VOLUME 15 ISSUE 6 JUNE 2010
JUNE 2010 Volume 15 | Issue 6 This month... Special Focus – 20 Years of LASIK 4
Cover Story: European LASIK pioneers discuss how far LASIK has come
Newsmaker Interviews with LASIK surgeons: 8 Ioannis Pallikaris
Marguerite B McDonald
Industry experts discuss LASIK advances and new technologies
Cataract Update 18
New techniques help reduce complications after cataract surgery
Congress Report 19
Emanuel Rosen is honoured by ASCRS
With this month’s issue...
Great potential with new imaging technology
Programme preview of 10th EURETINA Congress in Paris
EBO CME Committee wants to create common European standard of accreditation
ESCRS sets up Observership Programme for young ophthalmologists
DGII launches EUREQUO for monitoring outcomes in Germany and Austria
Features 35 Practice Development 37 Book Review 38 JCRS Highlights 39 Bio-Ophthalmology 40 Outlook on Industry 41 Industry News 46 Eye On Travel 47 EU Matters 48 Calendar
Our cover shows a montage of some of the LASIK pioneers. Featured are (top to bottom): Row 1: Stephen Brint, Lucio Buratto, Joseph Colin. Row 2: Paddy Condon, Sheraz Daya, José Güell. Row 3: Michael Knorz, John Marshall, Marguerite B McDonald. Row 4: Charles Munnerlyn, Thomas Neuhann, Ioannis Pallikaris. Row 5: Emanuel Rosen, Luis Ruiz, Theo Seiler. Row 6: Stephen Slade, Julian Stevens, Stephen Trokel.
Programme previews for the 10th EURETINA Congress (Pgs 20-22) and XXVIII Congress of the ESCRS (Pgs 42-45)
Published by The European Society of Cataract and Refractive Surgeons Publisher Carol Fitzpatrick
Managing Editor Caroline Brick
Executive Editor Colin Kerr
Production Editor Angela Sweetman
Editors Sean Henahan Paul McGinn
Senior Designer Paddy Dunne
Assistant Designer Janice Robb
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Circulation Manager Angela Morrissey
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Contributing Editors Howard Larkin Dermot McGrath Roibeard Ó hÉineacháin
Advertising Sales ESCRS, Temple House, Temple Road Blackrock, Co. Dublin, Ireland Tel: 353 1 209 1100 Fax: 353 1 209 1112 email: email@example.com
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.
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As certified by ABC, the EuroTimes average net circulation for the 11 issues distributed between 01 January 2009 and 31 December 2009 is 29,537.
Volume 15 | Issue 6
A GROUNDBREAKING PROCEDURE
Let us salute the pioneers in European Year of LASIK José Güell MD
international editorial board
ast year, ESCRS designated 2010 as European Year of LASIK. The society decided that it was fitting that we celebrate the 20th anniversary as LASIK originated in Europe and former ESCRS president and 2009 Binkhorst Medal lecturer Ioannis Pallikaris was the first surgeon to use the hinged flap technique in 1990. As president of ESCRS, I am very conscious of the fact that the development of LASIK is an international phenomenon and it would not have been possible without the support of our colleagues outside Europe. But as a European society it is only right that we should place the special emphasis on the achievements of the European ophthalmologists like Prof Pallikaris, Dr Lucio Buratto and Prof Theo Seiler who were among the first surgeons to experiment with this groundbreaking procedure. This issue of EuroTimes focuses on European Year of LASIK and the medical editors have decided that special attention should be paid to the achievements of those surgeons who carried out some of the first LASIK procedures in Europe. Of course, it is not possible to include everybody in this report and we will welcome any future contributions to EuroTimes to help us fill in some of the gaps. This issue is a first attempt to trace the early origins of LASIK and it also allows us to look forward to what we think the future holds.
LASIK in the future LASIK is now the number one refractive procedure around the world and it is important that we look at ways that we can improve the procedure. We must look at how we can achieve better results but most importantly, to avoid any future complications. We must continue establishing safety landmarks and teach our young colleagues the importance of avoiding complications. We welcome the development of new technologies and we acknowledge the major contributions of our partners in industry in developing instruments which are safer and easier to operate. Patient selection is very important and it is improving because of the new devices that are now available to help us explore topography and biomechanics to help us build up our data. We do not need to convince our patients about the safety of LASIK. We need to convince them that when properly indicated and properly performed in 2010 it is extraordinarily safe. The problem we have is that LASIK complications continue to appear because of some of the surgeons performing the procedure. LASIK complications occur not because LASIK is not safe, this is exceptional, but because some surgeons performing the procedure do not strictly follow the correct guidelines In the future, we need to look at how we can help surgeons to proceed with LASIK but also to assist patients who are considering putting themselves forward for LASIK surgery.
EUROTIMES | Volume 15 | Issue 6
Emanuel Rosen Chairman ESCRS Publications Committee
Noel Alpins australia Bekir Aslan TURKEY Bill Aylward UK Peter Barry IRELAND Roberto Bellucci ITALY In the next six months, EuroTimes will continue to highlight the hot topics that are developing around European Year of LASIK and the ESCRS has also a number of important initiatives planned for our XXVIII Annual Congress in September in Paris, France. These are exciting times and as president of ESCRS I am grateful for the opportunity to help to stimulate new debates not only on the future of LASIK but also on the future of cataract and refractive surgery. As always, I welcome your comments and I look forward to hearing your views both in EuroTimes and at our meeting in Paris in three months’ time.
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 Gisbert Richard GERMANY Robert Stegmann SOUTH AFRICA Ulf Stenevi SWEDEN Emrullah Tasindi TURKEY Marie-Jose Tassignon BELGIUM Manfred Tetz GERMANY
José Güell is president of ESCRS and a medical editor of EuroTimes
Carlo Enrico Traverso ITALY Roberto Zaldivar ARGENTINA
Cover Story //
20 YEARS OF LASIK Celebrating LASIK surgery
A proud herItage
From the invention of LASIK to the present day, European ophthalmologists have pioneered the world’s premier laser refractive procedure By Howard Larkin
LASIK is the number one laser refractive procedure all over Europe, except for Italy, where they still do a lot of PRK José Güell MD
EUROTIMES | Volume 15 | Issue 6
y late 1990, José Güell MD and his colleagues were already well versed in photorefractive keratectomy (PRK) at their Barcelona clinic. But while refractive outcomes overall were quite good, slow recovery was a problem for many PRK patients, and corneal haze could be severe for larger corrections. “From time to time the outcomes were not as good as we wanted for high myopes,” he recalls. So when Ioannis Pallikaris MD, PhD, reported rapid recovery and clear corneas in blind human eyes for the hinged corneal flap laser in situ keratomileusis procedure he pioneered in a rabbit model, Dr Güell was ready to take the plunge. In early 1991 he performed his first LASIK procedures. “We believe they were the first LASIK procedures on sighted eyes in Europe because we were unaware of any other group who already did it,” Dr Güell says. He later published two-year follow-up results of some of these early cases. The results exceeded Dr Güell’s expectations. “For some of us with previous refractive surgery experience, the switch to LASIK was fantastic. There was the ‘whoa’ factor of immediate visual recovery. It was equally rapid for -2 D or -12 D.” The results were so good that Dr Güell and others pushed the LASIK envelope hard. “We thought we could correct any degree of myopia up to -20 D, especially in Europe. It wasn’t until later that we realised that LASIK was not the best for correction of high myopia, not only for the risk of ectasia but also because of quality of vision issues. It took five or six years to realise the limits.” In the mid-1990s Dr Güell codified these insights in published papers noting that outcomes for corrections beyond -12 D were less predictable. These findings also led to his exploration of
combining LASIK with phakic IOLs to achieve higher corrections, and the use of LASIK to correct residual errors after other refractive procedures, or induced astigmatism due to decentred previous ablations. Nonetheless, LASIK caught on quickly, at least in some southern European countries. From the early to mid-1990s, he together with another few colleagues were frequently invited to lecture and instruct in Germany, France, the UK and other northern countries where LASIK was slower to catch on. “In those days they were not doing LASIK, but now there is very little difference from north to south. LASIK is the number one laser refractive procedure all over Europe, except for Italy, where they still do a lot of PRK.”
A worldwide effort Other European LASIK pioneers also played a major role in making the procedure a worldwide hit. In Italy there was Lucio Buratto MD, an early innovator who used the excimer laser to ablate stroma under and on the back of free corneal caps at about the same time Prof Pallikaris conducted his animal experiments with hinged flaps. In 1991 Dr Buratto schooled Stephen Slade MD, and Stephen Brint MD, in stromal ablation procedures at his Milan clinic. Dr Brint carried the knowledge back to New Orleans, where he performed the first LASIK procedure in the US. Dr Brint, Dr Slade and other colleagues then headed up the FDA clinical trials for the Summit excimer laser. At the same time, Stephen Trokel MD, who originally developed the excimer laser for ophthalmic use with the UK’s John Marshall PhD, and Charles Munnerlyn PhD, whose ablation algorithms are still the basis for today’s procedures, began LASIK trials with their VISX laser, which was already in trials for PRK. FDA
approval of these lasers for PRK in 1995 and LASIK in 1998 paved the way for even broader acceptance of laser refractive procedures worldwide. And it didn’t take long for the bread that Dr Buratto and other early innovators, such as Theo Seiler MD, PhD, of Switzerland and Julian Stevens MD, of the UK, cast upon the international waters to come back to Europe. The first LASIK procedures Thomas Neuhann MD, PhD, did in Munich in 1995 went “astonishingly well, not least due to the fact that I had the foremost teacher, Steve Slade, who was kind enough to come to assist in my first cases.”
Evidence overcomes sceptics
Even so, LASIK was a difficult sell in Germany, and remained so for years, Prof Neuhann notes. “Like everything new, it was denounced as ‘criminal’, ‘jeopardising healthy people’s eyesight for money – greediness,’ etc,” he says. Cultural norms also played a big part, Dr Neuhann believes. “If you look at the curves for refractive laser surgery increase in the US and Canada, Europe and Germany, the very slow adoption rate over time in Germany is more than obvious. Why is that? It’s wide open to speculation, but certainly the German mentality plays a major role. Germans are by default perfectionists. The typical German will say ‘Most important is perfection of vision, without visual aids if possible, but I prefer perfect vision with glasses to ‘good enough’ vision as an acceptable compromise for freedom of glasses.’ That is even more so if they pay out of pocket for it. The Mediterranean, Latin American and even North American cultures are very different from that.” Prof Neuhann himself was initially sceptical, but the early experience of his European colleagues changed his mind.
A schematic representation of the LASIK procedure from the first LASIK publication
Photo of Oliver Frenschock MD, resident in ophthalmology, taken during early animal studies. An industrial LAMBDA PHYSIK Excimer laser and a home-made beam delivery optical system were employed
Courtesy of Ioannis Pallikaris MD, PhD
“Having done my PhD thesis on corneal wound healing, I could not really imagine that cutting or lasering across the visual axis would not negatively affect vision. That is why I was not a ‘first adopter’. Having seen first cases, however, I became an ‘early adopter’ since my theoretical concerns did not come true.” In recent years LASIK has gained greater public acceptance in Germany, thanks in large part to the work of Prof Michael Knorz MD, PhD, of the University of Mannheim. He performed the first LASIK in Germany in 1993 after attending a presentation at the 1993 ESCRS conference in Innsbruck by Luis Ruiz MD of Colombia. Dr Ruiz, a protégé of Jose Barraquer MD, inventor of freeze keratomileusis and the microkeratome among other things, was a major refractive surgery innovator in his own right. He invented the dual-keratome procedure known as ALK and played a major role in developing microkeratome and related technologies that advanced LASIK over time. “I flew to Bogota and spent a few days with Dr Ruiz to learn the LASIK procedure,” recalls Prof Knorz, who was experienced with PRK. “We both used the same laser at this time, the Technolas Keracor 116. LASIK was still very tricky. I used the ACS designed by Ruiz, originally designed to perform ALK. In 1993, the ACS did not have a mechanical stop; it was up to the surgeon to stop in time to leave a small hinge. In some of my early cases, as you can imagine, I had too big a hinge, and in some a free cap. “From the first time I saw Dr Ruiz perform LASIK it rather intrigued me as a perfect way to use an excimer laser. I never liked PRK and all the pain, the slow healing, the ‘haze,’ which is just another word for scar, and the not-very-happy patients. LASIK was so much better.” Nonetheless in the early days in Germany LASIK remained suspect. Prof Knorz believes he was able to get started mostly because he was in a university setting, making him less of a target than if he were in a private clinic. Prof Neuhann limited the procedure to patients he believed had disabling refractive conditions. Prof Knorz also initially limited LASIK to high myopes, from -6 D to -25 D – which turned out to be a mistake. “Later on, I published my results in Ophthalmology and concluded that LASIK above -15 D is not feasible. Today, we know that the upper limit is even lower, around -8 to -10 D.” Dr Güell defines the range another way: “Besides the well known thickness limitation, human beings have a corneal mean curvature between 39 and 46 D. As long as the final K is within these limits, it is OK. If you end up with a lower K than 39 or higher than 46, you have quality of vision problems.” Still, Prof Knorz says his early LASIK patients were happy despite the side effects resulting from their high myopia. Those early patients were adventurous personalities, not comparable to the mainstream patients we have today. He says it was easier to get started in LASIK in a university because he conducted his work in a university setting.
Ioannis Pallikaris performing refractive surgery in 1990
Eventually, the research conducted by Prof Knorz, Prof Neuhann and others broke down resistance. Surgeons from all over Germany and Europe came to Mannheim to study with Prof Knorz. He also went on the road as a trainer, introducing LASIK in India. In Germany, a committee known as the KRC was formed in 1996 to develop standards for LASIK and other refractive procedures, and in 1999 LASIK was approved by the German Ophthalmological Society (DOG).
Technical advances drive acceptance While some of the earliest
pioneers of laser surgery hailed from Britain, including Prof Marshall and Julian Stevens MD, FRCS, who developed PRK with Dr Trokel, concerns about LASIK slowed its acceptance in the UK, notes Emanuel Rosen FRCS, FRCOphth. “British society is innately conservative; we wanted to know it was safe and stable before undertaking it. The real pioneers were in Europe, not the UK.” Like others, Dr Rosen was attracted to LASIK because it seemed to solve many of
the problems of PRK. But microkeratome issues, and difficulties with early widebeam lasers such as creation of central islands and problems maintaining a consistent beam profile, gave him pause. The introduction of flying spot lasers with eye tracking helped. “I was partly waiting for the equipment to improve and partly waiting for the literature.” In 1995, he did the first LASIK procedure in the UK, closely followed by Sheraz Daya, MD. With more-reliable equipment and better outcomes thanks to the research of the pioneers, in the late 1990s LASIK moved into the mainstream. By the time the first ESCRS member survey was conducted in 1998, 33 per cent of respondents said that they did at least one LASIK procedure a month in the previous year. In 1999, that figure shot up to 72 per cent. Surgeons also showed a marked preference for LASIK over PRK in 1999, with 83 per cent saying they planned to start or increase LASIK compared with 49 per cent planning to do more PRK.
One of the first commercial videokeratographers from EyeSys
Like everything new, it was denounced as ‘criminal’, ‘jeopardising healthy people’s eyesight for money – greediness,’ etc
Thomas Neuhann MD, PhD
...we wanted to know it was safe and stable before undertaking it. The real pioneers were in Europe, not the UK Emanuel Rosen MD, PhD
EUROTIMES | Volume 15 | Issue 6
Cover Story //
20 YEARS OF LASIK
In addition, LASIK will be used to finetune results of other refractive surgical procedures, such as phakic implants and refractive lens exchange. I believe LASIK is here to stay Michael Knorz MD, PhD
As aberrometers and custom-guided ablations became available, European surgeons were again out front. Among them, Prof Seiler’s investigations of overcorrecting existing aberrations and correcting aberrations induced by decentred aberrations helped develop guidelines and limits for wavefrontguided procedures. Prof Pallikaris and others developed methods for fine-tuning ablations. Surgeons including Prof Neuhann have added to the understanding of the importance of centring ablations on the visual axis – and helped develop increasingly sophisticated eye-tracking technology that can follow cyclotorsion and z-axis shifts to maintain the precise aim upon which wavefront-guided ablations rely. “I see LASIK going to corneal wavefront-oriented ablation algorithms as opposed to total wavefront based. I see intraoperative pachymetry, cyclo-tracking and automatic visual axis finding in the near future to become standards of care,” he says.
José Güell – firstname.lastname@example.org Ioannis Pallikaris – email@example.com Emanuel Rosen – ERosen9850@aol.com Thomas Neuhann – firstname.lastname@example.org Michael Knorz – email@example.com
“The LASIK of the future will be all-laser LASIK, which means we will use a femtosecond laser to cut a flap and then an excimer laser to ablate the tissue to perform the refractive correction.” Michael Knorz MD, PhD
Dr Güell believes that the reliability of LASIK is such that it will remain the dominant laser refractive procedure for some time to come especially on the lower corrections rate in both primary and secondary surgeries. While the number of procedures has plateaued in Europe, he expects growth will resume as a new generation of myopes ages and can afford the procedure. However, better pain and haze management will also benefit surface procedures. Femtosecond approaches beyond flap cutting are also likely to gain, he believes. European surgeons are at the forefront of this research as well, he notes. Prof Knorz foresees LASIK settling into
a niche among other refractive surgery options. “The LASIK of the future will be alllaser LASIK, which means we will use a femtosecond laser to cut a flap and then an excimer laser to ablate the tissue to perform the refractive correction. I also think that LASIK will be used for lower myopes and hyperopes only. I envision a range from +3 D to -6 D. In addition, LASIK will be used to fine-tune results of other refractive surgical procedures, such as phakic implants and refractive lens exchange. I believe LASIK is here to stay.”
Don’t miss Newsmaker04.05.2010 Interview with Ioannis Pallikaris, see page 8 18:04 Uhr Seite 1
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EUROTIMES | Volume 15 | Issue 6
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Newsmaker Interview //
20 YEARS OF LASIK Celebrating LASIK surgery
the right decision
Preoperative evaluation of LASIK candidates has become much more accurate and effective than it was in the past
Ioannis Pallikaris MD, PhD is professor of ophthalmology, School of Medicine, University of Crete and founder and director of the Vardinoyannion Eye Institute of Crete. Considered the originator of LASIK, in 1989 Prof Pallikaris was the first to conduct animal trials with the technique. He has since remained at the forefront of research in refractive surgery, and counts among his mentors Theo Seiler MD and John Marshall PhD. Dr Pallikaris was also president of the ESCRS from 2006 to 2008.
Much has changed since the early days of laser refractive surgery. Tell us a little about your early experiences. What were you thinking as you began your first LASIK surgery? After my first studies in 1988 on corneal healing after excimer laser surface ablations (PRK), I was sure that we needed to go deeper with the ablation. However, because of the suturing problems and aberrations with in situ keratomileusis, I knew we needed a technique with a more viable and stable corneal button to cover the ablated stroma. From my experience in plastic surgery I was aware that for the viability and optimal healing of the detached tissue, it was best to preserve a connection, or bridge, with the intact healthy tissue. That is how I came up with the idea of the flap. The first animal studies in 1989 proved the viability and the healing course of the flap approach. The first clinical study in 1990 proved that the flap would not create an extreme astigmatic effect.
