VOLUME 16 ISSUE 7/8 JULY/AUGUST 2011
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july/august 2011 Volume 16 | Issue 7/8 This month... Special Focus: Practice Development 4
Cover Story: Sizing up the competition crucial to the success of your practice
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Applying aviation teamwork techniques to your practice can improve performance
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Collaboration with Harvard business students improves practice efficiency
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Threat assessment can save time and money for your practice
Cataract and Refractive 12 Experts discuss where to draw the line with laser treatment
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13 Post-refractive surgery eyes pose particular problems for IOL power calculations 14 Examining ocular surface key to reducing incidence of post-LASIK dry eye 15 New laser technique effective for hyperopic presbyopes 16 New toric IOL shows good early results 17 YAG laser effective for treating post-LASIK epithelial ingrowth
Cornea 22
Sri-Lankan eye bank producing high quality corneas
23 Initiative aims to eliminate trachoma by 2020
Glaucoma 24
New glaucoma treatments on the horizon
25 Creating forums for information exchange important to advance surgery
Retina
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27 Vitrectomy for treating eye floaters? 28 Highlights from the 11th EURETINA Congress
Ocular 30
New technologies could become more prominent in ophthalmology teaching
Global Ophthalmology 32 Study looks at dramatic improvements in cataract surgery in Sudan 33 Glaucoma summit looks to reduce glaucoma-related vision loss in west Africa
News 35 Record numbers take part in EBO diploma examinations 36
Being a good resident provides the foundation for future success
37 ESASO campuses attract students from all over the world
Features
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38 Industry News 39 Book Review 40 Legal Matters 42 JCRS Highlights 43
Outlook on Industry
44 Calendar
With this month’s issue... The current understanding of dry eye disease supplement, vienna 2011 preview of the xxix congress of the escrs & 2nd eucornea congress, & practice development workshop & masterclass brochure
editorial staff
ESCRS
EUROTIMES
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Published by The European Society of Cataract and Refractive Surgeons Publisher Carol Fitzpatrick
Managing Editor Caroline Brick
Executive Editor Colin Kerr
Production Editor Angela Sweetman
Editors Sean Henahan Paul McGinn
Senior Designer Paddy Dunne
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Circulation Manager Angela Morrissey
Colour and Print Times Printers
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: escrs@escrs.org
Contributors Devon Schuyler Eisele Stefanie Petrou-Binder Maryalicia Post
Published by the European Society of Cataract and Refractive Surgeons Temple House, Temple Road, Blackrock, Co Dublin, Ireland. No part of this publication may be reproduced without the permission of the managing editor. Letters to the editor and other unsolicited contributions are assumed intended for this publication and are subject to editorial review and acceptance.
ESCRS EuroTimes is not responsible for statements made by any contributor. These contributions are presented for review and comment and not as a statement on the standard of care. Although all advertising material is expected to conform to ethical medical standards, acceptance does not imply endorsement by ESCRS EuroTimes. ISSN 1393-8983
As certified by ABC, the EuroTimes average net circulation for the 11 issues distributed between 01 January 2010 and 31 December 2010 is 32,019.
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EUROTIMES
Editorial
ESCRS
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GUEST EDITORIAL
Medical Editors
Volume 16 | Issue 7/8
José Güell
Ioannis Pallikaris
Clive Peckar
Paul Rosen
DEVELOPING A VISION
ESCRS Practice Development Programme provides knowledge to help you plan for the future
by Keith Willey BSc, MBA
International Editorial Board
Emanuel Rosen Chairman ESCRS Publications Committee
Noel Alpins australia
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am delighted with this invitation to write the editorial promoting the ESCRS Practice Development Programme and Masterclass during the XXIX ESCRS Congress. I am also very pleased to learn that ESCRS will be holding a Practice Development Workshop and Masterclass in Dublin on November 12 and 13. One of the challenges facing anyone who wants to teach business principles to ophthalmologists is that you are dealing with a diverse group that includes doctors in purely private practice, those in public practice who are thinking of going private and then those who are in both private and public practice. These doctors have all been trained as surgeons but not in business, and the ESCRS’s Practice Development Programme gives them the opportunity to meet other colleagues and discuss how to set up and run their practices and talk about the challenges facing them. Some ophthalmologists who think they are running good and profitable practices and that they do not need any guidance on the business of ophthalmology may find that one day when they want to sell their practices that they have not considered basic questions such as: what price do you put on your practice? They may find that the financial gain from the sale of their practices is a lot less than they would have got if they had spent some time thinking about the business aspects of their practice.
Bekir Aslan TURKEY leadership and management. That is very difficult in medical practice because that would mean doctors would stop doing surgery. But I would argue that doctors can still work hard in the surgery and be able to free up more time to plan and manage their practices. I also think that ophthalmologists need to be able to describe their visions for their practices. At my masterclasses at the recent ESCRS Congresses in Barcelona and Paris, I have found that not many of them have thought about this. You find this with professionals in other spheres who say: “I just want to do my work.” You cannot do that if you are building a practice because you are responsible for other people and they need to know what your long-term plans are. A good practice vision can be tested and reviewed and will help you to plan your practice better. One thing that ophthalmologists share with other businessmen and businesswoman is that they are customer focused, in many cases more so because ophthalmologists must always put their patients first. There are a lot more of these principles I could discuss, but I would urge you, as ESCRS members, to attend the society’s Practice Development Workshops in Vienna and Dublin and I will be delighted if you can attend my masterclass.
EUROTIMES | Volume 16 | Issue 7/8
Roberto Bellucci ITALY 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
Manage your practice
Some ophthalmologists who work in the public health service and have their salaries paid for by the state may also argue that they do not face the financial challenges of their colleagues in the private service. I would argue that public health is coming under such pressure that hospitals and other centres of excellence will be given less resources in the future and could even face closure. In this scenario, they may find that they would be wise to look for new management ideas developed by those working in private medicine. Another interesting challenge for ophthalmologists is that with other businesses one of the guiding principles is to find what the leaders of these businesses can stop doing to allow them to spend more time on
Bill Aylward UK Peter Barry IRELAND
Gisbert Richard GERMANY Robert Stegmann SOUTH AFRICA Ulf Stenevi SWEDEN Emrullah Tasindi TURKEY Keith Willey Keith Willey, associate professor of strategic and international management and entrepreneurship, London Business School. For more information on Practice Development Workshops and Masterclasses visit: www.escrs.org.
Marie-Jose Tassignon BELGIUM Manfred Tetz GERMANY Carlo Enrico Traverso ITALY Roberto Zaldivar ARGENTINA Oliver Zeitz germany
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Cover Story
practice development
Is there a market for my services?
A little research about demographics, patients and competitors can help grow your practice by Howard Larkin
Dr Robin also specially trains his staff to do complex workups to gauge patients’ refractive needs and determine the best solution before surgery Nader Robin MD
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It makes more sense to find a place that is under-served rather than one where there is lots of competition
Rod Solar, client services director for LiveseySolar Practice Builder
EUROTIMES | Volume 16 | Issue 7/8
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ith an estimated 1.4 billion patients worldwide due to develop presbyopia by 2020, ophthalmic surgeons like Nader Robin MD are targeting their practices to that ever-growing patient population. Dr Robin has even chosen the name of “Presbyview” for his practice in Grenoble, France. Dr Robin’s practice website touts the broad range of presbyopia options he offers, including LASIK, PRK, INTRACOR, the KAMRA pinhole intracorneal inlay, and his own hyperopic presbyLASIK that uses a hyperprolate cornea to extend depth of focus. Dr Robin also specially trains his staff to do complex workups to gauge patients’ refractive needs and determine the best solution before surgery. They also provide additional support as patients adjust after surgery. Dr Robin has had good clinical results and high patient satisfaction with a variety of approaches, but he also concedes that his clinic faces special challenges with patients who haven’t needed glasses before: “Pure emmetropes with high expectations remain the most difficult cases to manage.” Of course, not every surgeon has the desire, the resources, or the business interests to target an elective market in this way. The lasers and implants for refractive surgery are expensive, and the marketing and financing headaches of running a private practice focusing on refractive procedures may not appeal to many surgeons – particularly those more interested in treating disease processes. Plus, the private market can be brutally competitive, with internationally run refractive surgery clinics depressing procedure prices even as the cost of new technology inexorably rises. That said, the implants, equipment, and facilities for cataract surgery are also costly, too. They also may become much more so if femtosecond lasers become the standard of care. As major manufactures look for
revenue opportunities as some major drugs go off patent, even glaucoma and retinal surgery are moving toward more devices and less manual surgery, pushing initial treatment costs higher. Whether these costs are borne by public or private organisations, the higher they go the more competition is likely among surgeons to gain access to the resources needed to practice.
What kind of practice do you want? So how do you know if there is
enough of a market for you to support your practice using the skills and providing the services you worked so long to master? The answer depends on many factors, practice development experts say. Among them are how many potential patients there are in your area, what kind of competition you face, how you can distinguish your practice from competitors – and what, exactly, it is you want out of your practice.
As a human being and surgeon, you may well be motivated more by personal and professional satisfaction than business success, notes Rod Solar, client services director for LiveseySolar Practice Builders, London, UK and leader of the Marketing Your Practice Workshop which will take place at the XXIX Congress of the ESCRS this September in Vienna. “If you want a reasonably comfortable life practising wherever it is that you live, fine. But if this is your only goal, you need to be conscious that where you live will have a tremendous influence on how successful you are from a business perspective.” Many doctors embrace this outlook, and generally are reluctant to uproot themselves and their families unless their practice financial situation is untenable, Mr Solar says. In fact, many studies show that most doctors eventually settle close to where they trained, possibly because they have developed clinical support and referral networks there.
EUROTIMES | Volume 16 | Issue 7/8
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Google Insites Web Search Interest
Courtesy of Rod Solar
However, if your goal is return on investment, it’s wise to look at your practice more as a business than a personal vocation, Mr Solar says. “If I were to open a Starbucks would I open it right down the road from another one? No, I would open it in a place where I am likely to sell a lot of coffee.” While the differences between selling lattes and surgeries are obvious, to some extent the same logic applies. “In your town you can count how many operations are needed. It makes more sense to find a place that is under-served rather than one where there is lots of competition,” Mr Solar says. Some countries may offer ophthalmic surgeons and other healthcare professionals financial incentives to move away from urban areas to lessserved regions, says Kristine Morrill, a partner in medeuronet, a consulting and market development company based in Strasbourg, France, and London, UK. However, a larger concentration of surgeons in urban areas does not necessarily indicate a shortage of patients. For example, in Paris, clinics have developed wide-ranging referral networks in the city suburbs, she says. “There are more patients than ophthalmologists, so you probably have to have a good market position to do well,” Ms Morrill says. However, in Germany much of the competition for ophthalmic surgery takes place at the level of residents competing for surgical training, she notes. Likewise, the restricted number of ophthalmic specialists in the UK almost guarantees a comfortable living, she adds. But even in countries with a limited supply of ophthalmic surgeons, relocation isn’t the only way to build business, say Keith Willey BSc, MBA, professor at London Business School, and conductor of the annual ESCRS/EuroTimes Practice Development Masterclass, which will take place for the third time at the XXIX Congress of the ESCRS this September in Vienna. “The trick is, ‘How do you position yourself in your market?’ and ‘How is everyone else positioned?’” Prof Willey observes. “One big question is the range of procedures you are offering. If you want to do LASIK, you can nail down the process and become very fast at it,” he says. “You can make a lot of money, but it is geared to the economy. Or you can say ‘I am not tempted by the quick buck, but I will do the more difficult but less remunerative procedures, but I know I will always have business and I will be making a difference in people’s lives. I think that is at the heart of the business decisions surgeons make. We have seen some who went into LASIK, and with the global economic crisis, have had to readjust.” It may well be that if you offer patients competent and pleasant service, and take care to communicate promptly with referring doctors – and make sure you send the patient back – you may well carve yourself a market niche that is both lucrative and long-lasting. Understanding where your patients and referrals come from, and what they want, is the key to success no matter what services you offer. And it’s not terribly difficult or expensive to do.
Google Insights
How big is your market? Because the incidence of eye conditions is relatively well known and most countries track the population size, age, ethnicity and other demographics at least every 10 years, much of the basic market research for publicly paid medical services already exists, Mr Solar notes. He suggests getting the latest demographic information available, and also to following real estate trends. If new houses are going up in the district, chances are the need for services is rising as well. These locations may be good opportunities to open a practice or a part-time office. In most cases, patients won’t travel more than 100km or so to see a doctor. So usually your market area may cover a town or small city, or part of a large city. One way to find out for sure is to look at your existing patient base to see where they live, and ask them how they heard about your practice, Ms Morrill says, in order to get an idea of your catchment area. Then look on the Internet, in phone books, and in hospitals and other facilities to see how many surgeons offer similar services in the area. If there are more than enough to serve the population, you may be better off elsewhere or focusing on a different service in order to differentiate yourself. “What we are looking for is your competitive advantage,” said Mr Solar. It may be special training or expertise, such as subspecialty training in retinal surgery or glaucoma, which is hard to reproduce. Or it may be convenience – if everyone
else is working bankers' hours, seeing patients on nights and weekends may be enough to set you apart. And don’t forget other physicians, Prof Willey warns. He suggests surveying GPs on where they send their eye patients, and what they like and don’t like about the experience. Also, find out where the local operating facilities are and see who is booking patients. “That will tell you a lot about who does what and how things are really getting done.”
