study is planning to enroll 90 eyes. Dr Chen reported one-year data from the first 50 eyes that on average had received almost 27 prior ranibizumab injections, including more than 10 within the past year; the mean time between the previous injection and screening/day zero treatment was 36 days. Mean baseline ETDRS BCVA was 68.8 letters (Snellen equivalent about 20/44), and mean retinal central subfield thickness was 414 microns. Most patients received retreatment at all scheduled follow-up visits during the capped PRN phase. OCT imaging at one week after the first 2.0mg injection showed retinal thickness decreased in a significant

proportion of patients and by a mean of 53.3 microns. There was some mild regression of the effect thereafter, but a mean reduction from baseline of 30 to 40 microns was maintained at one year. BCVA also improved early and improved further over time. By eight weeks, patients in the four- and six-week follow-up groups had mean gains of almost five and three letters, respectively, and at one year their BCVA had improved 4.9 and 3.7 letters from baseline. There was one patient who developed a subretinal hemorrhage after his month three injection, which could not definitely be attributed to the higher dosage medication. “The rationale for using a higher dose in these incomplete responders derives from pivotal clinical studies showing better outcomes using ranibizumab 0.5mg versus 0.3mg. The gains in BCVA are impressive, considering that these eyes had already been treated aggressively with ranibizumab so that they had good BCVA on entry,” commented Dr Chen. “Based on these interim results, we think super dose treatment has some benefit for incomplete responders, although it is not a solution for everyone. Whether or not treatment frequency can be reduced with super dose treatment is a question yet to be answered, but the fact that vision improved over time in our patients followed every six weeks suggests it may be possible,” he said. He added that the data also provide good scientific rationale for the Phase 3 HARBOR study that is comparing ranibizumab 0.5 and 2.0mg administered monthly or PRN in eyes with treatment-naïve exudative AMD, although results may differ given the different study populations. 

Flattening vPED Clement Chan MD, FACS, a retinal specialist in private practice, Palm Springs, CA, reported results of a oneyear, multicentre, randomised, open-label study with four arms comparing intravitreal ranibizumab 2.0mg and 0.5mg administered monthly or PRN for the treatment of vPED associated with neovascular AMD. The PRN dosing groups initially received four monthly injections. Between 2008 and 2010, the study enrolled 27 eyes of 27 patients with submacular vPED ≤12 disc area in size, ETDRS BCVA ≥19 and ≤69 letters, and

Eric Chen – ecmd@houstonretina.com Clement Chan – pschan@aol.com

Our outcomes are consistent with the interim results reported last year from the vPED study showing ranibizumab 0.5mg resolved subretinal fluid, haemorrhage, and exudates, but did not flatten the vPED Clement Chan MD, FACS

submacular haemorrhage or fibrosis <50 per cent of the entire PED. Mean followup was nine months with a range of three to 12 months. There were no clinically relevant differences between groups in baseline characteristics, and number of injections administered was similar in all groups after adjustment for differences in follow-up duration. Mean BCVA improved from 55.8 to 63.7 letters, and the vision change did achieve statistical significance. There were no differences in any functional or anatomic outcomes comparing the monthly and PRN regimens, and analyses with patients stratified by dose showed both ranibizumab 0.5 and 2.0mg significantly decreased central 1.0mm thickness, subretinal fluid, and mean height, surface area and greatest linear diameter of the vPED. CME decreased significantly only in the 0.5mg group, but the 2.0mg dose was significantly more effective than 0.5mg in reducing subretinal fluid and vPED dimensions earlier in the study (Week-4 to 8) as well as for consistently flattening vPED. Early significant BCVA improvement (Week-4) was also found only with the ranibizumab 2.0mg dose. “Our outcomes are consistent with the interim results reported last year from the vPED study showing ranibizumab 0.5mg resolved subretinal fluid, haemorrhage, and exudates, but did not flatten the vPED, and the substantial overall improvement in BCVA in our study was driven primarily by the benefit of the 2mg dose,” Dr Chan said. “However, an RPE tear developed in three eyes in our study, each in a different treatment group, and further study is needed with both doses to investigate this safety issue." In both SAVE and the vPED study, there were no unexpected ocular adverse events and no serious systemic adverse events associated with ranibizumab 2.0mg.


11

Special Focus

retina

implant

Injectable steroid preparation can improve outcomes in eyes with diabetic macular oedema by Roibeard O’hEineachain in London

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biodegradable sustained-release implant containing the steroid dexamethasone (Ozurdex®, Allergan) can be useful in the treatment of eyes with diabetic macular oedema, according to studies presented at the 11th EURETINA Congress. “Sustained-release delivery of dexamethasone may be particularly beneficial in eyes with diffuse macular oedema, or in previously vitrectomised eyes. Its longer duration of action and the absence of ‘floater’ or ‘clouding’ symptoms compared to injectable triamcinolone are other advantages. In addition, cataract and IOP complications have a low frequency and are manageable,” said David Callanan MD, Dallas, Texas. The Ozurdex implant consists of dexamethasone integrated within a polymer matrix of lactic and glycolic acid. Following implantation in the vitreous cavity, the polymer gradually breaks down into water and carbon dioxide. The implant’s pharmacokinetics are such that by 90 days the concentration of dexamethasone will have fallen to just below the clinical level. The current practice with the implant is to re-inject it every six months. The FDA and the European Medicines Agency (EMA) have approved Ozurdex as a treatment for macular oedema resulting from either non-infectious uveitis or retinal vein occlusion. Dr Callanan noted that the results of the PLACID study indicate that the use of the implant in combination with conventional laser treatment in patients with macular oedema can provide significantly better improvements in visual acuity and greater reductions in macular thickness and leakage area than laser alone. In the prospective randomised doublemasked trial, which involved patients with diffuse macular oedema, 126 patients initially received the implant, while 127 patients received a sham injection. Patients in both groups underwent laser photocoagulation one month later, and received repeat dexamethasone or sham injections at six or nine months as required, and repeat laser treatments, as required at three-month intervals. The inclusion criteria for the study were: age of over 18 years, a diagnosis of Type 1 or 2 diabetes, a best corrected visual acuity from 20/40 to 20/200 and retinal thickening due to diffuse macular oedema with a central retinal

EUROTIMES | Volume 16/17 | Issue 12/1

thickness at baseline 275 microns or more as determined by OCT. Among patients with reader-verified diffuse macular oedema, those receiving the combination treatment had significantly higher mean increases in letters of bestcorrected visual acuity compared to patients treated with laser alone at months one, four, six, seven and nine. The overall rate of ocular adverse events was significantly higher in patients receiving the implant (73.6 per cent), compared to those receiving laser alone (58.3 per cent). However, the only specific adverse event to occur significantly more often in the implant group was increased IOP. In addition, cataracts, which have been a near universal complication of fluocinolone acetate implants, occurred in only 13 (14.3 per cent) of phakic patients in the implant group, of whom four only required cataract surgery. That compared to six (6.3 per cent) of phakic patients in the laser alone group, five of whom required cataract surgery. Results from another trial, the CHAMPLAIN study, indicated that previous vitrectomy does not reduce the longevity of its effect in eyes with diabetic macular oedema that have previously undergone vitrectomy, said Anat Loewenstein MD, TelAviv, University, Tel Aviv, Israel. In the six-month, prospective, multicentre, open-label study, 56 patients with treatmentresistant DME and a history of pars plana vitrectomy received a single injection of Ozurdex 0.7mg. At eight weeks’ follow-up, there was a mean central retinal thickness decrease of 156 μm from a baseline value of 403 μm, by (P < 0.001). By 26 weeks’ followup there was still a mean decrease of 39 μm (P = 0.004), Dr Loewenstein said. Conjunctival haemorrhage, conjunctival hyperaemia, eye pain and increased intraocular pressure were the most common adverse events. Eight patients initiated IOP medication during the study. “Ozurdex has shown promising results in Phase II trials, with no significant side effects and with better final visual acuity results in laser-treated eyes and a good response to treatment in vitrectomised eyes,” Dr Loewenstein concluded.

contacts David Callanan – dcallanan@texasretina.com Anat Loewenstein – anatlow@tasmc.health.gov.il

Nidek rpt Nov hpa


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12

Special Focus

retina

GEOGRAPHIC ATROPHY

New software helps track progression rates in geographic atrophy

Courtesy of Frank Holz MD

by Dermot McGrath in London

Application of the RegionFinder software in a patient with multifocal geographic atrophy (GA). Autofluorescence images at baseline (upper left) and after 12 months (upper middle) showing enlargement of the atrophic patches. Delineation of the atrophic areas (blue) by the image processing software (lower left and middle). The areas of growth during the observation period is given in orange (upper right) and in square mm listed in a spread sheet (lower right)

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ovel imaging modalities allied to new image processing software offers clinicians an accurate, reproducible and time-efficient quantification of geographic atrophy and progression rates in affected patients, according to Frank Holz MD. “Advanced atrophic dry AMD or geographic atrophy is extremely common and is four times more common in the elderly over 80 years of age than the neovascular form of the disease, so it represents a huge unmet need. This means that we need tools not only to monitor natural history of disease progression but also to have sensible outcome measures for interventions that are employed in these patients,” Dr Holz told delegates attending the 11th EURETINA Congress. Dr Holz, director of the Department of Ophthalmology at the University of Bonn, Germany, said that the new software called RegionFinder, developed by Heidelberg Engineering, should prove useful on a clinical routine basis in tracking patients with geographic atrophy.

EUROTIMES | Volume 16/17 | Issue 12/1

“Major components of the software are automated according to FDA requirements. The software tool facilitates geographic atrophy measurements in natural history studies and also in interventional trials of new agents aiming at slowing enlargement of geographic atrophy,” he said. Dr Holz said that in vivo probing by imaging tools allows physicians to identify areas of atrophy and measure growth of the atrophic lesions over time. “Ideally we would like to have prognostic markers that tell us about the individual fate of the geographic atrophy. This should be highly reproducible and raises the question of whether in fact it might be more sensible in the future to use anatomical outcome parameters as the primary endpoint instead of the functional primary endpoint that we have seen in wet AMD studies,” he said. Dr Holz noted that autofluorescence imaging provides an easy and reliable means of identifying atrophic lesions. “One of the interesting aspects of geographic atrophy is that it is not really a macular disease, but actually keeps

Frank Holz – Frank.Holz@ukb.uni-bonn.de

growing in an overall linear fashion for the whole lifespan of the patient after its first appearance. This makes it quite handy to study interventions to slow the progression and see whether they have any impact or not,” he said. When examining areas directly surrounding the atrophic patch, autofluorescence imaging obtained with a confocal scanning laser ophthalmoscope proved very helpful in defining certain patterns of abnormal autofluorescence surrounding atrophic patches that impact future growth, said Dr Holz. “These are very important prognostic markers and this is not the case for other known AMD high-risk markers. The abnormal patterns can help us to identify if an individual patient is a slow or a fast progressor. This has been confirmed in another large-scale natural history multicentre study, the geographic atrophy progression (GAP-) trial. We have built up quite an extensive list of not just abnormal patterns but also other markers that give us an idea if the atrophy is slow or fast progressing and that can be put to effective use in clinical trials,” he said. Looking at the features of the software in more detail, Dr Holz said that it allows for direct export of autofluorescence images from its database, as well as semi-automated detection of atrophic areas by selection of seeding points. “It is a very reliable tool which can detect differences from baseline to follow-up images and compensates for differences in rotation, alignment, and so forth. The software comes up with a report form including all the information which you might require for your patient or your clinical study,” he said. To assess the reproducibility of the results obtained using RegionFinder, a trial was conducted and recently published in IOVS using seven independent readers who looked at serial images of 30 patients with geographic atrophy. The images included not only autofluorescence images, but also near-infrared and blue reflectance images at baseline, and at six and 12 months. One of the challenges often encountered in assessing macular atrophy images is the high prevalence of peripapillary atrophy, which may become confluent and may hinder precise measurements, said Dr Holz. He said that the RegionFinder software surmounts this hurdle by using a constraint tool to draw a limiting vertical line at the most narrow part of the confluent atrophy, and any atrophy located nasally to this line is disregarded for geographic atrophy quantification. The software then provides an automatic copy option for such constraint to ensure consequent grading at following visits. The results of the trial showed a high level of agreement between the independent readers and also showed that corresponding reflectance images are helpful for lesion boundary discrimination eg, in the presence of luteal pigment. Summing up, Dr Holz said that the image processing software offers an accurate reproducible and timeefficient identification and quantification method for looking at progression rates in geographic atrophy. It may also prove extremely useful at facilitating geographic atrophy measurements in natural history studies and in intervention trials of new agents aimed at slowing the progression of the disease. “The modest aim so far is – similar to glaucoma – not to improve vision for these patients but to slow the progression of the geographic atrophy, so this technology may be highly clinically relevant if we consider that we might be able to spare the fovea for many more years and enable these patients to maintain their reading vision,” he concluded.


12th EURETINA Congress 6-9 September 2012

www.euretina.org

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15 March 2012


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contact

Peter Scanlon – peter.scanlon@glos.nhs.uk

Special Focus

retina

retinopathy

A range of factors contribute to the progression to advanced disease By Roibeard O’hEineachain In London

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espite advances made in improving the outcome of patients with proliferative diabetic retinopathy, many patients still require surgery for the condition owing to poor access to care, inadequate treatment and a host of other factors, said Dr Peter Scanlon MD, MRCOphth, Gloucestershire and Oxford Eye Units, at the 11th EURETINA Congress. A leading cause of delayed treatment is poor screening attendance, which can result from socioeconomic factors and poor attendance even at free screening programmes. For example, a study carried out in Iceland, showed that blind diabetic patients had only a 27 per cent level of compliance with their regular screening programmes, compared to a 77 per cent level of compliance among non-blind diabetic patients (Zoega et al, Acta Ophthalmologica Scandinavica 2005; 83: 687–690). Another study, conducted in Somerset UK, showed a correlation between a patient’s grade of retinopathy and the number of reminders they had required for attendance in the screening programme (Gray et al. Eur J Ophthalmol 2009; 19: 510). In another study, which he and his associates conducted in Gloucestershire UK, sight-threatening diabetic retinopathy appeared to occur most frequently among the most socio-economically deprived patients, who were also the least likely to attend for screening (Scanlon et al, J Med Screen 2008; 15(3): 118–121). Poor screening attendance leads to late presentation, which in turn diminishes the efficacy of treatment. According to the results of the Early Treatment of Diabetic Retinopathy Study (ETDRS), four per cent of eyes not treated until they had reached the stage of high risk proliferative diabetic retinopathy required vitrectomy, under the ETDRS protocol within five years, compared to only 2.1 per cent of eyes treated with early full scatter photocoagulation (Flynn et al. Ophthalmology 1992; 99(9): 1351–1357).

Prevention better than cure As with many diseases, in eyes with diabetic retinopathy an ounce of prevention is worth a pound of cure, Dr Scanlon noted. Patients can delay the onset and slow the progression of retinal disease through the adoption of lifestyle and dietary habits that will keep EUROTIMES | Volume 16/17 | Issue 12/1

their blood sugar pressure and blood lipids levels at the recommended levels. Smoking cessation may also reduce the risk in people with Type 1 diabetes although the evidence in Type 2 diabetes remains controversial. “When I reviewed patients at our clinics who had gone blind, I found that they had had high HbA1c’s and high blood pressure for years which I had only vaguely been aware of. And although they had been turning up regularly at my clinic they had not been attending the diabetic clinic. So I was doing patchwork but the underlying blood sugar and blood pressure had been pretty poor for years,” Dr Scanlon said. There is also a range of psychological factors that could be addressed to ensure diabetic patients manage their condition more effectively. Self-efficacy and active coping behaviour influences maintaining blood glucose levels close to normal whereas depressive illness can cause patients in turn in to neglect their glycaemic and bloodpressure control regimes. In addition, as is the case in the general population, some diabetic patients have eating disorders that can cause problems with metabolic control and cause progression to very severe diabetic retinopathy particularly in young women. “Eating disorders in Type 1 diabetes are a nightmare, some run their blood sugars high in order to keep a certain body shape and that has a disastrous effect on their eyes,” Dr Scanlon said. Some diabetic patients are in denial of their condition. Dr Scanlon described the case of a woman with Type 1 diabetes who hid her condition from her partner for 11 years. Needle phobia is another condition that can have a negative bearing on a patient’s management of their disease and can lead to serious retinopathies. However, a number of non-modifiable risk factors remain, such as genetic predisposition to more advanced disease, duration of diabetes, and the age at diagnosis and at subsequent examinations. Ethnicity may also play a role, though it is often difficult to deduce an ethnicity factor independent of the other risk factors.