What has changed in your practice over the years? For example, whom would you not treat now that you might have considered treating in the past? What range of correction do you consider safe? We now know the limits of LASIK’s ability to correct refractive error. Therefore, in
comparison with the early years of refractive surgery, we are generally more conservative and much more effective. The main factors that help us to decide if we should treat a patient with overall healthy eyes are the refractive error, corneal topography and corneal thickness.
Has your relationship with patients changed as the technology has changed? How do you balance the promise of vision improvement versus the potential risks? Today I have a much better understanding of the relationship between the subjective problems of the patient and the objective measurements obtained with the more sophisticated technology that is now available. For that reason, I feel much more secure in guiding the patient to the right decision with the right expectations.
What is your current approach? Tell us about the pre-op work-up, which laser and keratome you use, etc. Preoperatively, our patients go through a complete ophthalmic examination. That includes manifest and cycloplegic refraction, Placido-based corneal topography, Scheimpflug imaging and ultrasound pachymetry. We perform wavefront analysis with the iTrace in combination with topography. Regarding our surgical equipment, we use both the Allegretto 400 Wave Eye-Q and the Pulzar Z1. We create LASIK flaps in our practice with the iFS Advanced Femtosecond Laser. Although this device has very high accuracy, we always perform intraoperative pachymetry in LASIK procedures in case the flap is thicker than expected.
What influence do you think these various technical improvements have had on LASIKrelated complications? For example, are you better able to spot bad LASIK candidates (eg keratoconus patients)? Is
Don’t miss Congress Report, see page 19 EUROTIMES | Volume 15 | Issue 6
the risk of ectasia less severe? Are you seeing fewer problems with post-op night vision haloes and glare? With the use of new technology, preoperative evaluation of LASIK candidates has become much more accurate and effective than it was in the past. We can now detect subclinical keratoconus with very sensitive examinations and this has minimised the ectasia risk.
Looking ahead, what technology looks the most interesting to you? Is thin-flap, wavefront-guided all-laser LASIK setting the bar high for future improvements in technology? Thin-flap LASIK will play an important role in the future of refractive surgery, since it increases safety and allows more patients to be treated. Wavefront-guided technology is a useful tool for the correction of aberrations that cause visual complaints, but for the moment it cannot yet provide the so-called “super-vision”. On the other hand, vision free of aberrations is not our goal, since a normal small amount of higher order aberrations gives us a depth of focus that seems to be essential for normal vision.
Does LASIK have a role, primary or adjunct, in the treatment of presbyopia? What about intrastromal ablation via allfemtosecond correction, INTRACOR ablation, etc? In the treatment of presbyopia we must select the most appropriate method for each patient taking into consideration parameters such as profession, hobbies, age, refraction and any concomitant ocular
Stills from Ioannis Pallikaris’ first LASIK procedure
pathologies. For young presbyopes with pre-existing refractive errors I perform monovision or multifocal laser, whereas for emmetropes I prefer to use corneal inlays because this technique is reversible, safer and minimally invasive. I prefer clear lens extraction in emmetropes 60 years or older or in ametropes more than 55 years. I avoid multifocality in patients with high mesopic expectation, whereas I do not perform monovision in patients with high stereoptic expectation. The femtosecond laser is a very interesting tool for presbyopia. It can provide intrastromal ablations for flapless multifocal corneas and also enables the creation of optimal corneal pockets for the implantation of inlays. In the future, the use of femtosecond laser in crystalline lens surgery will probably play an important role in the correction of presbyopia.
What would you imagine refractive surgery will be able to offer patients 10 years from now? The next goal is surgical correction of presbyopia. In the future, exciting new technology will enable us to reshape or rejuvenate the normal human lens and also use more advanced IOL material that can be remodelled in situ. Regarding LASIK surgery, I believe that corneal remodelling techniques will be used for fine tuning of the optics of the eyes in order to achieve a custom induced aberrations optical system, based on patients’ specific demands and expectations. Prof Pallikaris was interviewed by contributing editor of EuroTimes, Roibeard O’hEineachain
Ioannis Pallikaris - firstname.lastname@example.org
Newsmaker Interview //
20 YEARS OF LASIK Celebrating LASIK surgery
Patients trust us
Knowing when to say ‘no’ has improved LASIK
On October 25, 1989, Lucio Buratto MD performed what many believe was the first intrastromal ablation using an excimer laser for the treatment of high myopia on a sighted eye. He also invented the superior hinge flap for LASIK in 1996. Dr Buratto has published and presented his work around the world, training and influencing many pioneers in laser vision correction.
What were you thinking as you began your first LASIK surgery?
I was in Bogota in 1984, but I was not convinced about the freeze cut keratomileusis. In 1986 I saw [Jorg] Krumeich in Germany and began doing keratomileusis using a nonfreeze cut. This was a good choice, it was much more reliable than freezing. We were treating high myopes at that time, the patients were -10 to -15 D. It was done with a blade and we had to cut 15 or 20 microns. It was real surgery and it was difficult. You could not treat low myopes, it was not precise enough. But if you treat -12 D and you are off target by two or three at the end it is a big improvement. I still see some patients who were done at that time and they are fine from the refractive point of view. The only problem is the small optical zone, 4.04.5mm so at night their quality of vision is very bad With the laser the quality of the refractive cut made it more reliable and we also increased the optical zone. Instead of making the refractive cut with the blade we used the laser. At the beginning we used it on the stromal cap because that was how the keratomileusis procedure was done at that time. Today LASIK is a very different surgical procedure.
What has changed in your practice over the years?
The original procedure was developed to treat high myopia. We started moving back when our patients were complaining about glare when you treat high myopia with a small optical zone. Today I would not treat more than -7 D generally speaking, depending on
the thickness of the cornea and the pupil size. I would not treat patients with thin corneas or large pupils or with corneal abnormalities. We get much more pre-op information and we understand the technology better. We know more about the cases to avoid. With iris recognition rotational eye trackers you can do high astigmatism with more precise correction, and you can do better with hyperopia. You can correct spherical aberration on higher myopes and you get better centration and smoother surfaces. Today every single patient is treated differently and LASIK is much more customised. I don’t mean everyone is wavefront treated, but every patient can have a differently optic zone, thickness of cut, personalised software like wavefront optimised or tissue saving, or aspheric or just standard software can be used. You can give the patient what is best for their needs and quality of vision and reduce glare and related negative visual effects. There are much less induced higher order aberrations now.
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What influence have these improvements had on LASIKrelated complications? With the femtosecond laser it is getting much easier. Sometimes we lose suction with the femtosecond laser or we have a little decentration, but not much. We also are much better at identifying preoperative suspect cases, so we can avoid a lot of problems.
Has your relationship with patients changed as the technology has changed? We understand better who should be treated and who should not be treated with the laser. If I am not sure about the good refractive and visual results in a patient, I prefer not to do the treatment. I would rather lose the patient than have a poor outcome. I am very prudent, I would say, and most of my colleagues are too. My relationship with patients is very good because we give them what they want. The amount of retreatment is very low. When you follow the rules of good patient selection and for a safe surgery, your patients are happy. We have earned our patients’ trust. Dr Buratto was interviewed by contributing editor of EuroTimes, Howard Larkin
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Lucio Buratto - firstname.lastname@example.org
EUROTIMES | Volume 15 | Issue 6
Newsmaker Interview //
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Prof Michael Knorz MD is the medical director of the FreeVis LASIK Center in Mannheim, Germany. He introduced LASIK to Germany in 1993 and established the first German LASIK Centre at the University Eye Clinic Mannheim. His main areas of research are cataract and refractive surgery, concerning which he has presented many research papers and has had numerous original articles published in peer-reviewed journals. He also has the distinction of having undergone LASIK himself in 1999. Prof Knorz was interviewed by contributing editor of EuroTimes, Roibeard O’hEineachain
What has changed in your practice over the years? When I started performing LASIK first in 1993 it was mainly for higher myopes. I treated patients from -6.0 D all the way up to -29.0 D, and, later on, hyperopes from +3.0 D to +9.0 D. Most patients were happy despite many complications, mainly poor vision at night and huge haloes as well as some glare. We have since learned that the upper limit is about -8.0 D of myopia and about 3.0 D or +4 .0 D of hyperopia. I do not use LASIK outside this range anymore.
Has your relationship with patients changed as the technology has changed? How do you balance the promise of vision improvement versus the potential risks? What has changed significantly is that complications have become far less frequent. I am now using all-laser-LASIK, using the IntraLase iFS femtosecond laser and the VISX Star S4 excimer laser, and the rate of complications is extremely low. Today the promise of vision improvement far outweighs the risks.
4 Stewart Court, Denville, NJ 07834 • USA ☎ 973-989-1600 • 800-225-1195 • www.katena.com
EUROTIMES | Volume 15 | Issue 6
Much has changed since the early days of laser refractive surgery. Tell us a little about your early experiences, what were you thinking as you began your first LASIK surgery? LASIK was far more stressful to the surgeon than it is today. When I started, all I had was the automated corneal shaper (ACS) without a mechanical stop. I had to stop right in time, or the hinge would be either too big or I would get a free flap. What intrigued me from the first day was the lack of pain and the fast visual recovery, the “wow” factor that made my patients smile.
What is your current approach? Tell us about your pre-op work-up, which laser and keratome, etc. My current system is the so-called iLASIK suite from AMO. I perform wavefront measurements in all my patients, with a capture rate of about 99 per cent. I start with a femtosecond laser flap (IntraLase iFS laser) with a diameter of 8.5mm (9.0mm in hyperopic corrections) and a thickness of 100µm and a superior hinge. I then perform wavefrontguided ablations with the VISX Star S4 excimer laser, based on the wavefront measurements. The main reason I like to use wavefront-guided ablations in everybody is that they allow me to use iris registration, which means that I can treat the astigmatism exactly on axis and without decentrations, since the eyetracker will compensate for the pupil shift. The second reason is that higher-order aberrations are minimised, but this is only important in eyes with a lot of higher-order aberrations.
I do not use intraoperative pachymetry because the thickness of the femtosecond laser flap is very predictable, much more so than with a mechanical microkeratome.
What influence do you think these various technical improvements have had on LASIKrelated complications? With the use of a femtosecond laser, flap-related complications have virtually disappeared. Furthermore, modern corneal topography and the knowledge about suspicious topographic patterns have made corneal ectasia a rarer complication. In addition, the old ablation algorithms induced large amounts of spherical aberration, which in turn caused night vision problems. Moreover, with modern aspheric ablation algorithms and wavefront-guided ablations, night vision problems have become very rare. What technology looks the most interesting to you? Is thin-flap, wavefront guided all-laser LASIK setting the bar high for future improvements in technology? Mechanical microkeratomes will disappear, they are not precise enough and carry too many complications. And fully customised ablations will become even more prominent, because they minimise coma and other higher-order aberrations, in addition to just the spherical aberration.
Does LASIK have a role, primary or adjunct, in the treatment of presbyopia? What about intrastromal ablation via all-femtosecond correction, INTRACOR ablation, etc? Yes, the most frequent LASIK technique for presbyopia used today is monovision LASIK, which leaves the nondominant eye about -1.25 D myopic. At least 50 per cent of presbyopic patients can tolerate this. Modified ablation algorithms such as ablations which induce negative spherical aberration may also play a role in the future. Intrastromal procedures such as INTRACOR also create negative spherical aberration and as such improve depth of field, which in turn improves near vision. INTRACOR has the advantage that it does not create an external wound in the cornea, which means that infection cannot occur.
What would you imagine refractive surgery will be able to offer patients 10 years from now? I think we will be able to offer some truly accommodating IOLs, although the range of accommodation will still not be perfect. Laser surgery will still be dominated by LASIK with a femtosecond laser, and eye tracking devices will track rotation on the X, Y and Z axis, as well as tilt. Wavefront-guided systems combined with topography will be used to perform fully customised ablation in everybody. Finally, toric phakic IOLs will correct higher myopes and hyperopes.
Michael Knorz - email@example.com
Dr Emanuel Rosen was the first UK ophthalmologist to do LASIK. He remains active in medical ophthalmology, research and education and is chairman of the Medical Advisory Board of CustomVis, manufacturers of the PULZAR Z 1 solid state laser.
Newsmaker Interview //
20 YEARS OF LASIK Celebrating LASIK surgery
LASIK’s long future Q:
Transition from PRK to LASIK has been remarkable because of patient comfort and acceptance
What were you thinking as you began your first LASIK surgery? My early experience with LASIK was very good. We waited until we had the autonomous laser and we used the Hansatome microkeratome. It was a remarkable transition from photorefractive keratectomy (PRK) because of the patient’s comfort and acceptance of the procedure.
What has changed in your practice over the years? I was very conservative, particularly in relation to hyperopia. I would not treat
EUROTIMES | Volume 15 | Issue 6
more than two dioptres of hyperopia and I would not treat older patients. I believe there are suitable procedures available for these patients such as phakic implants or refractive lens exchange.
Has your relationship with patients changed as the technology has changed? As I have stated I was always very conservative but I became very confident because my early experience of LASIK was excellent.
What influence do you think these various technical improvements have had on LASIK-related complications? Another feature of our work was that we did very wide ablations. The early experience with PRK was small ablations with people with large pupils which created significant problems and also we did standard ablations before we moved eventually to customised ablations. Another feature of our patient assessment was that we carried out active pupillometry.
Looking ahead, what technology looks the most interesting to you? Is thin-flap, wavefront-guided all-laser LASIK setting the bar high for future improvements in technology? I think it is clear that most people like femtosecond flaps and treatments. I have a vested interest in believing that solid state lasers will have a prominent place in the evolution of LASIK.
Does LASIK have a role, primary or adjunct, in the treatment of
presbyopia? What about intrastromal ablation via all-femtosecond correction, INTRACOR ablation, etc? I am quite keen on mild monovision which LASIK can certainly do. As I said I have a vested interest in CustomVis whose PULZAR Z1 solid state laser has a presbyLASIK platform which seems to work very well. But I am also concerned with the question of how to handle patients who don’t do well. In summary, I don’t think LASIK per se will provide the solution for presbyopia. Intrastromal ablation is interesting but it remains to be proved and the data available so far is too early.
What would you imagine refractive surgery will be able to offer patients 10 years from now? I think LASIK will continue as the standard for modest myopia and hyperopia and it has a long future. Dr Rosen was interviewed by executive editor of EuroTimes, Colin Kerr
Newsmaker Interview //
20 YEARS OF LASIK Celebrating LASIK surgery
LASIK procedures will improve, but patient safety must be major priority
Born in Ravensburg, Southern Germany on February 12, 1949, Theo Seiler MD, PhD is credited as being the first physician to use an excimer laser on the human eye in Berlin in 1992. He is professor and chairman of the Department of Ophthalmology at the University of Zurich in Switzerland. Prof Seiler received the Binkhorst award from the American Academy of Ophthalmology (AAO) in 1994; the Barraquer Award from the AAO in 1995; the Graefe Award from the Deutsche Ophthalmologische Gesellschaft in 1996; and the Honour Award from the AAO in 1997.
Tell us a little about your early experiences, and what you were thinking as you began your first LASIK surgery? I did the first photorefractive keratectomy (PRK) in 1986 so I had six years of experience with PRK before I did LASIK in 1992. The first thing I did was to create a free cap and I stopped immediately with LASIK for the next four years. I had to stop because if you get such a complication in the first eye, you cannot continue. My primary concern as a doctor is that I am responsible for my patients.
Despite its popularity, LASIK is not suitable for every patient – such as those with thin corneas, unusual corneal topographies, dry eye problems, or simply a reluctance to have their eyes cut. Surface ablation is an alternative, but many have been put off by the disadvantages of PRK and LASEK. Epi-LASIK addresses the unmet needs of such patients by providing faster healing and visual recovery than PRK and LASEK - with less discomfort. Discover why an increasing number of refractive surgeons prefer Epi-LASIK to PRK and LASEK for surface ablation and are experiencing substantial growth in patient volume.
What has changed in your practice over the years? For example, whom would you not treat now that you might have considered treating in the past? LASIK was heralded as the procedure to use for high myopia. My highest degree of myopia was -23 dioptres and today I am doing on average -8 dioptres and at maximum -10 dioptres.
• • • •
Faster healing and visual recovery than PRK and LASEK No intrastromal flaps – Better biomechanics Practice growth opportunity - treats a wider range of patients than LASIK The most widely used epikeratome on the market – by a very wide margin
Has your relationship with patients changed as the technology has changed? I can now tell my patients that the procedure has become safer because we don’t have scars any more but we do have new complications like ectasia.
What is your current approach? Tell us about your pre-op work-up, which laser and keratome, etc. I use wavefront measurement in every patient and I am treating about 30 per cent of my patients wavefront-guided. I also do Scheimpflug topography in every patient. We have intraoperative pachymetry online with the Concerto laser.
What influence do you think these various technical improvements have had on LASIK-related complications? For example, are you better able to spot bad LASIK candidates (eg keratoconus patients)? One of the things that has had a major impact on the acceptance of LASIK is the safety of the microkeratomes. The femtosecond lasers have also become so good that they are creating very reliable flaps and the risk of ectasia is also much less severe. Our diagnostics are also much better now and we have data available to tell us which corneas we should not treat and which corneas we can. Since we introduced wavefront-optimised and wavefront-guided treatments, night driving problems have become much less frequent. In the old days the standard statement of my patients was: “Professor, during the day you are my hero but at night my husband drives.”
Looking ahead, what technology looks the most interesting to you? Is thin-flap, wavefront guided all-laser LASIK setting the bar high for future improvements in technology?
MORIA SA. 15, rue Georges Besse 92160 Antony FRANCE. Phone: +33 (0) 1 46 74 46 74 - Fax: +33 (0) 1 46 74 46 70 firstname.lastname@example.org - www.moria-surgical.com
I think thin-flap LASIK has to find its place. At the very beginning people talked about 90 micron or 70 micron flaps but we are very clear today that we do not want to do that anymore. On the other hand, we do not want to do 130 micron flaps and the majority of my colleagues use 100 to 110 micron flaps, which seems to be a good compromise.
Does LASIK have a role, primary or adjunct, in the treatment of presbyopia? What about intrastromal ablation via all-femtosecond correction, INTRACOR ablation, etc? We don’t have a good solution for presbyopia of the cornea, period. The results so far for intrastromal ablation are not very convincing.
What would you imagine refractive surgery will be able to offer patients 10 years from now? 10 years from now I think refractive surgery has to become much cheaper and much easier. LASIK has become easier and cheaper in the last 20 years and this will continue. I also think that 10 years from now we will not need two lasers and we will have one laser for everything.
Prof Seiler was interviewed by executive editor of EuroTimes, Colin Kerr
Theo Seiler – email@example.com
EUROTIMES | Volume 15 | Issue 6
Newsmaker Interview //
20 YEARS OF LASIK Celebrating LASIK surgery
Procedure will keep evolving
Femtosecond laser offers more control over flap thickness, diameter, shape, and the edge Marguerite B McDonald MD was present at the birth of laser vision correction surgery. She was involved in the early pre-clinical and clinical work with the excimer laser. From 1981 until 1993, Dr McDonald was at the LSU Eye Centre in New Orleans; she was a professor of ophthalmology, chief of the cornea service, and director of the refractive surgery unit. From1993 until 2005, Dr McDonald was the director of the Southern Vision Institute in New Orleans, Louisiana. She is currently a clinical professor of ophthalmology at NYU Langone Medical Centre in Manhattan, and an adjunct clinical professor of ophthalmology at Tulane University Health Sciences Centre. She is a former president of the ASCRS.