Going private When it comes to refractive surgery, good market data is harder to come by, Mr Solar says. And because a substantial investment in equipment is usually involved, the stakes are much higher. Here again, research can help you position yourself for success even in a very competitive market. As with publicly funded services, the process starts with demographics. But income and how well LASIK and other procedures are accepted in the community are just as important as medical need. One way to find out is to ask industry vendors. They often have a good idea of volume in your target area, Mr Solar says. You can even call your competitors and ask how many cases they do, though this might be considered sneaky by some. However, salesmen may tell you what you want to hear rather than what you need to know, Mr Solar warns. “If they say something that is favourable, as a rule of thumb cut it by 20
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There are more patients than ophthalmologists, so you probably have to have a good market position to do well
Kristine Morrill, a partner in medeuronet
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The trick is, ‘How do you position yourself in your market?’ and ‘How is everyone else positioned?’
Keith Willey BSc, MBA, professor at London Business School
contacts
Cover Story
practice development
Nader Robin – Celine.reibel@presbyview.fr Keith Willey – keith@keithwilley.com Kristine Morrill –kmorrill@medeuronet.com Rod Solar – rod@liveseysolar.com
Ms Morrill recommends going through a SWOT analysis process – identify your practice’s Strengths and Weaknesses, which are internal, and market Opportunities and Threats, which are external. “It’s a good way to find your comfort zone”
Keith Willey gives the Practice Development Masterclass in Barcelona
Courtesy of Rod Solar
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Figure 1
per cent. If they tell you something negative, increase it by 20 per cent. This helps you get to the middle.” National penetration numbers may also help, Mr Solar adds. In the UK, about 0.3 per cent of people who can benefit from LASIK have it done (about 100,000 people) in any given year. Penetration in the UK pales in comparison to the three per cent figure found in the US. You can predict your annual volume by estimating the percentage of people in the eligible population who will likely have the procedure in any given year. “Of course, you’ll need to carve your market share from that total number, unless you’re the only provider for 100 km. “There is also a considerable amount of information that can be derived from Google Insights (http://www.google.com/insights). For example, you can conduct a simple search for 'laser eye surgery' and identify web search (to evaluate trends) and regional interest in the procedure. It’s horribly unscientific, but if you survey a lot of different numbers you can get a pretty good idea of the volume or interest in the market.” Just as important is to see where your competitors are in the market, Mr Solar says. In the abstract, value to the customer equals the benefit divided by the price. To find an opening in the market, he suggests mapping competing practices on price against some aspect that distinguishes your practice. It could be customer service, convenience, perceived quality, your reputation, brand equity, or scope of services. In the example shown (Figure 1), practice C4 finds that by
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providing personalised service, it can justify a higher price than the international chains in the market, C7 and C8, while still positioning itself as an attractive alternative to the highest priced practice, C6. Mr Solar recommends going through this exercise periodically to ensure your practice remains responsive to market needs. Ms Morrill recommends going through a SWOT analysis process – identify your practice’s Strengths and Weaknesses, which are internal, and market Opportunities and Threats, which are external. “It’s a good way to find your comfort zone. It is textbook business planning, but it can be really useful.” Prof Willey agrees. He suggests writing down in detail where you want your practice to be and how you are going to get there. “People struggle with the question, but it forces them to figure out what they are going to do and work back from there.” But the most important question may be do you really want to go private, Prof Willey says. It can be a tough choice. “A lot of doctors we see in the workshops have one foot in the public system and one foot in the private system. They see benefits and drawbacks to both. If you are on staff at a hospital you have access to operating space and patient flow is automatic. But if you are private, you are outside the mainstream and you have to think of ways for the patient to find you, and for doctors to refer to you instead of someone else. It requires a different set of skills and not everyone really wants it.”
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contacts
Feature
PRACTICE DEVELOPMENT
Kristian Gerstmeyer – kristian@gerstmeyer.net Steve Harden – sharden@saferpatients.com
SAFE AS AIRPLANES
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Many healthcare organisations have improved their clinical performance and their efficiency by applying teamwork techniques derived from aviation practices
Applying aviation teamwork concepts may help reduce ophthalmic surgical errors by Howard Larkin
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n the safety professional literature, they’re known as the “dirty dozen” – 12 sources of human error at the root of most aviation maintenancerelated accidents. By understanding the insidious influence of complacency, poor communication and stress, and systematically applying tools to neutralise error, commercial aviation has become one of the safest industries on earth. At about 19 in one billion, the incidence of passengers dying on airplane trips well exceeds the “six-sigma” quality benchmark to which many industries aspire, which works out at about 3.4 in a million. By contrast, preventable hospital deaths occur at a rate more than two orders of magnitude higher, or 3.5 sigma, according to the US Institute of Medicine. The “dirty dozen” model has been validated in many industries. But how well does it describe errors in ophthalmic surgery? And can the tools developed to address it benefit ophthalmology? The answer may well be “yes”, according to research presented by Kristian Gerstmeyer MD, of Minden, Germany, at the XXVIII Congress of the ESCRS. Dr Gerstmeyer and colleagues at the University of Lueneburg sent surveys to virtually all practising ophthalmic surgeons in Germany. The surgeons were asked to rate the relevance of each of the 12 categories as causes of surgical errors in their environments, and to give examples of errors in each category as appropriate. Of the 1,063 surgeons contacted, 208 responded, a rate of nearly 20 per cent. The categories with the highest mean scores were pressure at 3.4 on a fivepoint Likert scale, followed by lack of communication, stress and lack of awareness. However, all 12 were as significant contributing factors, with lack of
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... the causes of errors in ophthalmic surgery are typically multifactorial rather than sequential or linear Kristian Gerstmeyer MD
EUROTIMES | Volume 16 | Issue 7/8
knowledge rated lowest at 2.4. This suggests that like many other heavily studied safetycritical industries, the causes of errors in ophthalmic surgery are typically multifactorial rather than sequential or linear, Dr Gerstmeyer said. “At first glance, there is no need to modify the ‘dirty dozen’ concept.” Taking the analysis one step further, Dr Gerstmeyer found that just two factors – organisational context and social interaction – explained 59 per cent of the variance observed in the responses. Organisational context was highly correlated with fatigue, stress and pressure. Social interaction correlated with lack of teamwork, lack of communication, social norms and complacency. The relative loads of the “dirty dozen” categories also parallel those found in other industries, providing further evidence of the model’s validity, though Dr Gerstmeyer noted that the twodimensional human factors model and the questionnaire he presented are tentative, and more research is needed to validate this structure.
Team-building Many healthcare organisations have improved their clinical performance and their efficiency by applying teamwork techniques derived from aviation practices, Steve Harden, president of LifeWings in Memphis, Tennessee, US, told the 2011 ASCRS annual meeting. An airline captain and former TOPGUN fighter pilot instructor for the US Navy, Mr Harden consults on team-building with checklists in medical settings around the world. While acknowledging that medicine is vastly more complex than aviation, Mr Harden believes the major challenge is much the same – finding ways to mould a group of individual experts into an expert team that can flexibly meet any challenge by efficiently working together. To a great degree, this means overcoming communication errors by standardising communications and procedures, briefing team members before procedures, crosschecking each other’s work, and speaking up when something doesn’t seem right. This creates a framework in which decisions can be made and clearly executed based on the input of all team members. Daily debriefings to assess performance and improve procedures keep the process moving forward.
Steve Harden, president of LifeWings
The Dirty Dozen
Lack of resources Complacency n Lack of teamwork n Stress n Lack of communication n Distraction n Lack of knowledge n Lack of awareness n Lack of assertiveness n Fatigue n Social norms n Pressure Source: Gordon Dupont,1997; Kristian Gerstmeyer MD, 2010 n n
Courtesy of Steve Harden
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Airbus A-320 Dual Engine Failure Checklist
Checklists outlining the most important processes play a key role in keeping teams on track – but are often derided by clinicians as “cookbook medicine,” Mr Harden said. He points out that there are two kinds of checklists: a “read-and-do” checklist in which each step is laid out and you do it, then return to the list for the next task; and a “read-and-verify” checklist in which you perform tasks from memory and use the checklist to verify that the most important steps have been taken. “There are 65 things I must do to prepare an airplane before starting the engines, but only 11 of those items are on the checklist,” he said. The checklist is a way of hard-wiring correct procedures and communication into the workflow, but they only work if they are customised to the specific circumstances at hand, and used by the team leader to manage the process, Mr Harden said. “Checklists are a trigger to have a structured communication with the team. I use them as a tool to manage workflow.” Active leadership engagement is essential to avoid turning the checklist into a pro forma ritual. Also needed are training and efforts to standardise communication terms in the operating room, as well as coming up
with a term, such as “Delta,” that any team member can use to flag a potential problem. “Everyone stops and focuses on what they are doing to figure out what is wrong,” Mr Harden says. He reports significant reduction in medical errors in hospitals that have implemented such teamwork training and tools. Other benefits include improved employee morale and patient satisfaction. Mr Harden credits years of disciplined checklist-guided communication and teamwork activities with the successful resolution of one of the most famous aviation mishaps in recent history – the landing of an airliner disabled by bird strikes in the Hudson River in New York City. Captain Chesley Sullenberger III conducted pre-flight briefings with his crew – as well as a post-flight debriefing when they reached dry land after the rescue. “It was called a miracle. But it really was a demonstration of the adage that every system is perfectly designed to produce the results that it gets,” Mr Harden said. In this case, the system produced quick thinking and teamwork that saved more than 150 lives.
contact
Brad Shingleton – bjshingleton@eyeboston.com
Feature
PRACTICE DEVELOPMENT
SPARKING INNOVATION
Harvard Business School inquiry leads to innovation in the surgery suite by Howard Larkin
EUROTIMES | Volume 16 | Issue 7/8
Collaboration counts Clinical fellows in ophthalmology, optometrists and technicians routinely collect and analyse outcomes data on new surgical techniques, pharmacologic treatment, and other product and process changes, which helps ensure continuous quality improvement. It also means that Dr Shingleton is readily able to document the quality of his work. The clinic’s staff meets regularly to review performance and process changes. Dr Shingleton’s management style is to identify and correct errors as soon as they are made, which helps reduce future MENU
errors. But the work atmosphere is highly collaborative, and staff members are also semi-autonomous, authorised to make and analyse process changes on their own. For example, nurses began giving post-op patient instructions before surgery rather than after, in part to make better use of waiting time before surgery. Outcomes analysis showed that patients retained information delivered before surgery better than after, possibly because the patient is more alert and less distracted by the aftereffects of surgery. The change stuck. About three-quarters of staff-initiated process changes end up being adopted, Dr Shingleton says. This, too, is consistent with basic industrial process improvement theory, which holds that the people doing the job are in the best position to tell you how to improve quality – if you allow them. Not every surgeon is as comfortable with this level of delegation, nor as flexible in
Eye Chat with Oliver Findl
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Capsule Tears
Dr Oliver Findl talks with Boris Malyugin MD, PhD about capsule tears, perhaps the most dreaded intraoperative complication of cataract surgery.
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The students also asked why Dr Shingleton spent time at the beginning of each surgery adjusting equipment foot pedals and the operating microscope. Borrowing from industrial best practices, grids were developed so these items were in place when he entered the operating theatre. Templates were also developed to precisely position the bed and patients’ heads. All of this is now done by highly trained team members. “These changes alone save 30 to 60 seconds per case. That doesn’t sound like much, but when you are doing 30, 40 or 50 cases in a day this has a significant impact.” This extensive preparation also helps Dr Shingleton focus by eliminating distractions, he says. “It allows the surgeon to concentrate on what the surgeon needs to do, and to do the best job.” In the interest of increasing efficiency – and quality – Dr Shingleton also delegates many other pre-op, post-op, and followup tasks to his team of ophthalmologists, optometrists, nurses and technicians. Incoming patients are “triaged”, with routine follow-up and checkups performed by his personally trained team, reserving the bulk of Dr Shingleton’s time for more complex problems requiring his higher level of expertise.
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The business problem Dr Shingleton faced was declining reimbursement. He either had to accept lower pay or expand volume. With his surgical team already operating near its capacity, expanding meant increasing efficiency. Doing so without sacrificing clinical quality was the real challenge. The insights from the Harvard business students were invaluable, Dr Shingleton says. Work in the operating room was staged to minimise surgical time and turnaround between cases. For example, the students suggested that left eye and right eye cases be segregated, which made it easier and quicker to turnaround operating rooms.
Miguel Sousa Neves MD
EUROTIMES
Doing more with less
“All ophthalmologists should have some knowledge of healthcare management to improve their situations”
ESCRS
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radford Shingleton MD already had a thriving cataract and glaucoma surgical practice when he was approached in the late 1990s by Prof H Kent Bowen of the Harvard Business School. “Prof Bowen wanted to see if issues related to improving quality and production efficiency at Toyota could be extrapolated to the healthcare industry,” Dr Shingleton recalled. To that end, Prof Bowen sent students to observe and comment on how the practice operates. As a result, Dr Shingleton’s practice, Ophthalmic Consultants of Boston, has become one of the most studied and best known in all of ophthalmology. The analysis was published as a Case Study in the Harvard Business Review in 1997 and revised in 2008. It has been the basis for discussion at the ESCRS EuroTimes Practice Development Masterclasses presented in 2009 and 2010, and will be once again in Vienna in September. “The Case Study sheds light on many issues for professionals in developing a practice that meets business, professional and personal needs,” says Keith Willey BSc, MBA, of London Business School, who conducts the annual ESCRS Masterclass. Dr Shingleton says the exercise improved the efficiency and clinical outcomes of his practice. “Without question, the input provided was highly productive for me. We had bright, inquisitive minds who were not biased by medical training asking a lot of questions. My answer often was ‘we’ve always done it this way.’ It forced me to take an unbiased look at what I was doing.”
constantly changing care processes. Indeed, the 2008 Harvard Case Study identified the lack of adoption of Dr Shingleton’s methods by the 18 other surgeons at Ophthalmic Consultants of Boston as a significant dilemma. Accommodating Dr Shingleton’s unique scheduling needs and administrative practices to the overall practice has been problematic at times. In the ESCRS Masterclasses, Dr Shingleton’s approaches have also been the subject of lively debate. “All ophthalmologists should have some knowledge of healthcare management to improve their situations. To see what other doctors are doing helps me refine my own ideas,” Miguel Sousa Neves MD, of Povoa de Varzim, Portugal told EuroTimes at the Paris Masterclass. “It does not matter where you come from in the world, we are all doctors and we have the same problems. It’s good to come together with physicians of different ages and see the path they took to build their own clinic. They had the same challenges we are having,” said Herminio Luis Negri MD, of Buenos Aires, Argentina. While many physicians would be leery of airing the intimate details of their practice so publicly, Dr Shingleton is glad to do it. “If I can make things better for my patients, we have achieved our goal. If our experience benefits other surgeons and their patients, that is even better.”