“Eating disorders in Type 1 diabetes are a nightmare, some run their blood sugars high in order to keep a certain body shape and that has a disastrous effect on their eyes”

in the UK now treat patients when they develop neovascularisation (either NVE or NVD) and they do not wait until high risk characteristics have developed [RCOphth Guidelines 2005]. This is because the risks of laser treatment are considered to be less than when the original ETDRS studies were performed," Dr Scanlon said. However, there is no universal consensus as to what constitutes adequate laser treatment. For example, whereas the Diabetic Retinopathy Study (DRS) group recommended treating an area equivalent to 157mm to 314 mm2 of the retina, the ETDRS recommended an area equivalent from 236 mm2 to 314 mm2. Another study conducted around that time indicated that more treatment may be necessary Another condition that will not respond for regression of the proliferation among to laser treatment is progressive severe patients with a high number of risk factors fibrovascular proliferation. This is a (Reddy et al. Am J Ophthalmol. 1995 Jun; problem that may become more common 119(6):760-766). The general view amongst with the increased use of anti-VEGF agents, ophthalmologists is that the amount of panDr Scanlon said. On the other hand, the retinal laser treatment needs to be tailored use of anti-VEGF agents appear to be a to individual patients. useful treatment for neovascular glaucoma He noted that even with optimum associated with diabetic retinopathy laser treatment there will still be some because they enable regression of the patients who will require vitrectomy. They neovascularisation that occurs in the angle include patients with non-clearing vitreous of the anterior chamber, reducing the haemorrhage, those with a large subhyaloid intraocular pressure and enabling a clearing haemorrhage on or adjacent to the macula, of the corneal oedema so that adequate laser tractional retinal detachment, and taut treatment can be applied Dr Scanlon said. posterior hyaloid in diabetic macular oedema. pubb_sitrac_Layout 1 29/07/11 13.58 Pagina 1

Treat sooner rather than later

Delayed treatment appears to increase a patient’s risk of developing more severe disease (Flynn et al. Ophthalmology 1992; 99:1351-1357). "Most ophthalmologists

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Practice Development

Workshop and Masterclass Thanks to everyone who attended the Practice Development weekend at The Four Seasons Hotel, Dublin, Ireland Delegates attending the weekend workshop and masterclass said:

“Very powerful” “Stimulating, fun, unique”

“Great idea and well executed” “Good to get a business perspective on our work” “Interesting to get business advice which is lacking in our medical education both at undergraduate and postgraduate level”

For details of all our 2012 events, visit www.escrs.org/practice-development


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17

Update

cataract & refractive

2012

BLENDED VISION

Presbyopia correction results good at three months by Howard Larkin in Vienna

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early all 605 presbyopic patients participating in a multicentre trial achieved binocular uncorrected 20/25 or better distance vision combined with J2 or better near vision three months after surgery using the Laser Blended Vision software nomogram, Jean-Francois Faure MD, Paris, told the XXIX ESCRS Congress. The nomogram was developed by Dan Z Reinstein MD, London, UK, for the Carl Zeiss Meditec MEL-80 excimer laser and VisuMax femtosecond laser platform. Laser Blended Vision is designed to take advantage of a nonlinear aspheric ablation profile that increases depth of vision in each eye, Dr Faure noted. The fields are then combined using a micro-monovision approach that overlaps depth of field in each eye. “The dominant eye has good vision from distance to intermediate. The nondominant eye has good vision from near to intermediate. The brain merges the two images and a blended zone is created that provides patients with quality uncorrected visual acuity at near, intermediate and far,” Dr Faure explained. The trial Dr Faure reported involved 243 male and 362 female patients from 39 to 71 years old. Preoperatively, 41 per cent were myopic with a mean spherical equivalent of -3.73 +/- 1.98 D ranging up to -10.25 and mean cylinder -0.91 +/- 0.70 ranging up to -4.74. Some 44 per cent were hyperopes with a mean spherical equivalent of +2.14 +/- 1.02 ranging up to +6.75 with mean cylinder -0.78 +/- 0.81 ranging up to -4.50. Another 15 per cent were emmetropes with mean spherical equivalent of +0.33 +/- 0.38 ranging from -0.50 to +0.75 with mean cylinder of -0.49 +/-0.92 ranging up to -4.50. Each of the five centres was equipped with the same platform and each of the seven participating surgeons used the same operating procedures. Patients were assessed for ocular dominance, tolerance of micro-monovision, understanding of the procedure and suitability for LASIK. Target refraction was plano in the dominant eye and -0.75 to -1.5 D in the non-dominant eye. Data on age, refraction, gender, ocular dominance and degree of tolerance were loaded, and all treatment was determined using the Laser Blended Vision nomogram. EUROTIMES | Volume 16/17 | Issue 12/1

The brain merges the two images and a blended zone is created that provides patients with quality uncorrected visual acuity at near, intermediate and far Jean-Francois Faure MD

Patients were followed at one day and three months after surgery. For all five centres at three months, 78 per cent of emmetropes achieved binocular uncorrected vision of 20/20 J1 or better and 97 per cent 20/25 J2 or better. For hyperopes, 69 per cent achieved 20/20 J1 and 93 per cent 20/25 J2. For myopes, 72 per cent achieved 20/20 J1 and 95 per cent 20/25 J2. Overall, 96 per cent reached 20/25 and 93 per cent 20/20 with 95 per cent reaching J2 or better and 87 per cent J1 or better. However, eight per cent of myopes, nine per cent of hyperopes and 11 per cent of emmetropes lost one line of best spectaclecorrected vision while one per cent of myopes and emmetropes and two per cent of hyperopes lost two or more lines. About 69 per cent overall had no change in lines of vision while 22 per cent of myopes, 20 per cent of hyperopes and 16 per cent of emmetropes gained one line. One per cent of myopes and two per cent of emmetropes gained two or more lines. Dr Faure noted that patients who do not achieve 20/25 or spectacle independence for near vision could be retreated. “Presbyopia and ametropia can be treated successfully providing a high level of patient satisfaction. Histograms prove that the visual outcome is excellent with a good reproducibility. The method can be proposed to all presbyopic patients,” he said.

contact Jean-Francois Faure – j.f.faure@noos.fr

Frankfurt Retina Meeting March 10 th - 11th 2012 Live Surgery · Lectures · Video Presentations Claus Eckardt, Chairman The program will cover the full spectrum of vitreoretinal surgery with an emphasis on concepts and techniques. Audience participation will be encouraged and extensive discussion will be provided. Information and registration: www.eckardt-frankfurt.de Faculty Donald D'Amico - USA Carl Awh - USA Bill Aylward - Great Britain Adiel Barak - Israel Audina Berrocal - USA Tillmann Eckert - Germany Heinrich Heimann - Great Britain Raymond Iezzi - USA Kazuaki Kadonosono - Japan Shunji Kusaka - Japan Carlos Mateo - Spain Andreas Mohr - Germany Hassan Mortada - Egypt Yusuke Oshima - Japan Grazia Pertile - Italy Stanislao Rizzo - Italy Gabor Scharioth - Germany Cyrus Shroff - India Peter Stalmans - Belgium Peter Szurman - Germany Ramin Tadayoni - France Cynthia Toth - USA Brian Ward - USA Keith Warren - USA David Wong - China Klinik für Augenheilkunde – Klinikum Frankfurt Höchst Gotenstraße 6 - 8 · 65929 Frankfurt /Germany Phone: +49 69.3106-2972 · Fax: +49 69.3106-3695 c.eckardt@em.uni-frankfurt.de


contacts

Update

cataract & refractive

HYDROPHOBIC ACRYLIC IOL

Novel material and design aim to bring optimised optical and anatomic performance by Cheryl Guttman Krader in Vienna

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ataract surgeons report favourable early experiences with a new, single-piece IOL constructed of a novel hydrophobic acrylic material (enVista MX60, Bausch+Lomb). In a free paper session during the XXIX ESCRS Congress, Roberto Bellucci MD, Department of Ophthalmology, Hospital and University of Verona, Italy, and Richard Packard MD, Prince Charles Eye Unit, Windsor, UK described the features of the new IOL, reviewed its handling characteristics, and reported postoperative outcomes. The IOL has a 6.0mm optic with an aspheric (aberration-free) design and 360-degree square edge. It has modified C-haptics, an overall length of 12.5mm, lies flat on the bench, and has a five-degree posterior vault when compressed. Its hydrophobic acrylic material is a highly cross-linked acrylic copolymer designed specifically for IOL use. It has an optimised refractive index (1.54), a high Abbe number (40.5), and low silicone oil affinity. The IOL is hydrated to an equilibrium water content of four per cent and packaged in physiological sterile saline so that its water content is maintained. “The refractive index of this novel acrylic material allows for a thin lens and is similar to that of the acrylic of the AcrySof IOLs, but it has a higher Abbe number. Hydration of the material to equilibrium prior to implantation should eliminate the driving force for water diffusion into the IOL in the eye, theoretically eliminating the potential for haze, glistenings and other material defects,” said Dr Bellucci. “Surface hardness is also excellent, making it resistant to damage from surgical instruments, and the surface properties of the IOL are more stable after implantation compared to other hydrophobic IOLs that are packaged dry,” said Dr Bellucci.

Design features Dr Packard also commented on the unique material and design features. “The Abbe value of this material is important because the higher the number, the less the chromatic aberration and therefore the better the retinal image quality. Its four per cent equilibrium water content, which is much higher than the 0.35 per cent to 0.5 per EUROTIMES | Volume 16/17 | Issue 12/1

EnVista lens in cartridge

The refractive index of this novel acrylic material allows for a thin lens and is similar to that of the acrylic of the AcrySof IOLs, but it has a higher Abbe number Roberto Bellucci MD EnVista lens emerging into eye with elbow of haptic forward

cent water content of other hydrophobic acrylic IOLs, should allow the material to remain stable in the eye without water exchange, which is believed to cause glistenings,” he said. The hydrophobic acrylic is not as sticky as some lens materials, but it does have a good contact angle and with its 360-degree square posterior edge, it should have good PCO characteristics, he added. Dr Bellucci reported that the BCVA outcome in his series of 10 patients was “very satisfying”. At six months, logMAR

BCDVA was -0.02 ±0.06. Slit-lamp examinations performed throughout the follow-up period confirmed continued centration and absence of any internal vacuoles or surface scratches. Findings from wavefront aberrometry showed a pattern consistent with that of neutral aspheric IOLs. Optical quality was investigated by determining the pointspread function (Strehl ratio) measured using both Hartmann-Shack (Topcon) and double-pass (OQAS) aberrometers, and the results were satisfactory.

Richard Packard – mail@eyequack.vossnet.co.uk Roberto Bellucci – robbell@tin.it

“These first optical and anatomical results are encouraging, and because the IOL could have absorbed water in its packaging prior to surgery, even this short-term study is important as initial confirmation of its potential to remain glistening-free. Longer observation is needed,” said Dr Bellucci. Dr Packard’s study included 20 patients, 10 of his own and 10 operated on by David Spalton MD, St Thomas’ Hospital. The surgeries were done under topical anaesthesia through a 2.75mm clear corneal incision. Ease of insertion using a proprietary injection device was rated with an overall score of four (best possible = five). “The injector system worked well through a 2.75mm incision, and the IOL unfolded slowly, which made it easy to position. Now, a new injector system is available allowing implantation through a 2.2mm incision,” Dr Packard said.

Courtesy of Richard Packard MD

18

No adverse events He also reported that consistent with the surface hardness of the hydrophobic acrylic material, he observed no markings from instrument handling in slit-lamp examination, and there were no adverse events during a mean follow-up of 17.3 days. Mean Snellen UDVA improved from 21.9/6 to 10.4/6 and mean CDVA improved from 14.3/6 to 8.2/6. However, Dr Packard observed the results were skewed because visual prognosis was guarded in two patients with ocular co-morbidities. Mean MRSE was +0.4 ±0.9 D compared with a formula predicted target of -0.27 ± 0.2 D. Power calculations were performed using the SRK/T formula with the manufacturer’s original recommended A-constant of 118.7 for optical biometry. However, based on the refractive outcomes, the manufacturer has revised the A-constant to 119.1, Dr Packard said. Dr Packard also presented a video to demonstrate IOL loading and implantation through a 2.2mm incision. After the IOL is placed in the cartridge with the haptics tucked under the edge, the implant is rotated to align its long axis, ie, along the optic-haptic junction, with the long axis of the cartridge. This causes the leading haptic to turn into an elbow on the top of the lens and assures that when the lens is released, the leading haptic is properly positioned and the IOL can be pushed directly into the capsular bag. “Proper loading of the IOL in the cartridge is important for ease of positioning. In addition, to enable pushing the lens into the bag, surgeons should fill the whole capsular bag with viscoelastic before filling the rest of the anterior chamber,” Dr Packard said.


n a l i M

XXX Congress OF THE ESCRS 8-12 September

2012

15 March 2012 Submission Deadline: Abstract

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Update

cataract & refractive

Out-of-the-bag IOLs

Many options for IOL placement in eyes with poor capsular support by Roibeard O’hEineachain in London

I

n cataract cases where the eye has poor capsular support because of capsular rupture or ocular co-morbidities, there is a range of options available, though a vitreoretinal surgeon may need to be on hand for assistance, according to Marc de Smet MD, PhD, Lausanne, Switzerland. “In the management of secondary IOL implants you need to judge the amount of capsular support that is left and the retinal integrity, particularly with regard to a patient’s likelihood of developing a retinal detachment in the future, in which case you would want to have a good view of the periphery,” Prof de Smet told the 11th EURETINA Congress. In some situations there may be inflammation, and as a result the corneal epithelium may lose some of its transparency during surgery. Scraping the cornea or applying other means such as hypertonic glycerol will restore the transparency and enable the surgeon to assess the intraocular situation and perform surgery. In cases of well controlled uveitis, there are many reports in the literature stating that a standard IOL placed in the capsular bag will produce good results, Prof de Smet noted. However, in cases where there is any evidence of constant inflammation or hypotony the wiser course is to remove of the capsular material and use a different type of implant.

Implantation of an intraocular lens into the capsular bag is possible in some eyes with capsule tears and ruptures if there are two regions 180 degrees apart that remain intact, and 90 degrees away from regions where there is no capsule, he said. Otherwise, the best results will be obtained with a sulcus-fixated or anterior chamber IOL, Prof de Smet noted.

Sulcus-fixated approach Many of the IOLs commonly used for implantation in the capsular bag are inappropriate for implantation in the sulcus, Prof de Smet noted. The haptic angulation and edge design of such IOLs means that they will tend to rub against the iris, potentially causing pigment dispersion and iris transillumination, or in some cases even glaucoma and cystoid macular oedema. “The ESCRS recommended avoiding these as much as possible and to select instead a three-piece IOL with foldable optics and rounded anterior optic edges, as they don’t irritate the iris. With posteriorly angulated haptics and larger implants, they fit securely in the sulcus. In this way you are able to avoid some of the potential complications of inappropriate lenses,” Prof de Smet said. He noted that single-piece IOLs could increase the rates of posterior iris synechiae after phacovitrectomy particularly in eyes where longstanding tamponade is required,

since it will tend to push the implant forward causing it to rub against the iris. Silicone oil can have a similar effect (Kim et al, Ophthalmologica. 2009; 223:222-227). “In cases where there is a posterior capsular rupture but the anterior capsule remains intact, one technique that can be very useful to prevent contact between a sulcus fixated IOL and the iris is to try and push the optic posterior to anterior capsule, leaving the haptics in the sulcus anterior to the capsule. The way to do this is to put some pressure superiorly and inferiorly on the IOL, perpendicular to the axis plane, until the optic is well-positioned and the anterior capsule takes somewhat of an ovoid shape,” he said. Capturing the optic in this way not only enhances the stability and centration of the IOL, but also provides a vitreoretinal surgeon with an added advantage, following an air exchange or silicone oil tamponade, there will be less tendency for leakage into the anterior chamber. Dr de Smet noted that sulcus fixation is often associated with some problems or complications. They include tilt, anterior segment and vitreous haemorrhages and secondary glaucoma. Persistent ocular inflammation may also occur when the haptic is positioned elsewhere than in the sulcus. Under these circumstances, macular oedema is frequent, and ciliary erosion may appear two to three years later, he

Marc de Smet – mddesmet1@mac.com

At a follow-up of about seven months you can see the position of the haptic through the sclera but there is no overlying erosion of scleral tissue Marc de Smet MD, PhD

said. Correct positioning when in doubt can be confirmed or insured by use of an endoscope (Olsen et al., Am J Ophthalmol 2011;151: 287-296). IOLs that have fallen into the vitreous cavity can best be repositioned through an intrascleral tunnel. “At a follow-up of about seven months you can see the position of the haptic through the sclera but there is no overlying erosion of scleral tissue. Moreover, the visual results are good and complications are limited. With a UBM you can see that there is no inflammation being generated by the haptic itself when it’s placed mid-sclera,” Prof de Smet added.

Iris claw lens Using an Artisan IOL is another alternative for eyes without capsular support, Prof de Smet noted. He cited the findings of a study that showed that Artisan IOL implantation provided good visual results in aphakic vitrectomised eyes without capsular support after trauma (Riazi et al, Eye, 2008; 22:1419-24). The lens appears to cause few complications apart from a few giant cells precipitates on the IOL. “When placed on the iris surface it will very seldom dislocate or separate itself from the iris surface and there is no problem with regard to repairing retinal detachments since you get a very good view of the peripheral retina,” Prof de Smet added.

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General eU

21

Update

cataract & refractive

NEW IOL

New hydrophobic acrylic IOL provides good visual outcomes without glistenings by Roibeard O’hEineachain in Vienna

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he new EC-3 hydrophobic acrylic IOL (Aaren Scientific) appears to provide good visual results with little PCO and a zero incidence of the vacuoles, or glistening, reported with older hydrophobic IOLs, reports Christophe Pey MD, Le Puy en Velay, France. “The EC-3 has remained well-centred and transparent through the nearly four years of follow-up at our centre, with no appearance of intra-lenticular vacuoles,” he told the XXIX Congress of the ESCRS. Dr Pey presented the 46.8-month results of 62 eyes of patients who underwent implantation of the new lens as part of an international multicentre trial begun in April 2007 involving a total of 354 patients. Inclusion criteria for the study were a minimum age of 50 years, a best corrected visual acuity no better than 20/40, less than 1.5 D of corneal cylinder, no significant retinal or corneal disease, and clear intraocular media. Dr Pey noted that all of the patients at his centre underwent phacoemulsification followed by insertion of the EC-3 IOL through a 3.2mm incision. Dr Pey said that the BCVA results in the patients at his centre were very satisfactory, with all eyes achieving 20/40 or better. In addition, the BCVA was 20/32 in 98.4 per cent, 20/25 or better in 90.2 per cent, and 20/20 or better in 61.3 per cent. The patients’ mean BCVA was 20/32, he said. The patients' age did not appear to have much effect on visual results. That is, mean logMAR visual acuity was 0.0 among patients aged 60 years or younger, 0.03 among those aged 60 and 69 years, and also 0.03 among those aged 80 to 89 years. Dr Pey noted that the incidence of PCO was low. Slit lamp examination showed that posterior capsule fibrosis occurred in 10 per cent of eyes, but 77.0 per cent had no PCO at four years, 16 per cent had a minimal amount, seven per cent had a moderate amount and there was no incidence of dense PCO in any eyes. Moreover, none have yet required YAG laser capsulotomy. In addition, and in contrast to older hydrophobic IOLs, there were no glistenings in the implanted lenses in any

Don’t miss EU Matters, see page 40 EUROTIMES | Volume 16/17 | Issue 12/1

“Patients implanted with the lens out of our centre and followed for four years have demonstrated excellent visual acuity outcomes, low complication rates, no glistening and no YAG laser procedures” eyes after four years. That compared to a six per cent incidence of glistenings in the contralateral eyes of patients implanted with older hydrophobic IOLs. In the eyes with the older IOLs the glistenings were grade +1 in three per cent and grade +2 in three per cent. The EC-3 intraocular lens has a hydrophobic acrylic optic with a UV blocker and polyvinylidene fluoride (PVDF) haptics. Its square edged optic has a diameter of 6.0mm and the implant’s overall length is 13.00mm. The lens is CE-marked and FDA approved and has been implanted in 10,000 eyes. “Patients implanted with the lens out of our centre and followed for four years have demonstrated excellent visual acuity outcomes, low complication rates, no glistening and no YAG laser procedures,” Dr Pey concluded.