Tell us about your early experiences with laser refractive surgery. The thing in my career about which I am most proud is that I had the honour of performing the world’s first laser vision correction procedure in a human subject in 1988. I was working on the surface ablation approach with Steve Trokel MD and Charles Munnerlyn PhD starting in 1984, first on plastic, then on animal cadaver eyes, moving up to human cadaver eyes, to live animals and finally to humans. Steve was at Columbia, which did not have animal facilities, but we did at Tulane. Charles was involved as a physicist, so we were like the three legs of a stool, supporting each other during our effort of turning the excimer laser into a refractive tool. In the early days the excimer was an industrial model the size of a breadbox. We
would aim it from six feet away at sedated rabbits. It was a broad beam laser with five diaphragm positions. We would shoot for a few seconds, then hand crank the diaphragm down to the next smallest size. The first several dozen rabbits had significant corneal scarring. Indeed, my corneal fellow, my chief technician, and my assistant technician all quit, as they didn’t think this project would amount to anything. Then Charles hooked up a little motor to the diaphragm, so that we had 40 diaphragm positions with smooth transitions, and the corneas were pretty clear. Over time things got more automated and we brought the laser into a vertical position. Charles wanted to have the patients put their heads in a box-like unit, with the doctor looking at a video monitor during the surgery. I felt that if we want acceptance from ophthalmologists, we needed to put them in their “comfort zone”, ie, looking through an operating microscope as in other ophthalmic surgery. After thousands of plastic, cadaver, and animal experiments, we had a remarkable opportunity. A woman named Alberta Cassady, an otherwise healthy 62-year-old female, was referred to us with a malignant melanoma on the conjunctiva that had spread back into the orbit. Mrs Cassady needed exenteration, and quickly, as a desperate move to save her life. She had a 20/20 eye that was going to be removed. With incredible equanimity she asked if any of the LSU doctors wanted to perform an experiment on her eye before it was removed. We told Mrs Cassady about the excimer project, and told her no one had ever had this treatment. She said ‘OK, let’s go’. It went well. We finally went from broad beam to flying spot, and then trackers and wavefrontbased ablations were introduced, along with the iris registration and pupil centroid shift compensation technologies, bringing us up to the present.
n n n n n n
EUROTIMES | Volume 15 | Issue 6
In the early days there was a fair amount of discomfort associated with photorefractive keratectomy (PRK), and visual recovery was slow (one to two weeks). LASIK came along and solved that, though modern PRK has almost closed the gap between the two procedures in regard to speed of return of vision and early postoperative comfort, due to advanced hardware and software, and novel perioperative regimens. Today, there is no question that the femtosecond laser has taken more and more market share from mechanical microkeratomes. It is safer, and offers more control over flap thickness, diameter, shape, and edge configuration. With femtosecond technology, we can now customise every parameter of the flap, which we cannot do with a mechanical keratome.
What has changed in your practice over the years? At first we really didn’t know anything about the appropriate range of dioptric correction. There are some things you can only learn when you get to humans. One of the first things we learned is that extremely high myopes are not good candidates. In the early days we tried correcting -23 D, -15 D, then -12 D. Now it would be rare to treat anyone over -10 D, and most have a cut-off at -8 D or so. In early days we also did not have an appreciation for screening patients topographically, to rule out patients with keratoconus and other ectatic disorders such as pellucid marginal degeneration. There wasn’t an appreciation that you could destabilise the cornea or cause post-LASIK ectasia.
What is your approach to refractive laser surgery today? I still do a fair amount of surface ablation. I do perform LASIK with the femtosecond laser, and I perform customised ablations on everyone that I can. I would only do standard ablation in those who can’t be captured for some reason, or in someone who had received a refractive multifocal IOL. I don’t do intraoperative pachymetry because I don’t want to wet the bed in an uneven fashion. If a patient is just on the border of not having enough stroma for LASIK, I just default to PRK.
Does LASIK have a role, primary or adjunct, in the treatment of presbyopia?
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I’m a big fan of monovision with LASIK. It takes more chair time to explain than if the surgeon simply corrects both eyes of the presbyopic patient for distance, but it’s worth it. Some patients will become angry postoperatively if they didn’t know that monovision was an option. Many patients enjoy “mini-monovision”, which is a 0.75 D add in the non-dominant eye. Even programming the laser to leave this small amount of myopic refractive error in the non-dominant eye will cut the use of reading glasses by up to 50 per cent. The presbyLASIK results are quite good. The AMO Abbott studies in Canada have been under way for over five years under the direction of Dr Bruce Jackson, and they are impressive. The US clinical trial results, conducted under the direction of Dr Coby Kraff, also look very encouraging. I’m also very encouraged by INTRACOR, the intrastromal femtosecond concentric treatment zones that correct presbyopia. We need to know if the corneal changes are temporary or permanent. If they are temporary, that would still be acceptable, if the procedure can be repeated safely every couple of years or so.
Care to prognosticate about the future? Laser vision correction will continue to evolve. We can expect better iterations of surface ablation and LASIK. Intraocular surgery will get better and be safer, with novel drug delivery systems to prevent endophthalmitis. These systems will further reduce the barrier to intraocular surgery as a means to correct refractive error. Intracorneal inlays such as the AcuFocus will help a lot of patients; the KAMRA inlay can be implanted in plano presbyopic patients, and postoperative cataract patients from the recent and distant past (even extracapsular patients from years ago, ie, anyone who received a monofocal implant). Similarly, multifocal and accommodating IOL patients who are disappointed in their near vision could be helped. Finally, we will have a selection of effective accommodating IOLs. That will be another watershed moment in ophthalmic history; that will change everything. Dr McDonald was interviewed by Sean Henahan, editor of EuroTimes
Marguerite B McDonald – firstname.lastname@example.org
Missed the XXVII ESCRS Congress in Barcelona or the 14th ESCRS Winter Meeting in Budapest? Available to view now at www.escrsondemand.org
Newsmaker Interview //
20 YEARS OF LASIK Celebrating LASIK surgery
Confidence with experience
LASIK will be much safer and more accurate in the future in better selected patients
What were you thinking as you began your first LASIK surgery? We started in 1992. The early procedures did well, with some nervousness. However, the confidence came from a previous experience with in situ Ruiz Keratomileusis; we had experience with keratomileusis and a two-year experience with photorefractive keratectomy (PRK).
What has changed in your practice over the years? LASIK was very slow to be accepted by colleagues (who preferred the ease of PRK) and by patients. It took at least five years to become the gold standard. However, we must remember that at this time we performed LASIK for myopia up to -20 D or more! LASIK was promoted to avoid corneal haze that occurred with PRK for treatments of myopia greater than -8 D. With the help of femtosecond lasers, we can now treat patients with thinner corneas. The flaps are created with a better accuracy and reproducibility. Now we safely treat myopia up to -8 or -10 D according to the corneal thickness, hyperopia up to 5 D, not more, and astigmatism up to 6 D.
Has your relationship with patients changed as the technology has changed? How do you balance the promise of vision improvement versus the potential risks?
The technology is now much safer, and if the patient has no contraindications, we are very confident to recommend the surgery. We have a long follow–up of many patients that will help the patients to choose the right procedure.
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What is your current system: pre-op work-up, which laser and keratome? We are using the IntraLase Ifs platform combined with the VISX S4 laser.
innovative and educational symposia during the 10th EURETINA Congress and XXVIII Congress of the ESCRS.
Friday, 3 September
What influence do you think these various technical improvements have had on LASIK-related complications? For example, are you better able to spot bad LASIK candidates (eg keratoconus patients)? Is the risk of ectasia less severe? The answer is Yes. We now have information that we did not have 15 years ago. For each patient, we evaluate the risk of post-LASIK ectasia. However, the risk still exists as we have no perfect tool to detect early or subclinical keratoconus.
Looking ahead, what technology looks the most interesting to you? The future will be excellent with new tools (especially technology to explore the biomechanical properties of the cornea) to select the best patients for the best results; safer and safer flaps with advanced femtosecond lasers; better intra-operative image technology controls; no flaps with intrastromal in situ ablations.
Does LASIK have a role in the treatment of presbyopia? What about intrastromal ablation via all-femtosecond correction, INTRACOR ablation, etc? It is a necessary step to the future: corneal treatments are current compromise to help presbyopic patients to have better vision. However, the initial disease is not in the cornea but in the lens.
What will refractive surgery be able to offer patients 10 years from now? LASIK will be a much safer and more accurate procedure in better selected patients with a better preoperative evaluation, with thinner flaps or no flaps. Presbyopia will be treated by femtolaser reshaping of the lens to restore the normal elasticity of the crystalline material... maybe.
2-8 September 2010 EURETINA/ESCRS
SAVE THE DATE to join your colleagues for these
Treatment Paradigms in Surgical and Medical Retina 18:00 – 18:15 Registration 18:15 – 20:00 Symposium (reception to follow)
Saturday, 4 September Cataract and Refractive Live Surgery 18:00 – 18:30 Registration 18:30 – 20:30 Live Telecast
Sunday, 5 September Maximizing Surgical Outcomes: Therapeutic Considerations and Clinical Experiences 12:30 – 13:00 Registration 13:00 – 14:00 Symposium (box lunches will be provided) Impact of New Torsional Technology on Interesting Cases 12:30 – 13:00 Registration 13:00 – 14:00 Symposium (box lunches will be provided) Innovations in Refractive IOL and Laser Technology 18:15 – 18:45 Registration 18:45 – 19:45 Symposium (reception to follow)
Monday, 6 September Surgical Techniques: Injecting the Latest Technologies 12:30 – 13:00 Registration 13:00 – 14:00 Symposium (box lunches will be provided)
©2010 Alcon, Inc.
Joseph Colin received his MD in 1977 from the Brest University; he completed his ophthalmology residency and fellowship in Brest University Medical School and Nantes University, France, where he specialised in anterior segment surgery. Promoted to professor of ophthalmology in 1982, he was chairman of the Department of Ophthalmology at Brest University Medical School until September 2000. He is currently chairman of the Department of Ophthalmology at Bordeaux University Medical School. He was president of the French National University Council for Ophthalmology (1995-2003). He is currently president of the French Society of Implant and Refractive Surgery (SAFIR).
Dr Colin was interviewed by contributing editor of EuroTimes, Dermot McGrath EUROTIMES | Volume 15 | Issue 6
20 YEARS OF LASIK Celebrating LASIK surgery
Industry aids LASIK advances
Commitment to excellence generates technical advances that improve outcomes Howard Larkin in Chicago
HE history of LASIK is largely the history of industrial technology applied to surgery, says Stephen Trokel MD, PhD. “[Jose] Barraquer had the idea of using industrial technology for surgery. Before that surgeons’ tools were basically barbers’ tools. The best technology he had in 1949 was the jeweller’s lathe. The best we have today are lasers. It’s no coincidence that the original research on using the excimer laser on tissue was done at IBM.” Indeed, since Dr Trokel and colleagues first developed the excimer laser for corneal surgery in the 1980s, manufacturers all over the world have played a critical role in developing and refining the technologies that have made LASIK and other laser eye surgeries the safe, effective, precise and efficient procedures they are today. Their investments in research, surgical education, clinical trials, new technologies and improved design and manufacturing techniques continue to improve not only clinical outcomes, but also the speed, reliability and ease of ophthalmic surgery. Variable spot technology employed by VISX and the option to use more than one power level as in the SCHWIND AMARIS further increase ablation control. “It took perseverance,” says David Muller PhD, founder of Summit Technology and now president and CEO of Avedro. “When we tried to raise money from the venture guys, they’d show it to an ophthalmologist who would say ‘you can’t possibly use this thing on a human cornea’.” It was the support of a few early believers like John Marshall PhD, and Theo Seiler MD, that got the industry off the ground, Dr Muller says. “Introducing it in Europe, outside the US regulatory environment, was key. We were able to introduce it earlier rather than later and we got a few key ophthalmologists comfortable with it. In the early days it was unacceptable to many people who are now zealots for the technology. It’s been interesting to watch.”
Broad beam to flying spot The corneal ablations produced by the early broad-beam excimer lasers such as those manufactured by VISX, Summit and Technolas were an order of magnitude more precise than mechanical keratomileusis, notes Dr Trokel, who, with Charles Munnerlyn and Terry Clapham, founded VISX to produce ophthalmic lasers. Where the cryolathe developed by Dr Barraquer could machine a frozen corneal cap to a tolerance of two to three microns, the 193 nm excimer laser could get to about one-fifth of a micron. “We could split a dioptre into 12 or 14 layers,” Dr Trokel recalls. The lasers were also much more predictable and easier to use than automated lamellar keratoplasty (ALK) or other blade-based procedures that also required a high level of skill to correctly align successive corneal incisions. Moreover, photorefractive keratectomy (PRK) and LASIK didn’t destabilise the cornea or induce large amounts of irregular astigmatism the way some of the mechanical procedures could. And these lasers were extraordinarily robust. “The first EUROTIMES | Volume 15 | Issue 6
Technolas 116 system is still running somewhere in Anatoly,” says Kristian Hohla, PhD. Now CEO of Technolas Perfect Vision, Dr Hohla was one of the earliest developers of excimer lasers with Lambda Physik, then for Technolas. But the broad-beam lasers suffered from some inherent shortcomings. Maintaining a homogenous beam profile was difficult and the broad beam required a lot of power. It could take an hour or more to calibrate the laser each day, and the systems required frequent gas changes that were both expensive and potentially hazardous. And they took up a huge amount of floor space. Achieving the proper ablation profile was an ongoing challenge. A variety of ingenious approaches were used early on, including iris shutters. Still, central islands and other issues, such as abrupt transitions between ablation zones, emerged as issues. The Meditec MEL 60 and early NIDEK systems used scanning slits to achieve a smoother ablation. Erodible masks also were used by Summit Technology. The early CoherentSCHWIND systems used a series of circular and oval apertures on a rotating belt to correct myopia and astigmatism. Later on the system changed to a fractal mask design where a rotating mask created the ablation profile for the refractive correction. The flying spot laser solved many of these issues. Because it was smaller in diameter it needed less power and was less sensitive to variations in beam profile. The flying spot also reduced the accumulation of thermal energy and debris thought to be responsible for central islands with broad beam lasers. But to piece together an ablation, flying spot lasers must be kept on-target. “Speed is nothing without precision,” says Rolf Schwind, president of SCHWIND, which introduced passive eye tracking as standard equipment in 1994. Autonomous developed one of the first eye-tracking system, known as Laser Radar or LADARVision, which was acquired by Summit Technology (which was ultimately acquired by Alcon). “After that we saw a lot of fast eye trackers come on the market, including WaveLight,” says Ernie Bravo, Alcon’s global director of refractive marketing. Over time eye trackers have progressed from 2-D to 3-D to what WaveLight and SCHWIND calls 5 and 6-D, including rotational and z-axis movement. One of the most important advances is corrections for cyclotorsion, says Kazuharu Sugiyama, technical/ clinical support manager for refractive surgery at NIDEK’s international division. “We focused on the cyclotorsion error correction system from the very beginning to improve the accuracy of treatment of astigmatism and higher order aberrations.” NIDEK released Torsion Error Detection (TED) module in 2003, and developed active Torsion Error Correction (TEC) system in 2007. TEC is not only detecting the cyclotorsion error, but also correcting it automatically during laser ablation. Alcon defined the requirements for cyclorotational tracking with the introduction of LADAR CustomCornea. VISX introduced 3-D tracking in 2000 and an advanced
torsional eye tracker with iris registration on the STAR S4 system in 2004 and has improved it since, says Jim Mazzo, president of Abbott Medical Optics. Technolas Perfect Vision’s eye tracker, now known as Advanced Control Eyetracker (ACE™) technology, which is able to compensate for static and dynamic cyclotorsion, was first made commercially available in 2003. Carl Zeiss Meditec, NIDEK, SCHWIND and WaveLight all feature 1000 Hz eye tracking speed, and the ability to respond in milliseconds. Such capabilities are now becoming standard as a growing body of research suggests that eye trackers improve outcomes and are more likely to keep ablations centred.
Cutting the flap Stephen Slade MD, has written that LASIK is 90 per cent “flap” and 10 per cent “zap.” The continuous development of microkeratomes and then the femtosecond laser have played a central role in making LASIK safe, repeatable and effective. The microkeratome, including a suction ring to keep it in place and guide channels to keep the blade on track, was originally developed by Dr Barraquer in the 1960s to more easily create a uniform corneal cap for freeze keratomilieusis. Jorg Krumeich, Germany, Casimir Swinger, US, and Barraquer introduced BKS 1000 for non-freeze keratomileusis, while Luis Ruiz MD, also of Colombia, developed a version to support the two-cut ALK procedure. While the early mechanical flap cutters produced cuts that were more consistent than using a manual keratome, they were originally developed to create free caps. Some had to be stopped manually to create a hinge, and maintaining a consistent flap thickness from case to case was difficult. Manufacturers all over the world rose to the challenge. Notable among them was the Chiron Hansatome, which facilitated the superior “down-up” hinge developed by Lucio Buratto MD, who suggested it was less likely to lose adherence than a nasal hinge. Prior to the Hansatome many designs could not be positioned to create a superior hinge in patients with deep eye sockets, and even those that could were awkward to manipulate for a surgeon standing to the side of a patient. The Hansatome has continually been improved and is perennially the most widely used microkeratome in both the ESCRS and ASCRS annual surveys. Elsewhere, SCHWIND introduced its enhanced keratome in 1994, and in 2004 the Carriazo-Pendular microkeratome, which generates planar flaps. NIDEK’s MK-2000 also produces more-consistent flaps, Mr Sugiyama says. “We are able to minimise the error of flap thickness within +/- 20 microns compared with +/- 25 to 30 microns in ordinary mechanical microkeratomes. We believe that this stable and high accuracy of flap creation helps the improvement of clinical outcomes.” Producers such as Moria and Zeimer also have steadily improved the microkeratome, making consistent thinner flaps a reality. The need to cut flaps also influenced the design of excimer lasers. Many early lasers designed with PRK in mind didn’t leave enough room between the laser head and the eye to manoeuvre a microkeratome. Designs such as Technolas’ 217 corrected that, making it possible to cut a flap and laser without repositioning the patient. This made the procedure more comfortable for the patient and quicker for the surgeon, Dr Hohla notes. In 2001, IntraLase, now part of AMO, revolutionised flap cutting with the femtosecond laser. Now in its fifth generation, IntraLase offers not only greater control over flap thickness and consistency, it enables custom flap
HIGHRES_LDV_Venus_ET_A07L06_5.51x9.06in.pdf 1 28.04.10 14:09
17 The Femtolaser for Z-LASIK and Lamellar Corneal Surgery
shapes to accommodate asymmetric ablations and to preserve corneal nerve connections, and even flap edges designed to improve flap adherence and preserve structural integrity of the cornea. Spurred by competition from firms including WaveLight, Zeimer, Carl Zeiss Meditec and Technolas Perfect Vision, FS technology has advanced rapidly. Flaps can now often be cut in 60 seconds or less. FS procedures, refractive procedures are also emerging. And as with the microkeratome, manufacturers includingÂ Carl Zeiss Meditec,Â VISX, SCHWIND, WaveLight and Technolas Perfect Vision have developed platforms that integrate FS and excimer lasers, again contributing to patient comfort and surgeon efficiency. â€œReplacing the hand-held microkeratome blade with a computer-guided laser improved safety and predictably of all LASIK procedures,â€? Mr Mazzo says. FS lasers are now the most commonly used flap cutters in the US and are rapidly gaining ground in Europe and elsewhere. Still, the technology is expensive and mechanical microkeratomes continue to improve. â€œThe femtosecond laser will further establish itself in the market and will substitute microkeratomes to a certain extent. However, microkeratomes still have a right to exist and will stay in the market as an option during the next years. Whether femtosecond laser or microkeratome, the LASIK trend towards thinner flaps has reached a level (90 micrometres) where much thinner flaps are not realisable. Enhancements will be observed regarding creating a flap without any complications. Flap thickness will become more and more precise, variances in flap thickness will diminish, and cutting edges will become smoother,â€? SCHWIND says.