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Oliver Findl
Boris Malyugin
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Feature
PRACTICE DEVELOPMENT
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10
DISASTER PLANNING
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Incoming patients also are screened for risks, such as any invasive neuro procedures such as spinal taps, neurosurgery or dura transplants, though the efficacy of this precaution is undetermined
Detailed preparation helps maintain patient services and aids recovery by Howard Larkin
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n 2005, the Ophthalmology Department at Hanusch Hospital, Vienna, Austria, received a disturbing call from the neurology service. They had admitted a patient they strongly suspected had prion disease. Six weeks earlier this patient had uncomplicated cataract surgery at the hospital, raising the possibility that subsequently treated patients had been exposed. “My predecessor immediately closed the operating theatres,” says Oliver Findl MD, Hanusch’s current ophthalmology chair. Seven days later the patient died. Pathology confirmed spongiforme encephalopathy and immunohistochemical evidence of prion proteins. While the risk of transmitting CJD via contaminated instruments was probably extremely low – in fact, no cases for cataract surgery have ever been reported – it could not be ruled out entirely. So, 153 patients treated after the infected patients were informed of their potential exposure in the presence of a psychologist, according to a published account in Spektrum der Augenheilkunde (2006) 20/4: 191-195. The hospital staff also could not be sure which operating rooms or instruments may have been contaminated directly or indirectly, nor could they be sure that their regular sterilisation routines eradicated the prion. So out of an abundance of caution, all operating rooms were decontaminated, and all instruments destroyed. During the seven working days this took, 111 admissions for surgery were cancelled and delayed. While this precise incident was not anticipated, Hanusch’s crisis staff was prepared. They immediately researched the disease and mobilised resources to contain it and inform the public. Nonetheless, the cost of this incident was estimated to have been e360,000. To reduce both the human and financial impact of future contamination events, including less lethal but more common threats such as toxic anterior segment syndrome, Hanusch implemented several new processes, Dr Findl says. These
include a bar-code tracking system for surgical instruments and phaco cassettes, which allows the hospital to track which devices were used with which patients, and which were processed together. This helps both narrow the universe of potentially contaminated devices, and identify potentially exposed patients. Pre-sterilisation cleaning processes have also been revised to reduce risks, and disposable instruments are used where possible. Incoming patients also are screened for risks, such as any invasive neuro procedures such as spinal taps, neurosurgery or dura transplants, though the efficacy of this precaution is undetermined, Dr Findl adds. With the science and regulation of hygiene ever advancing, keeping up takes effort and expertise. While large institutions like Hanusch generally have sufficient in-house resources, including dedicated infection control and risk management staff, to manage this kind of disaster, private clinics and small units may not, Dr Findl notes. These practices may be best served by outsourcing instrument sterilisation, and hiring consultants to ensure ongoing compliance, he suggests. The cost of such prevention may be high – but the human and financial cost of even one avoidable outbreak could easily be much higher.
Threat assessment An infection outbreak is just one of a nearly infinite range of disasters that can strike a practice. These include relatively common accidental events such as fires and power loss due to winter storms, all the way up to hurricanes, floods and the combined earthquake-tsunami-nuclear meltdown now under way north of Tokyo. And then there are man-made threats, such as bomb threats, robberies and terrorist attacks. Any one of them could temporarily compromise your ability to deliver patient care, or even shut down your practice permanently, says Owen Dahl, Houston, US, author of The Medical Practice Disaster Planning Workbook (Greenbranch Publishing, 2000-2009).
Don’t miss Highlights from 11TH EURETINA Congress, see page 28 EUROTIMES | Volume 16 | Issue 7/8
Mr Dahl recommends assessing your specific physical and medical risks, and preparing a plan to address them. The overall goals are to survive the event, maintain services if possible, and re-establish your business. Among the universal precautions he advises: n
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Protect medical records – Access to records can allow you to practice even if your physical location is completely destroyed. This is easy for practices with electronic records. Install fireand-water-resistant drives on-site, back up off-site, or even use a remotehosted record system. Paper records are tougher. On-site record rooms should be behind firewalls and resistant to floods. Off-site copies should be kept in facilities with similar protections. Maintain patient communications – Major disasters, such as earthquakes, hurricanes, floods, often disrupt both landline and mobile phones. HAM or citizen band radios and satellite phones can reestablish immediate communication. Forwarding practice communications to an answering service or information recording can help, as can updating a practice Website. Broadcast TV and radio may also be important communication tools.
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Prepare employees – All practice staff should know who to contact and what to do in an emergency. Phone trees may come in handy.
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Coordinate with local hospitals and emergency agencies – Hospitals, fire departments, police and regional and national medical and emergency response agencies typically have detailed plans. Coordinate your plans with theirs.
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Pack an emergency kit – It should include clinical items you may need in an emergency as well as documents – such as your medical licence or other credentials – that you may need to work even in an emergency situation.
Oliver Findl – oliver@findl.at
Oliver Findl MD You may also want to take important financial information, chequebooks, contracts or other business-related papers that will help you restore your practice after a disaster. n
Get proper insurance – This is especially important for private practices. Make sure your equipment and premises are covered sufficiently to replace them if needed. Loss-ofincome insurance may also be worth looking at if it can be had. Also be sure to document your practice equipment with photographs, purchase receipts and other documents that may be needed to file a claim.
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“It’s not just the headline event you should worry about. It’s much more likely to be a fire or flood or accident,” Mr Dahl says. But if you’re prepared, it won’t be the end of the world.
The Medical Practice Disaster Planning Workbook Owen Dahl (Greenbranch Publishing, 2000-2009)
ESCRS
EUROTIMES
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During the XXIX Congress of the ESCRS Reed Messe, Vienna, Austria
Practice Development Workshops
Saturday 17 September – Sunday 18 September 2011
Marketing Your Practice Saturday 17 September Rod Solar, LiveseySolar Practice Builders Market positioning and competition n Developing a website and internet marketing n Bringing new patients to your practice n Improving patient communications and services n
Managing Your Practice Sunday 18 September Paul McGinn, Barrister At Law, Eurotimes Editor Tom Harbin, MD and Author of “What Every Doctor Should Know but was Never Taught in Medical School” Kris Morrill, Managing Director, Kam Communications Effective practice management n Your practice management bag n Staffing requirements and incentivising staff n A legal audit for your practice n
Workshops are free of charge but capacity is limited. Early registration is essential at www.escrs.org
Cataract & refractive
contacts
Update
Hyperopic patients
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While the results were not as good for the larger treatments, the findings were an improvement on earlier studies
Where to draw the line with LASIK? by Gary Finnegan in Brighton
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sing an excimer laser to perform large corrections in hyperopic patients can lead to poor outcomes, particularly in older people. However, consensus on where to draw the line in terms of magnitude of correction and patient age is hard to find, particularly as technology has helped reduce the risks. Some surgeons say using the excimer for treatments greater than 3 D is too risky while others will go as high as +6 D, arguing that alternative treatments for hyperopic patients are far from risk free. Julian Stevens MRCP, Moorfields Eye Hospital, London, told the UKISCRS annual meeting in Brighton that while excimer laser surgery is very effective for smaller treatments, it is not an option for larger corrections. “Large treatments should be avoided. The treatment of hyperopia by excimer laser surgery has been available since the mid-1990s but debate continues as to what are the age and degree limits. I argue for modest limits, rather than the wide limits
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Large treatments should be avoided. The treatment of hyperopia by excimer laser surgery has been available since the mid-1990s but debate continues as to what are the age and degree limits Julian Stevens MRCP
advocated by some others, because of the complications that can arise,” he said. Dr Stevens said one of the key questions is how steep surgeons should make the cornea, given that tear-film behaves differently on a highly curved surface that is held vertically. “You get a very fast tear film break-up time when the cornea is very steep. Even small amounts of tissue elevations or depressions on a curved surface have a large optical effect. So the current consensus is that the maximum keratometry should not exceed 48 D in the steepest meridian or spherical equivalent,” he said. He presented findings of a study by Williams and co-workers that looked at end outcomes of hyperopic LASIK in a group of patients where the mean treatment performed was 3.5 D. For those corneas that were relatively less curved, less than 43 D to begin with, four per cent lost two lines of best-corrected visual acuity (BSCVA). For the steeper corneas, greater than 43 D to begin with, 40 per cent lost BSCVA of two lines or more. Dr Stevens noted that hyperopic treatments tend to result in some reduction in corrected acuity but losing two lines is a significant loss. The impact of this on patient satisfaction is, unsurprisingly, severe. “In terms of satisfaction, the score is really low in the steep corneas group. A steeper post-op K is 10 times more likely to lose two or more lines of BSCVA – that is a huge statistic. There is no getting away from it. It doesn’t matter which laser system you use, you still have the issue of basic optics: subtle irregularities on a steep cornea have huge optical effects,” he said. “For patients with a flatter cornea to begin with there is slightly less loss of visual acuity. So a steep cornea to begin with
and a big treatment are associated with the worst outcomes,” he told the meeting, adding that predictability is very poor in these patients. Dry eye can also pose problems with steeper corneas and, unlike myopic dry eye that resolves with time, these patients will suffer persistent symptoms. When it comes to setting an age limit, Dr Stevens said that most patients aged 60 years and older have significant lenticular change and he tends to exercise caution with those above 55 because of dry eye. Mark Wevill MD, who practices in Birmingham, UK, took a somewhat less conservative view. He told EuroTimes that while some surgeons are happy to perform corrections of up to +6 D, he personally uses an upper limit for hyperopic LASIK LVC of +4 D in his own practice. Addressing the UKISCRS annual meeting, he played devil’s advocate in the interest of debate and set out the arguments against Dr Stevens’ approach. Dr Wevill said a landmark study published by Varley in 2002 had recommended that corrections of up to +3 D LASIK are safe and effective while the case for up to 5 D was described as “less compelling”. However, he noted that the technology on which much of that evidence is based date back more than 10 years. Looking at some more recent work changes the picture, he said. A paper by Kanellopoulos in 2006 used a small-beam Allegretto laser, which has a tracker, to treat patients up to +6 D. “While the results were not as good for the larger treatments, the findings were an improvement on earlier studies. Also, it was found that no patients lost more than two lines of acuity,” said Dr Wevill.
Julian Stevens – info@julianstevens.co.uk Mark Wevill – mail@wevs.fslife.co.uk
Mark Wevill MD
He said the advantages brought by new technology and techniques have improved outcomes. Larger optical zones, sixdimensional trackers, improved registration and centration and femtosecond flaps are some of the factors that have helped give better outcomes, Dr Wevill said. Femtosecond flaps have been shown to give less dry eye, less aberrations, and a faster recovery, he added. Based on his own team’s results with 1,192 eyes, he said results were still very good at +3 D with somewhat diminishing results after +4, and a decline is seen above +5 D. “So up to about +5 D we’re getting good results. We’re not talking in a vacuum when discussing laser vision correction; we’ve got to look at the alternatives. IOLs also have limitations and risks,” he said. The alternatives include phakic lenses, but many eyes are excluded if they have shallow anterior chambers, and there are sight-threatening risks such as acute angle closure glaucoma and endophthalmitis. Another option, refractive lens exchange, also carries risks of vitreous degeneration, retinal detachment, endophthalmitis and can result in reduced best-corrected visual acuity. “Many authors now consider that LVC treatment of up to +6 D to be safe and effective with modern lasers. You still have issues with regression and so on, but those issues have diminished. There’s more predictability and better safety, with around two per cent losing two lines of visual acuity. That seems a reasonable trade-off for most patients to consider laser correction for their hyperopia,” he said.