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contact Christophe Pey – christophe.pey@wanadoo.fr

Ziemer Ophthalmic Systems AG Allmendstrasse 11, CH-2562 Port, Switzerland

www.ziemergroup.com marketing@ziemergroup.com


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Update

cataract & refractive

Thomas Olsen – tkolsen@dadlnet.dk

an inspiration

Optical principles defined by Nobel prize-winner still relevant today By Dermot McGrath in Vienna

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ne hundred years after the Swedish ophthalmologist Allvar Gullstrand received the Nobel Prize for Medicine, his teachings and contributions to the science of optics are still relevant and inspiring to modern practitioners, Thomas Olsen MD told delegates in a special Gullstrand Lecture given at the XXIX Congress of the ESCRS. “Allvar Gullstrand was the first and to date the only ophthalmologist who has been awarded a Nobel Prize. Together with other giants from the birth of modern science, like Hermann von Helmholtz, he applied the theory of physical mathematics to the study of ocular refraction. Among his achievements are numerous scientific papers on optical instrumentation and modelling of the human eye and many of his methodologies and schematic eye assumptions are still valid today,” he said. In his lecture, Dr Olsen, assistant professor at the University Eye Clinic of Aarhus, Denmark, paid tribute to the life, work and lasting legacy of one of the true pioneers of refractive optics, whose inventions are still in use in ophthalmic practices today. “One such example is the slit lamp which Gullstrand invented as a tool to study the interfaces of the ocular media. Yet another example is his invention of the reflex-free ophthalmoscope, the principle of which is still in use in modern fundus cameras,” Dr Olsen said. Dr Olsen said that Gullstrand’s most important contribution, however, was probably his theoretical work to pave the way for a complete understanding of the human eye as an optical system. In delving into subjects such as real ocular imagery, corneal optics, astigmatism, spherical aberration, accommodation, and the gradient index of refraction of the crystalline lens, Gullstrand helped to significantly advance the state of

Allvar Gullstrand knew a lot, but when it came to surgical modalities he could actually do little Thomas Olsen MD

EUROTIMES | Volume 16/17 | Issue 12/1

knowledge on the structure and function of the human optical system. Born in 1862 in Landskrona, Sweden, Gullstrand started his medical studies in 1880 at Uppsala University, paid a one-year visit to Vienna in 1885, finally returning to Sweden and graduating from Stockholm University in 1888. In 1890, he wrote his thesis on the theory of astigmatism and in 1894 he was appointed the first professor of ophthalmology at Uppsala University. Gullstrand was entirely self-educated in the fields of geometric and physiological optics and in 1909 he published the famous chapter “The Dioptrics of the eye” in Helmholtz’s textbook on Treatise on Physiological Optics (3rd edition).

Great inspiration As Dr Olsen noted, Gullstrand was professionally active in a period of considerable scientific achievement, including major advances in physical science, electromagnetic theory, thermodynamics, atomic particles and experimental design. He was also deeply interested in mathematics and its potential applications for the human optical system. “Although he never studied mathematics per se, he was 'educated and self-taught' and attracted by the power of this discipline on ocular optics,” said Dr Olsen. “There is no doubt that a great inspiration for Gullstrand at this time was von Helmholtz. Thanks to him, for the first time it was possible to look into the eye and see what nature had designed for us to see with. Imagine how challenging this would be to someone with a bright mind and a growing knowledge of optics such as Gullstrand.” Gullstrand’s initial work remained largely unknown to his scientific contemporaries, as his first papers describing the optics of the human eye were written in Swedish, followed later by papers in German, the most commonly used scientific language at that time. The title of his Nobel lecture in 1911 was: “How I found the mechanism of the intracapsular accommodation”, in which Gullstrand set out to describe the physical mechanism behind the accommodative power of the crystalline lens. He also described the methods and logic involved in developing complete optical analysis of the eye, with the human crystalline lens considered as a special case.

Allvar Gullstrand

Hermann von Helmholtz

Courtesy of Thomas Olsen MD

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The Beginning of the 20th century – Birth of modern science

Even today, 100 years after its delivery, the Nobel lecture makes very interesting and relevant reading for a modern ophthalmologist, said Dr Olsen. “For those of us who have been interested in the calculation of IOL power for many years, this is fascinating material. You have to understand the situation – very little was known about the lens of the eye, there was no ultrasound, optical biometry or sophisticated equipment like Scheimpflug imaging, nor was there topography, tomography, wavefront, or aberrometry. What they did have, however, was the science of optics and mathematical skills,” said Dr Olsen. Gullstrand fully appreciated that as an optical device the eye operated quite differently from cameras or telescopes. “Thin lens calculations or first order optics were simply not sufficient for a good understanding. In optical terms the eye is a small aperture, short focal length, wideangle optical system and this makes the eye and the optics very challenging to describe,” said Dr Olsen.

Gullstrand rose to the challenge, however, using differential equations up to the fourth order and setting up complex mathematical models before he felt confident that his schematic eye model would be a realistic one. The Gullstrand theoretical eye provided exact model data for all components of the optical system, including intraocular distances, indices of refraction of the ocular media, and radii of curvature of the corneal and lenticular interfaces, together with the cardinal points of the eye. Summing up, Dr Olsen said that Gullstrand was an outstanding thinker and pioneer whose scientific writings are still capable of illuminating and stimulating ophthalmologists in the modern era. “Allvar Gullstrand knew a lot, but when it came to surgical modalities he could actually do little. His was the era of exact, descriptive science. Today as a corneal or a lens surgeon we can do a lot, but do we actually know what we are doing? This is why it is important to continue to read those old papers because they still have much to teach us.”


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Simonetta Morselli - simonetta.morselli @gmail.com

Update

CATARACT & REFRACTIVE

REFRACTIVE SURPRISES

Expect the unexpected when dealing with unusual eyes of cataract surgery patients by Roibeard O’hEineachain in Vienna

P

EUROTIMES | Volume 16/17 | Issue 12/1

Figure 3: Vergence formula can be removed through 2.2mm incisions

Figure 1: MICS after RK

We can control and manage expected and unexpected refractive surprises by paying attention to the preoperative anatomy and the condition and surgical history of the eye

Courtesy of Simonetta Morselli MD

atients undergoing cataract surgery can have both expected and unexpected refractive surprises, but many can be avoided and most can be fairly easily remedied, said Simonetta Morselli MD, chief of Ophthalmic Department, San Bassiano Hospital, Bassano del Grappa, Italy. “We expect refractive surprises after corneal refractive surgery. We don’t expect refractive surprises after implantation of a +4 D or -3 D monofocal IOL, but they can occur,” Dr Morselli told attendees at the XXIX Congress of the ESCRS. Refractive surgery patients represent some of the more difficult cases in terms of IOL calculation, she noted. That first became evident in cataract patients who had undergone radial keratotomy, she noted. The non-standard curvature of eyes that have undergone RK make standard keratotomy readings inaccurate, she said. Furthermore, since the earliest procedures were performed at a time when IOL implantation was nothing like the standard practice it is today, preoperative K readings are never available. Therefore corneal topography is mandatory. In addition, the reduced rigidity of the eye requires the optical measurement of axial length (Figure 1).  A similar situation prevails in regard to eyes that have undergone PRK, where corneal topography is also necessary for IOL calculations, although most types of axial length measurement will suffice, but optical methods are probably better, she said. In the case of both RK and PRK, getting the hoped for refraction following cataract surgery right the first time is not something surgeons should rely on. Moreover, following radial keratotomy it can take a month after cataract surgery for the eye to reach its final refraction. Eyes that have undergone PRK, however, generally achieve their final refraction more or less immediately after surgery. In either case Dr Morselli said she recommends implanting IOLs that are easily removed and replaced. Hydrophilic acrylics are particularly useful in that regard because they can be removed through 2.2mm incisions (Figure 2). Cataract patients with phakic IOLs present much less of a problem since the procedure has little impact on keratometry readings, although optical measurement of the axial

Figure 2: Hydrophilic acrylic IOL can be removed easily through 2.2mm incisions

length is necessary. The IOLMaster includes an option for dealing with such cases, Dr Morselli noted. It is usually clear in the immediate postoperative period whether the patient has achieved the correct refraction, which is true in around 90 per cent of cases, she added. “If there is a refractive surprise in such cases I will sometimes replace the lens immediately, another possibility is to implant a piggy-back IOL in the sulcus. Implanting a light-adjustable lens to begin with is another option,” she said.

Unexpected refractive surprises

IOL calculation in eyes with unusual anterior chamber depths requires special attention, she noted. In a highly hyperopic eye the flat K can lead to the assumption that the anterior chamber will be shallower

Simonetta Morselli MD and that the implanted IOL closer to the cornea and conversely in a highly myopic eye the steep K can lead to the assumption that the anterior chamber will be deeper and that the IOL will be further from the cornea. However, in reality, the capsular bags in such eyes are not in the normal position, and therefore the A constant for the IOL used will not be correct because it will not reflect the true effective lens position. The result is an unexpected refractive surprise, Dr Morselli said. “Fortunately, there is a new sevenvariable formula, the Holladay 2, created by Jack Holladay MD, which in addition to taking into account the standard axial length and keratometry measurements, also incorporates anterior chamber depth, lens thickness, white-to-white diameter, patient refraction, and age,” she added.

The multivariable formula tends to be more accurate than the two-variable formulae in eyes with extreme refractive errors, she said. It is available as part of the Holladay IOL Consultant/Surgical Outcomes Assessment Program (HICSOAP, available at www.hicsoap.com). For surgeons who find themselves dealing with very long or very short eyes, but who don’t have the HIC-SOAP formula ready to hand, calculating for about 1.0 D of myopia may be the best alternative. “This is only my experience, but sometimes it works,” Dr Morselli said Refractive surprises can also occur with piggyback IOLs even when using the refractive Vergence formula (Holladay et al J Cataract Refract Surg 1997; 23:1356-1370), which is the standard formula for piggyback IOL power calculation, Dr Morselli noted. She cited as an example a recently reported case in which a myopic patient ended up with a +3 D overcorrection because of an unexpected amount of space between the two IOLs (McCartney, J Cataract Refract Surg. 2011 Jul; 37(7): 1372-3)(Figure 3). Delayed refractive surprises can occur when lenses become dislocated, as has been the case with some of the early lenses designed for implantation through the micro-incisions used in MICS procedures. The early lenses were designed to be highly pliable, but as a result were unable to maintain their position in the bag during capsular contraction and were dislocated either forward or backward. The resulting refractive surprises were particularly pronounced in IOLs with high refractive powers. “We can control and manage expected and unexpected refractive surprises by paying attention to the preoperative anatomy and the condition and surgical history of the eye. In the less predictable cases the most important point is to explain to the patients that the difficult nature of their cases means that a second procedure may be necessary to enhance the results of the first,” Dr Morselli concluded.

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Update

cornea

medal LECTURE

Remarkable progress made in ocular herpes treatments by Dermot McGrath in Vienna

E

normous strides have been made in the diagnosis, treatment and management of epithelial herpes simplex keratitis over the past 50 years, giving some grounds for optimism that a cure will one day be found for this particular disease, according to Peter R Laibson MD. “Hopefully someday we will be able to cure herpes and be able to talk about it in retrospective like we do today with smallpox. I think that the fact that there is only one paper out of 320 dealing with ocular herpes on the programme at this meeting indicates the extent to which the disease has now been controlled to some extent,” Dr Laibson said in his EuCornea Medal Lecture at the Opening Ceremony of the 2nd EuCornea Congress. Dr Laibson, an attending surgeon and director emeritus of the Cornea Service at Wills Eye Institute and

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professor of ophthalmology at Jefferson Medical College, explained that herpes is manifested in a number of different ways on the cornea. In the very earliest phases, he said that individual cells are involved, followed by small dendrites and geographic herpetic ulcers as the disease progresses. “We need to remember that the cornea is not the only epithelial area that may be affected by the herpes virus. It may grow on the conjunctiva, and onto the cornea and we may see conjunctival dendrites alone. Very few physicians look at conjunctiva for dendritic lesions. It is important before treating a patient with combination medication such as antibiotics and steroids because of a red eye, to put fluorescein or other dye into the eye to make sure that there are no dendritic changes in the conjunctiva,” he said. Dendritic lesions are not so simple to deal with, noted Dr Laibson, and it is not

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Hopefully someday we will be able to cure herpes and be able to talk about it in retrospective like we do today with smallpox Peter R Laibson MD

always clear why some superficial dendritic ulcers respond well to anti-viral medication while others go deep into the stroma and eventually perforate. Looking at the history of ocular herpes treatment, Dr Laibson cited the groundbreaking research of Trygve Gundersen who reported in 1936 that tincture of seven per cent iodine, followed by cocaine neutralisation, was able to denude the corneal epithelium and with it the dendritic or geographic lesions. Another study of note came in 1961 when Sery and Furgieule investigated over 150 compounds to see if any besides iodine was effective in treating herpes simplex dendritic keratitis. “They found that in vitro a number of agents were effective, but in vivo there was very little that was effective in the rabbit cornea. Chemical cautery, as advocated by Gundersen, was recommended and used for treatment even after that,” he said. Dr Laibson said that Herbert E Kaufman was the first to utilise an antiviral drug, idoxuridine (IDU), to treat epithelial herpes in the rabbit in 1961. “It was originally synthesised as an anti-cancer therapy and IDU blocked DNA synthesis of intracellular herpes simplex virus. In a study with Nesburn and Moloney, Kaufman showed for the first time ever that an antiviral drug was effective against treating a human virus disease. Unfortunately, it also proved toxic and with serious side effects if used too long,” he said. In 1996 the French company Thea produced ganciclovir (Zirgan), which became the drug of choice for epithelial herpetic keratitis in Europe. It would take another 15 years before the same compound under a different name, Virgan (Bausch + Lomb), became available in the US and gave ophthalmologists an alternative to topical trifluridine, said Dr Laibson. Other oral medications, such as acyclovir, famciclovir and valacyclovir were also effective in treating topical dendritic keratitis, he added. The preferred treatment today, said Dr Laibson, is probably ganciclovir gel (Zirgan

Peter R Laibson – plaibson@willseye.org

or Virgan) 0.15 per cent administered five times a day, followed by trifluridine (Viroptic), which is still quite effective. The Cochrane Collaboration, a landmark study of almost 6,000 herpetic eyes conducted by Kirk Wilhelmus MD, further advanced understanding of the optimal treatment for herpes simplex virus infection. “The study concluded that the ophthalmic formulations of trifluridine, acyclovir ointment, and gancyclovir gel are effective and safe. However, antivirals and interferon may also speed healing in cases of recalcitrant HSV, and debridement along with antiviral was also shown to be an effective treatment for HSV,” he said. Other advances in knowledge for treating more problematic forms of stromal HSV came with the Herpetic Eye Disease Study (HEDS), made up of five randomised double-masked placebo controlled trials conducted in nine centres around the US. The studies cumulatively showed that while oral acyclovir showed no effect in arresting stromal herpetic disease, steroids were found to be highly effective in treating the disease when used appropriately, said Dr Laibson. In terms of treating herpetic kerato-uveitis, Dr Laibson said that the group felt confident enough with the findings to recommend 400mg of acyclovir five times a day, even though statistical significance had not been achieved in the trial due to limited patient numbers. In cases of recurrent HSV, oral acyclovir was found to be highly statistically significantly better than placebo in treating patients and preventing recurrent herpes. “If someone has had one episode of recurrent herpes there is about a 13 per cent recurrence rate on acyclovir and almost twice that with placebo. If someone has had more than four episodes of recurrent herpes the incidence of recurrence doubles even in the acyclovir treated group but it goes up to almost 50 per cent in the placebo group,” he said. Looking to the future, Dr Laibson said that earlier diagnosis of HSV keratitis would be helpful and that the RPS detector currently under development may prove useful in this regard. However, he thought it unlikely that new antiviral medications will enable further progress in the treatment of HSV. “It took 15 years for ganciclovir to become accepted in the United States so I don’t think we are going to get another topical antiviral any more effective than ganciclovir in the near future – it is simply too expensive to test these drugs,” he concluded.