The custom revolution The advent of wavefront aberrometers, topographers and tomographers capable of precisely measuring higher order aberrations and corneal irregularities led to the next great innovation â€“ wavefront-guided and other customised ablations. In 2000, Bausch + Lomb, which had acquired Chiron and Technolas, came out with its Zyoptix system, closely followed by Alconâ€™s entry with the LADARVisionÂ CustomCornea system which received FDA approval in 2002. Alconâ€™s current WaveLight system supports a variety of custom options including wavefront guided, wavefront optimised and topo-guided systems outside the US.Â Not to be outdone, VISX introduced the WavescanÂ wavefront guided systemÂ in 2000. â€œWavescan allowed measurement of the complete optical path of the eye. The STAR S4 allowed the laser to receive instructions from the Wavescan aberrometry. In 2003 AMO received CustomVue Approval. This reinvented the market and allowed AMO to provide a premium procedure,â€? said Mr Mazzo.Â Combining wavefront, excimer, and femtosecond technologies with advanced diagnostics and treatment planning capabilities, have significantly improved outcomes, particularly in minimising induced aberrations, Mr Mazzo says. NIDEK combines a corneal topographer, aberrometer, auto-Refractor/ keratometer, and pupillometer in its OPD-Scan system, which exports data to a calculator that develops an optimal ablation profile. Along with advanced eye tracking, this system also has been shown to reduce higher order aberrations. NIDEK also offers a topography-guided system for treating highly aberrated corneas. Combining diagnostic technologies also Carl Zeiss Meditec combines topography and OCT data to detect and diagnose keratoconus, notes CEO Ludwin Monz, PhD. SCHWIND began offering online pachymetry in 2005 as a safety feature. According to Mr Mazzo, there will be major advancements in medical equipment used to diagnose visual complaints. These advancements will be incorporated into improving treatment planning capabilities. The next-generation eye care diagnostic equipment will incorporate multiple technologies such as high-resolution Wavefront, auto refractors, topography, pupilometry, keratometry and pachymetry. â€œWeâ€™re looking to reduce the number of diagnostic machines while delivering better, more reliable information. Improper diagnosis leads to higher costs; improper mapping leads to poor outcomes.â€? Patient satisfaction is essential to expanding LASIK market penetration, Mr Mazzo notes. Dr Monz believes that LASIK will soon be eclipsed by a femtosecond-only laser procedure, such as ReLEx, in which a flap and refractive lenticle are cut
Sandro Botticelli, The Birth of Venus, Italy
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in one pass, taking about 30 seconds and just one femtosecond laser. â€œThis is the first real advance in refractive surgery since LASIK,â€? he says. While LASIK uses ablation for re-shaping the cornea, ReLEx is based on laser cutting, which is not affected by ambient room conditions, corneal hydration or other factors. ReLEx aims at preserving biomechanics as it allows for very small flap sizes, typically just 0.5 to 1mm larger in diameter than the optical zone.Â However, many surgeons are reticent to go with a new technology when LASIK is as reliable and predictable as it has become. â€œWe will need to see data,â€? Dr Buratto says. And while Mr Mazzo, Dr Hohla, SCHWIND and other industry leaders see a growing role for competing surgeries, such as femtosecond lenticular procedures and intraocular lenses, they predict LASIK will remain an important refractive option. â€œWe are looking for the right patient with the right modality with the right surgeon,â€? Mr Mazzo says. â€œWe canâ€™t be complacent. We need to keep improving the technology to broaden the funnel of potential patients.â€? EUROTIMES | Volume 15 | Issue 6
Meet the OCULUS Diagnostic Experts
PBK after cataract surgery
New technology and techniques continue to decrease the incidence and improve the treatment of the sight-threatening complication Roibeard O’hEineachain in Budapest
P Experts meeting at the OCULUS booth 15A/10 at WOC in Berlin. Take the opportunity and inform yourself about our sophisticated technology of highest quality. Get the latest information and hands-on introduction. More information about our WOC activities like Pentacam Users’ Meeting, Pentacam Breakfast Symposia and our daily booth talks at www.oculusexperts.com.
Rudy Nuijts- email@example.com
EUROTIMES | Volume 15 | Issue 6
seudophakic bullous keratopathy (PBK) after cataract surgery is becoming an increasingly less common complication. But its incidence is still high enough to cause problems in a substantial proportion of patients, said Rudy M M A Nuijts MD, PhD University Hospital Maastricht, the Netherlands. “As an indication for penetrating keratoplasty [pk], PBK has decreased by 50 per cent over the last decade. Its incidence following phacoemulsification is around one in 2,000 patients, so the problem is still there, but it is decreasing,” he told the 14th ESCRS Winter Meeting. He noted that in the US, the rate of PBK declined by 1.3 per cent every year from 1990-2004 (Darlington et al, Ophthalmol 2006; 113:2171). Possible explanations for the decrease include the abandonment of iris-plane and closed loop IOLs and the introduction of modern phacoemulsification machines. PBK has also become less common in the Netherlands, where it accounted for only seven per cent of keratoplasty procedures in 2009, compared to around 20 per cent in 1997-1998, he added. (See figure.) In the literature, endothelial cell loss after phacoemulsification ranges from five per cent to 12 per cent, although the published studies provide little in the way of long-term follow-up, Dr Nuijts said. However, in an older study, endothelial cell loss continued for at least 10 years after ECCE cataract surgery, at a rate of 2.5 per cent per year, or four times the rate in eyes that have not undergone cataract surgery (Bourne et al, Ophthalmol 1994; 101:1014), he said. Effective strategies for avoiding endothelial cell loss in published studies include the use of soft shell OVD technique and modern oscillatory phacoemulsification technology, especially in eyes with hard cataracts and those with Fuchs’ dystrophy, he noted. “The soft shell technique involves the use of a low viscosity dispersive OVD on top of a high viscosity cohesive OVD. The high viscosity cohesive maintains space well and is useful for manipulation of tissue. The low viscosity dispersive adheres to corneal endothelium and provide protection against air bubble damage during phaco procedures,” Dr Nuijts said. He said that in a randomised study that compared outcomes of soft shell techniques with those achieved with a single OVD in the phacoemulsification of grade 4 cataracts, after two months the endothelial cell loss was 12.2 per cent in soft-shell group, compared to 19.6 per cent in the single OVD group (Kim et al, JCRS 2004;30:2366). In another randomised comparative study that involved Fuchs’ dystrophy patients with cataracts, corneal thickness increased less in eyes that underwent phacoemulsification with the soft shell technique, than in those who underwent the procedure with a single OVD (Tarnawska et al, JCRS 2007; 33:1907). There is also evidence that the most important
predictor of corneal clarity at day one is the amount of ultrasound energy used in the cataract procedure. As a result all of the major phacoemulsification platforms now use power modulation to decrease the ultrasonic energy. Torsional ultrasound (OZil, Alcon) can reduce phaco power still further. It uses rotary oscillations of the tip to achieve more efficient cutting and decrease in repulsion of nuclear fragments from the phaco tip. He cited a randomised study which showed that torsional ultrasound resulted lower use of ultrasound time and energy and faster visual recovery than conventional ultrasound. The rate of endothelial cell loss was only 12.5 per cent in the torsional group, compared to 19.1 per cent in the conventional ultrasound group (Liu et al, JCRS 2007; 33:287). Furthermore, in a study Dr Nuijts and Dr Doors conducted involving Fuchs’ endothelial dystrophy patients with cataracts, torsional mode resulted in significantly lower cumulative dissipated energy (CDE) and total ultrasound time, as well as a significantly smaller increase in corneal thickness at 6 o’clock than occurred in patients who underwent conventional phacoemulsification. Since often the stroma is still clear in eyes with PBK, surgeons have the option of performing a Descemet’s stripping automated endothelial keratoplasty (DSAEK) in many cases, Dr Nuijts said. The advantages of DSAEK over PK include better wound healing, lower astigmatism and faster visual recovery, he added. An American Academy of Ophthalmology study collated the findings of other studies involving DSAEK, he said. It showed that following the endothelial keratoplasty procedure, endothelial cell loss ranges from 29 per cent to 61per cent at 12 months’ follow-up, graft rejection ranges from one per cent to 45.5 per cent at three to 24 months’ follow-up and graft survival varies from 55 per cent to 100 per cent, after a follow-up of 12 to 24 months (Lee et al, Ophthalmol 2009; 116:1818). Dr Nuijts noted that when used in phakic eyes, DSAEK causes cataract formation in 100 per cent of eyes within one year (Price et al, JCRS 2004;30:1310). Surgeons must therefore decide whether to first perform phacoemulsification and then at a later date performing the graft, or to perform a combination of both procedures in one operation, he said. In a series of 225 eyes that underwent phacoemulsification and DSAEK in one procedure, BCVA was better than 20/40 in 93 per cent of eyes at six months’ follow-up, and the rate of endothelial cell loss was 36 per cent. Patients were hyperopic by about one dioptre and the only serious complications were dislocations of the graft, which occurred in two eyes (Terry et al, Ophthalmol 2009; 116:631). It is important, when performing a DSAEK and phacoemulsification procedure, to choose a slightly myopic lens power in order to compensate for the hyperopic effect of the graft, Dr Nuijts said.
Congress Report //
NEWS THE NEW MEGATRON® S4
Emanuel Rosen honoured by ASCRS
Seminal role in the creation of the JCRS recognised for advancing anterior segment surgery
DYNAMI C DEV ICE SY STEMS FOR IN D IV ID U A L STY LES OF OPERATI NG . IN TELLIG EN T TECH N OLOG Y FOR TH E HI GH EST SU RG ICA L EX PERTISE.
Dr Emanuel Rosen (pictured right) receiving his Honoured Guest award from incoming ASCRS president R Doyle Stulting Jr
ways to your sister organisation the ESCRS, where I have been proud to play a part in its continuing evolution. The cooperation between our societies is nowhere more evident than in our joint production of the JCRS,” Dr Rosen said. “I am ever grateful for the foresight of Steve Obstbaum and his colleagues in 1995, which influenced the American and European journals of cataract and refractive surgery joining forces to produce what evidently has been a major influence on the evolution of our subspecialty since 1996,” he added. Dr Rosen expressed his gratitude to the pioneers who advanced both the publication and the subspecialty. “I am particularly indebted – in the past to Charles Kelman in fond memory, to the evergreen Bob Sinskey, Spencer Thornton and Howard Fine for their friendship, surgical leadership and general encouragement and many more too numerous to mention here.” Present collaborators who Dr Rosen thanked included Dr Obstbaum, Doug Koch MD, Thomas Kohnen MD, PhD, Nick Mamalis MD, PhD, William (BJ) Dupps MD, PhD and Christine Ford, the journal’s longtime managing editor, “for the pleasure of participating with me in JCRS teamwork.” Dr Rosen concluded with an acknowledgement of the value of the trans-Atlantic partnership that has been so productive. “I know our two societies will continue to work closely together for mutual benefit and the pleasures of individual friendship which is so prevalent and indeed important.”
VISIT THE GEUDER LUNCH SYMPOSIUM DURING THE WOC IN BERLIN ON JUNE 05TH AT 12.30 PM, ROOM STOCKHOLM. W W W.G EU D ER.COM/WOC2010BERLIN
manuel S Rosen MD, FRCSE, FRCOphth was one of two honoured guests of the American Society of Cataract and Refractive Surgery (ASCRS) annual meeting this year. Dr Rosen was recognised for his role in advancing anterior segment surgery as founding co-editor of the Journal of Cataract and Refractive Surgery (JCRS). “In 1995 Emanuel Rosen was editor of the European Journal of Implant and Refractive Surgery,” R Doyle Stulting Jr MD, incoming ASCRS president, told the congress’ opening session. “He and Steve Obstbaum, then editor of the Journal of Cataract and Refractive Surgery agreed to combine their respective journals to produce the definitive peerreviewed publication of anterior segment surgery. After approval was received from the ASCRS and ESCRS Boards, the new journal was launched in January 1996 with Dr Rosen and Dr Obstbaum as co-editors. Today the journal is edited by Drs Rosen and Mamalis.” Dr Rosen credited the many colleagues and staff members who have contributed to his own development as a surgeon, and helped build JCRS into the influential publication it is today. He noted that this was his 32nd consecutive ASCRS meeting since his first attendance in 1978. “By that time I had accumulated four years of personal experience in IOL implantation, which changed me from an enthusiast for dealing with posterior segment problems to one for providing anterior segment solutions. My many friends at ASCRS have helped to guide my contributions in so many
THE FLEXIBLE WAY OF PERFECTION.
EUROTIMES | Volume 15 | Issue 6
paris 2010 10TH EURETINA Congress
MAIN SESSIONS MAIN SESSION 1: Research I: Retinal Imaging Chairperson: E. Stefansson Thursday 2 September 10.00 – 11.30 ~ MAIN SESSION 2: Research II: Stem cells / Gene therapy / Prosthesis Chairperson: D. Wong Thursday 2 September 11.30 – 13.00 ~ MAIN SESSION 3: Imaging to Monitor Progression Chairperson: J. Cunha-Vaz Thursday 2 September 14.00 – 16.00 ~ MAIN SESSION 4. Vitreoretinal Surgery Chairperson: B. Aylward Friday 3 September 08.00 – 10.00 ~ MAIN SESSION 5: Vascular Diseases and Diabetic Retinopathy Chairperson: F. Bandello Friday 3 September 14.00 – 16.00 ~ MAIN SESSION 6: Intraocular Inflammation - Uveitis Chairpersons: P. Lehoang, C. Pavesio, JJ. De Laey Friday 3 September 14.00 – 16.00 ~ MAIN SESSION 7: Innovation in Vitreoretinal Surgery Chairperson: A. Gaudric Saturday 4 September 08.00 – 10.00 ~ MAIN SESSION 8. Anterior/Posterior Segment Surgery Chairperson: G. Richard Saturday 4 September 11.00 – 13.00 ~ MAIN SESSION 9. Intraocular Tumours: New Perspectives Chairperson: E. Midena Saturday 4 September 14.00 – 16.00 ~ MAIN SESSION 10. AMD: Imaging Metrics Chairperson: F. Holz Saturday 4 September 16.00 – 18.00 ~ MAIN SESSION 11. AMD: Inflammation or Ischemia? Chairpersons: E. Stefansson & G. Soubrane Sunday 5 September 08.00 – 10.00 ~ MAIN SESSION 12. AMD: Metabolic or Degenerative? Chairpersons: G. Soubrane & E. Stefansson Sunday 5 September 11.00 – 13.00 ~ MAIN SESSION 13. German Retinal Society Chairperson: H. Heimann Sunday 5 September 10.30 – 12.30
2–5 September Le Palais des Congrès
THURSDAY 2 SEPTEMBER Bordeaux
08.00 09.00 FREE PAPERS
MAIN SESSION 1
MAIN SESSION 2
RETINAL DETACHMENT COURSE UVEITIS COURSE
MAIN SESSION 3
SURGICAL SKILLS COURSE
OPENING CEREMONY WELCOME RECEPTION
18.00 19.00 20.00
FRIDAY 3 SEPTEMBER 08.00 09.00
Main Hall Ternes
MAIN SESSION 4:
COURSE 1: Macular Dyst.
10.00 PFIZER SATELLITE SYMPOSIUM
11.00 12.00 13.00
MAIN SESSION 5
SURGICAL SKILLS COURSE
BAUSCH+LOMB SATELLITE SYMPOSIUM
COFFEE BREAK MAIN SESSION 6
NOVARTIS SATELLITE SYMPOSIUM
AMSTERDAM RETINA DEBATE
ALCON SATELLITE SYMPOSIUM
Le Palais des Congrès
THE 2010 KREISSIG AWARD
Thursday 2 September 16.20 – 16.35
Friday 3 September 11.00 – 12.00
Retinovascular disorders of childhood
Immunology in Uveal Melanoma: Friend or Foe?