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Update
Cataract & refractive
IOL POWER
Post-refractive surgery eyes pose problems for IOL strength calculations by Dermot McGrath in Paris
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ataract surgery after corneal refractive surgery can be particularly challenging for the surgeon because of the difficulty of obtaining accurate intraocular lens (IOL) power, with unexpected refractive surprises. Understanding the source of these errors can help the surgeon to plan appropriate treatment strategies, according to Cati Albou-Ganem MD. “Patients who have previously undergone refractive surgery want to achieve spectacle independence after their cataract surgery. The calculation of the implant is a real challenge for these patients, with errors after refractive surgery occurring at a number of different levels. Furthermore, certain residual ametropias may be badly tolerated by the patient and necessitate surgical correction,” Dr Albou-Ganem MD told delegates attending the French Implant and Refractive Surgery Association (SAFIR) annual meeting. Identifying the principal sources of error in post-refractive surgery eyes, Dr Albou-Ganem noted that the direct use of the standard IOL power formulas, which incorporate keratometric values with no allowance for previous surgical procedures, result in less accurate calculation of IOL power. “The measurement of the anterior corneal radius is systematically incorrect, since it is not performed on the central cornea, but more peripherally. After myopic laser surgery, the measured radius of curvature will be too small, resulting in an over-estimation of the power of the implant,” she said. Another source of error derives from the fact that the keratometry readings assume a constant ratio of anterior to posterior radius in these eyes, whereas in reality the ratio has been deliberately changed by the refractive procedure. Finally, Dr Albou-Ganem noted that some IOL formulas induce further errors by using prediction algorithms for the postoperative effective lens position that make use of corneal power without adjusting for the impact of refractive surgery on the likely IOL position in those eyes. Taken cumulatively these errors may result in an over-estimation of the corneal power after myopic refractive surgery due to an under-estimation of the power of the implant, potentially inducing a hyperopic shift after phacoemulsification. Conversely, after laser
EUROTIMES | Volume 16 | Issue 7/8
refractive surgery for hyperopia, inaccuracy in the keratometric power estimation could result in a myopic outcome after cataract surgery, warned Dr Albou-Ganem. Errors derived from keratometry readings, which assume a constant ratio of anterior to posterior radius, can be avoided if the surgeon takes account of the patient’s refractive history, said Dr Albou-Ganem. For this purpose, keratometry data prior to the refractive procedure as well as the exact knowledge of the achieved change in refraction is necessary. Using more recent formulas such as the Haigis-L algorithm, which is available on the IOLMaster, also allows surgeons to obtain more predictable outcomes for LASIK cases where the refractive history data is not available, said Dr Albou-Ganem.
Fixing post-op errors In order to correct refractive errors due to incorrect power calculations, Dr Albou-Ganem said that several surgical options such as laser refractive surgery, implant exchange, piggyback implantation, or the use of an adjustable implant may be proposed. Looking at these options in turn, Dr Albou-Ganem said that LASIK, and in particular femtosecond-laser refractive surgery, is a technique which works well for cases where the initial refractive surgery procedure was performed using PRK. For those patients whose initial refractive surgery was a LASIK procedure, this may pose some problems for lifting the flap or creating a new flap in a secondary LASIK surgery. Using OCT for such cases allows the surgeon to accurately measure the thickness of the first flap in order to safely programme the secondary flap creation, she said. She added that the refractive results for LASIK to correct ametropia after cataract surgery showed very good efficacy and predictability in line with the initial refractive outcomes, and seemed to have no negative effects on the implant position, intraocular pressure or the retina. PRK can also be envisaged if the first surgery was a PRK procedure, if the residual ametropia is moderate or if the time between the cataract surgery and the PRK has to be reduced, she said.
contact Cati Albou-Ganem – cati.ganem@wanadoo.fr
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Update
Cataract & refractive
POST-LASIK DRY EYE
Pre- and postoperative examination of ocular surface key to optimum prevention and treatment by Roibeard O’hEineachain in Istanbul
Diffuse lamellar keratitis
Epithelial ingrowth
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efractive surgeons can reduce the incidence of persistent postLASIK dry eye through careful examination of the ocular surface, and by employing remedial treatments both pre- and postoperatively, said Beatrice Cochener MD, University of Brest, France. “Preoperative assessment is crucial to minimising the risk of dry eye following refractive surgery. It enables us to identify those with subclinical dry eye who might be at risk for more severe form postoperatively, and can help us decide whether to cancel the procedure or consider a surface ablation,” she told delegates at the 15 ESCRS Winter Meeting. She noted that the diagnosis and treatment of dry eye has changed over the past 10 years in tandem with the definition of the disease. In the 1990s the standard description of the disease tended to focus on poor tear production, whereas more modern definitions stress the multifactorial nature of the condition, including such factors as changes in tear film quality and inflammation of the ocular surface. “The underlying mechanism of dry eye is that alterations in one or several components of the ocular surface system
EUROTIMES | Volume 16 | Issue 7/8
result in changes in the tear film and/or corneal epithelial surface composition, which in turn leads to epithelial damage, inflammation and a chronic deregulation of the ocular surface system,” she said.
Dry eye after LASIK Some dryness of the ocular surface is very common during the first three months following LASIK, with an incidence that can go up to 50 per cent, Prof Cochener said. Although it is generally mild and responsive to lubricants, 10 per cent of LASIK patients report severe discomfort from the condition. Dry eye symptoms include a foreign body sensation, burning, itching, stinging and lid heaviness. Visual symptoms include fluctuating acuity, degradation of vision quality with an increase of HOA, a decrease in BCVA, glare and night vision problems. The theories as to how LASIK induces this complication tend to centre on the disruption in the feedback loop for tear secretion through the severing of corneal nerves by the microkeratome and the ablation, Prof Cochener noted. “The severing of a large number of afferent sensory nerve fibres during the lamellar cut impacts the integrated lachrymal gland/
Beatrice Cochener – beatrice.cochener@ophtalmologie-chu29.fr
Furthermore, dry eye can contribute to flap complications, such as persistent corneal defect epithelial cell in-growth, and diffuse lamellar keratitis. It can also contribute refractive regression, and can be a factor in infectious keratitis. The therapeutic strategy for dry eye depends on the severity of the condition. In milder cases, preservative-free artificial tears are the first line of defence. More severe cases may respond to twice daily administration of 0.05 per cent Cyclosporine A eye drops, which can be combined with anti-inflammatory agents. Bandage contact lenses are very useful when the condition occurs following PRK.
Courtesy of Beatrice Cochener MD
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Infectious keratitis
ocular surface system and the alteration of the corneal shape leads to a change in the tear film dynamics,” she added. The reduced sensitivity of the ocular surface reduces the blinking and basal and reflex tear production. Meanwhile, the alteration of corneal shape alters tear film distribution and changes the relationship between the ocular surface and the upper lid, increasing evaporative tear loss. Moreover, the lachrymal regulation loop has a central role in epithelial wound healing, she said. The lachrymal gland produces cytokines that modulate corneal epithelial proliferation, migration, and differentiation, all of which are normally increased in epithelial wound healing, she pointed out. In addition, research has shown that the reduced tear function following LASIK can increase the tear film’s osmolarity, which in turn increases the production of pro-inflammatory cytokines by limbal epithelial cells and increases the amount of matrix degrading enzymes in the tear film, she noted. The resulting inflammation can directly damage the ocular surface epithelial cells and thereby prolong injury to corneal nerves.
Identifying those at risk The principal risk factor for post-LASIK dry eye is the presence of preoperative ocular dryness, which is often subclinical, Prof Cochener noted. There are strategies to help identify patients with milder and even asymptomatic amounts of dry eye, which can help designing treatment plans that will reduce postoperative manifestations. The first step in measuring ocular dryness is to interview the patients regarding their symptoms, and review their clinical history. Afterwards the physician should evaluate the three major components of the tear film, the aqueous layer, by the Schirmer’s test, the mucin layer by the breakup time and lissamine green staining, and the lipid layer by lid examination. Prof Cochener said that although these tests measure factors that are all involved in the pathophysiology of dry eye, their results actually do not correlate with patients’ symptoms. She noted that a new objective test for tear film osmolarity is showing promise in predicting which patients are more likely to require additional treatment to alleviate their symptoms. The new device, called Tear Lab (Tear Lab Corp/MedEuronet) provides a fast, noninvasive test for tear osmolarity and requires only 50 nL of tears. In a study involving 18 PRK candidates and 10 control patients with no known dry eye, the Tear Lab testing device detected mild-to-moderate dryness in 44 per cent of patients. She noted that although preoperatively there was no correlation between hyperosmolarity and subjective discomfort scores, those with higher preoperative osmolarity scores spontaneously chose to use a greater amount of eye lubrication postoperatively. “Tear osmolarity can define a preoperative predisposed population deserving a pre- and postoperative treatment of dryness to avoid patient disappointment. This new tool appears to be at that day an interesting instrument to add in clinical trials about ocular surface,” she said.
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Update
Cataract & refractive
Presbyopic LASIK
New technique enhances near vision without reducing distance vision
Courtesy of Stephen Slade MD
by Roibeard O’hEineachain in Istanbul
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reliminary results with a new refractive laser technique called Supracor, a LASIK procedure that steepens only the central cornea, appears to be very effective in improving the near visual acuity in hyperopic presbyopes, said Stephen Slade MD, Houston, Texas, US. In a study involving 40 eyes of 20 presbyopic patients who underwent the new LASIK procedure, uncorrected near visual acuity (UCNVA) at one month’s follow-up was 20/32 in 88 per cent of eyes, and 20/20 or better in 38 per cent. No eyes lost more than one line of corrected distance visual acuity (CDVA), with 100 per cent achieving 20/25 or better CDVA and 88 per cent at 20/20 or better, Dr Slade said at the 15th ESCRS Winter meeting. The patients in the study had a mean age of 49.6 years. The mean preoperative spherical equivalent refraction of the Supracor-treated eyes was 1.25 D. All patients underwent Supracor in one eye and conventional LASIK in their other eye with the Technolas laser (Carl Zeiss Meditec). “Like Intracor, Supracor increases the steepness of the central cornea but leaves the remaining cornea unchanged (see image above). However, unlike Intracor, which involves the creation of nested cylinders within the stroma to create its effect, Supracor can be combined with other LASIK treatments for hyperopia and astigmatism and myopia,” Dr Slade noted. Among 14 eyes with six months of followup, UCNVA was 20/32 or better in all eyes, 20/25 or better in 92 per cent and 20/20 or better in 64 per cent. In addition, uncorrected distance visual acuity (UCDVA) was 20/40 or better in 90 per cent of eyes throughout EUROTIMES | Volume 16 | Issue 7/8
The central steepening of the procedure is evident in this Orbscan change map showing the difference between pre- and postoperative corneal curvature
the follow-up period and 20/32 or better in around three quarters of eyes. By comparison, only 76 per cent were 20/40 or better preoperatively. All had a corrected distance visual acuity (BCDVA) of 20/20 or better from one month postoperative onward. Only one eye lost a line of BCDVA and among 14 eyes with six months of follow-up seven had gained one line of best-corrected visual acuity. Binocular UCNVA was 20/25 or better in 90 per cent of 20 patients at one month, 85 per cent of 20 patients at three months and all eight patients tested at six months. Binocular UCDVA was 20/25 or better in all patients and 20/20 or better in 87 per cent of patients tested at one month, 100 per cent tested at three months, and 87.5 per cent tested at six months. Furthermore, in response to a questionnaire at three months’ follow-up, 74 per cent of patients said they could read newspapers without glasses, compared to only nine per cent preoperatively. 78 per cent said they could read menus and package inserts without glasses, compared to only 18 per cent and 21 per cent preoperatively. In addition all except for one of 27 patients said they would undergo the procedure and even that patient would recommend the procedure to a friend. “Preliminary results find this presbyopic LASIK treatment provides good improvement in near vision to treat presbyopia, without compromising distance vision. The algorithm allows enhancement to adjust the target sphere. A myopic presbyopic study will be undertaken in the near future,” Dr Slade added.
contact
Stephen Slade – sgs@visiontexas.com
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Update
Cataract & refractive
PROMISING IOL
Early test shows excellent uncorrected VA, rotational stability by Howard Larkin
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ne-month results of a new microincision toric aspheric intraocular lens from HOYA (Tokyo, Japan) yielded better mean uncorrected distance visual acuity than previously reported toric IOL results. Of the 19 eyes in 14 patients implanted, all but one achieved UDVA of 20/25 or better. Stability was also good, with mean rotation of 3.66 degrees from baseline, similar to published studies of other widely used toric lenses. “Our UDVA was better than previous reports,” Hiroko Bissen-Miyajima MD,
PhD, Tokyo, Japan, told a symposium of the 2011 ASCRS annual meeting. Longer follow-up with more patients is needed to confirm the results, she acknowledged. Such studies are under way. The patients in this report were all operated on by one surgeon as part of a larger trial involving more than 100 eyes in Japan. Other trials of the new HOYA NHT toric IOLs are under way in other countries.
Microincision toric lens All lenses were injected using a cartridge through
HOYA toric microscope
2.0mm incisions. This lens can be implanted through a 1.8mm incision if the surgeon uses a scleral incision. This is a smaller incision than other toric lenses now on the market. The theoretical advantage is a reduction in induced corneal astigmatism, potentially allowing a more-precise cylindrical correction and better visual outcomes. Mean preoperative corneal astigmatism was 1.59D +/-0.645, ranging from 0.75D to 2.94 D. Axial length averaged 23.7mm +/-0.79, ranging from 22.9 to 25.3. Axial length and keratometry were measured with an IOL Master (Carl Zeiss Meditec, Jena, Germany), and lens power calculated using the SRK/T formula. IOL models were selected using the HOYA Toric Calculator. Toric lenses in three cylindrical powers were implanted: nine eyes with the +1.5 D NHT15; six eyes with the +2.25 D NHT23; and four eyes with the +3.0 NHT30. Proper axis registration was superimposed on topography maps and marked on the cornea and conjunctiva before surgery. Distance corrected and uncorrected visual acuity, corneal and manifest astigmatism and IOL rotation were measured one day, one week and one month after implantation. A wavefront analyser was used to measure rotation by comparing total aberration and corneal aberration. This method is far more accurate than measuring slit lamp photos with a protractor, yielding a precision of 1.0 degree compared with the five to 10 degrees, Dr Bissen-Miyajima said. Uncorrected and corrected distance visual acuity improved significantly on one day post-op, and was stable with no statistical differences at one day, one week and one month after surgery. At one month, all eyes achieved 0.7 or better uncorrected, while 73.7 per cent achieved 1.0 or better. The 94.7 per cent at 20/25 or better compares favourably with reports in the literature for toric IOLs, which range from 66.6 per cent (Mendicute J et al, J Cat Ref Surg 2008; 34(4):601-7) to 84.3 per cent (Ruiz-Mesa Am j Ophth 2009; 147 (6): 990-996).