Don’t miss Practice Development, see page 39 EUROTIMES | Volume 16/17 | Issue 12/1


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European Society of and and European Society ofCornea Cornea Ocular Surface Disease Specialists Ocular Surface Disease Specialists

GENE THERAPY

May protect donor corneas, improve survival of epithelial allograft by Howard Larkin in Vienna

T

ransferring a gene producing the anti-apoptotic protein p35 to corneal tissues could prolong donor cornea storage by preventing endothelial cell death, and improve allograft survival by preventing epithelial cell death and related immune response, Thomas A Fuchsluger MD, PhD, of the Schepens Eye Research Institute at Harvard University, and Düsseldorf University Eye Hospital, Germany, told the second EuCornea Congress. Human corneas in 4 degree C hypothermic storage that were treated with the p35 gene using a lentiviral vector lost epithelial cells more slowly than untreated corneas, retaining enough cells to be viable for more than 11 weeks compared with seven weeks for untreated tissues. Another gene, producing the anti-apoptotic protein bcl-xL, also slowed cell loss in storage, but was not as effective as p35. Moreover, the endothelial cells expressing anti-apoptotic genes retained physiological cell morphology. Maintaining denser corneal tissues with functional morphology through anti-apoptotic gene therapy could increase the number of highquality grafts in storage and reduce graft failure after transplantation, Dr Fuchsluger said. Similarly, p35 gene-treated corneal epithelial sheets transplanted in a mouse model resisted induced apoptosis and associated opacity better and displayed enhanced epithelial barrier integrity compared with untreated allografts, leading to higher graft survival rates at 51 days in the treated group, Dr Fuchsluger reported. Over-expression of the p35 protein was observed in the treated group for at least two weeks. In addition to preserving cells, reduced apoptosis also appeared to reduce immune response toward the allograft. This research demonstrates the crucial role apoptosis plays in graft survival and suggests that preventing apoptosis by introducing p35 genes may improve survival rates.

A better vector However, vectors remain problematic, with HIV-derived lentiviruses potentially inducing pathology. Dr Fuchsluger tested several adenoassociated virus, or AAV, variants in a murine model to determine suitability. EUROTIMES | Volume 16/17 | Issue 12/1

3rd EuCornea Congress

Three of the AAV serotypes showed much higher proportions of endothelial cells expressing GFP than untreated corneas, suggesting that less-pathogenic AAV may be an alternative to HIV-based lentiviral vectors. Calcium phosphate nanoparticles may be a viable non-viral vector, Dr Fuchsluger said. He noted that they are highly biocompatible, biodegrade easily, and low-cost preparations are stable in storage for up to two weeks. After transfection, the particles dissolve into calcium and phosphate, and the small increase in Ca2+ levels has been shown to not affect cell viability. Dr Fuchsluger has demonstrated that calcium nanoparticles can be used to efficiently transfect endothelial cells of human cornea. He used a preparation of nanoparticles coated with polyethylenimine surrounding nucleic acids to produce EGFP to treat the corneas. After 12 hours, 55 per cent of cells in the treated group expressed EGFP compared with none in a negative control and about 15 per cent in a positive control. Polyethylenimine to the calcium phosphate nanoparticles increased the transfection efficiency, he noted. “Calcium phosphate nanoparticles are suitable tools for transfection of corneal endothelial cell,” Dr Fuchsluger said. Since they produce little apoptosis, they may be an alternative to viral vectors. References 1. A new tool for the transfection of corneal endothelial cells: Calcium phosphate nanoparticles. Hu J, Kovtun A, Tomaszewski A, Singer BB, Seitz B, Epple M, Steuhl KP, Ergün S, Fuchsluger TA. Acta Biomater. 2011 Sep 17. [Epub ahead of print] 2. [Viral vectors for gene delivery to corneal endothelial cells]. Fuchsluger TA, Jurkunas U, Kazlauskas A, Dana R. Klin Monbl Augenheilkd. 2011 Jun;228(6):498-503. Epub 2011 Jun 7. German. 3. Anti-apoptotic gene therapy prolongs survival of corneal endothelial cells during storage. Fuchsluger TA, Jurkunas U, Kazlauskas A, Dana R. Gene Ther. 2011 Aug;18(8):778-87. doi: 10.1038/gt.2011.20. Epub 2011 Mar 17. 4. Corneal endothelial cells are protected from apoptosis by gene therapy. Fuchsluger TA, Jurkunas U, Kazlauskas A, Dana R. Hum Gene Ther. 2011 May;22(5):549-58. Epub 2011 Mar 17.

contact Thomas Fuchsluger - thomas.fuchsluger@ med.uni-duesseldorf.de

MILAN 6 - 8 September 2012 www.eucornea.org


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26

Update

CORNEA

3-D TOMOGRAPHY

Technique goes beyond the surface and improves detection of corneal pathology by Cheryl Guttman Krader in Vienna

T

hree-dimensional (3-D) tomography offers multiple advantages over 2-D topography for corneal analysis, and yet uptake of the superior diagnostic technology has been surprisingly slow, said Michael W Belin MD, in a keynote address at the 2nd EuCornea Congress. “Ophthalmologists have used 2-D surface evaluation of the cornea for over 20 years and are comfortable with it. However, while ophthalmologists are usually on the cutting edge and early adopters of new technology, there is a surprising reluctance to let go of this old and more limited technology,” said Dr Belin, professor of ophthalmology and visual science, University of Arizona, Tucson. “3-D tomography has been embraced in other areas of ophthalmology, and it is time to apply it to evaluation of the cornea in order to truly understand pathology that exists and improve diagnosis.” Tomography, whether generated via Scheimpflug photography or ocular coherence tomography, uses a series of cross-sectional images to recreate the anterior segment in three dimensions. Placido-based corneal imaging only provides information on the curvature of the anterior corneal surface, while 3-D tomography analyses the anterior and posterior surfaces and allows creation of a full pachymetric thickness map. It also provides better coverage of the cornea, often from limbus to limbus, whereas images from reflective technology cover at most 60 per cent of the cornea, Dr Belin explained. Using a series of clinical examples, Dr Belin illustrated how the benefits of 3-D corneal analysis allow for improved diagnosis of keratoconus, pellucid marginal degeneration (PMD), and post-LASIK ectasia. He also discussed its use for planning intracorneal ring (ICR) surgery and identifying corneal oedema. For diagnosis of keratoconus, 3-D tomography is clearly superior to anterior surface analysis because posterior surface abnormalities and/or changes in pachymetric distribution typically predate

Figure 2 – A subtraction map of the posterior corneal surface. The map on the left is the post-LASIK posterior elevation. The map in the middle is the preoperative map. The difference map (far right) shows a significant change representing early identification of post-LASIK ectasia

Figure 1 – A 4-map composite display showing early ectatic change on the posterior corneal surface (lower right) in spite of a normal anterior curvature (upper left) and anterior elevation (upper right) (OCULUS Pentacam)

3-D tomography has been embraced in other areas of ophthalmology, and it is time to apply it to evaluation of the cornea in order to truly understand pathology that exists and improve diagnosis Michael W Belin MD changes in the anterior surface (Figure 1). Dr Belin highlighted use of 3-D tomography in a patient with so-called “unilateral keratoconus” whose disease was apparent in one eye based on anterior surface mapping, but whose fellow eye had normal anterior curvature, elevation and curvature indices. 3-D tomography revealed an ectatic region on the posterior elevation map along with an abnormal progression index. “If this patient presented for laser vision correction, most surgeons would not have operated on the ‘normal’ eye because of the pathological fellow eye. But what if both eyes looked like the so-called normal eye on

Don’t miss JCRS Highlights, see page 43 EUROTIMES | Volume 16/17 | Issue 12/1

Figure 3 – Placido overlay showing the area of corneal coverage. The lower elliptical area represents the location of the area of thinning seen in true Pellucid Marginal Degeneration. This area is significantly outside the area of Placido coverage (TechnoMed C-Scan)

screening with 2-D corneal analysis?” The ability of 3-D tomography to image the posterior corneal surface also accounts for its advantage over Placido-based analysis for diagnosing post-LASIK ectasia. Dr Belin explained that early diagnosis of post-LASIK ectasia couldn’t be done using anterior surface analysis only because the anterior surface has been surgically altered and changes to it are a late sign of ectasia development. A standard pachymetry map is also not useful for diagnosing postLASIK ectasia because the cornea has been surgically thinned and so its pachymetry is no longer normal.

Michael Belin - mwbelin@aol.com

“The earliest changes from postLASIK ectasia are seen in the posterior corneal surface, and that is the best time to intervene. If our goal in performing crosslinking is to halt ectasia before vision loss, waiting for the patient to become symptomatic with anterior surface changes is really too late,” Dr Belin said. He added that the best way to screen for post-LASIK ectasia using 3-D tomography is with a posterior elevation subtraction map created using pre- and postoperative images (Figure 2). “As we have published, changes in the posterior corneal surface do not occur after uneventful LASIK or PRK,” Dr Belin said. The superiority of 3-D tomography over 2-D analysis for diagnosing PMD relates to the greater corneal coverage achieved with the former technique. Using 3-D tomography, the pachymetric map offers the best way to diagnose PMD, which will be identified as a band of thinning 1-2mm from the inferior limbus. “A standard Placido system not only can’t image where the pathology is in eyes with PMD (Figure 3), but it loses all data in the area of pathology. Therefore, it cannot be used reliably for diagnosis,” Dr Belin said. For guiding ICR surgical planning, 3-D tomography is better than anterior surface analysis because the tomographic elevation map more accurately identifies the location of the cone than an anterior curvature map. In addition, the pachymetric map generated with 3-D analysis more accurately identifies the thinnest point than a standard pachymetric map and therefore enables safer determination of channel depth. Dr Belin explained that standard pachymetric maps look at the normal to surface tangent whereas with 3-D analysis also allows the computation of thickness determined based on the minimal distance. “These two measures can be very different in an ectatic eye,” he said, illustrating the point with a case in which the thinnest point identified by 3-D analysis was 23 microns less than that read on a standard pachymetric map. Dr Belin concluded by showing how the pachymetric progression map can be used for assessing corneal oedema in addition to diagnosing corneal thinning disorders. In eyes with oedema due to endothelial dysfunction, the pachymetric progression map shows flattening from the centre to the periphery. This finding often predates changes on specular microscopy and thereby may allow early detection, Dr Belin said.


PRAGUE 2012 16 ESCRS WINTER MEETING TH

In conjunction with the Czech Society of Cataract and Refractive Surgery

3-5 February 2012 Hilton Prague Hotel For further information visit:

www.escrs.org

PROGRAMME OVERVIEW FRIDAY 3 FEBRUARY

SATURDAY 4 FEBRUARY

SUNDAY 5 FEBRUARY

08.00 09.00

Free Papers

Free Papers

10.00 11.00

ESCRS/ EuCornea Cornea Day

12.00

Cornea Course

Basic Optics Course Free Papers

Refractive Course Part 2

Cataract Course Part 2

BREAK

Free Papers

Czech Society Session

Symposium The evaluation of visual function in refractive & cataract surgery candidates

Symposium Anterior segment complications: What to do next?

13.00

Free Papers

BREAK

14.00 15.00

ESCRS/ EuCornea Cornea Day

16.00

Basic Optics Course Cataract Course Part 1

Refractive Course Part 1

Live Surgery (Organised by the Czech Society)

Cornea Course

17.00 18.00

Symposium Correction of irregular astigmatism

Symposium Cataract surgery in glaucomatous eyes

19.00 20.00

EUROTIMES 16th ESCRS Winter Meeting Satellite Education Programme ™

SATELLITE EDUCATION PROGRAMME

Saturday 4 February

Friday 3 February 13:00 – 14:00 INNOVATIVE OPTIONS TO IMPROVE CATARACT AND REFRACTIVE SURGERY OUTCOMES

13:00 – 14:00

13:00 – 14:00

13:00 – 14:00

INTRODUCING FEMTO-CATARACT TO IMPROVE REFRACTIVE OUTCOMES

INNOVATIONS IN SURGICAL OPHTHALMOLOGY

Moderator: TBC

RELEX® SMILE: FLAPLESS. ALL-FEMTO. SINGLE-STEP LASER VISION CORRECTION BEYOND LASIK Moderator: W. Sekundo

Moderator: B. Malyugin

Sponsored by

Sponsored by

GERMANY

Sponsored by

Moderator: TBC

RUSSIA

Sponsored by


PRAGUE 2012

16TH ESCRS WINTER MEETING In conjunction with the Czech Society of Cataract and Refractive Surgery

SYMPOSIA

BASIC OPTICS COURSE

Friday 3 February 17.00 – 18.30

Saturday 4 February 17.00 – 18.30

Friday 3 February 08.30 – 15.40

CATARACT SURGERY IN GLAUCOMATOUS EYES

CORRECTION OF IRREGULAR ASTIGMATISM

Chairpersons: I. Pallikaris GREECE, M.J. Tassignon BELGIUM

Chairpersons:

Chairpersons:

R. Bellucci ITALY, I. Liehneová CZECH REPUBLIC

B. Cochener FRANCE, P. Stodulka CZECH REPUBLIC

PART I. VISUAL OPTICS Moderators: M.J. Tassignon BELGIUM, I. Pallikaris GREECE 08.30

F. Van de Velde BELGIUM Light propagation in the eye

17.00

J. Thygesen DENMARK Phaco-trabeculectomy: is it still an option?

17.00

T. Kohnen GERMANY What is irregular astigmatism?

08.50

S. Marcos SPAIN Aberrations of the optical system

17.10

C.E. Traverso ITALY Lens surgery in eyes with filtering blebs

17.10

C. Koppen BELGIUM Contact lenses: a first-step approach

09.15

17.20

N. Koerber GERMANY Cataract surgery after canaloplasty or other non-penetrating procedures

17.20

TBC Topography-guided ablation: promising, but not applicable to all corneas

A. Glasser USA Optics of crystalline lens and accommodative response

09.35

17.30

I. Claerhout BELGIUM Cataract surgery in PEX eyes

17.30

09.55

17.40

S. Miglior ITALY Cataract surgery in open angle glaucoma

D. Pietrini FRANCE Intracorneal ring segments: what to choose and for which cornea?

T. Van den Berg THE NETHERLANDS Straylight: importance of different domains of the point-spread function M.J. Tassignon BELGIUM IOL optics

17.50

M. Fichtl CZECH REPUBLIC Lens surgery in angle closure glaucoma

18.00

Discussion

18.30

End of session

17.40

J. Güell SPAIN Intraocular toric lenses: phakic, pseudophakic or piggy-back?

10.15

J. Rozema BELGIUM Epidemiology of the optical parameters of the eye

17.50

M. Busin ITALY Is there still a role for penetrating keratoplasty?

10.35

W. Haigis GERMANY IOL power calculation

10.55

Discussion

18.00

Discussion

18.30

End of session

PART II. VISUAL BEHAVIOUR (VISUAL FUNCTION) Moderators: I. Pallikaris GREECE, R. Applegate USA

Saturday 4 February 11.30 – 13.00

Sunday 5 February

ANTERIOR SEGMENT COMPLICATIONS: WHAT TO DO NEXT?

THE EVALUATION OF VISUAL FUNCTION IN REFRACTIVE AND CATARACT SURGERY CANDIDATES

Chairperson:

Chairpersons:

D. Spalton UK, K. Vannas FINLAND

Case Study Discussions with the Panellists Panellists give their answers to tricky/difficult situations in cataract surgery. Panellists: R. Bellucci ITALY J. Colin FRANCE B. Dick GERMANY B. Malyugin RUSSIA R. Packard UK K. Tjia THE NETHERLANDS

11.30 – 13.00

I. Pallikaris GREECE, P. Studeny CZECH REPUBLIC

11.00

R. Applegate USA Retinal image quality

11.20

I. Pallikaris GREECE Presbyoptics

11.40

S. Plainis GREECE State of the art assessment of visual acuity and contrast sensitivity

12.10

P. Artal SPAIN Visual function assessment using adaptive optics

12.30

H. Ginis GREECE Modelling visual function

12.50

Discussion

13.00

Break

11.30

S. Plainis GREECE Psychophysics and visual function

11.40

H. Ginis GREECE Assessing highly-aberrated eyes

11.50

V. Molebny UKRAINE The use of ray tracing in the objective evaluation of visual performance

PART III. IMAGING THE HUMAN EYE

12.00

T. Van den Berg THE NETHERLANDS Preoperative evaluation of glare or straylight

14.00

12.10

P.J. Pisella FRANCE Corneal asphericity assessment for custom aspheric IOLs

A. Pallikaris GREECE Confocal microscopy, from research to clinical practice

14.20

12.20

Z. Biro HUNGARY Selecting appropriate candidates for multifocal IOLs

J. Rozema BELGIUM Scheimpflug imaging, from research to clinical practice

14.40

B. Malyugin RUSSIA OCT imaging, from research to clinical practice

12.30

Discussion

15.00

13.00

End of session

O. Stachs GERMANY Very high frequency ultrasound imaging, from research to clinical practice

15.25

Discussion

15.40

End of Session

Moderators: A. Pallikaris GREECE, B. Malyugin RUSSIA


CATARACT SURGERY DIDACTIC COURSE

REFRACTIVE SURGERY DIDACTIC COURSE

CORNEA DIDACTIC COURSE

Friday 3 February

Friday 3 February

Saturday 4 February

15.00 – 17.00

15.00 – 17.00

08.00 – 16.00

PART 1

PART 1 Moderators: R. Bellucci ITALY, D. Epstein SWITZERLAND

08.00

Chairpersons: R. Packard UK, P. Rosen UK 15.00

15.00

C. Roberts USA Corneal topography and IOL power calculation

CLINICAL CORNEA

15.25

D. Siganos GREECE Patient selection and preoperative preparation

08.05

G. Kymionis GREECE Basic science: anatomy, physiology and biomechanics

15.30

- Patient flow -Theatre Nurses - Setting up microscope - Principles in surgery - Draping and anaesthesia L. De Benito-Llopis SPAIN