07.00 08.00 09.00
10.00 11.00 12.00
THEA SATELLITE SYMPOSIUM
MAIN SESSION 8
13.00 ALLERGAN SATELLITE SYMPOSIUM
MAIN SESSION 9
DORC SATELLITE SYMPOSIUM
JOINT SYMPOSIUM ESCRS Myopia
MAIN SESSION 10
4. ESASO EURETINA: New & Future diagnostic tools for retinal diseases Organiser: G. Guarnaccia Italy & B. Corcóstegui Spain
What, When and How: Surgical Discussions Organiser: C. Mateo Spain
Electrophysiology Organiser: G. Holder UK
Simple Approach to PVR Management Organiser: B. Corcóstegui Spain
Advanced OCT Organiser: A. Polito Italy
Screening and Management of ROP Organiser: A. Kychenthal Chile & G. Caputo France
How to read Autofluorescence Images Organiser: F. Holz Germany
Vitrectomy in Diabetes Organiser: A. Laidlaw UK
ARMD Organiser: G. Soubrane FRANCE
New Strategies in Trauma Organiser: C. Forlini Italy
17. Current Management in Uveal Melanoma 2010 Organiser: D. Pelayes Argentina
MAIN SESSION 11
10.00 COFFEE BREAK
Screening for Diabetic Retinopathy Organiser: C. Egan UK
16. Managing Complications in Vitrectomy Surgery Organiser: P. Sullivan UK
MAIN SESSION 13 MAIN SESSION 12
2. The Characteristics and Interpretation of SD-OCT Organiser: C. Delaey Belgium
SUNDAY 5 SEPTEMBER
REGULAR INSTRUCTIONAL COURSES: 1. Macular Dystrophies Organiser: E. Souied France
14. Guidance in intravitreal therapy Organiser: U. Schmidt-Erfurth Austria
Retinal Detachment Organiser: I. Kreissig Germany
5. Management of proliferative diabetic retinopathy Organiser: A. Laidlaw UK
MAIN SESSION 7
SATURDAY 4 SEPTEMBER Main Hall Ternes
FULL DAY COURSES: 1. Uveitis Organiser: C. Pavesio UK
14.00 * Please note that this is a preliminary programme and the content may be subject to change
Available at www.euretina.org: • Congress Registration • Courses and Wetlabs • Full Programme Info • Hotel Bookings • Membership Application
JOINT SYMPOSIUM ESCRS Endophthalmitis
2010: The up-to-date Vitrectomy Techniques using only 25G and 25 Plus+ Organiser: T. Nikolakopoulos Greece
Surgical Approach to the Vitreoretinal Interface Organiser: P. Brazitikos Greece
Small Incision Vitrectomy Organiser: C.Pruente Switzerland
21. Managing diabetic macular oedema: pearls and pitfalls Organiser: E. Midena Italy 22. Fluorescein and ICG-angiography – interpretation and diagnosis of macular diseases Organiser: D. Pauleikhoff Germany 23. Modern OCT imaging: Clinical value and scientific perspectives Organiser: U. Schmidt-Erfurth Austria 24. Vitreoretinal Complications of Cataract Surgery Organiser: B. Little UK *Instructional courses available on ticket only basis
SATELLITE EDUCATION PROGRAMME
Satellite Education Programme
10TH EURETINA Congress 2-5 September 2010
Morning Symposia (Refreshments included)
Lunchtime Symposia (Lunchbox included)
Friday 3 September
Friday 3 September
Friday 3 September
10:00 – 11:00
13:00 – 14:00
Pfizer Satellite Symposium
Novartis Satellite Symposium
Saturday 4 September
13:00 – 14:00
Empower Your Future with TSV The Stellaris PC Launch Symposium
10:00 – 11:00
Nutrition and AMD. Evidence Based Medecine. From AREDS to ALIENOR and PIMAVOSA studies
Treatment Paradigms in Surgical and Medical Retina Moderator: A. Augustin Germany Speakers:
C. Claes A Loewenstein S. Rizzo
Moderator: Y. Le Mer France Sponsored by
Moderator: J. F. Korobelnik FRANCE Speakers: M. N. Delyfer FRANCE M. B. Rougier FRANCE
Saturday 4 September
Inflammation and Retinal Disease
13:00 – 14:00
13:00 – 14:00
New D.O.R.C Vitreoretinal Developments
A EUROPEAN OUTLOOK ON THE WORLD OF OPHTHALMOLOGY
SATELLITE EDUCATION PROGRAMME
Please note that this is a preliminary programme and is subject to change
F R EE T O A L L D EL EG AT E S – INS T RU C T IO NAL C O URSE
EUREQUO European Registry of Quality Outcomes for Cataract & Refractive Surgery
EUREQUO EUREQUO for improving my outcomes
uropean Registry of Quality Outcomes for Cataract & Refractive Surgery
Sunday 5th September 08.00 – 10.00 Le Palais des Congrès
What do we need to know about refractive surgery? Paul Rosen UK
XXVIII Congress of the ESCRS
EUREQUO, purpose, background & design Mats Lundström SWEDEN What do we need to know about cataract surgery? Ype Henry THE NETHERLANDS
Presentation of the EUREQUO system Eva Wendel SWEDEN Pause Tools for clinical improvement Susanne Albrecht SWEDEN How can we do better cataract surgery using EUREQUO? Ype Henry THE NETHERLANDS How can we do better refractive surgery using EUREQUO? Paul Rosen UK
Project co-financed from the EU Public Health Programme
Output from the EUREQUO system for benchmarking Mats Lundström SWEDEN Concluding remarks Mats Lundström SWEDEN Do not miss this opportunity to become part of the future. Come and see the benefits to be gained by you!
See www.eurequo.org for more information
*20/16 results delivered with excimer laser; clinical studies sent to the FDA via P930016 supplement 021. Please see brief statement on adjacent page. ÂŠ2010 Abbott Medical Optics Inc. Abbott trademarks and products in-licensed by Abbott are shown in bold and italics. Accutane is a registered trademark of Hoffmann-LaRoche Inc. Cordarone is a registered trademark of Sanofi-Synthelabo, Inc. 2009.09.09-IL1311 Rev. C
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Adaptive optics breathes new life into OCT Dermot McGrath in Paris
Courtesy of Joseph Carroll PhD
EW imaging technology that combines spectral domain optical coherence tomography (SD-OCT) and adaptive optics to provide high-definition, three-dimensional images of the retinal microstructures of a living human eye may help to pave the way to earlier detection and better management of a range of retinal pathologies, according to a number of researchers. “It is still very early days in terms of establishing the clinical benefit of this new
imaging technology, but the potential is now there to study individual photoreceptors and examine the living retina at the cellular level,” said Wolfgang Drexler PhD, Head of Center for Medical Physics and Biomedical Engineering at the Medical University, Vienna, Austria. Speaking at the Macula of Paris 2010 meeting, Dr Drexler said that adaptive optics has taken ophthalmic imaging to a new level and significantly raised the bar for future OCT systems.
AO-OCT has the potential to aid in the detection of the earliest disease stages...
The cone mosaic in a patient with ocular albinism. Each bright dot is a single cone photoreceptor. Normally, at this retinal location cone density is changing rapidly, however in this patient the cone density remains relatively constant across the image. Scale bar is 100 microns
Joseph Carroll PhD
“The capability of this imaging system has been demonstrated in preliminary studies by probing cellular intraretinal structures that have not been accessible so far with in vivo, non-invasive, label-free imaging techniques such as pigment epithelial cells, microvasculature of the choriocapillaris, single nerve fibre bundles and even ganglion cells,” he said. He noted that OCT had already taken a major leap forward with the introduction of 3D OCT at 1060 nm (compared to 800 nm devices previously), which allows for enhanced visualisation of the choroid up to the sclera. “This device gives us much better penetration into the choroid than was possible with conventional OCT. In an optically clear eye we have very good penetration of all the vessels up the sclera. However, even in patients with cataract we have much better visualisation of the intraretinal structures with this imaging system,” he said. Looking at some of the potential applications of the technology, Dr Drexler said that it may help to shed further light on the role of the choroid in certain retinal pathologies. “With this type of imaging technology we can start to build up a normative database as to what a healthy choroid is. In a previous study, we were able to map choroidal thickness in 30 healthy patients and correlate the results with axial eye length. The results indicate a decrease in choroidal thickness with increasing axial eye length,” he said. Dr Drexler noted that a further refinement of the advanced OCT came with the addition of adaptive optics – which was originally developed to improve the resolution of astronomical imaging – in order to minimise ocular aberrations and reduce the spot size needed to image the retina. He explained that the technology works by interfacing the mirao 52-d Electromagnetic Deformable Mirror (Imagine Eyes) with OCT to correct for the eye’s monochromatic aberrations and allow nearly diffractionlimited imaging of the retina. He added that while the possibilities of AO-OCT are very exciting, a lot of work still needs to be done to translate the enhanced detail of the high-speed transversal OCT images into clinically useful information. “We need to be careful in interpreting these images and compare them with ex-vivo and histology data before we begin to have a better idea of their true significance,” he concluded.
Evolving clinical utility The clinical utility of adaptive optics has taken important strides in the last few years and will continue to push back the boundaries of imaging technology, according to Joseph Carroll PhD, Medical College of Wisconsin, US. EUROTIMES | Volume 15 | Issue 6
Wolfgang Drexler – firstname.lastname@example.org Joseph Carroll – email@example.com
“The clinical utility of adaptive optics has evolved significantly in recent years and I think in about five to 10 years’ time it will come to be considered a routine imaging device,” he said. Echoing Dr Drexler’s message concerning the ability of AO-OCT to glean information from less than optimal optical systems, Dr Carroll said that his team has succeeded in obtaining high-quality retinal images of patients with nystagmus. “We have been imaging some patients with ocular albinism and by using a short exposure and a high frame rate we showed that nystagmus need not be a limiting factor in obtaining cellular resolution images in the retina,” he said. Illustrating how adaptive optics is already helping to clarify the etiology of certain pathologies, Dr Carroll cited the example of oligocone trichromacy, a rare cone dysfunction syndrome, characterised by reduced visual acuity and photophobia and reduced amplitude of the cone electroretinography (ERG), but with normal fundus and normal colour vision. “The hypothesis was that these patients have a reduced number of functioning cones. With adaptive optics we were able to show that the hypothesis is actually correct. So certainly in these hereditary retinal pathologies it is clear that there is a lot of information that can be gleaned from adaptive optics retinal imaging,” he said. Using another example, Dr Carroll noted that longitudinal imaging of a section of retina showed no significant difference in cone density measurements from images taken six years apart. “There was less than three per cent difference in the number of cones. So from this we could say that the retina was quite stable in this particular individual and we were able to return to exactly the same section of retina and that is very important from a diagnostic perspective for a range of pathologies,” he said. Turning to age-related macular degeneration (AMD), Dr Carroll said that AO-OCT could prove useful in helping clinicians to understand how drusen impacts on healthy photoreceptors. “The evidence suggests that drusen negatively affect the health of the overlying photoreceptors. Photoreceptors nearby and overlying drusen undergo significant changes in gene expression and synaptic morphology. The photoreceptor layer thinning over drusen in AMD has already been shown using SD-OCT by Schuman et al and this has been suggested to be an indicator of a degenerative process. AO-OCT has the potential to aid in the detection of the earliest disease stages, tracking progression and monitoring treatment response,” he concluded.
10th EURETINA Congress EURETINA partners annual meeting with XXVIII ESCRS Congress in Paris, France
he 10th EURETINA Congress will take place in Paris from 2–5 September 2010. For the first time, The European Society of Retina Specialists (EURETINA) will partner their annual meeting with that of the European Society of Cataract and Refractive Surgeons (ESCRS). The 10th EURETINA Congress will precede and overlap with the XXVIII ESCRS Congress, which runs from 4–8 September also at the Palais des Congrès. The Programme Committee of EURETINA is planning an exciting scientific programme for 2010, which
will feature world leaders in the field of retina. Throughout the congress the latest developments will be presented at the main sessions and at two joint EURETINA/ ESCRS Symposia on Saturday, September 4 and Sunday, September 5 on the topics of Myopia and Endophthalmitis in Cataract Patients. The programme will also include important scientific contributions including a combination of popular features from 2009 and new features for 2010. These include the EUROLAM Symposium, Amsterdam Retina Debate, ARVO Symposium, French
and British Vitreoretinal Symposium (CFSR/ BEAVRS) and FAN Club. The 2010 Congress will once again present a range of popular Surgical Skills Training Courses, while there will also be a wide range of other courses on offer, including 24 Instructional Courses and the all-day Retinal Detachment and Uveitis Courses. Free Papers, Electronic Posters and Video Presentations will once again feature.
EURETINA Lecture The highlight of the Opening Ceremony on Thursday September 2 will be the EURETINA Lecture which will be delivered by Dr Tony Moore. Dr Moore has honorary consultant appointments at Moorfields Eye Hospital and the Hospital for Children, Great Ormond Street, London where he has his clinical practice. Kreisig Lecture The Kreisig Lecture on Friday 3 September will be delivered by Dr Martine J Jager, head of the Laboratory of Ophthalmology at Leiden University, The Netherlands.
From left to right: Bill Aylward, Tony Moore and Martine Jager
Significant landmark The president of EURETINA, Dr Bill Aylward, said that the EURETINA meeting has gone from strength to strength in recent years and the holding of the 10th EURETINA Congress in Paris marked another significant landmark in the society’s development. “As retina specialists, it is important that we share our knowledge and expertise with colleagues in other specialties and I am delighted that for the first time we will have the opportunity to hold an ESCRS/ EURETINA meeting under the one roof,” said Dr Aylward.
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eURoPEAN boARD OF OPhthalmology
UEMS continuing medical education (CME) accreditation as a sign of European quality By Dermot McGrath
n a profession such as ophthalmology, where technology and techniques are constantly evolving, the need to keep one’s skills and knowledge up-to-date lies at the very heart of good medical practice. For the European Board of Ophthalmology (EBO), therefore, the goal of continuing medical education (CME) has always been a core function of the organisation and one of the main motors behind the Board’s expansion in recent years. “As a working body of UEMS (Union of European Medical Specialties), it is a fundamental part of our mission to promote and ensure a high and uniform standard of education amongst ophthalmologists within member countries in order to harmonise and improve the quality of eye care in Europe,” says Marko Hawlina, president of EBO. The responsibility for pursuing this mission is the remit of EBO’s CME Committee, which controls the quality of CME activities in member countries by working together with the committees, scientific societies and universities or equivalent centres of each country. “The goal of the EBO CME Committee is to create a common European standard of CME and CME accreditation,” explains CME Committee chairperson Gordana Sunaric-Mégevand MD, who describes it as an honour to have served in the executive for four years and to “chair this very important and dynamic committee.”
Standardise and harmonise Dr Sunaric-Mégevand told EuroTimes that the effort to standardise CME standards and accreditation across all European countries has become ever more important with the recent expansion of the EU. “As the migration of doctors and also citizens throughout Europe has become easier and more frequent, harmonisation
of quality of education becomes essential in order to ensure equal and high standards of care in all member countries. Therefore standardisation of requirements in education as well as standardisation of quality control is of great importance,” she said. One of the key issues currently facing the CME Committee is that not all of the member countries have the legal or professional obligation for CME, points out Dr SunaricMégevand. “Some European countries have a national authority responsible for the local CME activity but only 14 out of 27 member countries have an obligation of CME and CME control. Our wish and our mission is to increase this number to the majority of countries and we are working actively to achieve this. We hope that in a few years all countries will have an obligation for CME as well as a standardised quality control and accreditation system,” she said. She also acknowledges that CME accreditation by the national authorities, when present, is very different from one country to the other. “The qualitative and quantitative requirements vary and are often very different from those of the EBO. Only seven countries out of 27 have aligned their CME evaluation system to ours or have a similar CME evaluation system in place. A positive development is that many delegates from Eastern Europe, where CME is either lacking or is not mandatory, have expressed interest in integrating with our system,” she said. Controlling the quality of CME activities in member countries requires a considerable investment of time and effort, notes Dr Sunaric-Mégevand. She explained that the CME Committee defines the requirements for European CME in accordance with the
Journal Watch by Sean Henahan LCA gene therapy advance
Last year, researchers reported success with a ground-breaking clinical trial of gene therapy that helped a group of children overcome their near complete blindness associated with Leber congenital amaurosis (LCA), restoring some vision in one eye of all 12 patients. Now, the same team of researchers has taken an important step toward the ability to offer these patients the same treatment for their second eyes. They demonstrated in animal studies that an adenovirus-associated viral vector could be used a second time without inducing a limiting immune reaction, and without diminishing the effect. Moreover, the therapy was safe even if the animals had pre-existing immunity to the virus vector; a characteristic that excludes some patients from gene therapy trials. These researchers believe that results broaden the scope of patients eligible for treatment; those with pre-existing immunity may be able to receive treatment in their first eyes, and patients who already received gene therapy in the first eye may have a chance to restore vision in their second eyes. n D Amado et al, Science Translational Medicine, “Safety and Efficacy of Subretinal Readministration of a Viral Vector in Large Animals to Treat Congenital Blindness,” 3 March 2010 2:21ra16. DOI:10.1126/scitranslmed.3000659.
European Accreditation Council for CME (EACCME) and the National Accrediting Authorities (NAA) and validates the scientific meetings and courses that fulfil these requirements. “In practical terms, to accredit an international or national congress with European CME credits [ECMEC], EACCME forwards the demand to the EBO CME Committee and the National Accrediting Authority when present. These two bodies evaluate separately the qualitative and quantitative value of the event and send their appreciation/accreditation to EACCME. On the basis of these evaluations, EACCME can then validate those meetings or courses that fulfil the set requirements,” she said. The EBO has created special application forms for EBOaccredited courses, which are defined as events that fulfil special requirements in terms of number of hours, quality of providers, quality and number of multiple-choice questions (MCQs), and so forth. After evaluation by the CME Committee these events may then receive an official EBOaccreditation. “This EBO accreditation, which is only given once EACCME accreditation is obtained, is meant to designate a particular ‘sign of quality’. Our wish is that more and more courses throughout Europe become EBO accredited,” explains Dr Sunaric-Mégevand. Dr Sunaric-Mégevand said that busy times lie in store for the EBO CME Committee as the EBO continues to expand. “One of our very important goals is to enhance UEMS CME throughout Europe and to standardise quality control in order to agree on a common European standard. As an educational board, EBO has no direct influence in the national system of medical care of each country. Nevertheless, with the help of delegates and colleagues we are still in a position to promote the idea of standardised requirements and equal quality control of CME in all countries,” she said. Another important goal, she added, is to assist national societies in countries lacking a CME system to develop scientific meetings and to set quality criteria and an accreditation system aligned to the ECMEC. “Our wish is that ECMEC and EBO accreditation are perceived as a ‘guarantee of quality control’ and gains prestige and respect,” she said. Dr Sunaric-Mégevand said that serving on the EBO CME Committee has been a challenging but ultimately rewarding experience. “The problematic aspect is that establishing the direct contact between EBO and the national authorities for CME is a rather new process and therefore not always quick and easy, as well as the fact that in many countries the CME depends on the ministry of health and not on the ophthalmic society. This means that changes occur more slowly than we would like,” she said. Such drawbacks are, however, part-and-parcel of the job and are far outweighed by the positive benefits of involvement with the CME Committee, she said. “The most rewarding aspect is the fact that more and more international and national meetings, congresses and courses apply for ECMEC and EBO accreditation. Since January this year the EBO CME Committee has already received 13 demands for accreditation of important international meetings and courses. The contact and exchange with colleagues throughout Europe has been for me a very exciting experience” she said. Prof Hawlina adds: “The CME Committee and its chair continuously and efficiently work towards achieving the goal that UEMS CME accreditation becomes an accepted standard for every European country.” n More information on the EBO CME Committee can be found at: http://ebo-online.org EUROTIMES | Volume 15 | Issue 6
Practice Development Workshops
3–6 September 2010 During the XXVIII Congress of the ESCRS Le Palais des Congrès, Paris, France
Day 1: Friday 3 September 09.00 – 17.00
Transforming your Ophthalmological Practice Business Skills for Ophthalmologists Keith Willey, associate professor, London Business School This one-day masterclass will lead participants through the key areas to be considered when committing to improve your private practice – making it more successful and profitable in attracting patients and colleagues. The session will blend lessons from growing businesses of all types based on research from London Business School together with the special considerations necessary in ophthalmology practice.
Participants will diagnose their own situation, learn from a case study based on the growth of a 30-surgeon practice and debate the issues. The key take-away message from this session will be a comprehensive understanding of the steps necessary to grow your practice and an appreciation of how to reconcile your personal appetite for the risks, efforts and rewards involved.
Course fee €200. Only 50 places available.
Day 2: Sunday 5 September 14.00 – 14.05
14.25 – 14.45
Introduction and Welcome Paul McGinn, barrister at law and editor of EuroTimes
The Value of a Management Executive to a Clinical Practice
14.05 – 14.25
Sheraz Daya, medical director and consultant ophthalmic surgeon, Centre for Sight, London, England
Organisational Leadership and the Benefit to Clinicians Maggie Middleton, chief executive, Centre for Sight, London, England Centre for Sight chief executive Maggie Middleton will explain how she works with Centre for Sight medical director Sheraz Daya to run the practice. The workshop will offer advice on how to add an administrator to your practice, as well as the ‘dos and don’ts’ for clinicians once an administrator is in place.
This workshop will focus on evaluating the need for a chief executive to run your practice. Key points to be covered will include looking at how much time you spend on administrative duties, as well as putting a value to your time carrying out administrative work vs. time in the clinic and operating theatre. Dr Daya will also cover how to find the right person for the role and the implementation process.
14.45 – 15.00 Q&A
Day 2: Sunday 5 September (continued) 15.00 – 15.20
15.30 – 15.50
Changing the Paradigm for Marketing your Practice
Differences in Telephone Practices amongst European Ophthalmology Clinics
Kris Morrill, KAM Communications
Rod Solar, LiveseySolar Practice Builders
This workshop will focus first on tools for evaluating your practice’s current marketing and then discuss strategies for improving the effectiveness of your marketing plans. Special attention will be given to improving communication to patients, including examples of what works and does not work when talking to patients.