ESCRS Membership
Hiroko Bissen-Miyajima – bissen@tdc.ac.jp
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This method is far more accurate than measuring slit lamp photos with a protractor, yielding a precision of 1.0 degree compared with the five to 10 degrees
Hiroko Bissen-Miyajima MD, PhD
Courtesy of Hiroko Bissen-Miyajima MD, PhD
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HOYA toric
Corneal astigmatism values were not statistically different after surgery, with a mean difference of just 0.13 D. On the other hand, mean manifest astigmatism dropped from -1.63 D pre-op to -0.39 at one month, statistically significant at p< 0.01.
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Update
Cataract & refractive
post lasik
Laser proves safe and effective for epithelial ingrowth after LASIK by Dermot McGrath in Paris
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EUROTIMES | Volume 16 | Issue 7/8
Epithelial ingrowth before YAG treatment
Courtesy of Patrick Desprez MD
ost-LASIK epithelial ingrowth can be effectively treated using an Nd:YAG laser, a new French study suggests. “Nd:YAG treatment is efficient and is very simple to put in place. It also has the advantage of posing no risk of secondary iatrogenic complications and it is very well tolerated by the patients. The results thus far are very promising indeed and it gives us a viable alternative or complement to conventional treatments for the condition,” said Patrick Desprez MD. Addressing delegates attending the French Implant and Refractive Surgery Association (SAFIR) annual meeting, Dr Desprez in private practice in Nice, France, said that the Nd:YAG laser has become his treatment of choice for dealing with troublesome cases of epithelial ingrowth. Although relatively rare, the incidence of epithelial ingrowth is believed to vary considerably depending on the surgical techniques used, the method used to create the flap and whether the LASIK is a first-time procedure or a retreatment. The ingrowth may take weeks or months to become apparent and may cause blurred or distorted vision or flap melt if left untreated. The traditional treatment for epithelial ingrowth is to surgically re-lift the flap and mechanically remove the epithelial cells underneath it. The exposed stroma and the intern layer of the flap is then treated – sometimes needing an application of dilute alcohol solution to prevent epithelial cells from regenerating – and the flap is replaced. While this traditional method is usually effective, it is also associated with a high risk of recurrence of epithelial ingrowth as the stromal bed has once again been exposed as it was during the original LASIK procedure. Re-lifting a flap that has adhered to the underlying cornea as part of the postoperative healing process can also be problematic. By contrast, early intervention with the Nd:YAG laser at the first manifestation of mild-to-moderate epithelial ingrowth provides a straightforward and effective means of tackling the problem, restoring lost visual acuity and preventing the development of more serious problems, said Dr Desprez. Discussing the surgical steps, Dr Desprez said that the eye is first prepared with topical anaesthesia and then the Nd:YAG laser is
Immediate view after YAG treatment
focused on the level of the epithelium of the cornea, and then the beam is defocused at 125µ backwards in order to reach the area of epithelial ingrowth. “We set the laser at an energy level that is as weak as possible, usually in the range of about 0.6 mJ. to 0,9 mJ. The goal is to obtain a bubble in the interface, a little bit like we used to do with argon laser trabeculoplasty. When we see a bubble in the interface it means that the laser is focused on the right area and also that the energy being directed is sufficient to remove the epithelial ingrowth,” he said. The treatment is started in the centre of the area of epithelial ingrowth, then enlarged gradually towards periphery. If a fistule exists with the periphery of the flap, it is important to seal it with YAG spots also. Once the Nd:YAG session has ended, the patient is fitted with a contact bandage lens and given a course of antibiotic and AINS drops for the immediate postoperative period. The epithelial ingrowth usually disappears three to four weeks after treatment, although in some cases a second Nd:YAG might be necessary to remove the ingrowth.
contact Patrick Desprez – docteur-desprez@orange.fr Icare_eurotimes_ilmo.indd 1
5/30/11 9:34 AM
European Society of Cataract and Refractive Surgeons
Board Elections 2011 ESCRS Board elections to be held this summer Board elections are held every two years. ESCRS Board members serve for a term of four years and can be re-elected for one additional four-year term. Board members must have been a full member of the ESCRS for the last three consecutive years and each candidate standing for election must be nominated by five other full members of the society. Voting will take place online at: www.escrs.org/elections. Please note that only full members are entitled to vote. You will need your member username and password to log in. Voting closes on 31 August 2011. There are four positions open on the Board in this election and the names of the new Board members will be announced at the Annual General Meeting of the society in Vienna in September. The nine candidates standing for election are profiled below.
After graduating from Ankara University Medical School and completing my residency training in ophthalmology at S B Ankara Hospital, I did a vitreoretinal fellowship in Cambridge, UK. I am currently clinical director of TOBB Economy and Technology University Hospital Eye Clinic. I was one of the people who initiated modern eyebanking in Turkey. I have been author and co-author of papers and abstracts in peer-reviewed journals and book chapters.
Bekir Sıtkı Aslan Turkey
I am president of the Turkish Cataract and Refractive Society and have served as a co-opted Board member of the ESCRS since 2008. I am the editor of EuroTimes Turkey and am a member of the EuroTimes Editorial Board. Since my first meeting in 1987, the ESCRS has played a central role in my professional development through its annual meetings, journals, and educational programmes. I have been impressed by the leadership and vision of the ESCRS as it addresses the future of ophthalmology in a changing healthcare system. As a team, we can affect progress with medical education, physician/patient relations and medical advances.
Dan Epstein has been active within the ESCRS for the past 13 years. He has been a member of the Programme Committee among others, an initiator and faculty member of the Refractive Surgery Didactic Course, lecturer at the Young Ophthalmologists Programme, faculty at various ESCRS instructional courses, senior wetlab instructor, and the Programme Committee member responsible for the organisation of the main ESCRS symposia at the annual and winter meetings for the last eight years.
Dan Epstein Switzerland
If elected to the Board, he hopes to build on his teaching and organisational experience to expand the ESCRS’s role in providing superior educational programmes for Europe and beyond.
I am honoured to be nominated for the Board Elections. I hope to contribute a unique perspective, representing the interests and concerns of the general membership of the ESCRS.
I grew up as a child and teenager in Athens, Greece. My medical background includes medical degree in 1990, ophthalmology in 1994, sub-specialty with clinical fellowship in cornea transplantation and refractive surgery, and an additional clinical fellowship in glaucoma at the universities: Southern Illinois, State University of NY, Cornell and Harvard Medical School.
A John Kanellopoulos Greece
Since 2001, I have been practising in Athens, Greece. I became a member of the ESCRS in 1997 and have remained active in the scientific endeavours of the society; I participated in every annual meeting and most winter meetings, and contributed to over 30 didactic courses as an instructor, over 100 original paper/poster presentations, resulting in numerous original scientific published papers and book chapters (please refer to my online CV at www.laservision.gr for more detailed information). Mostly due to this scientific contribution I was elected as clinical professor with the Department of Ophthalmology at the New York University in 2010. I hope that my election as a Board member, along with my enthusiasm and hard work, will enable me to further contribute to the organisation of productive meetings, the education of younger colleagues and the propagation of the society’s mission. I am married and have 3 children.
He has been consultant ophthalmologist for refractive surgery at the Department of Ophthalmology, University Hospital, Zurich for 15 years, having previously held an appointment at Uppsala University Hospital in Sweden. Earlier he had received a PhD from the Karolinska Institute after completing his residency at the Karolinska University Hospital in Stockholm. In addition to collaboration with several universities and clinics in Europe and running a private practice, he is also active in research and the publication of papers, and has just completed a 15-year appointment as an editor of the Journal of Refractive Surgery.
Over the last number of years I have served the society as a Committee member and it has been a great pleasure and challenge. I am professor of ophthalmology at the Department of Cataract & Implant Surgery and chief at the S Fyodorov Eye Microsurgery Complex State Institution in Moscow.
Boris Malyugin Russia
If I have the chance to be elected to the ESCRS Board, I will continue doing my best to strengthen the relationships between the European ophthalmological community and eye care professionals from Russia and surrounding countries, to stimulate the exchange of new ideas, develop joint educational and research projects and spread the spirit of integrity.
Simonetta Morselli Italy
I fell in love with ophthalmic surgery when I graduated from medical school and was a fellow doctor in ophthalmology from 1991 to 1995. After graduating in ophthalmology in 1995 I worked with Dr Roberto Bellucci at the Verona Hospital and became the director of anterior segment surgery until 2008. In October 2008 I became the director of the Ophthalmic Department at the Bassano del Grappa Hospital, 60km from Venice. On 1 April 2011 I became the director of the Specialist Surgery Department at the hospital, with the directors of the Ear-andnose, Maxillofacial, Urology and Orthopaedic Departments all reporting to me. If elected, I will do my best to maintain the ESCRS society at the high level it is today. I would try to standardise cataract and refractive surgery techniques in Europe and put in place standard guidelines and indications for cataract and refractive surgery for all the society members.
Thomas Olsen is head of the Cataract Service Center at the University Eye Clinic, Aarhus University, Denmark. For many years his main interest has been the optical benefit of modern lens surgery with the emphasis on biometry and the evolution of the latest generation IOL power calculation formulas. He has developed the computer program PhacoOptics ® to assist surgeons in the calculation of IOL power and designed electronic case record systems for cataract patients.
Thomas Olsen Denmark
In the years 1999-2004 he served as chairman of the Danish National Cataract Outcome Registry. Since 2006 he has been president of the Scandinavian Society of Cataract and Refractive Surgery (SSCRS). He is a member of the Scientific Committee of the German Ophthalmic Surgeons (DOC). Since 2007 he has been an ESCRS Board member. He is co-founder and secretary of the IOL Power Club, a newly established group of scientists devoted to the refractive aspects of biometry and IOL power calculation.
I would like to improve the active web contact and interaction between the members, and create a web forum to facilitate the sharing of surgical pre- and postoperative experiences. Thank you in advance for your support during the elections for the ESCRS Board members.
I have served as Board member and president of the ESCRS with pleasure over the last six years, initiating and contributing to a plethora of successful projects, (eg, two courses on visual optics and refractive surgery, video posters, the EUREQUO Registry and the creation of the Education and Humanitarian Committees).
As a head-surgeon of Gemini Eye Centers, Pavel Stodulka performs a wide range and high volume of surgeries from cataract and refractive through glaucoma to vitreoretinal and corneal surgery. He was the first surgeon in his country to perform LASIK (1994), epi-LASIK (2004), femtosecond laser LASIK (2006) and MICS (2001). He was also the first in his country to treat retina with Avastin (2006) and one of the world pioneers in DMEK (2004).
My aim has always been the correct promotion of our society, as we offer a unique forum for discussion and learning, ensuring that international expertise is shared by ophthalmologists across Europe.
Ioannis Pallikaris Greece
Of paramount importance to me is improving the quality of life of the European patient, promoting the visions and aims of our society and - by extension - our profession as a whole, entirely without the necessity of personal, financial or other gain. Indeed, my own activities personally and professionally have, I feel, contributed positively to the public image of our society, while personal or institutional financial benefit has never constituted an incentive. I hereby confirm my willingness to stand as Board member of the ESCRS again and thank you for your ongoing support, without which so much would never have been achieved. Rest assured of my continued interest and wholehearted dedication to the aims of the ESCRS.
Kaarina Maunontytär Vannas was a founding member of the Finnish Society of Cataract and Refractive Surgeons. Secretary from 1996-2006 and chairman from 2006-2010, she is now professional relations officer of the society. Dr Vannas was also a Board member of the Finnish Society of Ophthalmology, treasurer from 2002-2004 and negotiating member from 2004-2008. She is vice-president of the Scandinavian Society of Cataract and Refractive Surgery.
Kaarina Vannas Finland
She has completed various fellowships including: postdoctoral student at the Department of Ophthalmology, University of San Francisco 1980-82 residents’ programme; laboratory research on gyrate atrophy of the choroid and retina; neuro-ophthalmology fellowship with Dr William Hoyt 1981. She was certified in ophthalmology from the Helsinki University Eye Clinic in 1986 and completed a thesis on gyrate atrophy of the choroid and retina in 1989. She completed her subspecialty degree in ophthalmic surgery in 2001 and EBO certification in 2007. Currently she performs cataract surgery and oculoplastics at Helsinki University Eye Hospital and private clinics. Dr Vannas has been an ESCRS Board member since 2007 and is a member of the Programme Committee. Her goal is to continue working for high-level ESCRS meetings and cherish companionship and sense of communality within all levels of ESCRS.
Pavel Stodulka Czech Republic
He successfully treated several blind patients for over 10 years with Boston KPRO artificial cornea. One was blind for 53 years, which might be the longest blindness ever cured, according to the literature. The president of the Czech Republic is his patient. He holds a teaching position at Charles University in Prague. For many years he has educated residents and fellows, and has given over 500 lectures, mostly in Europe and North America. He has dual Czech and Canadian citizenship, speaks fluent English and Russian. He was a member of the ESCRS Quality Management Committee and is an instructor for the basic phaco course at ESCRS meetings. As a member of the Board he would like to pursue education and innovation, and the exchange of information with other specialties.