Incisions - Temporal vs superior -Knife technology 15.50

G. Kymionis GREECE Lasers in refractive surgery

15.55

R. Bellucci ITALY LASIK: surgical technique

08.20

M.J. Tassignon BELGIUM Pathological responses of the cornea

16.15

T. Seiler SWITZERLAND Surface Ablation Techniques (SATs): surgical technique

08.30

J. Merayo SPAIN Microbiologic and cytologic testing

08.50

D. Epstein SWITZERLAND Results of corneal refractive surgery

B. Frueh SWITZERLAND Infectious keratitis

09.10

B. Cochener FRANCE Corneal and anterior segment evaluation techniques

09.30

Break

D . Spalton UK, M.J. Tassignon BELGIUM - Basic ergonomics - Use of needle and forceps - Staining - Tear out recovery - Posterior capsulorhexis - Management of PCO including YAG laser surgery

Moderators: B. Cochener FRANCE, G. Kymionis GREECE

15.40 - Corneal vs scleral

The Capsule

J. Güell SPAIN Introduction

16.35 16.55

Questions and answers End of session

16.20

I. Pallikaris GREECE Femtosecond lasers and cataract surgery

17.00

16.30

Discussion

Saturday 4 February

17.00

End of session

08.00 – 12.45 PART 2

Moderators: M. Busin ITALY, J. Colin FRANCE 09.50

G. Grabner AUSTRIA Immunological disorders of the cornea

Saturday 4 February

Moderators: G. Grabner AUSTRIA, C. Roberts USA

10.10

08.00 – 12.45

08.00

R. Applegate USA Quality of vision evaluation

M. Morral UK Non-infectious keratitis

10.30

08.20

J. Colin FRANCE Intrastromal corneal implants

E. Coşkunseven TURKEY Corneal dystrophies

10.50

08.30

A. Marinho PORTUGAL Overview of phakic IOLs

TBC Ectasia disorders and degenerations

11.10

08.50

E. Rosen UK Refractive lens exchange

F. Kruse GERMANY Dry-eye and ocular surface disease

11.30

Questions and answers Break

PART 2 Chairpersons: R. Packard UK, P. Rosen UK 08.00

Teaching the teachers of cataract surgery

08.20

Learning how to learn cataract surgery

08.30

R. Packard UK

21st Century Phaco Dynamics - Physics - Pump mechanisms - Tip Technology - Power and delivery

09.10

O. Findl UK Multifocal IOLs

11.50

R. Packard UK, A. Franchini ITALY, S. Morselli ITALY

09.20

G. Grabner AUSTRIA Presbyopia

SURGICAL CORNEA

- For soft, medium, hard cataracts - Phaco chop - BMICS - CMICS

09.40

J. Krumeich GERMANY Overview of microkeratomes

12.40

10.20

Break

10.00

10.40

Z. Biro HUNGARY Viscoelastics

C. Roberts USA Biomechanics of the cornea

J. Krumeich GERMANY Penetrating keratoplasty: preoperative consideration technique, postoperative management and complications

10.20

J. Güell SPAIN Refractive reoperations and enhancements

13.00

10.40

L. De Benito-Llopis SPAIN Customised ablational procedures

R. Bellucci ITALY Anterior lamellar keratoplasty procedures: up to date

13.20

10.55

Break

R. Nuijts THE NETHERLANDS Management of postkeratopathy astigmatism

13.40

J. Colin FRANCE Corneal cross-linking: intracorneal ring segments in ectatic disorders

14.00

Break

09.20

Phaco Techniques:

LENSES 11.00

The ideal Intraocular lens

11.10

Aspheric lenses

11.20

O. Findl AUSTRIA Multifocals

11.30

G. Auffarth GERMANY Accommodating lenses

11.40

B. Frueh SWITZERLAND Toric IOLs

11.50

M. Amon AUSTRIA Supplementary lenses

12.00

C. Peckar UK Monovision

12.10

VIDEO SYMPOSIUM: COMPLICATIONS AND COMPLEX CASES B. Malyugin RUSSIA, V. Picardo ITALY, P. Rosen UK, I. Prieto PORTUGAL, V. Pfeifer SLOVENIA

12.45

End of session

Moderators: J. Krumeich GERMANY, R. Nuijts THE NETHERLANDS

Moderators: V. Katsanevaki GREECE, T. Kohnen GERMANY 11.15

V. Katsanevaki GREECE Non-optical complications of LASIK and corneal surgery

11.40

V. Katsanevaki GREECE Optical complications of refractive surgery

11.55

Moderators: G. Grabner AUSTRIA, J. Güell SPAIN 14.20

R. Nuijts THE NETHERLANDS Complications of phakic IOLs

J. Güell SPAIN Conjunctival surgery

14.40

12.15

T. Kohnen GERMANY Incisional and coagulative corneal procedures: Principles, technique and results

J. Güell SPAIN Amniotic membrane

15.00

M. Busin ITALY Endothelial transplantation: up to date

12.25

Questions and answers

15.20

12.45

End of session

G. Grabner AUSTRIA Limbal transplantation and keratoprosthesis

15.40

Questions and answers

16.00

End of session


PRAGUE 2012

16TH ESCRS WINTER MEETING In conjunction with the Czech Society of Cataract and Refractive Surgery

3-5 February 2012 Hilton Prague Hotel ANNUAL CORNEA DAY (Organised by ESCRS and EuCornea)

CZECH AND SLOVAK SOCIETY SESSION

Friday 3 February 09.30 – 16.30

Sunday 5 February 08.30 – 11.00

Chairperson: J. Guell SPAIN

Moderators: A. Cernak, P. Kuchynka, P. Studeny

Topics will include: – Management of corneal complications after refractive surgery

LIVE SURGERY

– Tips and pitfalls in corneal graft surgery: DALK, DSEK, PK Saturday 4 February 14.00 – 16.30

– Ocular surface disease: what worked and what did not – Corneal potpourri (miscellaneous cases) The Cornea Day Programme will comprise a number of expert keynote lectures and a series of case presentations on the topics listed above. For further details go to www.escrs.org

For further information please visit:

www.escrs.org

(Organised by the Czech Society of Cataract & Refractive Surgery) Organised by: J. Pasta, P. Studeny Transmitted from: Department of Ophthalmology, the Faculty Hospital Královské Vinohrady, Prague and Department of Ophthalmology, the Central Military Hospital, Prague

SURGICAL SKILLS TRAINING COURSE SCHEDULE Course Directors: C. Peckar UK, R. Bellucci ITALY Course No.

Time

COST PER COURSE: €100 Course

FRIDAY 3 FEBRUARY 01 02 03 04 05 06 07 08 09

09.00 – 10.30 11.00 – 12.30 13.30 – 14.45 15.30 – 16.30 17.00 – 18.00 08.30 – 10.30 11.00 – 13.00 14.00 – 16.00 16.30 – 18.15

LASIK LASIK Verisyse Phakic IOL Artisan Phakic IOL PRL Phakic IOL Basic Phacoemulsification Basic Phacoemulsification INTACS Basic Suturing Techniques

09.00 – 10.00 10.30 – 11.45 14.00 – 15.30 16.00 – 17.30 18.00 – 20.00 08.00 – 09.45 10.15 – 11.45 12.15 – 13.45 14.45 – 16.15 16.45 – 18.15 18.30 – 20.00

Artisan Phakic IOL Verisyse Phakic IOL PRK, LASEK & Epi-LASIK PRK, LASEK & Epi-LASIK KeraRings Basic Suturing Techniques Bimanual Micro-Incision Phaco Bimanual Micro-Incision Phaco Phaco: Management of Complications Phaco: Management of Complications Ferrara Rings

SUNDAY 5 FEBRUARY 21 22 23 24

TH

In conjunction with the Czech Society of Cataract and Refractive Surgery

SATURDAY 4 FEBRUARY 10 11 12 13 14 15 16 17 18 19 20

PRAGUE 2012 16 ESCRS WINTER MEETING

09.00 – 10.30 11.00 – 12.30 08.00 – 10.00 10.30 – 12.30

LASIK LASIK Basic Phacoemulsification Basic Phacoemulsification

3-5 February

Hilton Prague Hotel


contacts

Günther Grabner - g.grabner@salk.at Donald Tan - snecdt@pacific.net.sg

Update

CORNEA

KERATOPROSTHESIS

Current options bring success and help identify areas for further research by Cheryl Guttman Krader in Vienna

C

ornea specialists contemplating the current state of keratoprosthesis (KP) surgery are encouraged by recent progress and optimistic about the future. However, they are realistic in recognising that multiple challenges must be overcome before KP surgery successfully fills the gap left by cadaveric keratoplasty in alleviating the worldwide burden of corneal blindness. Speaking at the 2nd EuCornea Congress, Donald Tan MD, medical director, Singapore National Eye Centre, and professor of ophthalmology, National University of Singapore, said there are now two options that have shown good success in different indications representing the least and most challenging KP candidates. The first is the Type I Boston KPro (Massachusetts Eye and Ear Infirmary, Boston, MA) for eyes with failed or high risk grafts without chemical burns or autoimmune disease. The second is the osteo-odonto KP (OOKP) for those with end-stage ocular surface disease. “While essentially yesterday’s designs, these two most successful KPs continue to

surprise us with results that are encouraging and even improving,” said Dr Tan. However, moving forward in the field will depend on success in solving the complications occurring with today’s devices, the development of new options, and promoting interest in KP surgery among cornea specialists and within industry. Providing his perspectives on the future of KP surgery, Dr Tan noted that while the Boston Type 1 KPro was once relegated to last resort status for patients with multiple failed grafts, it is now being considered as a reasonable first-line treatment in some situations, and with growing international interest in this device and broadening of its indications, especially in developing countries, there is a great push to improve outcomes, simplify and improve postoperative management, and discover ways to increase cost effectiveness. Ongoing studies investigating immunomodulators and inflammation pathways may help expand the indications for the Type I Boston KPro. However, in terms of increasing its global use, challenges

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remain in replicating the outcomes being achieved in the US, particularly in developing countries where need for KPs is greatest but where conditions of poor hygiene and sanitation compromise success. Dr Tan noted that modifications in topical antibiotic prophylaxis protocols have reduced the risk of infectious endophthalmitis in eyes with the Type I Boston KPro. However, there is concern over lifelong antimicrobial use coupled with bandage contact lens wear, especially in paediatric patients. In addition, the development of secondary fungal infections is an emerging issue and a risk that is particularly high in certain Asian countries. Discussing the OOKP, Dr Tan said that the bizarre and complex nature of the procedure poses hurdles to its growth. “The OOKP optical cylinder costs no more than a non-premium IOL, and manpower and surgical time, which account for the greatest cost of this procedure, are cheap in developing countries. Still, failure with OOKP is unforgiving,” Dr Tan said. In addition to the need for research to develop new KPs, evidence is needed that can help guide understanding of the relative roles of corneal transplantation, ocular surface transplantation, and KP surgery, as well as how these techniques might be used in combination. This research should aim to collect long-term follow-up data and while heretofore unheard of, perhaps even involve randomised controlled trials, said Dr Tan.

Current choices Günther Grabner MD, professor of ophthalmology and chairman of the University Eye Clinic,

Paracelsus Medical University, Salzburg, Austria, outlined a current algorithm for guiding decisions on KP surgery. Assuming no limitations to device access and surgical care, the major factors to consider are whether corneal disease is unilateral or bilateral, limbal stem cell status, ocular surface dryness, and existence of healthy teeth, he said. For a patient with unilateral disease, a sufficiently wet ocular surface, and sufficient stem cells, penetrating keratoplasty (PK) with or without immune suppression is unquestionably the treatment of choice. Given the same circumstances but with complete loss of stem cells, autologous stem cell transplantation with or without PK is indicated. “For these scenarios, there is not a good reason to do a KP unless the patient doesn’t want the second eye touched. Then, consideration can be given to the Type I Boston KPro if the eye is wet or possibly the AlphaCor (Addition Technology),” Dr Grabner said. If the patient’s disease is unilateral and the eye is dry, there is currently no good option, but fortunately this is a very rare situation. PK with immunosuppression is again the best choice if there is bilateral disease with sufficient wetting and stem cells. In a bilateral case with sufficient wetting but stem cell insufficiency, the Boston KPro or possibly the AlphaCor is probably indicated, according to Dr Grabner. “Some surgeons would advocate the OOKP in the latter situation, but I favour the Boston KPro because it’s faster and is delivering some excellent results,” he said.

31


contact

Update

Glaucoma

Canaloplasty failure

Microhyphema a good prognostic indicator in uneventful canaloplasty by Dermot McGrath in Vienna

T

he absence of microhyphema on the first postoperative day seems to be a negative prognostic indicator in uneventful canaloplasty procedures in patients with primary open angle glaucoma (POAG), according to a study presented at the XXIX Congress of the ESCRS. “Our study indicates that the absence of microhyphema after uneventful canaloplasty seems to be a poor prognostic factor in relation to IOP reduction and these eyes required more frequent and earlier Nd:YAG laser goniopuncture after surgery,” said Matthias C Grieshaber MD, FEBO, a consultant at the Department of Ophthalmology, University of Basel, Switzerland. Microhyphema is defined as a small hyphema characterised by suspended red blood cells in the anterior chamber without the formation of a layered clot (Figure 1). The potential complications of a microhyphema are the same as hyphema including IOP elevation and secondary haemorrhage. Dr Grieshaber said that the prospective non-randomised study was carried out to assess the risk factors for failure in canaloplasty, a technique he described as a non-penetrating, bleb-independent procedure using micro-catheter technology. “In canaloplasty, the superficial and deep scleral flaps are dissected in order

to unroof Schlemm’s canal which is then circumferentially dilated and cannulated with a special micro-cannula. After full completion of the cannulation, a prolene suture is tied to the distal end of the tip and looped through the canal in order to stretch the inner wall of Schlemm’s canal (Figure 2). Importantly at the end of surgery the superficial flap is sutured watertight to avoid bleb formation but also to reinforce aqueous running through the physiological outflow system,” he said. (Figure 3.) Dr Grieshaber’s study included 47 consecutive patients with medically uncontrolled POAG who underwent primary canaloplasty. The mean preoperative IOP was 26.8 mmHg and the mean cup-to-disc ratio was 0.82. The average patient age was 70 years and the mean number of glaucoma medications was 2.8. Most of the patients had microhyphema on day one after uneventful canaloplasty (85.1 per cent), said Dr Grieshaber. “When we looked at the success rate of an IOP below 16 mmHg without medications we found microhyphema to be a positive prognostic indicator, whereas age, preoperative IOP, cup-to-disc ratio and gender were not prognostic indicators,” he said. A subgroup analysis was then carried out to determine if any difference could be found between eyes with and without microhyphema on day one postoperatively.

Further research is needed to assess the genuine effect of the tensioning suture in canaloplasty Matthias C Grieshaber MD, FEBO “While there was a slightly increased IOP before surgery in the eyes with microhyphema, it was not statistically significant. Interestingly most of the eyes without microhyphema needed laser goniopuncture after surgery and the time interval between surgery and goniopuncture was much shorter in the eyes without microhyphema. However, there were no differences in the group in regard to age, preoperative IOP, cup-disc ratio or number of medications before surgery and on postoperative IOP at day one,” Dr Grieshaber said. Focusing on the mean postoperative IOP, the eyes with microhyphema had a consistently lower IOP than those without, and that was true at each time point, he said. “Those eyes without microhyphema had an increase in IOP, and then we did laser goniopuncture and the IOP dropped again but it remained on average higher than the

Matthias C Grieshaber - mgrieshaber@uhbs.ch

eyes with microhyphema,” he said. Dr Grieshaber noted that Kaplan-Meier survival curves for complete success rate of IOP pressure target showed that the lower the IOP target was fixed, the greater the difference that emerged between the two groups. “We had 87 per cent complete success rate in the eyes with microhyphema compared to 21 per cent for those eyes without microhyphema for a target IOP under 16 mmHg, whereas it was 97 per cent versus 71 per cent respectively for a target IOP less than 21 mmHg. Likewise if the complete success rate was defined as a 30 per cent IOP reduction, the difference was 88 per cent versus 38 per cent for the microhyphema eyes compared to non-microhyphema eyes. Nevertheless, we did not find any factors associated with microhyphema in terms of age, preoperative IOP, cup-to-disc ratio or gender,” he said. Summing up, Dr Grieshaber said that the evidence of his study suggested that the absence of microhyphema after uneventful canaloplasty seems to be a poor prognostic factor in relation to IOP reduction and that these eyes required more frequent and earlier Nd:YAG laser goniopuncture after surgery. “We need to remember, however, that there was an IOP drop after goniopuncture, so creating a sufficiently large Descemet’s window might be important also in canaloplasty by serving as a back-up. If we consider the microhyphema as blood reflux from the episcleral veins, this may indicate a restored outflow system with permeable trabecular meshwork. However, it is not a sign of low IOP on day one since there was no difference between the two groups. It is also unclear whether it is an indicator for proper suture tension, so further research is needed to assess the genuine effect of the tensioning suture in canaloplasty,” he concluded.

Courtesy of Matthias C Grieshaber MD, FEBO

32

Figure 1: Microhyphema on day one after canaloplasty (gonioscopic view)

EUROTIMES | Volume 16/17 | Issue 12/1

Figure 2: Complete cannulation of Schlemm’s Canal by the microcatheter

Figure 3: No bleb formation after canaloplasty


contact

K Sheng Lim - shenglim@gmail.com

Update

Glaucoma

DRAINAGE IMPLANTS

This is an exciting time for glaucoma surgeons, with many implants currently in development

New devices are under development

by Roibeard O’hEineachain in Vienna

W

hile the various designs of glaucoma drainage devices currently under development all offer potential advantages, they all also have their drawbacks, said K Sheng Lim MD, FRCOphth, St Thomas’ Hospital, London, UK, at the XXIX Congress of the ESCRS. Dr Lim noted that the ideal glaucoma implant would incorporate into its design the best drainage site, the best design for regulating flow and the most biocompatible material. The available implants all have at least one of those factors in their favour, though in practice the lack of one or more essential quality limits their utility, he said. Regarding the different potential destinations for the drained aqueous humour, the four main options are: the outside of the eye, Schlemm’s canal, the subconjunctival space, and the suprachoroidal space, he noted. External drainage has both the obvious advantage of unlimited drainage capacity and the obvious disadvantage of infection risk, he said. One external drainage design that has been proposed has a tube going from the anterior chamber into the subconjunctival space and a plate that sits on top of the superior conjunctiva. At present there is no published data on any external drainage device, he said. “The theoretical disadvantages inherent in such a design are the risks of infection and also extrusion given the constant rubbing of the plate by the eyelid over time,” Dr Lim said.