Rod Solar reveals quantitative results of mystery calls conducted with over 30 private ophthalmology clinics across Europe. His presentation reviews how prospective patients are greeted on the phone and differences between clinics when asking them to make appointments. Finally, he’ll compare how clinics are performing against the best converting clinics in the industry and what clinics can do to improve their performance.
15.20 – 15.30 Q&A
15.50 – 16.00 Q&A and close
Day 3: Monday 6 September 14.30 – 14.35
15.50 – 16.00
Introduction and Welcome
Paul McGinn, barrister at law and editor of EuroTimes
14.35 – 15.15 How can Business Planning Improve your Ophthalmological Practice? Wilfrid Girard, medeuronet, Strasbourg, France. This workshop, using a case study, will explain why a thorough business plan is an important component of growing an ophthalmology practice, ensuring continued success, as well as helping to protect it from economic downturns.
15.15 – 15.30 Q&A
15.30 – 15.50
16.00 – 16.20 Social Media – Why Ophthalmologists Should be Using the Internet, Including Facebook and Twitter Oliver Findl, director of ophthalmology, Hanusch Hospital Vienna, Austria and consultant ophthalmic surgeon at Moorfields Eye Hospital, London, UK In this workshop, Oliver Findl will explain why ophthalmologists, young and old, should be using the Internet and social media including Facebook, YouTube and Twitter
16.20 – 16.30 Q&A and close
“It’s all About Managing Expectations” Paul McGinn, barrister at law and editor of EuroTimes Paul McGinn, who specialises in defending doctors and hospitals sued for malpractice, will discuss how ophthalmic surgeons can manage the expectations of their patients through the consent process. The take-home message is: a patient who understands the risks of eye surgery is more likely to accept a poor outcome.
Workshops are free ofof charge but are limited toto 200 Workshops are free charge but are limited 90delegates. delegates.The Thefee feefor forthe theone oneday daymasterclass masterclassisis€200. €200. Pleasebook bookininadvance advanceonline onlineatatwww.escrs.org www.escrs.org Please
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EUROTIMES | Volume 15 | Issue 6
In a major new initiative, the ESCRS has decided to set up an Observership Programme for young ophthalmologists By Colin Kerr
he Observership Programme will be for young ophthalmologists who are starting their surgical training or already in surgical training,â€? said Oliver Findl MD, MBA, chairman of the ESCRS Young Ophthalmologistsâ€™ Forum. â€œWe are looking at short observerships for a few days or a week at most in different European centres. We will ask participating centres to draw up a short curriculum and to give our observers the opportunities to see patients in a clinical setting.â€? Dr Findl said that while the young ophthalmologists taking part in the programme will not be able to carry out surgery, they will get the opportunity to see senior ophthalmologists working. â€œIt will also be interesting for them to see first hand the logistics of how an ophthalmological department is run,â€? he said. As part of the new programme, a special website is being set up to allow young ophthalmologists who are ESCRS members to register for the programme. The website will also include a list of participating sites. Young ophthalmologists who are not ESCRS members can join the society free of charge and this will allow them access to the website. The ESCRS will also give some financial support to young ophthalmologists to help them cover some of their travel and accommodation costs. While there are already existing observership programmes in different countries, the ESCRS Observership Programme will give young ophthalmologists the chance to travel abroad and see how their colleagues in different countries train and operate. â€œMany young ophthalmologists will go on for further education and training outside of their own countries, so the ESCRS Observership Programme will give them a chance early in their education to see how ophthalmology is practised in different settings,â€? said Dr Findl. â€œI think this is one of the big strengths of the ESCRS, the European Union and Europe. We have different cultures and different health systems and we should try to broaden our horizons and learn from seeing other systems, other surgeons and other techniques.â€? Dr Findl said that the new programme was one of the most exciting initiatives to be launched by the ESCRS in recent years.
We have different cultures and different health systems and we should try to broaden our horizons... Oliver Findl MD, MBA
â€œSometimes it may be difficult for trainees to take time off, even for a few days, but I think this will be very worthwhile as training and education is very important, particularly for young ophthalmologists.
Young Ophthalmologistsâ€™ Programme for ESCRS Congress
The Young Ophthalmologistsâ€™ Programme takes place on Saturday 4 September from 09.00 â€“ 16.00 at the XXVIII Congress of the ESCRS. The Programme, which will be chaired by Dr Oliver Findl, Austria and C Zetterstrom, Norway, will start with Basic Phaco. This will be followed by presentations on Advanced Cataract Surgery. Before the lunch break, the winner of the John Henahan prize for Young Ophthalmologists will be announced. In the afternoon, there will be a discussion on Refractive Aspects of Lens Surgery and Trends in Refractive Surgery. Prof Theo Seiler, Switzerland, will give the Guest Lecture on Cross-Linking. Further details are available on www.escrs.org.
Win a â‚Ź1,000 travel bursary to the XXVIII Congress of the ESCRS
Ophthalmologists who are members of the ESCRS and who are 40 years of age or under are invited to enter The John Henahan Prize for 2010. Entrants must write a 1,000-word article on the topic of The Outstanding Memory of My Residency. The closing date for entries is Friday June 26, 2010. Entries received after this date will not be considered. Entries, which must be accompanied by the authorâ€™s date of birth and an ESCRS membership number, should be sent to Colin Kerr, executive editor, EuroTimes at colin. firstname.lastname@example.org. n For further details visit www.escrs.org.
DGII endorses eurequo
Database will help surgeons track and improve cataract and refractive surgery results
FOCUS ON INNOVATION
By Howard Larkin
he German-Speaking Society for Intraocular Lens Implantation and Refractive Surgery, or DGII, is recommending that cataract and refractive surgeons, as well as ophthalmologists who refer patients to them, participate in the online European Registry of Quality Outcomes for Cataract and Refractive Surgery (EUREQUO), says DGII president Thomas Kohnen MD, PhD. Because EUREQUO tracks surgical outcomes across the continent and allows surgeons to compare outcomes with national and international peer groups, it is a powerful tool for monitoring and improving care, says Prof Kohnen, who is professor and deputy chairman of ophthalmology at Goethe University, Frankfurt. “Quality control systems can be very effective. If you monitor your outcomes all the time you can see when you are having problems and make changes to stay good. If I look back and see my outcomes weren’t as good in June as in March, I can look and try to see why. Maybe I didn’t have a vacation in all that time and maybe worked too much, next year I can do something about it. Or maybe I need to change IOLs or viscoelastics or my technique to get back on track,” Prof Kohnen says. Referring ophthalmologists also benefit from surgeons monitoring outcomes, Prof Kohnen points out. He encourages referring physicians to help out by sending information back to the surgeon when they see cataract patients on the day after surgery. “With refractive surgery it is a little easier for the surgeons to participate in EUREQUO, but cataract patients are more problematic because they are sent back to the referring physician and we don’t see them on the first day post-op. It takes a little time for the local physician to collect and enter the data, or to communicate with the surgeon’s office so they can input the data. But it is for the sake of our patients; they benefit. If you have 10 cases and five are out of the range, something needs to change, but you won’t know it if you don’t track it. If you provide good quality patients are happier. Quality control is good, everyone benefits,” Prof Kohnen says. A month into its launch by DGII in Germany and Austria Prof Kohnen is looking for ways to systematically involve referring physicians with EUREQUO. “Some of them have no computer and cannot enter the data.
Our clinic is working with local physicians to help them participate.” In the future, surgeons may be required to participate in registries to get paid, Prof Kohnen says. While no such requirement currently exists in Germany and Austria, The Netherlands requires cataract surgeons to electronically report quality measures to get insurance contracts. Other countries are considering similar moves. “There is a tendency that someday people will be forced to report quality to get reimbursed.” EUREQUO is partnering with DGII to collect cataract and refractive outcomes in Germany and Austria, Prof Kohnen notes. Under the system national registries are set up in each participating country. While EUREQUO establishes standards for data collection for participants in all countries, and is available via Web browser from anywhere, individual national societies including DGII determine data collection and audit standards within each country. DGII and other participating national societies also provide first-line technical support for surgeons and physicians who want to participate. All data is reported anonymously. Only the surgeons submitting data have access to their own data. Individual results can be compared with aggregate results for similar procedures overall, by country or clinic, or by patient characteristics, including demographics, preoperative visual acuity and co-morbidities. This makes EUREQUO a powerful research tool, Prof Kohnen says. EUREQUO was piloted last year in Scandinavia, The Netherlands and Spain, where kinks in the software user interfaces and integration with national registries were worked out. More than 600,000 cases are included in the registry. Sponsored by ESCRS, EUREQUO has attracted substantial matching funds from the EU as well as partnerships with 12 European countries to develop national visual outcomes registries for cataract and refractive surgery. Quality Registry Manager for Germany & Austria is Silke Hoehler who can be contacted via email: email@example.com. To register for EUREQUO, please use the following link: http://www.eurequo.org/join.asp.
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EUROTIMES | Volume 15 | Issue 6
managing your resources is crucial
Declining public budgets and private competition even for research grants makes understanding economics and patient service ever more important By Howard Larkin
wenty years ago a university faculty appointment in Germany ensured a steady stream of private patients seeking the best in medical and surgical care, says Thomas Kohnen MD, PhD, professor of ophthalmology and deputy chairman, Goethe University, Frankfurt. But with a growing number of private clinics offering big-name surgeons, cutting-edge diagnostic and surgical technology and excellent customer service, academic and public practices increasingly face stiff competition. “It is no longer a given that patients will come to you if you work in an academic institution. They only come if you have the latest technology, excellent outcomes and a good patient experience,” Prof Kohnen says. Many public sector physicians don’t see this as an issue. After all, they are funded by the state or university, and making a profit isn’t the goal. The real missions are research, education and serving the public. That’s a point of view Prof Kohnen heartily embraces. “We should not be too commercial. Everyone should be able to go to the university clinic for quality, safety and technology. We have to be less money driven; we do education, we do research and anyone who wants to come see us can do so.” However, being less commercial shouldn’t mean ignoring market and economic reality altogether, Prof Kohnen adds. As governments across Europe struggle with mounting deficits, public and academic clinic budgets are under pressure as never before. At the same time, the new technology needed to keep up both clinical operations and research is ever more expensive. As a result many public clinics face budget shortfalls. Attracting private patients, new grants and other private funding will be increasingly necessary to bring in enough money to maintain their academic and public service missions, he believes. To be successful in the clinical arena, clinics must invest in new diagnostic equipment, such as OCT, HRT, topographers, Scheimpflug cameras and advanced software for analysing progressive diseases of the retina and cornea, as well as up-to-date treatment equipment, including advanced phaco machines and femtosecond lasers, Prof Kohnen notes. “You need to
invest money to attract patients.” Residents and fellows also need access to advanced technology to complete their training. Insufficient funding also threatens the research enterprise for which so many academic institutions are known. Increasingly, development research is being carried out in private clinics, with the related grants and royalties flowing to individuals rather than back to a university. “If you only rely on government subsidies and the government doesn’t subsidise you, you are sitting there with the old technology and the research goes away, too. For the survival of the clinic, today, we have to think about money,” Prof Kohnen says.
Understanding costs Prof Kohnen emphasises that he is not suggesting that public and academic practices adopt a commercialised for-profit model. A completely market-based approach tends to ignore social needs for education, basic research and serving patients with complex needs and lower income precisely because they are not profitable. What he does suggest is that public and academic practices can – and should – do a better job of managing limited resources. Further, they can and should do a better job of making the case to governments, foundations and even corporations for grant support, and make their services more attractive to patients who can pay. On the savings side, a lot could be accomplished simply by educating surgeons on what things cost and how much the clinic is paid. “You can’t use three vials of viscoelastic for one cataract because it costs €250 and maybe you’re only getting €200 for the surgery. But if the surgeon doesn’t know this, they don’t care,” Prof Kohnen notes. He does not advocate that surgeons make decisions based on resource costs, just that they have some idea of costs so they can avoid waste. This makes more money available for serving more patients or funding new technology that can better serve patients. Similarly, a lot can be done to improve the patient’s experience without spending money. “You have patients coming in and they wait for two or three hours just because the office is not organised,” Prof Kohnen observes. This wastes all patients’ time and
drives off many who can afford to pay more, many of whom are busy professionals. “No one can afford this. You need to look at your practice with the eyes of a patient and see what you can do to make it better.” Prof Kohnen suggests that some basic classes in economics and management would help public and academic surgeons operate more efficiently and serve patients more effectively. “I took two semesters studying economics. You don’t have to go that far, but some basic understanding of costs and managing patient flow would be very valuable.”
You need to look at your practice with the eyes of a patient and see what you can do to make it better
Thomas Kohnen MD, PhD
Competition for research With more and more basic science and clinical research being done in private labs and practices, academic and public institutions also must consider economics in allocating research resources, Prof Kohnen says. Here again, the academic mission of advancing basic science cannot be ignored; indeed it remains a central driver of economic growth for institutions and entire nations. However, developing technologies that can be translated into practice is also clinically and socially valuable, plus it tends to enhance an institution’s finances and its ability to attract patients. Evaluating research based on its long-term and more immediate economic value as well as its academic value is essential to make the case for grants from government, foundations and private industry. Public practices should develop methods for doing so, Prof Kohnen believes. Attracting research funding also helps keep valuable staff in place, Prof Kohnen says. If salaries are too low even committed research scientists will leave for private situations where more of the money their research generates goes into their own pockets. Prof Kohnen encourages researchers to be entrepreneurial – again, not in the commercial sense, but in the sense of seeking out new opportunities to develop basic science and technology. This also tends to attract the funding necessary to sustain labs and studies from both government and private funders. “If you don’t invest in science and research there comes a day when you cannot compete. It may not happen tomorrow, but eventually it will happen.”
Don’t miss Industry News, see page 41 EUROTIMES | Volume 15 | Issue 6
Smaller incisions fulfilling bigger expectations
thing that it is supposed to do. After a time, concerns about functional outcome and side-effect profile begin to predominate. We see it with most drugs, with the The noted science fiction author, Arthur cynical advice that all new treatments C Clarke, once wrote that “any sufficiently should be taken as soon as possible – before advanced technology is indistinguishable the side effects are discovered. from magic”. There are no side-effects without Like many much quoted aphorisms, this interventions. The less cutting you do, is true, but the opposite of a great truth is the less chance of difficulty with the also a great truth. Sufficiently advanced complications of cutting. Minimising is technologies become indistinguishable from described in the introduction by the editors mundanity, and we begin to accept them and three co-authors as “a continuous trend first as routine, and then as annoyingly in cataract surgery”. Of course, ophthalmic flawed. Another science fiction writer, surgery is no different than any other area David Langford, once wrote that there is of surgery, all of which are involved in an no such thing as a fast computer after three overall trend toward minimally invasive and days. As we get used to the initially exciting simplified approaches. and innovative features of the computer, In the book’s introduction, the issues we increasingly become aware of the regarding the debate between traditional computer’s perceived limitations. (microcoaxial) phacoemulsification This book well illustrates the development and bimanual (biaxial) microincision of modern therapies, especially those phacoemulsification are discussed. dependent on advanced technology. When There are four major domains in a therapy is first introduced, it is enough faros_245x150_EuroT_e 6.5.2010 11:17 Uhrthese Seite which issues1arise – visual outcome, that it does whatever seemingly miraculous anterior chamber/corneal factors such
as corneal endothelial cell loss, incisionspecific factors, and technical factors such as total surgical time and effective phacoemulsification time. This book is an extremely thorough exploration of all these issues. This is a book for established practitioners and senior trainees, and those who wish to discover the true cutting-edge thought in this field. In their preface, Alio and Fine link all the various trends in cataract surgery to a single factor – the decrease in incision size. The book, they write, is appearing in the final stage of the evolution of cataract surgery as conceived today. They anticipate that new technologies will require as well as enable a transformation in surgical approach in the future. The use of biomaterials, new accommodating lenses, regenerating surgery, and new technology will all change the field radically. As the use of technology in ophthalmology increases, we can expect more volumes like this, explicitly focused on the optimisation of functional outcome and the avoidance of side-effects.
books editor: Seamus Sweeney publication: Minimising Incisions and Maximising Outcomes in Cataract Surgery Editors: Jorge L Alio and I Howard Fine Published by Springer Berlin and Heidelberg 2010
If you have a book you want reviewed please send it to: EuroTimes, Temple House, Temple Road, Blackrock, Co Dublin, Ireland
Brings Light to the World
by Oertli®, another milestone in eye surgery. Designed for cutting-edge surgical techniques and optimal results in cataract and vitreoretinal interventions, it is light, elegant and compact – a simply smart device made for you!
EUROTIMES | Volume 15 | Issue 6
JCRS Highlights Journal of Cataract and Refractive Surgery
JCRS Symposium Controversies in Cataract and Refractive Surgery 2010 Sunday, September 5, 2010
14:00-16:00 Chairs: Emanuel S. Rosen, MD, FRCSEd Thomas Kohnen, MD Presbyopia Treatment: Cornea or Lens n n
Accommodating and/or Multifocal IOL PresbyLASIK or Implant
Astigmatism Management in Cataract and RLE Surgery: Toric IOL or Corneal Incisions n Toric IOL n Incisions
Pediatric Refractive Surgery n Pro’s n Con’s
Phakic IOL n Anterior Chamber n Posterior Chamber
During the XXVIII Congress of the ESCRS, Paris, France
Nothing succeeds like success
As medical science and technology have evolved so too have definitions of successful outcomes. JCRS associate editor William J Dupps Jr MD, PhD tackles this issue in the lead editorial in the journal. He notes that increasingly sophisticated tools for assessing the disease state and its response to treatment can be seen all over the field of ophthalmology. Examples include molecular diagnosis, optical coherence tomography, contrast sensitivity testing, and wavefront sensing. These new tools not only enhance the diagnostic process, they can provide new perspectives on disease, in turn leading to the prospect of better treatments. However, he notes that the broader dimension of the patient experience also needs to be taken into consideration when measuring the success of treatment, and appropriate tools are required for capturing these data. For example, traditional assessments of LASIK and IOL outcomes often do not reflect an understanding of the patient experience. Improved metrics will help physicians understand what makes a patient more functional and more satisfied. The data these provide are likely to become increasingly central to the regulatory approval process for new devices and drugs. n WJ Dupps Jr, JCRS, “Redefining health, disease, and surgical success”, Volume 36, Issue 5, Pages 705-706.
Fixing the NEI-VFQ Questionnaire
How good is the National Eye Institute Visual Function Questionnaire (NEI VFQ)? Australian researchers tested the validity of the oft-used patient questionnaire in a study involving 536 cataract patients. Their analysis concluded the standard test tended to confound quality of vision and quality of life issues, and lacked unidimensionality, a key to a valid assessment system. Accordingly, they undertook to re-engineer the NEI VFQ by making the minimum changes required to establish satisfactory measurement properties. Two separate scales were formed: the visual functioning scale and the socio-emotional scale. Assuming minimum revision, the resulting scales were referred to as long-form scales. These reconfigured questionnaires showed good psychometric properties. The investigators caution that the re-engineered versions of the NEI VFQ are not without flaws. It calls for more work, particularly
adding more questions that target more able participants. It emphasises the value of using Rasch analysis in the initial development of these instruments. n K Pesudovs et al., JCRS, “Remediating serious flaws in the National Eye Institute Visual Function Questionnaire”, Volume 36, Issue 5, pages 718-732.