To vote go to www.escrs.org/elections Voting closes on 31 August 2011
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Update
CORNEA
Corneal blindness in Asia
New Sri Lankan eye bank providing high-quality corneas by Sean Henahan
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ith the recent opening of the new National Eye Bank of Sri Lanka, that country will be well able to meet its own needs for cornea donors, and will be able to export them throughout Asia and beyond. The new eye bank is situated at the Colombo Eye Hospital. It should be possible for the centre to ultimately process up to 2,000 corneas a year. This would allow the export of top-quality corneas, as good as any from the US or Europe, conforming to international medical standards, at an affordable cost, notes Donald Tan MD, director of both the Singapore National Eye Centre and Singapore Eye Bank. He is also the president of the Asia Cornea Society (ACS). The opening is a culmination of an ambitious programme initiated by the ACS, through the Association of Eye Banks of Asia (AEBA) of which Dr Tan is also president. The goal of AEBA is to address the chronic shortage of quality donor corneas by creating standards for the collection, preparation, storage and delivery of donor corneas throughout Asia. “We knew we needed to start a new eye bank. We focused on the one country where we thought this would be possible – Sri Lanka. From the 1960s into the 1980s that country had a very successful international eye bank that supplied corneas to many parts of Asia. However, that programme dwindled after the passing of its founder Dr Hudson Silva,” Dr Tan told EuroTimes.
“
Today because of all these initiatives the Singapore Eye Bank is able to cover 93 per cent of local needs Donald Tan MD
Dr Tan and colleagues at AEBA approached Sri Lankan authorities, offering to work with them to revitalise the nation’s eye bank. A local philanthropy organisation in Singapore provided start-up funds. Many of the Sri Lankan staff, which includes coordinators, managers and laboratory personnel, received training at the Singapore Eye Bank, which served as a model for the new project. “The new national eye bank was set up within the Colombo Eye Hospital, which is itself next to a large general hospital. The general hospital has proved to be a good source of donors. In earlier times, donor eyes came from around the country, including rural areas. It was very difficult to maintain the standards required to collect and preserve the donor eyes. So, using the Singapore Eye Bank as an example, we initiated a hospital eye donation programme. We had the enthusiastic support of the hospital staff, and everything went very well,” Dr Tan recalled.
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The eye bank had the early support of the Sri Lankan president His Excellency Mahinda Rajapaksa, who led the opening ceremonies. “He thought it was a fantastic idea, not only to provide corneas for Sri Lanka but for export as well, since the potential donor supply could easily outstrip their needs. He was keen to revitalise Sri Lanka’s role in providing corneas for Asia, and beyondto the Middle East, even to Europe. With government support we were able to get the eye bank up and running in a matter of months,” noted Dr Tan. Sri Lanka is predominantly Buddhist, with most of its people practising a particularly ancient form of Theravada Buddhism that dates to the 2nd century. This particular form places a very high value on helping others, and has long supported organ donation, which accrues merit to the donor. More than 800,000 Sri Lankans carry donor cards, and over the years prime ministers and presidents of that country have donated their corneas. “They have this great concept that values life and supports helping other people. “So we knew the intrinsic concept was correct. What is a major battle in other areas – promoting eye donation – was not that much of an issue in this case,” said Dr Tan. Corneal donation rates vary widely throughout Asia. Cultural taboos about organ donation greatly limit the supply in some countries. The AEBA has an outreach programme to improve education on the virtues of eye donation.
Donald Tan – donald.tan.t.h@snec.com.sg
“We learned form our experience in Singapore, where we have a Taoist kind of Buddhism. People believe in the afterlife, and on certain occasions we burn paper money for our ancestors. People burn paper Mercedes, and some don't want to give their eyes thinking they can't drive the Mercedes, so a bit tongue-in-cheek, we promoted a campaign saying you can burn a paper chauffeur with the paper Mercedes,” he explained. The Singapore programme also switched from whole eye donation to removing corneas in situ, retaining the globes, and using artificial eye caps. This enabled them to tell potential donors and family members that they were not removing the eyes, just the corneas, and replacing them with artificial corneas. Another approach was to ask to remove just one eye, which would still allow the departed one to see in the afterlife. Dr Tan and colleagues also approached all the religious leaders in Singapore for their help. Singapore is a microcosm of Asia, with all the races and all the religions represented. Buddhist, Hindu, Muslim and Christian religious leaders all provided active support, including pledging to donate their own eyes. “That had a profound effect. It clarified to the public that your religion is not contrary to eye donation. Today because of all these initiatives the Singapore Eye Bank is able to cover 93 per cent of local needs,” he noted. Following the early success of the Singapore and Sri Lankan cornea donor programmes, the AEBA hopes to create an Asian standard for cornea donation. The ultimate objective is to create a network of self sufficient eye banks that are able to procure local donors, match demand in the country, and be able to export excess tissue to other countries, all with highest quality clinical standards.
EUROTIMES
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India
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Update
CORNEA
GET 2020
Answers to research questions paramount for eliminating trachoma by Cheryl Guttman Krader in Fort Lauderdale
S
ince its launch in 1997, GET 2020, the Alliance for Global Elimination of Trachoma by 2020, has made some encouraging progress towards achieving its goal. However, the programme’s ultimate success may depend on finding answers on issues affecting the rapidity with which trachoma elimination can be achieved, said Sheila K West PhD, at the annual meeting of the Association for Research in Vision and Ophthalmology. “There is some good news to report that indicates the multifaceted strategy of GET 2020 is working. For example, although trachoma is still the leading infectious cause of avoidable blindness and visual impairment in the world, it has fallen from second place on the list of overall causes of blindness in 1997 to fifth in 2010. In addition, many countries are now poised to apply for certification of elimination of trachoma and that list is growing,” said Dr West, El-Maghraby professor of preventive ophthalmology, Wilmer Eye Institute, Johns Hopkins University, Baltimore, MD. GET 2020 defines elimination of trachoma as prevalence below five per cent for follicular trachoma in children less than 10 years old and below one per 1,000 population for trichiasis. The effort to achieve these objectives involves a four-pronged strategy aimed at controlling all phases of trachoma. Known by the acronym “SAFE”, the interventions involve Surgery for trichiasis in eyes in imminent danger of vision loss, mass treatment with Antibiotics to reduce the community pool of Chlamydia trachomatis infection, Face washing to reduce transmission from ocular and nasal secretions, and Environmental improvements to interrupt transmission and prevent re-emergence.
Surgery The fact that the rate of trichiasis recurrence one year after surgery has been reported to be as high as 80 per cent speaks to the importance of training and certification of surgeons, but also to the need for research to identify ways for increasing surgical success. “A clinical trial is ongoing comparing surgery using a new clamp versus the standard bilamellar tarsal rotation procedure. However, other creative ways must be thought of for modifying surgery to achieve better outcomes,” Dr West said. There is also a need to know how long an active trichiasis surgical programme must be EUROTIMES | Volume 16 | Issue 7/8
maintained to manage incident cases after active trachoma is eliminated. Available data suggests the answer is probably 10 years at least, but more definitive information is needed.
Antibiotics
Research is also needed to determine the trajectory of elimination of C. trachomatis so that when countries commit resources to mass antibiotic administration, they can be given accurate information about how long it will take to reach programme goals. While it was originally recommended that mass treatment with a single annual dose of azithromycin should continue for three years, a five-year programme is now being advocated for highly endemic areas, and other information suggests 10 years may be needed if coverage is not consistent or high. “We only have nine years left before 2020. It is possible we can shorten the time needed for mass treatment by treating more aggressively, perhaps treating children every six months, but research is needed to validate that approach,” said Dr West. It remains to be determined whether infection will re-emerge once antibiotic pressure stops, and what are the risk factors for its return. Experience so far shows that infection can re-emerge fairly quickly if mass antibiotic treatment stops too soon. However, even in Ethiopia, where children were treated aggressively and the infection rate declined to two per cent, the infection returned after antibiotic pressure ceased, Dr West noted. Research to identify better indicators of infection than simply signs of clinical trachoma is also needed considering there is a decoupling between clinical signs and infection status once mass antibiotic treatment begins. Face washing and environmental strategies provide the foundation for sustained elimination of trachoma. However, recognition of low uptake of hygienic measures in some areas speaks to the need for ethnographic research to identify barriers to community participation and trials evaluating the efficacy of methods for overcoming the impediments. GET 2020 could also benefit from research identifying ways to integrate the elements of SAFE with existing disease control programmes, such as for malaria and neglected tropical diseases.
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01-11-10 14:29
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Update
Glaucoma
John Samples - jrsmd2@hotmail.com
New glaucoma drugs coming
ROCK inhibitors, new prostaglandins, may open additional therapeutic pathways
by Howard Larkin in San Diego
A
s the early prostaglandin analogues go off patent over the next few years, rho-kinase, or ROCK inhibitors may become the first new class of glaucoma medications to hit the market in nearly two decades. Unlike existing glaucoma compounds, which lower intraocular pressure mostly by reducing aqueous production or increasing uveoscleral outflow, ROCK inhibitors target the trabecular meshwork. They have been shown in clinical studies to remodel the trabecular meshwork, restoring it as the primary aqueous outflow channel and lowering IOP about as well as prostaglandins. “We very much need a true trabecular drug, to complement our other pressure-lowering strategies,” said John R Samples MD, Park, Colorado “and it looks like rho-kinases are it.” In addition, new prostaglandins are under development that target a variety of cellular
receptors beyond those that current drugs bind, Dr Samples said. Notably absent are neuroprotectors. “I wish I could tell you we have a lot of neuroprotectors coming in the next year or two but we just don’t,” Dr Samples told attendees of ASCRS 2011 Glaucoma Day. But even here there is some progress, with some drugs developed for other purposes showing neuroprotective effects.
Targeting trabecular meshwork
ROCK inhibitors have been shown to increase aqueous outflow by relaxing cells in the trabecular meshwork and increasing the spaces between them. In animal models, increases in permeability of Schlemm’s canal and aqueous outflow of 80 per cent have been observed. While inflammation was an issue in early tests, recent trials suggest that ROCK inhibitors should be tolerable for most patients. There are now six companies
Eye Chat with Oliver Findl
“
Corneal Biomechanics Dr Oliver Findl talks to Dr Cynthia Roberts about the evolving role of corneal biomechanics in ophthalmic surgery.
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Oliver Findl
Cynthia Roberts
with ROCK inhibitors in phase 1 to phase 3 trials. Among the furthest along is AR-12286, which Aerie Pharmaceutical presented at the Association for Research in Vision and Ophthalmology 2010 meeting. In a phase 2a study of 89 patients, AR-12286 reduced IOP by up to -6.8 mmHg, or 28 per cent. Transient mild to moderate hyperaemia was seen in some patients, but no serious side effects were reported. Aerie reported positive results of a phase 2b study in September, and plans further phase 2 studies with larger populations to establish maximum effective dosing, and may begin phase 3 trials by the end of this year. Aerie is also developing several other glaucoma drugs, including AR-13324, which the firm characterises as a new drug class with a dual mechanism. Aerie is also beginning clinical trials of a conjunctival insert that will deliver glaucoma medications over a longer term, potentially improving efficacy over daily eye drops and reducing issues of patient noncompliance. Santen-Ube’s DE-104 ROCK inhibitors has successfully completed phase 2a trials in Japan and the US, and is undergoing phase 1 and 2a trials to establish improved efficacy at higher doses. The firm is also developing ATL313, an A2A agonist that it licensed from Clinical Data, as a glaucoma medication. Senjen-Novartis’ phase 2 trials of Y39983 show some side effects, but also “relaxing” effects on the trabecular meshwork. Evidence from animal models suggest it may also promote regeneration of optic nerve cells. Altheos claims that its ATS907 and related analogues were specifically designed for easier ocular administration and an improved therapeutic index compared to other ROCK inhibitors in development. Preclinical studies show promise for improved safety and efficacy, the company says. Clinical trials are planned for this year. ROCK inhibitors are likely to appear as once- or twice-a-day drops without BAK preservatives, Dr Samples says. They appear amenable to a multitude of alternate delivery systems, including sub-Tenon’s and conjunctival inserts, punctal plugs and longlasting gels, all of which are in development.
New prostaglandin targets
Dr Samples also expects a new round of prostaglandins that could expand
their effectiveness. “All of our current prostaglandins target the FP receptor. Bimatoprost also binds EP1. Butaprost from Allergan targets EP3 and EP4, and was shown at ARVO in 2002. I really think this is the way it is going with new EP-targeting drugs.” Promoting natural prostaglandin production is another alternative, Dr Samples noted. At the 2010 International Society for Eye Research meeting in Montreal, Allergan’s David Woodward presented a drug based on a compound present in rabbit eyes but absent in human eyes that caused the endogenous release of prostaglandins in human eyes. “We think that drug may have a whole lot of promise,” Dr Samples said.
Neuroprotectives problematic
Ultimately, glaucoma is a neural disease, and protecting the optic nerve is the goal. But testing neuroprotective agents is expensive, time consuming and costly. “Many [neuroprotective agents] under development borrow from the neurology and the neurosurgery literature. There are a lot of strategies, but the big problem is the cost to prove the efficacy of these drugs. Most recognise the glial cell as one of the potential culprits in glaucoma, but there are a lot of potential culprits,” Dr Samples said. Even so, drugs developed for other uses sometimes overlap. For example, some ROCK inhibitors have been shown to have a neuroprotective effect (Yoshinori Toshima et al A new Model of Cerebral Micro thrombosis in rates and the Neuroprotective Effect of a Rho-Kinase Inhibitor. Stroke 2000; 31:22452250) and even to promote regrowth of nerve cells in animal studies. And the drug firm Sucampo is considering a re-launch of unoprostone, FDA approved for IOP lowering in 2000, with a neuroprotective claim and possibly indications for retinitis pigmentosa and dry age-related macular degeneration. Other drug classes on the horizon include an adenosine-1 agonist from Innotek for which information was presented at the ISER meeting in montreal, muscarinic selective compounds from Acadia-Allergan, and a cannabinoid CB1/2 agonist from Novartis. “Watch for the Innotek compound, but Rho-kinase inhibitors and new prostaglandins will likely appear first.”