Schlemm’s canal As regards to drainage into Schlemm’s canal, one device that is currently generating a lot of interest is the iStent. This titanium device bypasses the trabecular meshwork, which is the main area of resistance to outflow in glaucomatous eyes. Another of its advantages is that if one of the stents does not adequately reduce IOP, more can be implanted. However, although the material is inert, its hardness may increase the risk of scarring and extrusion over the long term. However, it is one of the few drainage

K Sheng Lim MD, FRCOphth devices that have been tested in a proper randomised controlled trial (Samuelson et al, Ophthalmology. 2011; 118:459-67), Dr Lim pointed out. The study involved 240 cataract patients with open angle glaucoma who were randomised to receive either cataract surgery alone or with an iStent implant. At one year’s follow-up, IOP was 21.0 mmHg or lower without medication in 70 per cent of eyes with the implant, compared to only 50 per cent of control eyes (P<0.001). Moreover, 66 per cent of eyes with the implant achieved a 20 per cent or greater reduction of IOP compared to only 40 per cent of controls (p =0.003) On the other hand, the overall amount of the IOP reduction with or without medication was similar in the two groups, 8.4 mmHg in the iStent group and 8.5 mmHg in the control group, Dr Lim said. Dr Lim noted that the subconjunctival approach has a long history but has never worked unless there is a plate to maintain a minimum size bleb. Current designs include the ExPress Implant (Optonol) and the SIBS implant (Innovia). The theoretical advantages of both implants are their flow restrictors, but they also share an important disadvantage in lacking a plate. The SIBS implant may have an advantage over the ExPress implant in that its material may be more biocompatible, Dr Lim said.

Suprachoroidal drainage The suprachoroidal area may be the ideal place to direct aqueous out of the anterior chamber, since it has an almost unlimited capacity for drainage. Nevertheless, attempts at this type of drainage have proved problematic. One approach to suprachoroidal drainage is to create a scleral flap, as in trabeculectomy, and placing silicone tubes on either side into the suprachoroidal space and performing a trabeculectomy and peripheral iridectomy, so that the aqueous could drain into the suprachoroidal space. In a pilot study involving 23 patients who underwent the procedure for open angle glaucoma, the postoperative IOP

Don’t miss Ophthalmologica Highlights, see page 41 EUROTIMES | Volume 16/17 | Issue 12/1

after a mean follow-up of 324 days was 13.8 mmHg compared with a preoperative value of 25.4 mmHg. The mean number of postoperative medications was only 1.1 compared with a preoperative value of 3.0 (Jablonski et al, J Glaucoma. 2005;14(2) :91-7). However, many patients developed hypotony and hyphaema. Another implant designed for suprachoroidal drainage is the commercially available Gold Shunt (Solx). It has the advantage of a flow control mechanism, but like the Express implant it is composed of material that is inert but not necessarily biocompatible with ocular tissues. The shunt consists of a gold plate with channels that direct a titratable amount of aqueous directly from the anterior chamber into the suprachoroidal space with a lower risk of hypotony. In a recently published study involving a case of 55 eyes with refractory glaucoma

the rate of complete success with the shunt at one year was less than 20 per cent, although 80 per cent achieved partial or complete success. Fibrosis around the implant appears to have been a factor in the low rate of complete success and suprachoroidal drainage may require the use of more biocompatible material (Figus et al,Br J Ophthalmol, published online August 2011). “This is an exciting time for glaucoma surgeons, with many implants currently in development. Suprachoroidal drainage has the best potential. Scarring is still the main Achilles’ heel for this type of design, but in the future there will probably be a marriage of material and suprachoroidal drainage that will work,” he concluded.

European Board of Ophthalmology Diploma Examination Le Palais des Congrès, Paris

To take place on

Application deadline

26-27 April 2012

31 January 2012

For all further information log on to www.ebo-online.org

33


Tropical Breezes, Exceptional Education AND Shorter Flights, Lower Costs than other Winter Meetings! Next winter, join us for the 5th Annual ASCRS Winter Update and discover all Playa del Carmen, on Mexico’s ‘Riviera’ has to offer. Hosted at the AAA Five Diamond® Fairmont Mayakoba once again, the 2012 program will continue the tradition of excellent education in a spectacular location. Make your plans for next winter now for extra savings! Register today!

For registration, housing and program updates, visit:

www.WinterUpdate.org The meeting was great. The “casual atmosphere allowed open dis-

cussion. My family loved the resort and our day trips to Xcaret to snorkel and to Coba to see Mayan ruins.

Gary J. Foster, MD, Fort Collins, Colorado

Program Chairs

Program Committee

Edward J. Holland, MD Stephen S. Lane, MD Roger F. Steinert, MD

David F. Chang, MD Eric D. Donnenfeld, MD Richard A. Lewis, MD Keith A. Warren, MD

Faculty Brock Bakewell, MD Clara C. Chan, MD Vincent P. de Luise, MD Lisa Gangi, COE Terry Kim, MD W. Barry Lee, MD Richard L. Lindstrom, MD Nancey K. McCann Tina Pinke, COT, COE

Program at a Glance Thursday, February 16 • Networking & Welcome Friday, February 17 • Complicated Cataract • Cornea • Luncheon Workshops • Evening Session: Legislative Update Saturday, February 18 • New Technology in Cataract and Lens-Related Surgery • Retina • Luncheon Workshops • Evening Session: Video Complications Seminar • Attendee Networking Dinner

E. Ann Rose Jonathan B. Rubenstein, MD Thomas W. Samuelson, MD Paul Stubenbordt R. Doyle Stulting, MD, PhD Vonda Syler, COE Jonathan H. Talamo, MD Maureen L. Waddle, MBA Liliana Werner, MD, PhD

Sunday, February 19 • Challenging Cases for the Comprehensive Clinician • Glaucoma • Luncheon Workshops • Evening Session: Medicare Update Monday, February 20 • Keratorefractive • Faculty Roundtables/Wrap-Up

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News

ESASO

open forum

ESASO continues to search for advances in medical retina

T

he 11th International AMD and Retina Congress organised by ESASO in November 2011 highlighted a number of key topics that generated a lively debate at the congress. The congress was attended by 1,168 delegates from 47 countries and was one of the most successful meetings organised by the society to date. The Organising Committee for the meeting was Prof Borja Corcóstegui, Prof Francesco Bandello and Dr Giuseppe Guarnaccia. "There have been many topics of interest during the meeting," said Prof Corcóstegui. "The highlights included Prof CunhaVaz’s talk on macular edema classification, Dr Pablo Aceta’s session on glycemic compensation, Prof Gabrielle Lang’s talk about the extension of non-perfusion areas and Dr David Pelayes’ talk about cataract surgery. The “Meet the Expert Session” covered well-known aspects about AMD, but also looked at the economic aspects such as how to optimise, in a safe way, intraocular injections. Other issues covered in this session were presented by Prof Corcóstegui and Dr Capone, including the LeberCoats disease and the Familiar Exudative Vitreoretinopathy. Alternative forms of treatment for AMD were also discussed and Prof Leonidas Zografos’ talk about how to evaluate progression of AMD and Dr Bressler’s talk about measure of the retinal pigment epithelium atrophy were especially interesting. In another session Dr Falcomatà discussed the complications of angioid streaks and Dr Navarro explained the current concept of macular idiopathic telangiectasia. Dr Capone also discussed anti-VEGF treatment in paediatric ophthalmic diseases. Also of interest was Prof Gaudric’s presentation on vitreomacular adhesion syndromes and Dr Querques’ talk about vitelliform macular alterations. "In my opinion, the meeting succeeded in explaining on a very practical base the advances and news in AMD and other macular diseases, including of course, all advances in macular medical treatment," said Prof Corcóstegui. Prof Bandello said that one of the reasons for the success of the meeting was the new

EUROTIMES | Volume 16/17 | Issue 12/1

format they had established for a number of special sessions. Under this format there were two short presentations made by experts in the field which opened topics for discussion. These were followed by presentations by between five to seven panellists based on case studies which looked at the topics focusing on the initial two presentations. At the end of these presentations, all the panellists were invited to make comments and the discussion was then opened up to delegates attending the session. Prof Bandello said it was also important to mention the XOVA awards sponsored by Novartis, which were presented at the congress. XOVA provides funding for non-profit initiatives expected to have a positive impact on unmet needs in ophthalmology. Eligible projects must have a clear impact on the quality of ophthalmic care and must have long-term viability and sustainability. "These awards are very important," said Prof Bandello, "because they reward people doing work in the developing world."

Challenges ahead Following the success of the Lisbon meeting, the Organising Committee is now focusing on next year's meeting. "We have to keep on searching for advances in both macular age-related degeneration and medical retina in general, so that all the delegates that attended the meeting in Lisbon can be able to join us in Prague and keep learning and exchange concepts with their colleagues from the 47 different countries that attended the last meeting," said Prof Corcóstegui. “I think that ESASO has the task of assuring, through these types of congresses, that eye specialists are continuously kept informed of the latest developments, thus making them acquire the practical knowledge necessary to make their activity suitable for the clinical needs of their patients,” said Dr Guarnaccia. “The remarkable success of our AMD meeting is due to the organisational structure which granted an effective interaction between speakers and audience, simply by participation,” he said.

First Module 2012

Second Module 2012

Orbital, lacrimal & ophthalmic plastic surgery

Cornea and corneal refractive surgery

Valletta, Malta 30 January – 3 February 2012

Lugano, Switzerland 6 – 11 February 2012

Faculty

Faculty

L. Baldeschi, R. Collin, G. Davi, M. González, C. Hintschich, S. Morax, R. Medel, A. Tyers

H. Dua, D. Elies, J.L. Güell, S.B. Hannush, R. Nuijts, I. Pallikaris, R. Pinelli, F. Simona

ESASO c/o Università della Svizzera italiana (USI) Via Giuseppe Buffi 13 6904 Lugano, Switzerland Tel. +41 (0)58 666 4629 Fax +41 (0)58 666 4619 Email info@esaso.org

www.esaso.org

contact Gabriella Skala - gabriella.skala@esaso.org ES_31-11 ESASO_Anz_120x300_RZ.indd 1

11.11.2011 13:26:57 Uhr


News

RESEARCH

New Glaucoma Devices

The ESCRS Research Committee look at ongoing research on new glaucoma technologies by Manfred Tetz and Peter Knowlton, Berlin Eye Research Institute (BERI), Germany

R

ecently there has been an increasing demand for safer surgical glaucoma procedures with low postoperative complication profiles. In general, minimally invasive procedures are not associated with the severe complications that may result from penetrating surgery. The goal of most of these procedures is to enhance the natural outflow system of the trabecular meshwork, rather than creating a new drainage system as in classic trabeculectomy. Some surgeons believe that the newer, less tested, minimally invasive procedures should only be utilised in patients with early stages of disease. Others maintain that prospective, randomised clinical trials are required to compare minimally invasive procedures to trans-scleral surgeries in order to determine their efficacy. Some experts argue that minimally invasive procedures are appropriate for the treatment of moderate disease and that their safety may even warrant usage in cases of advanced glaucoma as a first-line treatment. Currently there is an increasing armamentarium of new glaucoma devices for minimally invasive procedures, some of which are US-approved, CE-marked or under clinical investigation. In this article we present a short overview of some new technological advances in the field of glaucoma surgery. Many of these devices are focused on reestablishing physiological outflow. To be concise, this overview does not focus on some of the devices intended for the supra-choroidal space. The following devices are currently

Figure 1: Canaloplasty suture in gonioscopic view in the canal of Schlemm

Figure 2. Detail of Alcon ® ExPress ® mini shunt. Property of Alcon, Ltd

under clinical investigation or in the first stages of clinical use:

1. Canaloplasty Canaloplasty utilises a microcatheter (iScience ®) to place a 10-0 prolene suture circumferentially into Schlemm’s canal, exerting tension on the canal wall and thus reducing the outflow resistance (Figure 1). Three-year follow-up studies have illustrated that canaloplasty can lead to a significant and sustained reduction of intraocular pressure in patients with open angle glaucoma1. The short- and long-term complication rates of canaloplasty are low, thus rendering an excellent safety profile. 2. The ExPress ® mini-shunt (Alcon ®) This device is made of

stainless steel and designed for insertion from a scleral lake into the anterior

visit our new look website for indian doctors

Figure 3. From: Nichamin, LD. Glaukos iStent trabecular micro-bypass. Middle East African Journal of Ophthalmology, Vol. 16, July 2009

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ESCRS

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India

www.eurotimesindia.org EUROTIMES | Volume 16/17 | Issue 12/1


37

Figure 5. IOP (purple) and medication use (light blue) in patients receiving both the Hydrus ® implant and cataract surgery concurrently. N=28 patients treated, with a follow-up of 28/28 at three months and 20/28 at six months. Property of Ivantis ®, Inc. Figure 4. Hydrus ® implant. Property of Ivantis ®, Inc

The way the world treats dry eye is about to change

chamber, allowing for device-supported sub-conjunctival filtration (Figure 2). This stent was evaluated in a study by Maris et al.2, who compared ExPress mini-shunt implantation to classical trabeculectomy. While a similar postoperative intraocular pressure and surgical success rate was achieved, the incidence of early postoperative hypotony and related complications was significantly lower in patients who received the ExPress mini-shunt.

3. The iStent ® (Glaukos ®) The iStent (Figure 3) is a surgical grade nonferromagnetic titanium trabecular micro-bypass system. It is inserted ab interno, bypassing the trabecular meshwork, and is placed into Schlemm’s canal. The United States FDA IDE trial compared cataract surgery plus iStent to cataract surgery alone. The study found that 73 per cent of patients who had received an iStent maintained an intraocular pressure of 21 mmHg or lower without medication at 12 months’ post-surgery, compared to only 50 per cent of those who underwent cataract surgery alone3. 4. The Hydrus ® implant (Ivantis ®) This scaffold is made of a

nickel titanium shape memory alloy (Figure 4). Suggested advantages of the device include excellent biocompatibility and elasticity. It is designed for insertion into Schlemm’s canal ab interno. Preliminary data are promising thus far, as the results of a small cohort clinical trial indicate significant lowering of intraocular pressure and decreased reliance on glaucoma medications by six months’ post-implant. These results were consistent and were seen both in patients who received only the implant and in patients who received the implant in combination with cataract surgery (Figure 5). EUROTIMES | Volume 16/17 | Issue 12/1

Figure 7: AqueSys ® implant

5. The Stegmann ® Canal Expander

The Stegmann ® implant is made by the Ophthalmos ® company in Switzerland. The stent is composed of polyimide and has a tube multi-fenestrated skeleton structure designed to expand Schlemm’s canal (Figure 6). Initial data suggest pressure-lowering effects at least similar to the published data of viscocanalostomy.

6. The AqueSys ® implant This is the only biological implant, designed to render minimally invasive surgery for subconjunctival fenestration. The implant is composed of a collagen tube with an inner diameter of around 65mm and can be placed with a special inserter ab interno (Figure 7). Early clinical study data is promising.

January 2012

Job code: EU/0622/2011 Date of preparation: October 2011

Figure 6: Stegmann ® Canal Expander visualised in the canal of Schlemm, gonioscopic view

Conclusion The field of new glaucoma devices and surgical technology today is rapidly developing and a lot of clinical research is on the way. Hopefully these innovations will help to render safer and more standardised surgical technologies for the cure of the challenging disease of glaucoma. Acknowledgements Support was provided by the Vanderbilt Medical Scholars program, Vanderbilt University, Nashville, TN, USA References 1. Lewis RA, von Wolff K, Tetz M, Koerber N, Kearney JR, Shingleton BJ, and Samuelson TW. Canaloplasty: Three-year results of circumferential viscodilation and tensioning of Schlemm canal using a microcatheter to treat open-angle glaucoma. JCRS. Vol. 37, Issue 4, pp. 682-690, April 2011. 2. Maris PJ Jr, Ishida K, Netland PA. Comparison of trabeculectomy with Ex-Press miniature glaucoma device implanted under scleral flap. J Glaucoma. 2007;16:14-19. 3. Spiegel D, Wetzel W, Neuhann T, Stuermer J, Hoeh H, GarciaFeijoo J, et al. Coexistent primary open-angle glaucoma and cataract: interim analysis of a trabecular micro-bypass stent and concurrent cataract surgery. Eur J Ophthalmol. 2009;19:393–9.

22027305-4 Optive Pre-launch_EuroTimesJournal.indd 1

14/10/2011 16:02


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News

16th ESCRS Winter Meeting

a proud tradition

Prague looks forward to hosting congress

by Pavel Studeny MD

W ESCRS Membership See the benefits! n Reduced Congress Fees n Journal of Cataract & Refractive Surgery n EuroTimes n Membersâ&#x20AC;&#x2122; Area on www.escrs.org n Membership Certificate n Voting Rights

To find out more, visit www.escrs.org EUROTIMES | Volume 16/17 | Issue 12/1

ith only a short time to go before the 16th ESCRS Winter Meeting, all eyes will be on Prague. Every year the ESCRS winter meeting gets bigger and bigger and as your hosts in the Czech Republic we look forward to sharing our experiences with you. The Czech Society of Cataract and Refractive Surgery was founded in 1998 and today the society has 120 members. The Czech Society of Cataract and Refractive Surgery was developed from the Implantology section of the national Czech Ophthalmological Society, which has a long tradition. The national society has 1060 members and in addition, the Slovak Ophthalmological Society has 580 members. We are proud of our ophthalmological tradition. There are three medical faculties and four University Hospitals in Prague and in each hospital there is a highly regarded ophthalmological clinic. In Czech Republic there are seven medical faculties in total and besides the public hospitals, there are several very qualified private ophthalmological clinics. Ophthalmology in the Czech and Slovak Republics has changed since 1993, when these two states were established as independent countries and the major clinics in both countries closely follow the latest trends in ophthalmology worldwide.