Lower add, greater intermediate vision
The goal of creating a multifocal intraocular lens that provides good near, intermediate and distance vision is the major challenge facing IOL developers. Recent aspheric IOLs with a low addition were designed to improve intermediate vision, reduce unwanted visual phenomena associated with multifocal IOLs, increase the range of focus, and improve image quality. Spanish investigators conducted a study to compare visual acuity at different distances after bilateral implantation of a spherical multifocal IOL with a +4.00 dioptre add (AcrySof ReSTOR SN60D3) or an aspheric multifocal IOL with a +4.00 D add (AcrySof ReSTOR SN6AD3), +3.75 D add (Acri.LISA 366D), or +3.00 D add (AcrySof ReSTOR SN6AD1). All IOL models resulted in good distance vision, with no statistically significant differences between models. Patients with the +3.00 aspheric IOL had statistically better binocular corrected intermediate visual acuity at 50, 60, and 70cm and binocular corrected near visual acuity at 40cm than patients with the other IOL models. n JF Alfonso, JCRS, “Intermediate visual function with different multifocal intraocular lens models”, Volume 36, Issue 5, pages 733-739.
Thomas Kohnen Associate Editor of JCRS
Become a member of ESCRS to receive a copy of EuroTimes and JCRS journal
Don’t miss Eye on Travel, see page 46 EUROTIMES | Volume 15 | Issue 6
Stem cell help for AMD
Stem cell therapy poised to advance treatment of retinal degeneration and vascular pathology By Gearóid Tuohy
ew research from the US has demonstrated the capacity for systemically injected stem cells to preserve photoreceptors, maintain visual function, and rescue vascular pathology. The exciting developments, reported in the online journal PloSONE (Wang & Lu et al, Volume 5, Issue 2, e9200; www.plosone. org), show that a simple systemic injection of mesenchymal stem cells (MSCs) may soon find clinical application across a range of retinal pathologies, including age-related macular degeneration (AMD), retinitis pigmentosa, and diabetic retinopathy. The achievements represent a significant milestone in the potential treatment of several retinal disorders and additionally present a strategy to develop a “one-sizefits-all” approach through the targeting of common characteristics found among many retinal diseases. In the studies, researchers led by Prof Ray Lund at the Casey Eye Institute of the Oregon Health & Science University attempted to develop a treatment strategy that might address the common features of retinal disease and thereby provide a clinical opportunity to tackle several retinopathies at once. In pursuit of such a goal, Prof Lund’s team investigated whether the systemic application of MSCs could represent the ideal approach to such a strategy. In the past, researchers have encountered a number of difficulties in stem cell research: n Injecting donor cells directly into the vitreous were ineffective because many of the introduced cells tended to cover the back of the lens interfering directly with the path of light; n Implanting encapsulated cell “factories” engineered to deliver neurotrophic growth factors caused problems if the concentration of factors was not tightly controlled; n Injecting donor cells sub-retinally often affected only the locality of the injection rather than the entire tissue.
RSC rats With such challenges in mind, Prof Lund and colleagues employed a systemic application of MSCs – derived from bone marrow – to so-called “Royal College of Surgeons” (RSC) rats. The rats are the first known animals with inherited retinal degeneration.
The application resulted in both a preservation of vision and a limited vascular pathology. In addition, the studies showed – in contrast to a number of alternative therapeutic options – that MSCs may provide an ideal source of cell-based materials because of their autologous characteristics, ease of isolation and scale-up, ability to secrete growth factors, and ability to “home in” on the retinal tissue following an intravenous injection. Analysing retinal sections stained for general morphological features and probed with photoreceptor-specific antibodies demonstrated that MSC-treated rats had significant photoreceptor cell rescue across the retina when compared to untreated or sham treated animals. Following tail vein injection at post-natal day 30, MSC-treated rats had between three and six layers of photoreceptors remaining at post-natal 90; by contrast, only a single layer of photoreceptors remained in controls. Detailed cell counting demonstrated that MSC-treated rats had a cone density of 18±3 cells/300 µm; by contrast, no meaningful count could be conducted in the untreated animals due to the severe degeneration that had occurred. While cell preservation is promising, the acid test is function. For such a therapeutic approach to develop into a clinical application, it would be critical for the team to demonstrate that the preserved tissue morphology had some correlation with visual acuity. To demonstrate visual acuity, an optokinetic system was employed comprising a rotating cylinder of black and white stimuli at altering spatial frequencies which could quantify sensitivity thresholds of the optokinetic response. Use of such apparatus showed that visual acuity decreased with age in the RCS rats from 0.5 cycle/degree (c/d) at post-natal day 30 to 0.3 c/d at post-natal day 90. In MSC treated animals the average optokinetic response was 0.41±0.01 c/d at post-natal day 90, compared to 0.29±0.02 c/d in untreated animals. A further test of functional photoreceptors is represented by a “luminance threshold” recording from the superior colliculus. As the RCS rat ages, an increasing luminance threshold is required to stimulate the visual apparatus and measurements recorded on MSC treated rats versus untreated showed
The bar chart illustrates representational data from a visual acuity test using the optokinetic response. MSCtreated RCS models were tested at post-natal day 90 and compared to both sham and untreated subjects showing that visual acuity measured in cycles/degree was significantly improved (p<0/001) in treated versus non-treated animals. (Representation adapted from PLoS ONE, Wang & Lu et al, Vol. 5, Iss. 2, e9200).
an increase in the required threshold among untreated animals, consistent with both the optokinetic data and the histological and cellbased analysis. the distribution of the MSCs in the body As photoreceptors degenerate in a diseased following tail vein injection. Labelled cells retina, a vascular pathology often develops were found in the eye, lungs, kidneys and and, in RCS rats, such pathology manifests liver but the mechanism whereby the “homeas a leakage from vessels within the deep in” on the degenerating retinal tissue is not capillary plexus around post-natal day 60. understood. Previous studies had shown Seepage can begin in the vicinity of the optic that such cell migration and organ specific nerve and eventually spreads to the whole homing might be mediated by chemokines retina. Staining of the retinal vessels can pick and their receptors and may be up-regulated up abnormalities, vascular complexes and in response to injury, ischemia and retinal pigment epithelium cell migration pathology. Retinal degeneration may cause along damaged vessels. up-regulation of certain chemokines which In MSC-treated rats, there was a dramatic then promote MSCs to home in on the eye. decrease in the number of pathological Regardless of how the MSCs reach the vascular complexes and any such complexes battleground, it is clear that their effect found in MSC-treated rats tended to be once present appears to be superior to local smaller and isolated rather than clustered. injection in that the benefit is pan-retinal Finally, using a simple cell membrane Ins_easyPhaco_120x120_EuroTimes 6.5.2010 11:21 Uhr Seite 1 rather than localised. labelling dye, the research team tracked
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EUROTIMES | Volume 15 | Issue 6
outlook on industry
Companyâ€™s recent restructuring seeks to add new compounds â€“ and many developed for other diseases â€“ to the ophthalmology armamentarium By Howard Larkin
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999T+%#4'6101/'6'4T%1/ EUROTIMES | Volume 15 | Issue 6
nti-VEGF compounds, including Pfizerâ€™s pegaptanib (Macugen), revolutionised the treatment of neovascular eye diseases, such as wet age-related macular degeneration (ARMD). However, there continues to be unmet medical need in the ophthalmology disease area and Pfizer is continuing its search for new compounds with novel modes of action. One such compound is PF-4523655. Currently being studied in Phase II clinical trials, this drug is an RNA segment that directly targets a gene, RTP-801, that plays a significant role in new blood vessel growth, inhibiting its expression in response to hypoxia. In animal models with laser-induced choroidal neovascularisation, the compound up-regulated not only anti-angiogenic factors but also neurotrophic factors, suggesting that it might help restore damaged neural tissue in addition to blocking blood vessel growth. Working in apparent synergy with VEGF inhibitors, it reduced blood vessel leakage in diabetic mice. In Phase I trials, it was well-tolerated by patients with ARMD and diabetic macular oedema. While it is too early to tell if PF-4523655 will be effective, Pfizer researchers believe the gene-targeting approach holds promise to improve the gains made with VEGF inhibitors, and possibly prevent vision loss through early intervention. â€œThe most important aspect of this research is that it is a different way of action for future clinical development,â€? says Bernhard Saller MD, PhD, medical director and team leader for ophthalmology and endocrinology in Europe for Pfizerâ€™s Specialty Care Business Unit. The way that PF-4523655 made it into Pfizerâ€™s development pipeline is also unusual. It results from collaboration with Quark Biotechnology, a small California firm. Quark, which discovered and patented the gene target, and developed the compound, exclusively licensed PF-4523655 to Pfizer for development. It is one of many research-sharing arrangements that Pfizer is actively pursuing with biotech firms and universities â€“ and among Pfizerâ€™s own internal departments, after a restructuring early last year designed in part to enhance its product development capabilities. â€œWe have shifted from a traditional R&D model to an R&D model focused on building partnerships. There are a lot of good ideas out there, and we are trying to fill up our pipeline with new ideas,â€? Dr Saller says. Pfizerâ€™s restructuring grouped company divisions that were focused on narrow therapeutic areas into five global business units, Dr Saller notes. This new structure promotes idea sharing and product development in several ways. For one, the business units are independent, so they can respond more nimbly to market demands than was possible when the firm was more centrally managed. At the same time, placing a formerly isolated therapeutic operation like ophthalmology into a unit with other specialty biopharmaceutical areas encourages research cross-pollination across, as does consolidation of research facilities. Pfizerâ€™s acquisition of Wyeth further enhanced its product development capacity, Dr Saller says. â€œThrough the acquisition of Wyeth we now have a very strong pipeline in many disease
areas, including inflammation, neuroscience, endocrinology, infectious disease, vaccines and pulmonary vascular disease.â€? A good example of how such cross-pollination can benefit research is Pfizerâ€™s concurrent development of several antiinflammatory therapies based on a Janus kinase, or JAK-3, inhibitor. This biologic agent targets a specific molecule which activates the cellular nucleus to produce cytokines and protoinflammatory compounds in a pathway common to several auto-immune diseases. Pfizer is in Phase III clinical trials of an oral preparation for rheumatoid arthritis and in Phase II trials of a topical eye drop for dry eye. The compound is also being developed for inflammatory bowel disease. Another example is a monoclonal antibody initially developed for Alzheimerâ€™s by Rinat, another California biotech firm. In animal models the antibody has been shown to reduce amyloid-beta plaque buildup in the brain, which contributes to progressive cell death in Alzheimerâ€™s. A similar mechanism might be at play in the development of dry AMD. Pfizer is investigating this compound as a possible treatment for the non-proliferative form of the disease. Pfizer is also partnering with the University College of London on stem cell transplants for treating advanced AMD. Pfizer is funding development of the project, which involves placing stem cells on a membrane in the retina to replace neural tissue destroyed by the disease. If successful, the treatment potentially could be used to restore vision in both wet and dry AMD patients. However, considerable work needs to be done to make it clinically and commercially viable. â€œThis is a completely new phase in medicine and there are no established processes to get the therapies approved,â€? Dr Saller notes. Pfizer and the team at the University College of London are currently working with regulators on designing a clinical development programme that protects patient safety. Pfizer isnâ€™t neglecting its existing products. Macugen is currently in Phase III development for diabetic macular oedema and findings should be available later on this year. Xalatan (latanoprost ophthalmic solution), the leading medication for open-angle glaucoma, has just completed a trial for paediatric approval, Dr Saller says. â€œWhen it comes to basic safety about treatment, dosing, pharmacokinetics for prostaglandins in paediatrics, there have been no answers. The Xalatan PANDA trial will address this.â€? Pfizer plans to present its findings later this year. The company is actively pursuing new glaucoma drugs, to replace Xalatan, which will lose patent protection over the next two years. â€œNew compounds are being tested as monotherapy and in combination with other drugs to better serve patients,â€? he says. â€œWe are continuously identifying new therapeutic targets and compounds from internal groups and from our partners. It is an excellent approach to rebuild our pipeline in the best possible way and provide new treatments for diseases which affect thousands of patients.â€?
contact Richard Condon â€“ Richard.Condon@Pfizer.com
industry news Recent developments in the vision care industry
VisuMax® femtosecond laser now available outside US
Carl Zeiss Meditec has announced that ReLEx, the first femtosecond-only method of laser vision correction, is now available for sale outside the US. ReLEx is a new application that allows ophthalmic surgeons to perform a variety of complete laser vision correction procedures using only the VisuMax® femtosecond laser. “After several years of clinical research and development, we are pleased to unveil the first femtosecond-only laser vision correction method as a completely new option in our refractive laser solutions offering,” said Ludwin Monz, CEO of Carl Zeiss Meditec. “Because the entire procedure can be performed on one advanced system, we are able to deliver unprecedented workflow benefits to the practice. We believe that providing refractive surgeons with a range of flexible treatment approaches allows them to select the most appropriate set of technologies for their surgical settings.” ReLEx is Carl Zeiss’ brand name for complete laser vision correction procedures that can be performed entirely with the VisuMax® femtosecond laser, such as the Femtosecond Lamellar Extraction (FLEX) method and the Small Incision Lamellar Extraction (SMILE) method. ReLEx uses precise laser cutting, while excimer LASIK uses ablation of tissue. Beyond ReLEx, with the VisuMax surgeons can perform lamellar keratoplasty, penetrating keratoplasty and tissue resection procedures as well as corneal flap cutting procedures. ReLEx allows for very small flap sizes, typically just 0.5 to 1mm larger in diameter than the optical zone. Furthermore, ReLEx provides an easier and much faster workflow for the surgeon as the entire procedure can be performed using a single laser. To date, ReLEx procedures have been performed on more than 1,000 eyes at a variety of locations outside the US. Carl Zeiss Meditec continues to perform clinical research for the SMILE method (in which the corneal flap is eliminated). In this procedure, the VisuMax® creates a series of small incisions to allow for manual removal of the lamellar without cutting a conventional flap. This next evolution of ReLEx is expected to become commercially available internationally (outside of the US) in 2011. n Further information: www.meditec.zeiss.com
Positive business results at Alcon for first quarter 2010
Alcon has reported strong financial results for the first quarter of the year. The company said global sales rose 15.3 per cent to $1.72bn for the first quarter of 2010, or 9.6 per cent excluding the impact of foreign exchange fluctuations and acquisitions. Revenue from acquisitions added 20 basis points to sales growth in the quarter. The company noted that US healthcare reform reduced sales by $5m in the quarter. Sales of advanced technology intraocular lens sales increased 43 per cent, and glaucoma product sales increased 24.0 per cent. “Our first quarter results reflect another strong quarter with solid sales growth driven by continued market share gains in most major product categories, balanced contributions from all geographic regions and generally improved market conditions,” said Kevin Buehler, Alcon’s president and chief executive officer. n www.alcon.com
Product Update No-touch surface treatment with AMARIS With the SCHWIND AMARIS laser it is now possible to carry out no-touch, all-laser surface ablations. SCHWIND says the so-called TransPRK (Transepithelial Photorefractive Keratectomy) is the most advanced version of surface treatments as LASEK, Epi-LASIK and photorefractive keratectomy (PRK). “The TransPRK is the only surface treatment where the eye doesn’t require contact with an instrument,” said a company spokeswoman. “Furthermore, the epithelium is removed more precisely and more easily than through manual abrasion. Because the wound surface is smaller than, for example, with manual PRK, the healing process is shorter. Additionally, both the epithelium and the stroma are ablated in a single procedure. This shortens the overall treatment time significantly and minimises the risk of corneal dehydration,” she said. “The TransPRK is also suitable, for example, for treatments or retreatments based on SCHWIND corneal wavefront data. The epithelium normally appears as a smoothing agent in the topographies and covers corneal irregularities, that is aberrations of the stromal tissue. By removal of the calculated volume through the epithelium no surprises will occur,” said the spokeswoman. n www.eye-tech-solutions.com
FDA grants approval for LenSx femtosecond laser The US FDA has granted 510(k) clearance for the LenSx® femtosecond laser for laser phacofragmentation during cataract surgery. Researchers at the 2010 American Society of Cataract and Refractive Surgery meeting in Boston reported that this approach provides the ability to deliver a perfectly centred and sized capsulotomy, resulting in more reproducible positioning of the replacement intraocular lens and the potential for reduced dependence on glasses, as well as reduced use of ultrasonic power to fragment and remove the cataractous lens. n www.lensxlasers.com
Special status for Crystalens The Crystalens AO (Bausch + Lomb) has received the new technology intraocular lens (NTIOL) classification from the US Department of Health and Human Services, Centres for Medicare and Medicaid Services (CMS). The new classification allows surgeons an additional payment adjustment for services in conjunction with cataract procedures performed at an ambulatory surgical centre. The original Crystalens recently marked its 10th anniversary at the recent American Society of Cataract and Refractive Surgery Annual Meeting in Boston. More than 200,000 Crystalens lenses have been implanted worldwide in the past decade. n www.crystalens.com
Hybrid retinal camera
The Canon CX-1 Hybrid Mydriatic/NonMydriatic Digital Retinal Camera has received 510(k) clearance from the US FDA. The CX-1 is its first fully hybrid digital retinal camera with both mydriatic and non-mydriatic modes, according to the company. The user can automatically switch between these modes, utilising different functions within seconds and performing several concurrent ocular tests. The CX-1 can also produce clear and detailed diagnostic images for immediate review. n www.usa.canon.com
Softec HD approval
Lenstec has announced it has received US FDA approval for the Softec HD Intraocular Lens Implant. The Softec HD is part of the company’s “Precision Series” of implantable monofocal and accommodating IOLs. The IOL is an aberration controlled bi-aspheric IOL. It is already approved throughout the EU, Australia, Canada, China and other international markets. n www.lenstec.com
EUROTIMES | Volume 15 | Issue 6
paris 2010 XXVIII Congress of the ESCRS
4–8 September Le Palais des Congrès
Available at www.escrs.org: • Congress Registration • Courses and Wetlabs • Scientific Programme • Hotel Bookings
Ridley Medal Lecture
Life and Death on the Posterior Capsule David Spalton St Thomas’ Hospital, London
Journal of Cataract & Refractive Surgery Symposium Controversies in Cataract and Refractive Surgery 2010
Sunday 5 September, 14.00 – 16.00
Sunday 5 September During the Opening Ceremony, 10.00 – 10.45
T. Kohnen GERMANY E. Rosen UK
Refractive Surgery Didactic Course Saturday 4 September, 08.30 – 17.00
CLINICAL RESEARCH SYMPOSIA
Surgical Video Symposia
Saturday 4 September
‘New Technology Applications in Ophthalmic Surgery’
Monday 6 & Tuesday 7 September, 14.00 – 16.00
New IOL Materials and Micro Design
High Definition Diagnostics and Imaging
Video Symposium on Challenging Cases
T. Olsen denmark D. Reinstein uk
Saturday 4 September, 16.30 – 18.00
Biomechanics of the Cornea
Myth and Reality of Clinical Research
(Joint Symposium with EVER)
Workshop on Visual Optics Sunday 5 September, 09.00 – 16.00
J. Alio spain P. Sourdille france
F. Malecaze france C. Roberts usa
J.J. Gicquel france (EVER) M. Tetz germany
R. Osher USA
Chairpersons: I. Pallikaris GREECE M.J. Tassignon BELGIUM
The Role of the Vitreo-Lenticular Interface
Young Ophthalmologists Programme
(Joint Symposium with EURETINA)
Saturday 4 September, 09.00 – 16.00
Chairpersons: O. Findl AUSTRIA C. Zetterstrom NORWAY
M.J. Tassignon belgium S. Wolf switzerland (EURETINA)
XXVIII Congress of the ESCRS
main symposia Sunday 5 September
Tuesday 7 September
The 10 EURETINA Congress will take place from 2–5 September at the Palais des Congrès in conjunction with the ESCRS Congress.