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Reay Brown - reaymary@comcast.net
Update
Glaucoma
Glaucoma surgery innovations
Breakthroughs may flow from exchange of ideas, industry support by Howard Larkin in San Diego
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The ‘adjacent possible’ Dr Brown suggested the concept of the “adjacent possible”, formulated by biologist Stuart Kauffman, well describes surgical innovation. Each advance creates opportunities for new advances that didn’t exist before. In his book, Where Good Ideas Come From, author Steven Johnson likens the process to standing in a room with four doors. Behind each door is another room with four doors, but to reach the third room, one must pass through the second. Each door represents a different set of “adjacent possible” developments. Modern cataract surgery is a good example, Dr Brown pointed out. It took years after the invention of phacoemulsification by Charles Kelman before supporting inventions, including foldable lenses, viscoelastics and the EUROTIMES | Volume 16 | Issue 7/8
This is the first trabecular bypass device that made it into phase 3 FDA trials before the company was forced to discontinue the trial because of insufficient funds
Glaucoma “tack” - a trans-corneal drainage device
Courtesy of Reay H Brown MD
uring his 30 years in practice, glaucoma surgery hasn’t advanced much, says Reay H Brown MD, Atlanta, US. But it’s not for lack of new ideas so much as insufficient support for realising them. He believes that’s about to change. “Glaucoma is becoming a surgical disease. The question is ‘why now?’” Dr Brown asked attendees of the 2011 ASCRS Glaucoma Day Stephen A Obstbaum Honoured Lecture. He gave two reasons. First, ageing populations are exponentially increasing demand. Second, major industry players are finally making serious investments in glaucoma surgery to offset their revenue losses as Xalatan and other big-money prostaglandins go off patent. “That’s going to take $500m (about €350m) out of glaucoma therapy. Meanwhile, the glaucoma device market may be $1bn,” Dr Brown said. Dr Brown also believes that glaucoma and ophthalmic specialty societies have a major role to play in fostering glaucoma surgery innovation by creating forums for information exchange. These should include “virtual coffeehouses” supported by social media and online services such as Eyetube, but also a greater focus on surgery by existing glaucoma societies, and formation of societies dedicated to glaucoma surgery. “There are plenty of ideas; what we need is an exchange of ideas, so the half-an-idea will always find the other half.”
Schematics of the trabecuphine - a device that performed an internal sclerectomy
capsulorhexis resulted in the elegant, reliable, and less invasive and very safe procedure we know today. To an extent, this was a result of serendipity. But mostly it was the rich exchange of ideas, one inspiring and making it possible to apply the next, and all driven by the principles of minimalism and simplification, Dr Brown said. But simplification is not simple, he pointed out. The tools of modern cataract surgery, including phaco machines, microscopes and diagnostic devices are anything but simple. And with femtosecond laser applications on the horizon, the complexity of cataract surgery technology may again increase by an order of magnitude. Rather, simplification means increased efficiency and improves outcomes, Dr Brown said. “Perhaps the best definition of ‘simple’ is when the patient says ‘thanks, doctor. That was easy.’”
Simplifying glaucoma surgery
By contrast, trabeculectomy, still the gold standard glaucoma procedure, is performed with manual tools that haven’t changed much in decades. The result can be anything but easy for patients. “If your patient asks whether it’s normal for vision to be worse after surgery and you say ‘yes;’ if you prefer to keep a patient on four drops with a red eye rather than operate, you might have what it takes to be a glaucoma surgeon,” Dr Brown quipped. But with adequate financial support and a robust exchange of ideas, glaucoma surgery will take advantage of adjacent possibilities and progress much as has cataract surgery. The principle of minimalism is an even greater factor favouring glaucoma surgery because it potentially takes the issues of medication cost and compliance off the table. “I don’t want glaucoma surgery to be a joke. I don’t accept that it is not compatible with good vision or should only be used
as a last resort. We need innovation,” Dr Brown said. Yet the history of glaucoma surgery innovation has been spotty. For example, in the early 1980s, Dr Brown and colleagues adapted emerging vitrectomy technology to create the automated mechanical trephine, known as the trabecuphine. This allowed iridectomy and sclerotomy to be performed through a 19-gauge incision, sidestepping the conjunctival incision and related failures due to surgical trauma and bleb scarring. “This was the adjacent possible. The instrument was the door to the next room.” However, the trabecuphine failed, in part because of difficulty controlling outflow. “If the hole was too open we got hypotony. If it closed up, the procedure failed,” Dr Brown said. Ironically, at about the same time Robert Ritch MD invented the “Ritch rivet” device for holding open a scleral hole. He even cited the trabecuphine in his patent – but never contacted Dr Brown, who sees the situation as a lost opportunity to exploit the “adjacent possible.” Similarly, he believes his early attempts at a corneal valve to regulate aqueous pressure and the Eyepass, a bi-directional trabecular bypass tube, which went all the way to a phase III trial, failed due to insufficient supporting research. But the possibilities these inventions created are still being investigated, and with renewed vigour, Dr Brown says. He sees three promising areas of advance: trabecular bypass using canaloplasty, iStents, Hydrus and the Trabectome; external drainage using devices such as Express and Aquasys; and suprachoroidal drainage. The glaucoma tack corneal valve is also under development to find the right materials and fixation technique. Tube shunts are also an area ripe for development, particularly given the reduced failure rates demonstrated in the trab. versus tube trial, he said. While Dr Brown suspects that surgery will not be sufficient in many cases, he envisions most patients being managed with one drop as better surgical options are developed. “There are just too many ideas out there not to be optimistic.”
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contacts
David Boyer - vitdoc@aol.com Stanley Chang - sc434@columbia.edu
Update
retina
Vitrectomy for floaters?
Disability may justify surgery, but careful patient selection is essential by Howard Larkin in Chicago
But then again… The task of convincing this sceptical audience otherwise fell to David S Boyer MD, of Retina Vitreous Associates Medical Group, Los Angeles, US. He presented a nuanced argument that symptomatic vitreous floaters can be debilitating, and when they are, vitrectomy may be an appropriate option. Dr Boyer acknowledged upfront that most vitreous floaters are benign and do not require treatment. But floaters can significantly reduce patients’ functioning, and it may be hard to pick this up using
“
Patients complain they can’t see, but they test 20/20 in our office. But when we take our standard Snellen visual acuity measurements they do not account for the speed at which someone reads or other aspects of visual disability that interfere with daily life David S Boyer MD
EUROTIMES | Volume 16 | Issue 7/8
“
These patients seem obsessed with them and even if you operate they will not be happy because there will still be peripheral floaters they can see Stanley Chang MD
standard tests or physical examinations. “Patients complain they can’t see, but they test 20/20 in our office. But when we take our standard Snellen visual acuity measurements they do not account for the speed at which someone reads or other aspects of visual disability that interfere with daily life. Subjective questionnaires such as the NEI VFQ-25 may show functional deficits, but this is not something we do routinely.” He suggested that patients with floaters who hesitate between letters when reading the chart may be exhibiting a functional deficit, and should be investigated further. “A lot of patients who have severe floaters can’t drive. So ask, can they read street signs when driving? Read for extended periods? Use their computer like they did before the PVD?” Dr Boyer asked. Functional vision tests may also be appropriate. For patients who do demonstrate ongoing disability, Dr Boyer believes that vitrectomy is preferable to NdYAG laser. Studies, including one by Stanley Chang MD and colleagues (Retina 2000; 20:591-6) have found vitrectomy leads to resolution or improvement of floater symptoms in nearly all eyes, while YAG laser improves symptoms in only 38 per cent of eyes, and actually makes the condition worse in nearly eight per cent (Eye 2002; 16. 21-26). “Would you withhold cataract surgery if the cataract was visually disabling despite good Snellen VA, where under certain circumstances the patient can’t drive? If they can’t function I would offer the patient the ability to improve their quality of life by vitrectomy surgery,” Dr Boyer said.
Yes, but… Arguing against was Stanley Chang MD, Edward Harkness Professor of Ophthalmology, Columbia University in New York, who co-authored one of the papers Dr Boyer cited. Published in 2000, this case series presentation involving six consecutive surgeries in five patients was the first peer-reviewed paper on the subject. “I do believe there is disability associated with floaters, but it is relatively rare. We selected these patients very carefully. All had PVD and several had previous retinal surgery.” All of the patients were also pseudophakic or aphakic, eliminating cataract risk. The results were good. All achieved corrected visual acuity of 20/40 or better, four had 20/25 or 20/20. No complications were observed. Significant functional improvements were demonstrated by VFQ-39 questionnaire, and all six patients reported a high degree of satisfaction. So why did Dr Chang take the ‘con’ side? He cited a study (Schulz-Key S et al, Acta Ophthalmol 2009; 1) in which 73 eyes in 61 patients were evaluated in a retrospective non-randomised study that used a lower threshold for surgery. Forty-two per cent were phakic and four combined vitrectomy
YOUR ADVERTISEMENT COULD BE HERE REACHING 32,019* READERS
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oogle “eye floaters” and plenty of promos for natural remedies and practices “specialising” in surgical and laser floater procedures pop up. Clearly there’s a market for treating anxious floater patients – and no shortage of dubious operators looking to cash in. But in the world of real ophthalmology, is pars plana vitrectomy appropriate for managing patients with visually significant floaters? In an instant poll of several hundred ophthalmologists attending the Great Debates symposium at the 2010 American Academy of Ophthalmology annual meeting, 67 per cent voted “No.” Not really surprising given the risks of penetrating surgery, including retinal detachment, endophthalmitis and future cataracts. Hardly seems worth it to clear up a few pesky spots.
with phaco. At the end of follow-up, 60 per cent of phakic eyes required cataract extraction, and nearly seven per cent developed retinal detachments. As a result, satisfaction rates were lower, with 75 per cent reporting improvement in symptoms. Other research suggests that for patients with no PVD, retinal tear rates may be as high as 23 per cent after vitrectomy. In many cases, floaters lessen with time, Dr Chang said. So he suggests patients wait at least a year before considering surgery. Also, in some cases symptoms are not consistent with opacities observed on slit lamp biomicroscopy. “These patients seem obsessed with them and even if you operate they will not be happy because there will still be peripheral floaters they can see.” Dr Boyer agreed that assessing patients is difficult and takes time. “You do not want to see somebody and operate the next week. There are risks involved. But there are risks involved in everything we do. In cases where the floaters are really bothering the patient, he may be a candidate.” Dr Chang concluded that he and Dr Boyer were “really not that far apart about the need to be very careful about evaluating patients. Yes, there are some who deserve this surgery, but be very careful about patient selection.” He said that the evaluation of these patients remains based on their subjective symptoms, and that objective measures to determine who are surgical candidates are lacking. And the audience? After the debate 62 per cent still voted “No” – a five per cent shift toward vitrectomy for floaters, but not exactly a ringing endorsement.
™
The highest audited circulation for any ophthalmic news magazine in Europe Thank you to our readers and advertisers for making us Number One * Average net circulation for audit period 1 January 2010 to 31 December 2010. See www.abc.org.uk
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Report
11TH EURETINA Congress
BIGGER & BETTER
Record attendance at the 11th EURETINA Congress in London
A
record number of medical and surgical retina specialists from all over the world converged on London, UK, at the end of May to attend the 11th EURETINA Congress in the Queen Elizabeth II Centre. A total of 3,000 delegates attended the congress making it not only the largest EURETINA meeting in the history of the society, but also establishing it as the largest retina meeting ever convened. Last year’s congress in the Palais des Congrès, Porte Maillot, Paris was attended by 2,700 delegates. Addressing the audience at the official Opening Ceremony, EURETINA president, Bill Aylward said the attendance bore testimony to the quality of education and insight the meeting provides to retinal specialists. “Each meeting has been larger than the previous one and this year’s meeting has nearly 3,000 registrations, so we’re very sure we’re giving you what you want. We have
13 main sessions, 24 instructional courses, 11 free paper sessions plus all the extras that we think make EURETINA special but we still want your feedback because we want to make this meeting better and better,” he said. Prof Borja Corcostegui MD, Spain, a past-president and founding member of EURETINA, delivered the EURETINA Lecture, titled “Modern Directions for the Surgery of Diabetic Retinopathy”. The Kreissig Lecture was delivered by Lawrence A Yannuzzi MD, US, on the topic of, “The Spectrum of Vitelliform Lesions in the Macula.” The winner of the inaugural EURETINA Innovation Awards was Prof Martin Rudolf of the University of Lübeck in Germany who received a cheque for €20,000 for his work on novel drug candidates for the prevention and treatment of AMD by reducing pathological lipid deposition and inflammation in the eye. Second prize and a cheque for €10,000
Bill Aylward, president of EURETINA, speaking at the Opening Ceremony
was awarded to Prof Eberhart Zrenner of the University of Tübingen, Germany, for his research demonstrating how subretinal electronic implants can restore basic visual function in blind retinitis pigmentosa patients. The winner of the EURETINA Video Competition was Chien Wong MD, US, for the video “Uveal Effusion Syndrome: Diagnosis and Management”. Second prize went to Alexandre Assi
MD, Lebanon, for “Modified 20-gauge Transconjunctival Sutureless Sclerotomies for Pars Plana Vitrectomy” and third prize went to Mahmut Dogramaci MD, UK for “Photo-stress During Removal of Silicone Oil”. The Kreissig Grant, an award of €1,000 to a retinal specialist from a less privileged part of the world, to help them attend the meeting, was presented to Dennis Sibanda MD, Zimbabwe.