Reduced registration We have seen many changes since 1993 in all areas of our society and it is a great pleasure to have the prestigious ESCRS Winter Meeting in Prague. The economic situation facing ophthalmologists in the eastern part of Europe is very challenging and because of this our ophthalmologists have not had as many opportunities to attend international meetings as some of their other colleagues. That is why we welcome the decision to hold this meeting in Prague as the location of the meeting will cut down the travel and accommodation expenses for delegates not only from the Czech Republic but also for ophthalmologists from other parts of eastern Europe. We are also delighted that the ESCRS has agreed to a reduced registration fee for the members of Czech and Slovak societies. These factors make the meeting more accessible and we are

looking forward to a big attendance from national delegates. We will also welcome all our visitors from other parts of Europe and outside Europe as the ESCRS Winter Meeting is now very well established as an important educational event in the ophthalmological calendar. I also look forward to meeting our young ophthalmologists who should find this meeting to be of great benefit.

Looking forward In previous years Prague has hosted a number of important ophthalmological events including the European VitreoRetinal Society (EVRS) annual meeting in September 2008 and the World Congress on Controversies in Ophthalmology in March 2010. Now we are looking forward to the great honour of hosting the 16th ESCRS Winter Meeting from 3-5 February, 2012. It is an excellent opportunity to share experiences, either through videos or short papers or by simply participating in the open forum, to search for new approaches and techniques, to express doubts and contribute ideas and to discuss thoughts with international experts. As Prague is a city in the heart of Europe it is also a great occasion for meeting ophthalmologists from western and eastern Europe. We look forward very much to the 16th ESCRS Winter Meeting and hope you will join us to make this meeting a great success. Pavel Studeny is a member of the ESCRS Board.


39

Feature

PRACTICE DEVELOPMENT NON PENETRATING APPROACH

innovation time

MINIMAL INVASIVE

Inaugural Practice Development Weekend may set benchmark for future meetings

NATURAL RESTORE OF IOP

by Colin Kerr

D

elegates from Estonia, France, Iceland, Greece, Portugal, Czech Republic, Jordan, Switzerland, Estonia, US, the UK and Ireland attended the inaugural ESCRS Practice Development Weekend at the Four Seasons Hotel, Dublin Ireland. The meeting, held on November 12 and 13, was the first Practice Development session held outside the annual ESCRS Congress and it is planned to consider similar initiatives in the future following the success of the meeting. "We have a Practice Development session at our main congress, but a lot of people cannot attend it because they are busy presenting or going to symposia," said ESCRS president-elect Peter Barry in his closing remarks. "I think we have got great value over the last two days because people have had more time to participate in the workshops and masterclass," he said. "The message is everybody has enjoyed this weekend and my personal view is that we should take this model forward and repeat it again in some city, perhaps once a year." Opening the meeting, Paul Rosen, chairman of the ESCRS Practice Development Committee, said the purpose of the Practice Development programme is to get business and management experts to advise doctors on how they can run their practices successfully. "We have been lucky to be able to attract some of the top opinion leaders in their fields to speak on topics which affect ophthalmologists in their day-to-day practice," he said.

Driving innovation Tim Clover, CEO of Optegra, a chain of 10 eye hospitals in the UK and Germany, delivered the keynote lecture on Innovation in Ophthalmology. The model Optegra had developed, he said, was to integrate their operations right at the beginning of the product development process and to influence the market rather than just to react to it. "We have produced this model," he said, "which basically says if you provide the best facilities, you would hope that you attract the best surgeons. “If you get those two things right, you should get the best outcomes," he said. "If you can get the best outcomes, in my view, long-term you are the one that wins." EUROTIMES | Volume 16/17 | Issue 12/1

“I am talking about doing things a little differently to the way you have done them in the past” Rod Solar, LiveseySolar Practice Builders

He said that in the future there would be a huge amount of consolidation in ophthalmology. "I don't think ophthalmology can survive with singlehanded practices or two or three ophthalmologists working together," said Mr Clover. "Technology is too far advanced, too fast and too well developed for that to be a sustainable model," he said. "I think the model for the future is multiple ophthalmologists with all the technology under the one roof," he said.

Comfort zone Rod Solar of LiveseySolar Practice Builders said that ophthalmologists who wanted to grow their practices needed to step out of their comfort zones. "You have to get into areas where you are not comfortable. I am talking about doing things a little differently to the way you have done them in the past," he said. Practical financial issues were discussed by David McCaffrey, a partner in MedAccount Services. He told the meeting that ophthalmologists must be diligent in keeping records of all their business transactions and in particular to separate their personal transactions from their business transactions. The issue of record keeping was also addressed by Paul McGinn, barrister at law, who said good record keeping would help ophthalmologists to avoid unnecessary legal actions which could prove to be very expensive. Mr Solar, in his second presentation to the meeting, discussed the importance of social media for ophthalmologists. The meeting concluded with a Practice Development Masterclass delivered by Prof Keith Willey which included a discussion on the new London Business School/ESCRS Case Study.

INTEGRATED BATTERY POWERED

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A NATURAL APPROACH TO CANALOPLASTY

FOCUS ON GLAUCOLIGHT Contact us to learn more or to arrange for a surgical demonstration.

The Glaucolight is a surgical ophthalmic canaloplasty device to facilitate the treatment of open angle glaucoma.

D.O.R.C. International B.V. Scheijdelveweg 2 3214 VN Zuidland The Netherlands Phone: +31 181 45 80 80 Fax: +31 181 45 80 90

The Glaucolight facilitates the new canaloplasty stretching-suture technology to re-establish the natural aqueous outflow and reduce the intraocular pressure.

The Glaucolight is a lightfiber based device with an integrated (battery powered) LED source and an atraumatic tip-design for a smooth transfer through the Schlemm’s canal. The bright LED illuminated fiber tip helps visualize the position of the fiber during the 360 degree Schlemm’s canal passage.

A full report of this meeting will appear on the ESCRS Practice Development website at www.escrs.org/practice-development 109-435_ADV_Glaucolight_120x300_tbv_Eurotimes.indd 1

01-03-11 10:23


40

Feature

eu matters

NEGLIGENCE STILL THE TEST

Ophthalmologists could escape liability for product defects unless patient proves negligence by Paul McGinn

Young Ophthalmologists’ Resource Centre Visit our new website http://youngophthalmologist.escrs.org

to find out more about the new ESCRS Observership Programme.

n

The ESCRS has developed a grant programme to support European trainee ophthalmologists who wish to observe clinical practice in a hospital or university setting.

n

The society is currently seeking interest from centres willing to offer observerships of one-to-two weeks’ duration in cataract and/or refractive surgery.

n

Those centres wishing to participate will be added to a database of centres available on this website.

EUROTIMES | Volume 16/17 | Issue 12/1

D

octors and hospitals should not be held liable for using defective equipment unless a patient can show they were specifically negligent in doing so, according to a leading legal opinion. The opinion, if adopted by the European Court of Justice, could ultimately prove a potent defence for ophthalmologists sued for inserting lenses or using equipment that they only later learn was defective. The opinion, by an advocate general at the Court of Justice, arose in a case in which a patient is suing a hospital in France for compensation for burns he sustained from a heated mattress in October of 2000. The court of Justice is currently reviewing the case after a French court asked the Luxembourg-based court for preliminary ruling on whether the patient could use EU law to make it easier for him to succeed in his compensation claim against the hospital. Under EU law, a preliminary ruling by the Court of Justice can assist a national court in interpreting any provision under EU law. It is then for the national court to dispose of the case in accordance with the Court’s decision. The preliminary ruling is also similarly binding on other national courts confronted with similar issues. Before giving its preliminary ruling, the court's judges routinely ask for an opinion from an Advocate General to assist them in their deliberations. While the opinion is not binding on the Court of Justice, the court more often than not adopts the opinion as its own judgment. The French case was brought by Thomas Dutreux, who was aged 13 years at the time of the accident at the University Hospital of Besançon. In his lawsuit, Mr Dutreux attributed his burns to a defective temperature control mechanism in the mattress. Under the EU’s Product Liability Directive, a “producer” of any product is ultimately liable to the consumer for any injury caused by a defect in the product. The definition of “producer” includes “the manufacturer of a finished product.” The law alters the standard burden of proof in legal cases. Under traditional rules of law in most European countries, a consumer had to prove negligence against a producer or manufacturer to collect

compensation for any injury caused by the product. Negligence can often be a time-consuming task involving extensive investigation – and cost – because negligence requires that a consumer prove the state of knowledge of the producer or manufacturer. That often translates into proving that officials in the manufacturing company knew or should have known that the product was defective when they first decided to place the product on the market. The Product Liability Directive, which was adopted in 1985, changed all that. Now, the burden of proving negligence has been lifted from the shoulders of the consumer harmed by a product. Now, a consumer need only prove that the product was defective to collect compensation for any injury caused by that defect. A defective product is defined by the directive as one that “does not provide the safety which may reasonably be expected”. Whether the manufacturer was at fault in putting such a product on the market is of no concern. The language of the directive is quite simple: “The producer is liable for damage caused by a defect in his product." If a consumer cannot identify – and thus sue – the manufacturer of a product, the directive provides that the consumer can sue the person or company who “supplied” the product: “If the producer of the product cannot be identified, each supplier will be treated as its producer unless he informs the injured person, within a reasonable time, the identity of the producer or person who supplied him with the product.”

The “supplier” provision became of particular importance in the French case because the French court reviewing the case also had to consider whether the directive had any bearing on French national law. Under French law, a public hospital must, even where it is not at fault, pay compensation for injury suffered by a patient as a result of a defect in equipment or a product used in the treatment. On that basis, the French court asked the Court of Justice whether the hospital should be considered a “supplier” for the purposes of the directive and thus be culpable for any defect if the manufacturer of a product were not identifiable. The advocate general, Mr Paolo Mengozzi, answered that a hospital was not a supplier or distributor for the purposes of the directive. According to the advocate general, Mr Dutreux should not be viewed as a consumer but as a patient. Mr Dutreux “was not a customer came in for a mattress, but a patient who entered a hospital. The safety of defective mattress should be considered in connection with the provision of care itself.” On that basis, Mr Mengozzi concluded that the Besançon University Hospital cannot be considered a "supplier" within the meaning of the directive.Therefore, the scope of the directive does not extend to the liability of a service provider for injury caused by a defective product in connection with the provision of a service. Although the directive does not apply to a hospital, the advocate general was quick to add that the directive did not affect the application of French national law, which, independently of EU law, required the hospital to pay compensation to Mr Dutreux for his burns without deciding whether the hospital was negligent. The directive “allows Member States to define the responsibility of those who use assistive devices or defective products in the framework of the provision of services and cause thereby damage to the recipient of the benefit,” the advocate general informed the court. Judgment in the case is expected in the near future. For more details about the case, view the website of the European Court of Justice at www.curia.eu.


Review

OPHTHALMOLOGICA HIGHLIGHTS Automated retinopathy screening

PDT and anti-VEGF for PCV

Retinal detachment prevention

SPVEP visual acuity testing

A new system for the automated grading of diabetic retinopathy from fundus photographs appears to have a sensitivity and specificity close to that of manual grading. The system uses a software program called RetmarkerSR, which detects the presence of microaneurysms and vascular lesions in the fundus and also compares consecutive examinations from the same patient. In a study in which researchers used the RetmarkerSR program to analyse 5,386 diabetes patients who had undergone manual screening in 2007, the automated grading system had a sensitivity of 95.8 per cent and a specificity of 63.2 per cent, when two consecutive fundus photographs taken a year apart were used. The authors noted that their novel two-step automated analysis system appeared to offer sensitivity and specificity superior to that of other published automated analysis systems

Photodynamic therapy (PDT) combined with intravitreal injection of anti-vascular endothelial growth factor can provide a good short-term effect in eyes with polypoidal choroidal vasculopathy, but its effects appear to become substantially diminished after two years. In a study involving 22 eyes with PCV who received a mean of 1.45 PDT treatments and a mean of 4.45 intravitreal anti-VEGF injections over two years, mean logMAR BCVA improved from a baseline value of 0.43 to 0.28 at one year’s follow-up but decreased to 0.39 at two years. Similarly the mean central foveal thickness decreased from a baseline value of 269 microns to 1.39.6 microns at 12 months but rose back to 199.6 microns at two years. The visual outcomes were similar to those of previously reported PDT monotherapy. Combination therapy, however, reduced the total number of PDT treatments

The testing of sweep pattern visual evoked potential (SPVEP) acuity can provide a reliable and objective measure of visual acuity in children who are very young and/ or uncooperative, according to the results of a study involving 26 amblyopic children and 31 normal children. The study showed that SPVEP testing correlated significantly with logMAR visual acuity in both groups, SPVEP acuity was recorded with the GT-2000 NV device (Guote Medical Apparatus Ltd.) (Li et al Ophthalmologica 2011; 226:220-227).

(Oliveira et al, Ophthalmologica 2011; 226:191-197).

(Kim et al, Ophthalmologica 2011; 226:205-213).

Scleral buckling and silicone oil tamponade can be useful in the prevention of retinal detachment in patients with post-traumatic endophthalmitis who are undergoing par plana vitrectomy, according to a new retrospective study. The study involved 62 consecutive patients with PTE and managed with PPV with or without scleral buckling and/or silicone oil tamponade. The researchers found that the additional interventions did not appear to reduce the likelihood of retinal detachment among patients with visual acuity limited to light perception. However, among patients with visual acuity better than light perception the incidence of retinal detachment was only nine per cent among those with scleral buckling, compared to 39 per cent among those without scleral buckling (p>0.05), and none of those with silicone tamponade had retinal detachment, compared to 30 per cent of those without silicone tamponade (p>0.05) (Lin et al Ophthalmologica 2011; 226:214-219).

EDITOR OF OPHTHALMOLOGICA, The peer-reviewed journal of EURETINA

Eye Chat with Oliver Findl

José Cunha-Vaz

Exclusive on www.eurotimes.org

Eye Chat features exclusive interviews with the major opinion leaders in ophthalmology. The podcasts are intended to give up to date information on the latest news and innovations in the field. They also offer instruction to young ophthalmologists on how they should deal with challenging cases.

New Approaches to Keratoplasty Oliver Findl

Dr Oliver Findl talks to Donald Tan, Director of the Singapore Eye Institute, about DALK, DSAEK and other new keratoplasty approaches.

Donald Tan

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EUROTIMES | Volume 16/17 | Issue 12/1

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43

Review

JCRS Highlights Journal of Cataract and Refractive Surgery Coaxial centration

Even very small amounts of subclinical decentration during excimer laser vision correction can degrade retinal image quality. Problems associated with ablation decentration include coma aberration, causing ghosting and monocular diplopia. Japanese researchers compared refractive outcomes, higher-order aberrations and contrast sensitivity of myopic wavefrontguided aspheric LASIK using two centration techniques, coaxially sighted corneal light reflex or line of sight. At the three-month postoperative point, the study of more than 500 eyes showed that centration on the coaxially sighted corneal light reflex resulted in better safety, effectiveness and contrast sensitivity than line-of-sight centration. Higher order aberrations and coma were statistically significantly higher in the lineof-sight group. The line-of-sight group also had a significantly greater change in contrast sensitivity. Centration on the coaxially sighted corneal light reflex was safer for myopic eyes with P-distances greater than 0.25mm. Therefore, the researchers suggest that to avoid suboptimal refractive outcomes and diminished visual quality, surgeons should determine the difference in the pupil centre and the coaxially sighted corneal light reflex and consider centring the excimer laser ablation on the coaxially sighted corneal light reflex once the difference is 0.15mm or larger. n S Okamoto et al, JCRS, “Comparison of wavefront-guided aspheric laser in situ keratomileusis for myopia: Coaxially sighted corneal-light-reflex versus line-of-sight centration”, Volume 37, No. 11, 1951-1960.

Hybrid monovision

Hybrid monovision may offer an effective approach for managing loss of accommodation in select cataract patients, while reducing some of the problems sometimes seen with multifocal IOL implantation. Bilateral multifocal IOL implantation is currently the most popular surgical approach for treatment of presbyopia. However, problems include glare and halo, loss of contrast and a high level of lens exchange. Moreover, this approach is not optimal for patients with glaucoma, retinal or macular disease. Researchers in Kanagawa, Japan, implanted 32 patients with a monofocal IOL (AQ310Ai) in the dominant eye and a diffractive multifocal (Tecnis ZM900) in the contralateral eye. They targeted both eyes for emmetropia. All eyes achieved mean binocular visual acuity better than 0.1 logMAR at all distances. Binocular contrast sensitivity was better than monocular vision in the eye with the diffractive multifocal IOL. Near stereopsis within normal range was maintained in 62.5 per cent of patients. Some 18.8 per cent of patients reported spectacle dependence. With EUROTIMES | Volume 16/17 | Issue 12/1

binocular vision, no patients reported waxy vision. The main cause of dissatisfaction was the lack of visual clarity at near and intermediate distances. Therefore, the researchers note that this option may not be best for patients whose work or lifestyle requires excellent near vision. n Y Ida et al., JCRS, “Pseudophakic monovision using monofocal and multifocal intraocular lenses: Hybrid monovision “ Volume 37, No. 11, 2001-2005.