11.00 – 13.00
11.00 – 13.00
Joint Symposia will take place on Saturday and Sunday.
For full details of the EURETINA programme please go to www.euretina.org
Saturday 4 September
11.00 M. Cormican IRELAND Bacterial isolates around the world and multiresistant organisms 11.15 P. Montan SWEDEN The intracameral cefuroxime/moxifloxacin debate: a critical look at the literature 11.30 J. van Meurs THE NETHERLANDS Endophthalmitis after anti-VEGF injections
14.00 – 16.00
Myopia: The Lens and the Retina Chairpersons:
P. Barry IRELAND G. Richard GERMANY (EURETINA)
P. Rosen UK B. Aylward UK (EURETINA)
14.00 A. Antón SPAIN Definition and epidemiology of myopia
11.45 L. Cordoves SPAIN A comparison of the Endophthalmitis Vitrectomy Study and the ESCRS endophthalmitis studies 12.00 A. Naseri USA Prophylaxis and cost effectiveness
14.15 C. Hammond UK Aetiology and genetics: a route for therapy?
12.15 E. Feretis GREECE Vitreous biopsy/intravitreal antibiotics vs vitrectomy: European vs American approach
14.30 J. Vryghem BELGIUM Surgical options for correcting myopia
12.30 Questions and Answers
14.45 B. Corcostegui SPAIN Myopic macular pathology: risks and treatment 15.00 J. Holladay USA The optics of (high) myopia and lens power calculations 15.15 P. Polkinghorne NEW ZEALAND Risks and prophylaxis of retinal detachment prior to laser or lens surgery 15.30 Questions and Answers 16.00 End of Session
Full details are available online at www.escrs.org
11.15 B. Malyugin RUSSIA Corneal surgical techniques: incisional 11.30 D. Reinstein UK Corneal surgical techniques: excimer ablation 11.45 T. Kohnen GERMANY Corneal surgical techniques: ring segments, coagulative procedures 12.00 R. Nuijts THE NETHERLANDS Intraocular surgical techniques: phakic IOLs 12.15 G. Auffarth GERMANY Intraocular surgical techniques: pseudophakic IOLs 12.30 Questions and Answers 13.00 End of Session
Monday 6 September
Wednesday 8 September
11.00 – 13.00
11.00 – 13.00
20/10 in 2010: The 20th Anniversary of LASIK
New Solutions for Presbyopia
B. Cochener FRANCE V. Katsanevaki GREECE
11.00 M. Knorz GERMANY Introduction
11.20 L. Buratto ITALY The mechanical LASIK flap concept and its refinements
There is an extensive programme of Instructional Courses and Wetlabs taking place during the Congress.
11.00 N. Alpins AUSTRALIA Astigmatism: definition and measurement
13.00 End of Session
11.05 J. Marshall UK Evolution of excimer delivery systems
instructional courses and wetlabs
J. Güell SPAIN K. Vannas FINLAND
11.35 T. Seiler SWITZERLAND Iatrogenic ectasia
D. Epstein SWITZERLAND D. Spalton UK
11.00 A. Glasser USA Correction of presbyopia: dreams and reality 11.15 O. Findl AUSTRIA Objective testing of near vision 11.30 J. Alio SPAIN The corneal way - presbylasik and other excimer strategies 11.45 G. Grabner AUSTRIA Corneal inlays - will they work this time?
11.50 J. Stevens UK Customized treatments
12.00 M. Holzer GERMANY Flapless and painless: can the femtosecond laser really correct presbyopia?
12.05 J. Colin FRANCE The advent of the femtosecond laser
12.15 R. Bellucci ITALY The lens approach - CLE and multifocal lenses
12.20 I. Pallikaris GREECE The future of LASIK
12.30 Questions and Answers 13.00 End of Session
12.35 Questions and Answers 13.00 End of Session
XXVIII Congress of the ESCRS
SATELLITE EDUCATION PROGRAMME
4-8 September 2010
Lunchtime Symposia (lunchbox included)
Lunchtime Symposia (lunchbox included)
Saturday 4 September
Sunday 5 September
13:00 – 14:00
13:00 – 14:00
Ziemer Refractive Symposium FEMTO LDV & Galilei
Maximizing Surgical Outcomes: Therapeutic Considerations and Clinical Experiences
Moderator: T. Seiler Switzerland
Moderator: J.P. McCulley
Sponsored by 13:00 – 14:00
Beyond 20/20: The Future of Laser Vision Correction Faculty: M. Knorz Germany B. Dick Germany R. Barraquer Spain
13:00 – 14:00
Impact of New Torsional Technology on Interesting Cases Moderator: K. Tjia
13:00 – 14:00 13:00 – 14:00
Bausch + Lomb Satellite Symposium
Croma Satellite Symposium Sponsored by
13:00 – 14:00 13:00 – 14:00
Innovations in Spectral OCT and Retina Function Testing Moderator: R. Rosen USA Sponsored by A Division of OPKO Health, Inc.
13:00 – 14:00
Rayner Satellite Symposium Sponsored by 13:00 – 14:00
Leading Technology in Refractive Surgery
Advanced Optical Biometry for Premium IOL Surgery
13:00 – 14:00
Carl Zeiss Satellite Symposium 13:00 – 14:00
Comprehensive Diagnosis of Retina & Glaucoma… What you have been missing… Sponsored by
SATELLITE EDUCATION PROGRAMME
Satellite Education Programme
XXVIII Congress of the ESCRS
4-8 September 2010
Lunchtime Symposia (lunchbox included)
Saturday 4 September
Monday 6 September 13:00 – 14:00
13:00 – 14:00
Surgical Techniques: Injecting the Latest Technologies Moderator: D. Serafano
Sponsored by 13:00 – 14:00
Innovating Premium Cataract Surgery – Optimizing Vision Moderators: J. Colin France A. Brézin France Speakers: J. Colin France G. Auffarth Germany P. Szurman Germany I. Ossma Colombia
A Decade of Experience with Selective Laser Trabeculoplasty
Cataract and Refractive Live Surgery
Moderator: J. Marshall UK
Moderator: D. Serafano USa Host Surgeon: L. Buratto Italy
13:00 – 14:00
Sunday 5 September
Innovations in Refractive IOL and Laser Technology
in conjunction with
Moderator: F. Carones
Sponsored by 13:00 – 14:00
Technolas Perfect Vision - True Solutions for Presbyopia with Laser Technology Moderator: M. Knorz Germany Sponsored by
Monday 6 September 18:15
“To MICS or not to MICS: Still asking the question?” Moderator: S. Morselli Italy Sponsored by 18:15
STAAR Satellite Symposium Please note that this is a preliminary programme and is subject to change
eye on travel
Paris, City of Light
Four ways of seeing the city in a brand new light By Maryalicia Post
Pyramids at the Louvre Museum (above), and a gilded St Joan of Arc (below)
Take a photo tour Combine the pleasure of a guided three-hour walking tour with a mini-photography workshop. Randy Harris, an award-winning American photographer now living in Paris conducts individuals or small groups on day or evening walks in various parts of Paris. I chose a daytime tour in the heart of Paris so our destinations included the Louvre, the Palais Royal, Place de la Concorde, the Eiffel Tower, and the cemetery in Passy where Debussy is among the “residents”. My fellow tourist was equipped with a Sony digital camera and a couple of lenses. I carried a Lumix point and shoot. Randy shared his favourite viewing spots with us and in three hours we learned a lot about framing, perspective, colour and use of reflections. Randy is knowledgeable about every type of camera and is happy to give pointers and tips. You’ll have a great time – and come away with Paris photos you’ll be proud of. Early booking is essential either online at www.phototoursinparis.com or by telephone: 06 40 14 84 49 (calling from within France) +33 6 40 14 84 49 (calling from outside France). Go sipping on the Seine Here’s a relaxing twist on the usual scenic boat ride on the river Seine. O-Chateau offers a champagne cruise that combines a late afternoon sightseeing opportunity with an introduction to champagnes. The boat leaves from a dock at the foot of the Eiffel tower. Participants on this tour do their viewing from a private glassed-in cabin in the prow of the boat attended by their own sommelier. During the hour-long cruise, he introduces three varieties of champagne – a dry and medium, and a rose. Explanatory remarks are kept to a minimum, so you can enjoy the view. But your sommelier does stand by to answer any questions. And he keeps the samples flowing. For details of these and other wine-themed tours, and to book, visit: www.o-chateau.com. See the city from a 2CV This eccentric automobile has become almost synonymous with Paris. Your driver will tootle you about from sight to sight in true Parisian style. On a fair day or a pleasant evening, the open roof adds to the fun.
EUROTIMES | Volume 15 | Issue 6
Symbol of Paris, the Eiffel Tower
Tours last two to three hours, but all-day tours are available as well. See the website for details: www.parisauthentic.com.
Be a dinner guest in a private home There are two versions of this
increasingly popular “insider” experience. The first puts the accent more on interaction with your hosts than the food, while the second offers a gourmet dinner in the company of other dinner guests. Volunteer Parisian hosts welcome you to join them in their home for a meal, which will be provided by a catering service. (You choose the menu in advance.) Hosts are not paid for their service but enjoy meeting visitors from other parts of the world, and sharing their enthusiasm for their city. You have a chance to specify the area of Paris you wish to visit and the agency tries to match the age and interests of guests and (English speaking) hosts. For details, visit http://www.meetingthefrench.com/dinnersparisian-hosts. The other option is a private dining club like “Hidden Kitchen”. Here, a couple of young food enthusiasts serve a 10-course gourmet meal to a dozen or so complete strangers who booked their place through the website. The “lingua franca” is English.www. hkmenus.com
New light on the Louvre When you’re looking for “something new” in Paris, the Louvre Museum may not be the first place you check out. But the venerable institution is being stirred and even shaken by contemporary art curator, Marie-Laure Bernadac, who is welcoming modern art into the home of the Mona Lisa. In March of this year, the dazzling new ceiling conceived by American artist Cy Twombly was revealed in the Salle des Bronzes – an immense blue “sky” – enlivened with spheres and seven white cartouches inscribed with the names of ancient Greek sculptors. It’s the third permanent addition
to the Louvre commissioned by Mme Bernadac. Anselm Kiefer’s monumental wall painting flanked by modern sculptures was unveiled in 2007. In 2009, the French artist Francois Morellet decorated the twin-spiral Lefuel staircase with seven opal and frosted glass windows. The juxtaposition of ancient masterpieces and contemporary art, Mme Bernadac believes, benefits both the old and new works. She continues to make her point, despite critics inside and outside the Louvre, scheduling a roster of temporary exhibitions to underscore the connection. It’s a bold idea, certainly, but a glimpse of the Twombly ceiling may convince you of her point of view. It converted me. Bypass the ticket queue with a Louvre pass. Buy it online at: http://paris.conciergerie. com/pass/louvre_museum_pass.php The Louvre is closed on Tuesdays.
“McLOUVRE” Earlier this year, an outraged international press revealed that a McDonald’s has opened in the Louvre. I can report no harm has been done. McDonalds is in fact only one of 45 shops and restaurants in a handsome shopping mall, the Carrousel du Louvre, located deep under the Louvre’s glass pyramid. With its own entrance from the Rue Rivoli, the Carrousel is open seven days a week, from 10:00 to 20:00. Also in the Carrousel: a dramatic Apple shop with a glass spiral staircase linking its two levels. Shop attendants will install a Louvre-guide application on your iPhone free of charge. * Paris is the venue for the 10th EURETINA Congress from 2-5 September and the XXVIII Congress of the ESCRS from 4-8 September, 2010. For further details visit www.euretina.org and www.escrs.org
Drug patent risks
EU court case could limit protection of patents for ophthalmic biotech drugs By Paul McGinn
case now before the European Court of Justice could undermine the future of biotechnologically derived drugs. The case, which involves a claim by the multinational Monsanto Corporation, may ultimately limit the legal protection of the patents on which developers of biotech therapies depend. At issue is whether a patent granted for a genetically modified substance for a particular use – known as a “biotechnological invention” – should apply to other possible uses of the same genetically modified substance. According to the advocate general of the Court of Justice – its top legal advisor – EU law only protects patent rights of genetically modified substances when the substance is used for the exact purpose for which the patient was originally granted. If the European Court of Justice follows the advice of the advocate general, which it does in most cases, the court could ultimately open the way for anyone to exploit biotech discoveries for uses that were not first contemplated when a patent was originally granted. Such a ruling may ultimately damage biotech research in ophthalmology by dissuading research companies from funding biotech research knowing that any research discoveries could ultimately be exploited by other companies who made no such investment in the primary biotech studies. The particular case now before the court arose over Monsanto’s much-publicised European patent for genetically modified soybeans. The patent specifically protects a genetically manipulated DNA sequence which, when introduced into the DNA of the seeds of a natural soya plant, makes that plant resistant to Monsanto’s own herbicide, “Roundup.” By planting such genetically modified seeds, farmers can use the Monsanto herbicide to destroy surrounding weeds without any worry of harming the soya. The genetically modified soya plants, known as “Roundupready” soya, are cultivated in various countries over the world but, of course, not in the EU. In 2005 and 2006, Dutch companies imported soy meal from Argentina to produce animal feed for sale in the EU. Interestingly, Roundup-ready soya is cultivated on a vast scale in Argentina, but Monsanto does not hold a patent for the DNA sequence in that county. To protect its patent – Monsanto decided to go to the courts. However, going to the Argentine courts would have proved futile without a patent there. Rather, Monsanto chose to enforce its patent by suing Dutch-based importers of the harvested soya beans on the basis of its EU patent.
As part of its lawsuit, Monsanto analysed the soya meal distributed by the Dutch importers and found that the meal contained traces of the DNA characteristic of Roundup-ready soya. In so doing, Monsanto established for the Dutch courts that the imported soy meal contained the genetically modified soya for which the company held the European patent. Faced with the Monsanto claim, the Dutch District Court asked the Court of Justice to clarify the extent to which patents
of so-called “biotechnological inventions” – and, in particular, patents relating to genetic information – are protected in the European Union. At issue was whether genetic information is protected – as a chemical compound – even when it is located as a sort of “residue” within a product resulting from the processing of the biological product in which the compound has already performed its function. In line with the practice of the Court of Justice, the court’s advocate general reviewed the law in the area and presented his opinion to the judges involved in the case to help them come to their own independent decision. According to the advocate general, the primary law governing the area of biotechnology – the Directive on the Legal Protection of Biotechnological Inventions – protects patented DNA-derived chemical substances – only where those substances perform the function for which they were patented. In his view, those are the only circumstances in which the protection also covers the “material” in which the DNA sequence is contained.
Discovery or invention The advocate general said that the Biotechnological Invention Directive enables the Court of Justice to draw a distinction between a “discovery”, which is not patentable, and an “invention”, which is patentable. By legal definition, a “discovery” involves the isolation of a DNA sequence without any indication of a function; an “invention” involves that discovery together with an indication of the function that the discovered substance will perform. Accordingly, the advocate general stated that if the court were to rule that a patent protected a DNA sequence for all possible functions – even those not identified at the time when the patent was applied for – the court would be making mere discoveries patentable, in breach of the basic principles governing patents. What is more, since it is not possible to say for how long, or up to which stage of the food and derived product chain, traces of the original DNA of the genetically modified plant are still identifiable, their very presence – even though they would no longer be performing any function – would mean that an unspecified number of derivative products would come under the control of whoever had patented the DNA sequence of a plant, the advocate general also stated. On that basis, the advocate general concluded that, “the protection for a patent relating to a DNA sequence is limited to the situations in which the genetic information is currently performing the functions described in the patent.” The advocate general added that the Biotechnological Invention Directive constitutes an exhaustive body of laws that precludes any EU country from extending patents to protect mere discoveries. A decision by the Court of Justice is expected within the coming months. n For more details about the case, Monsanto Technology LLC –v- Cefetra BV and others (Case C‑428/08), visit the European Court of Justice website at www.curia.eu.
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EUROTIMES | Volume 15 | Issue 6
Calendar of events Dates for your Diary
BERLIN, GERMANY 5-9 World Ophthalmology Congress
1-4 CAIRNS, AUSTRALIA
1st EuCornea Congress www.eucornea.org
2010 APACRS-AUSCRS Combined Annual Meeting
2 Brighton, East Sussex, UK Contact Lens Basics and Laser Refractive Surgery Complications Course Email: firstname.lastname@example.org
9-11CRETE, GREECE Aegean Cornea X www.aegeancornea.gr
26-27 16th Retina International World Congress 18-23 MONTREAL, CANADA www.retinaitalia.org STRESA, ITALY
ISER 2010, XIX Biennial Meeting of the International Society for Eye Research www.kenes.com/iser
GENEVA, SWITZERLAND 7PRESBYMANIA 2010
MUNICH, GERMANY 9-11 PRESBYMANIA 2010
13-15 MUMBAI, INDIA
12-16 EDINBURGH, SCOTLAND
Vilnius, Lithuania 20-22 XIII Baltic Ophthalmologicum Balticum
beijing, china 16-20 25th Congress of the APAO in combination
EyeAdvance 2010 www.eyeadvance.com
10th EURETINA Congress XXVIII Congress of the ESCRS www.euretina.org www.escrs.org
6-9 CRETE, GREECE
European Assocation for Vision and Eye Research 2010 www.ever.be
16-19 chicago IL, usa
American Academy of Ophthalmology www.aao.org/annual_meeting
HAMBURG, germany 21-24 23rd International Congress of German Ophthalmic Surgeons www.doc2010.de
10th Annual Conference of Uveitis Society of India & Moorfields Uveitis Course www.usi2010.in
The International Symposium on Ocular Pharmacology and Therapeutics â€“ ISOPT ASIA
Oculentis GmbH Page: 47
Alcon Pages: 15, 34, OBC
Oculus Page: 18
ASCRS Pages: 28, 36
Khairabad Eye Hospital Page: 26
Oertli Instrumente AG Pages: 37, 39
Benz Research and Development Page: 11
Medicontur Page: 6
Rayner Intraocular Lenses Limited Page: IBC
Geuder Page: 19 Haag Streit International Page: 32
Nidek Page: 27
with the 15th National Congress of the COS www.apao2010beijing.org
18-20 TURKEY 25-30 CA, USA ISTANBUL,
15th ESCRS Winter Meeting www.escrs.org
ASCRS/ASOA Symposium and Congress www.ascrs.org
3rd International Symposium on Macular Disease www.milosklinika.com
icare Page: 40
Moria Page: 13
SIDUO XXIII Congress www.siduo2010.org
Abbott Medical Optics Pages: IFC, 24, 25
Med-Logics, Inc Page: 12
D.O.R.C International BV Page: 33
VSY Page 6 Ziemer Page: 17
Joint Congress of SOE/AAO www.soe2011.org
XXIX Congress of the ESCRS www.escrs.org
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