Reducing hyperopia

Eyes with axial lengths of greater than 25.0mm often end up with postoperative hyperopia owing in part to problems with current IOL power calculation formulas. An international study group looked at the accuracy of refractive prediction of four popular IOL power calculation formulas in eyes with axial length greater than 25.0mm in an attempt to improve outcomes. They evaluated refractive prediction errors associated with the Holladay 1, Haigis, SRK/T, and Hoffer Q formulas in consecutive cases. The optimised axial length values were highly correlated with the IOLMaster AL (R2 from 0.960 to 0.976). In the validating group, the method of optimising axial length significantly reduced the mean numerical errors for IOLs greater than 5.00 D, from +0.27 to +0.68 D to -0.10 to -0.02 D. Errors in IOLs of 5.00 D or less improved from +1.13 to +1.87 D to -0.21 to +0.01 D. In two additional validation data sets, this method significantly reduced the percentage of eyes that would be left hyperopic. The researchers recommend caution when using the optimised axial length formulas as slightly myopic results may occur. They noted that as data are accumulated, the manufacturer’s lens constants should be optimised and the accuracy could be improved further. n L Wang et al., JCRS, “Optimizing intraocular lens power calculations in eyes with axial lengths above 25.0 mm”, Volume 37, No. 11, 2018-2027.

2nd EURETINA Winter Meeting ‘Innovation in Management of Retinal Disease’

Rome

Rome Cavalieri Waldorf Astoria Hotel

Saturday 28 January 2012 Include topics: • Imaging • Eye and Brain • Regeneration and Degeneration of the Retina • Retina and Stem Cells • Gene Transfer • Retina Basic Research

www.euretina.org Thomas Kohnen associate editor of jcrs FURTHER STUDY Become a member of ESCRS to receive a copy of EuroTimes and jcrs journal


ASCRS Symposium on Cataract, IOL and Refractive Surgery

April 20–24, 2012

ASOA Congress on Ophthalmic Practice Management

Registration Now Open Housing Available Now! www.ASCRS.org/gethousing

www.ASCRS.org www.ASOA.org

April 20–24, 2012

Technicians & Nurses Program

April 21–23, 2012

Come Early – Friday, April 20

Cornea Day 2012

www.CorneaDay.org

ASCRS Glaucoma Day 2012

www.ASCRSGlaucomaDay.org


The 2012 Cornea Day is geared towards practicing ophthalmologists with an interest in comprehensive ophthalmology, anterior segment surgery and corneal disease

Pressure is important — but don’t lose sight of the vision! Glaucoma treatment in a cataract and refractive context

McCormick Place

McCormick Place

Friday, April 20, 2012 8:00AM–4:30PM

Friday, April 20, 2012 8:30AM–5:00PM

www.CorneaDay.org

www.ASCRSGlaucomaDay.org

For registration, housing and program updates go to...

Cornea Day Planning Committee: Terry Kim, MD Co-chair Corneal Challenges for the ASCRS Cornea Clinical Committee Cataract Surgeon Donald TH Tan, FRCS Co-chair Moderators: Anthony Aldave, MD & Cornea Society David T. Vroman, MD Anthony Aldave, MD Innovations and Dilemmas in Cornea Society Refractive Surgery W. Barry Lee, MD Moderators: Marian Macsai, MD & Cornea Society Donald TH Tan, FRCS Marian Macsai, MD Cornea Society Advances in Corneal Diagnostics, Francis S. Mah, MD Therapeutics, and Imaging ASCRS Cornea Clinical Committee Moderators: W. Barry Lee, MD & Neda Shamie, MD Francis S. Mah, MD ASCRS Cornea Clinical Committee Controversies in Corneal and Ocular David T. Vroman, MD Surface Transplantation ASCRS Cornea Clinical Committee Moderators: Terry Kim, MD & Neda Shamie, MD This activity has been approved for Program at a Glance

(subject to change)

AMA PRA category 1 credit.TM

For registration, housing and program updates go to...

Program Chair:

Program at a Glance The 2012 Stephen A.

Thomas W. Samuelson, MD

(subject to change)

Program Committee:

Glaucoma Diagnostics Moderator: Steven R. Sarkisian Jr., MD

Garry P. Condon, MD Herbert P. Fechter, MD Douglas J. Rhee, MD Steven R. Sarkisian Jr., MD Barbara A. Smit, MD

Combined ASCRS/AGS Symposium: Tried and True vs. Novel and New Moderators: Douglas J. Rhee, MD and Steven R. Sarkisian Jr., MD Medicine & Lasers Moderator: Douglas J. Rhee, MD

Obstbaum, MD Honored Lecture Robert Stegmann, MD

Surgical Glaucoma Spotlight Moderators: Garry P. Condon, MD and Thomas W. Samuelson, MD Complications Avoidance & Management: Video Case Presentations Moderators: Herbert P. Fechter, MD and Paul C. Harasymowycz, MD

This activity has been approved for AMA PRA category 1 credit.TM


Feature

industry news

Recent developments in the vision care industry

Non-contact tonometer with high-speed camera

The OCULUS Corvis ST is a new noncontact tonometer in combination with an ultra-high-speed Scheimpflug camera (more than 4000 images/sec) that can visualise the reaction of the cornea on an air impulse. OCULUS say conclusions can be drawn regarding the bio-mechanical properties from the response of the cornea after the air impulse. “It is well known that IOP-measurements by Goldmann Applanation Tonometry (GAT) and Non-Contact Tonometry (NCT) are influenced by the corneal thickness of the cornea. It is not very well known that the IOP-measurements are even more affected by the biomechanical properties of the cornea,” said an OCULUS spokeswoman. The OCULUS Corvis® will be for sale from spring 2012. The device is not for sale in the US yet with FDA 510K pending. www.oculus.de/corvis-st

Reading desk technology

SRD Vision, LLC has agreed to acquire the Salzburg Reading Desk technology from its Austrian inventors. The Salzburg Reading Desk was invented by Prof Dr Grabner, Dr Dexl, Dr Wolbauer and Dr Schloegel in Salzburg, Austria in 2004. The motivation behind the invention was the desire to better quantify Reading Acuity, an important component of a patient’s visual quality of life. Current techniques rely on paper charts, stop watches and measurement cords. The Salzburg Reading Desk (SRD) uses a high resolution monitor, stereophotogrammetry and software to help an eye care professional measure reading acuity, reading angle and true reading distance. Reading speed is used as a threshold. “By using a high resolution monitor, the SRD can also be adjusted for contrast and luminance,” said a company spokesman. The SRD is not cleared for sale in the US by the FDA. The first regulatory priority is CE certification. www.srdvision.com

OCULUS Corvis ST

Week of sight

On the occasion of the Week of Sight in Germany, Geuder AG hosted a series of events for its 220 employees over a period of four days. Information concerning eye disease and blindness was presented and various activities demonstrated the challenges of living with sight impairment or blindness. According to Martina Pfister, vicepresident for strategy and business development and responsible for the social exposure and activities of the company, “All in all, the week was a success, and the events were well-received and appreciated by our employees.”

Journal Watch Steroids not beneficial for corneal ulcers?

Orbital abnormalities

Topical steroids are often prescribed as part of the treatment of bacterial corneal ulcers, but do they actually provide benefit? New research suggests the treatment does little to improve visual acuity. The randomised, placebo-controlled Steroids for Corneal Ulcers Trial (SCUT) examine the effectiveness of corticosteroids as adjunctive therapy for bacterial keratitis in 500 patients over a three-and-a-half-year period. At the three-month follow-up, the researchers observed no significant difference in the number of corneal perforations between treatment groups. More patients receiving placebo developed intraocular pressure greater than 25 mmHg, but no intraocular pressure of greater than 35 mmHg was observed in either group. Moreover, after controlling for visual acuity level at enrolment, analysis showed no significant improvement in best-corrected visual acuity for participants in the corticosteroid treatment group versus participants receiving placebo. The study included patients from the US, and India, where the corneal ulcers were more severe. The researchers believe there may be a role for topical corticosteroids in ulcers that are more severe at baseline. They call for a larger study examining only severe corneal ulcers to evaluate this question.

Space explorers planning to make long duration journeys are faced with the threat of vision loss, both in space and upon returning to Earth, a new study funded by NASA concludes. Researchers evaluated seven astronauts with ophthalmic anomalies upon return from longduration space missions to the International Space Station, and 300 additional astronauts who completed post-flight questionnaires regarding in-flight vision changes. Findings in International Space Station the seven astronauts who were examined after six months of space flight included disc oedema in five, globe flattening in five, choroidal folds in five, cotton wool spots in three, nerve fibre layer thickening by OCT in six, and decreased near vision in six astronauts. Five of seven with near vision complaints had a hyperopic shift of at least 0.50 D between pre/post-mission spherical equivalent refraction in one or both eyes (range, +0.50 to +1.75 D). These five showed globe flattening on MRI. Lumbar punctures performed in the four with disc oedema documented opening pressures of 22, 21, 28, and 28.5 cm H2O performed 60, 19, 12, and 57 days post-mission, respectively. Among the 300 astronauts who were queried regarding visual changes during space missions, 29 per cent and 60 per cent of astronauts on short and long-duration missions, respectively, experienced a degradation in distant and near visual acuity, some of which continued for some years after flight. The investigators hypothesise that the optic nerve and ocular changes might result from cephalad fluid shifts brought on by prolonged microgravity exposure.

n M

Srinivasan et al. , Arch Ophthalmol. Published online October 10, 2011, doi:10.1001/ archophthalmol.2011.303, 315.

EUROTIMES | Volume 16/17 | Issue 12/1

n T

Mader, Ophthalmology, “Optic Disc Edema, Globe Flattening, Choroidal Folds, and Hyperopic Shifts Observed in Astronauts after Long-duration Space Flight”, October 2011, Vol 118, Issue 10, pages 2058-2069.

Credit: NASA

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Feature

EYE ON TRAVEL

SPIRIT OF GENIUS

On the trail of Leonardo da Vinci in Milan by Maryalicia Post

L

eonardo’s spirit is alive in Milan, as delegates attending the XXX ESCRS Congress, 8-12 September 2012 will discover. In 1482, the Florentine painter Leonardo da Vinci, sent a job application to Ludovico Sforza, Duke of Milan. Hoping to appeal to the Duke's practical side, he presented himself as an engineer who could, if required, paint and sculpt. For the next 17 years, the Duke enjoyed the fruits of Leonardo’s genius; some of that work remains to enchant today's visitors.

The Last Supper Leonardo’s most important legacy to his adopted city is the painting in the refectory of the monastery of Santa Maria della Grazie. Leonardo worked on the mural, commissioned by the Duke, for three years. It's almost miraculous that the painting survived for us to see. Hoping to achieve greater luminosity, Leonardo experimented with oil painting on a dry wall; the paint began to flake off almost at once. Subsequent attempts at restoration damaged it further. By 1652, the painting was so obliterated the monks cut a door through to the adjoining room slicing off Christ's feet. A century and a half later, Napoleon's soldiers pelted the heads of the apostles with bricks. A bomb fell on the church in the Second World War, leaving the mural exposed to the elements for three years. In 1979, a definitive restoration was begun. It took 20 years; on some days only a postage stamp-sized piece of the 460 x 880cm painting could be repaired.

Some estimates suggest that, after this and previous restorations, a mere 20 per cent of the original remains. But so profoundly moving is the 'body language' of Christ and the 12 Apostles that the painting still leaves most visitors lost for words. A sophisticated monitoring system preserves the work from further damage; a thousand people a day, 25 at a time, pass through two 'air locks' before entering the refectory for a visit strictly limited to 15 minutes. It can be frustratingly difficult to get a ticket. The best solution may be to join a tour. Kuoni Travel will offer tours that include a visit to the Last Supper for delegates to the ESCRS Congress in Milan. Alternatively, apply to the booking office for the Cenacola Vinciano by phone at: 02.8942114. Tickets go on sale three months in advance and sell out quickly. Closed Mondays.

Navigli

Milan’s 13th century network of navigable canals, the Navigli, was crucial to the city's economic well-being. Ludovico assigned his new engineer the task of upgrading and improving it. The innovative system of locks Leonardo devised was used until the navigli were abandoned in 1979. Although most of the canals have since been filled in or have simply collapsed, two short stretches remain. A sightseeing boat offers a 55-minute cruise through the waterways Leonardo knew so well, leaving from outside number 4, Azaia Naviglio Grand. Space permitting, you can simply hop aboard the boat at the landing but if you'd rather be sure of a seat, phone: 02-92273118 or visit: www.naviglilombardi.it.

Leonardo da Vinci’s The Last Supper

EUROTIMES | Volume 16/17 | Issue 12/1

September afternoon on the Milan canals

The area between the canals is today Milan's liveliest neighbourhood, full of galleries, vintage shops, restaurants and clubs that on pleasant evenings spill out onto the street. Every Saturday morning, there's a flea market along the Darsena and on the last Sunday of the month, an antiques market beside the Naviglio Grande.

Sale Dele Asse Leonardo also served as “master of the revels” to the Duke by designing robots to entertain the guests and staging theatrical events. All that remains of these duties is a heavily restored ceiling in a reception room in Castle Sforza, a canopy of delicately painted tree branches. Sale dele Asse, Room 8. Closed Mondays

bronze horse, intended as a memorial for the Duke's father, Francesco Sforza. Eventually the clay model was produced and 80 tons of bronze set aside for casting. Then France invaded; the bronze was used for munitions and enemy soldiers destroyed the clay model. In 1977, this story caught the attention of an American philanthropist who devoted the rest of his life to the completion of the project. In 1999, the 25 ft tall cast bronze horse inspired by Leonardo's sketches and created by Nina Akuma was delivered to Milan as a gift to the Italian people. The largest bronze horse in the world, “Il Cavallo” stands in front of Milan’s Hippodrome, near the San Siro football stadium.

Il Cavallo Leonardo worked intermittently on plans for a gigantic Codex Atlanticus Until 2015, visitors to Milan have a unique opportunity to see pages of the Codex Atlanticus, one of the notebooks in which Leonardo sketched his inventions and recorded his research into everything from anatomy to the construction of armoured tanks. The notes are in “mirror writing,” possibly because it was easier for the left-handed Leonardo to pull his Leonardo’s inventions at Milan’s Science Museum plume pen from right to left. Normally, the 1115 pages of the Codex are kept in the Ambrosiana Library, where only accredited scholars may consult them. Currently, the pages are displayed to the public, half at the Ambrosiana and the other half in the sacristy of Santa Maria della Grazie in rotating exhibits designed along selected themes. Closed Mondays. To pre-book tickets, visit: http://en.milano.waf.it/museo.html. Thirty of the inventions recorded in Leonardo’s notebooks have been constructed from his sketches and are on permanent display in the Leonardo Gallery of National Museum of Science and Technology in Milan Closed Mondays. For details, visit: www.museoscienza.org.

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48

Reference

Calendar of events

Dates for your Diary

February

January 2012

13-15

2012

Athens, Greece

7th Pan-Hellenic Vitreo-Retinal Meeting www.gvrs.gr

28

rome, ITALY

2nd EURETINA Winter Meeting www.euretina.org

2012

2012

1-4

prague, czech republic

3-5

Athens, GREECE

April

13-16 korea 21 busan,

Belgrade, Serbia

International Symposium on Glaucoma – New Insights and Updates www.glaucoma–belgrade2012.org

27th APAO Congress www.apaobusan2012.com

20-24il, usa 27-30 chicago,

ASCRS Symposium Congress www.ascrs.org

July 2012

22-27

berlin,

germany

ISER 2012 XX Biennial Meeting of the International Society for Eye Research www2.kenes.com/iser/pages/home.aspx

118th SFO Congress www.sfo.asso.fr

paris, france

June

6-10

fort lauderdale,

FL, USA

ARVO Annual Meeting www.arvo.org

23-26

milan, italy

10th SOI International Meeting www.sedesoi.com

MILAN, ITALY

MILAN, ITALY

3rd EuCornea Congress www.eucornea.org

2nd World Congress of Paediatric Ophthalmology and Strabismus www.wcpos.org

2012

6-9 8-12

The 3rd World Congress on Controversies in Ophthalmology (COPHy) www.comtecmed.com/COPHy/2012/

14-17

Nurnberg,

germany

25th International Congress of German Ophthalmic Surgeons www.doc-nuernberg.de

September

6-8 7-9

Istanbul,

2012

September 2012

2nd EuroLam Macula and Retina Congress www.euro-lam.org

May 2012

2012

16-17

Miami, USA

22-25 TURKEY

Frankfurt Retina Meeting www.eckardt-frankfurt.de

2012

XVI National Congress of Italian Society of Corneal Transplant www.sitrac.it

10-11

Mainz,

Germany

April

23-25

rome, italy

2012

26th International Congress of the HSIOIRS www.hsioirs.org

16th ESCRS Winter Meeting www.escrs.org

World Ophthalmology Congress www.woc2012.org/

March

March

February

16-20 UAE

abu dhabi,

12th EURETINA Congress www.euretina.org

17-22

Copenhagen,

Denmark

10th EGS Congress www.eugs.org

November 2012

10-13 il, usa

chicago,

AAO Annual Meeting www.aao.org

XXX Congress of the ESCRS www.escrs.org

Advertising Directory: Alcon: Page: OBC; Allergan: Page: 37; ASCRS: Page: 34, 44, 45; DORC: Page: 17, 39; ESASO: Page: 35; Medicel AG: Page: 31; Nidek: Page: 11; Oertli Instruments AG: Page: IFC; S.I.T.R.A.C.: Page: 15; ThromboGenics: Page: 3; Ziemer: Page: 21;


3rd EuCORNEA CONGRESS 6-8 SEPTEMBER

12TH EURETINA Congress 6-9 SEPTEMBER

2nd WORLD CONGRESS OF PAEDIATRIC OPHTHALMOLOGY AND STRABISMUS 7-9 SEPTEMBER

XXX Congress of the ESCRS 8-12 september


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