focus on Vitelliform lesions
T
he correct diagnosis of vitelliform lesions requires a multimodal approach in order to determine the stage of disease, distinguish disorders of the retinal pigment epithelium from vascular lesions, and identify those cases where they are symptomatic of malignancy, said Lawrence A Yannuzzi MD, in his Kreissig lecture, which he delivered at this year’s EURETINA Congress. Vitelliform lesions take their name from “vitellus”, a Latin word for egg yolk, because of their fried egg-like appearance. They were first described by Frederich Best MD, who gave his name to Best’s disease, a paediatric hereditary disease of the retinal pigment epithelium that is characterised by the presence of the lesions. Subsequent authors have described the lesions occurring in other diseases of the retinal pigment epithelium, Dr Yannuzzi noted. They include other hereditary disorders such as pattern dystrophy, an adult onset disease, as well as various vitelliform dystrophies whose genetic basis is less clear and which are associated with chronic retinal detachment. There is also a condition called acute exudative vitelliform maculopathy, he said. Dr Yannuzzi said that pattern dystrophy accounts for about 19 per cent of eyes with vitelliform lesions. In
EUROTIMES | Volume 16 | Issue 7/8
such cases, fundus autofluorescence will show a pattern abnormality, he noted. Acuity remains good in such eyes during the early stages of disease, over time it will decrease in response to compression of the fovea, he said. In addition, the degeneration of the pigment epithelium will result in a fundus hypofluorescence. Soft drusen will sometimes have a vitelliform appearance. However, in retinal pigment epithelial dystrophies, OCT will show that the lesions are on top of the retinal epithelium, whereas soft drusen occur beneath the retinal pigment epithelium. Moreover, while both types of lesion can occur in the same eye, unlike soft drusen, retinal pigment epithelium dystrophies will not respond to antiVEGF injections. “The diagnosis of this disease is multimodal, you need the fundus autofluorescence and high resolution OCT,” he said. Dr Yannuzzi noted that acute exudative vitelliform maculopathy can be idiopathic and benign with a good prognosis in terms of vision. However in some cases the condition can be neoplastic in origin, and can represent an ocular manifestation of such conditions as malignant melanoma, CNS lymphoma, sarcoidosis, breast cancer or endometrial cancer.
Ingrid Kreissig, Lawrence A Yannuzzi and Bill Aylward, president of EURETINA at the presentation following the Kreissig Lecture
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Prof Einar Stefansson, chairman of the EURETINA Innovation Awards judging panel, presenting the first prize to Prof Martin Rudolf
Prof Einar Stefansson, presenting the second prize to Prof Eberhart Zrenner
EURETINA INNOVATION AWARDS
Cutting-edge research honoured
A
project featuring groundbreaking research into novel therapeutic agents that could be used in the future to treat and prevent age-related macular degeneration (AMD) has been accorded first prize in the inaugural EURETINA Innovation Awards. Prof Martin Rudolf of the University of Lübeck in Germany received a cheque for €20,000 for his work on novel drug candidates for the prevention and treatment of AMD by reducing pathological lipid deposition and inflammation in the eye. Second prize and a cheque for €10,000 was awarded to Prof Eberhart Zrenner of the University of Tübingen for his research demonstrating how subretinal electronic implants can restore basic visual function in blind retinitis pigmentosa patients. Prof Rudolf explained that AMD is associated with an abnormal accumulation of lipids within Bruch’s membrane of the eye. This lipid build up essentially creates a diffusion barrier between the retinal pigment epithelium and the choriocapillaris, compromising photoreceptor function and resulting in increased oxidative stress and impaired vision. “This lipid build-up is a crucial step in the development and persistence of all AMD forms and therefore it is a potential powerful therapeutic target,” he said. Prof Rudolf said that research has shown that apolipoproteins naturally regulate lipid transport within the bloodstream. With this in mind, synthetic apolipoprotein mimetics, which are functionally related small peptides, have been demonstrated to significantly increase the clearance of plasma cholesterol and remove excess lipid accumulation in vessel walls. In an animal model of AMD, a synthetic apo-mimetic peptide, known as 4F, was injected into the vitreous cavity of the eye, resulting in a reduction of lipid depositions and thickness of Bruch’s membrane, thereby indicating that 4F may be a potentially effective therapeutic and preventive agent for AMD. “4F induced reduction of Bruch’s membrane lipids with a concomitant structural remodelling of Bruch’s membrane. No serious adverse events were detected nor were obvious morphological alterations in the eye detected by light
EUROTIMES | Volume 16 | Issue 7/8
The nominees for the first ever EURETINA Innovation Awards pictured after the prize-winning presentation
microscopy. The proposed mechanism of 4F action may have to do with the acceptance of lipids from accumulated lipoproteins in Bruch’s membrane which reduces lipoprotein size and facilitates their removal,” he said. Dr Rudolf said that the agent could have potential applications in treating early-stage AMD, particularly for those patients at high risk of developing late-stage AMD, as well as geographic atrophy due to AMD and neovascular AMD. In a presentation of the second-place entry, Prof Zrenner said that electronic prostheses currently represent the best hope of restoring some visual function to patients with total photoreceptor degeneration. “The aim is to restore useful visual process in patients that are blind from utter retinal degeneration and to give them back the possibility of recognising or localising objects and achieving self-sustained mobility by implanting a subretinal electrode implant,” he said. Triggering electric stimulation enabled patients to perceive light in particular shapes and patterns. Visual acuity tests showed that patients were able to recognise foreign objects and in some cases read letters in order to form words. In some cases, bright objects set against a dark background were perceived and localised. One patient, who had been blind for 15 years, surprised investigators when he told them that his name had been misspelled when asked to read it.
Congress highlights The many presentations at the EURETINA congress included early reports from groundbreaking clinical research. They included a presentation by Francine Behar-Cohen MD, France, who described the research she and her associates have conducted involving gene therapy for retinal disease. Their work demonstrated that it is possible to use electroporation to transfect ciliary muscle cells with plasmids that will cause them to secrete in clinically useful amounts of antiTNF protein into the vitreous. The lack of a viral vector reduces the chances of an immune response and the secretion of the protein eliminates the need for repeated injections. Another study, presented by Akihiro Ohira MD, Japan, challenged the orthodoxy that eye drops cannot deliver sufficient amounts of therapeutic agents to the retina. In the pilot study a topical 1.5 per cent dexamethasone aqueous solution prepared by cyclodextrin nanoparticle technology produced significant reductions in mean macular thickness and significant improvements in mean visual acuity in 16 eyes of 16 patients with chronic diabetic macular oedema, Dr Ohira said. The agent was at its most effective in vitrectomised eyes. In another presentation at the EURETINA congress, Weng Tao MD, US, indicated that an implant employing encapsulated cell technology can deliver clinically useful amounts of the neuroprotective agent, ciliary neurotrophic factor, to the vitreous on a sustained basis. She presented the results from three dose-ranging studies involving a total of 120 patients with retinitis pigmentosa or geographic atrophy. In all three studies on patients with the implant there was an increase in the thickness of the photoreceptor layers of the retina in the eyes with implant. In addition, in eyes with geographic atrophy the increase in retinal thickness corresponded with a preservation of visual acuity. Other highlights at the London meeting included updates on Argus II subretinal implant, from Lyndon Da Cruz MD, UK, and a sub-retinal implant from Karl U Bartz-Schmidt MD, Germany and Florian Gekeler MD, Germany. They presented clinical findings in patients with end-stage retinal disease which indicated that the implants were able to restore a measure of useful visual function.
contact
Update
Ocular
Deepak P Edward - deepak.edward@gmail.com
A new approach
Technology set to revolutionise ophthalmology teaching by Dermot McGrath in Berlin
M
ajor advances in computer simulation and virtual reality technologies in recent years are likely to have profound implications for the way that ophthalmology is taught in universities and hospitals in the near future, according to Deepak P Edward MD, FACS. “Surgical simulation is an exciting area of surgical education and it offers a lot of possibilities for training current and future generations of ophthalmologists. However, we must move forward with care and try to ensure that proper standards are put in place to monitor progress and to determine the utility of simulation training. Ultimately we need to address the question of whether simulation training will result in improved surgical performance. This is the Holy Grail that we need to work towards,” he said. Dr Edward, a professor of ophthalmology at Northeastern Ohio Universities College of Medicine and Pharmacy and chair/ program director for the Department of Ophthalmology at Summa Health System, Akron, Ohio, said that surgical simulators provide an opportunity for trainee surgeons to gain confidence and competence in the same way that flight simulators are used by pilots. “Ophthalmic surgery is a complex task and teaching skills can be challenging in scenarios where patient safety is the primary concern and errors can prove very costly. We have less and less opportunity to train surgeons in more ‘risky’ procedures on real patients, patients are more demanding, and there are limited opportunities to experience rare surgical events and crises. Simulators have an obvious role to play in these scenarios,” he said. Dr Edward noted that traditional apprenticeship is a model where doctors have to wait for something to happen in order to be able to illustrate relevant techniques to trainees. “Teaching in circumstances where these rare events happen can be a little complex and are maybe not the best educational environment as such. Training for teamwork is also somewhat rare and simulation can obviously help in this respect as well,” he said. All trainees must pass through distinct phases in their progress towards becoming a surgeon, said Dr Edward. EUROTIMES | Volume 16 | Issue 7/8
“There is a stage of declarative knowledge, where we learn what to perform. This can be done in a classroom or a wet lab. We also have procedural knowledge that deals with how to perform certain procedures, and this can be done through observation, live surgery, wet labs and simulation. More advanced technical knowledge can also be learned in the operating theatre, surgical suite or possibly during simulation training.” Looking at current training simulators on the market, Dr Edward said that ophthalmology is somewhat lagging behind other surgical procedures such as laparoscopy or craniotomy, which have been using sophisticated virtual reality training for years. “One of the challenges with simulation is that there are very few eye simulators to evaluate. While we are lagging behind in development, this is not necessarily a bad thing because it is evident from other medical fields that the development has sometimes been too fast and there has not been a proper attempt to evaluate how this is really going to translate into better performance in the operating room.” The high cost of current commercial simulation systems is another factor preventing their wider adoption, said Dr Edward, as is the lack of research funding to develop and investigate the utility of such training devices in hospitals and universities. Devices such as the Eyesi eye surgery simulator (VRmagic AG) provide trainees with an immersive experience in cataract and vitreoretinal surgery. For anterior segment surgery, for example, the Eyesi platform includes a cataract eye interface, a cataract instrument set and foot pedals. The system’s training modules enables trainees to hone their skills in various phases of the cataract operation such as capsulorrhexis, hydrodissection and phacoemulsification. Complex interaction between instruments and discrete tissue and intraocular structures can be experienced in real time. Another system, the Sensimmer Virtual Phaco Trainer for Cataract Surgery (from ImmersiveTouch www.immersivetouch. com), provides a portable, haptic and touch feedback system that is particularly useful for capsulorrhexis practice, said Dr Edward. The PhacoVision system (Melerit Medical) allows the simulation of phacoemulsification, lens cracking
Sensimmer Phaco trainer uses a virtual eye model and virtual instruments. The robotic arm manipulates the virtual instrument and provides haptic feedback
Courtesy of Deepak P Edward MD, FACS
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View of the virtual eye and capsulorrhexis through the stereoviewer
and aspiration of lens materials. The development of this product is currently dormant. While virtual eye surgery systems such as the Phaco Trainer and the Eyesi include metrics to objectively evaluate the user’s skills, the role of the instructor remains critical to the entire training process, insists Dr Edward. “As an instructor, you cannot just leave the resident with the simulator and hope that your job is done and walk away. There is a lot of instruction that can go handin-hand with the simulator, especially in teaching trainees how to hold instruments and manipulate them and avoid bad habits before they enter the operating room. The data can then be saved and evaluated later by
the resident and instructor,” he said. One of the key obstacles to more widespread adoption of simulation training technologies is the need for data-driven validation of the training modules, said Dr Edward. While simulators may appear to improve surgical skills as measured by the simulator and wet-lab performance, there is still a paucity of data showing improved operating room performance as a result of their use. Looking to the future, Dr Edward urged the creation of a committee structure within the International Council of Ophthalmology and other ophthalmic organisations in order to develop clear and coherent standards and validation procedures for surgical simulation systems.
ESCRS
EUROTIMES
™
During the XXIX Congress of the ESCRS Reed Messe, Vienna, Austria
Masterclass in Practice Development Monday 19 September 2011
Developing High Performance Practices Keith Willey, BSc, MBA Associate professor of strategic and international management and entrepreneurship at London Business School UK. Course fee: Ð200 50 places available In this Masterclass, Prof Willey will share the profiles of participants taken from a pre-course survey and offer comparison to businesses in other sectors and will discuss growth models, entrepreneurial leadership, organisation and planning. He will examine at length the interface between the professional and commercial facets of the practice with input from leading European ophthalmogists who have developed successful business models. Key discussion points n Are you growing revenues n What are your most pressing problems n How can you solve these problems
To register see www.escrs.org
32
Update
MICS and ZEISS: The smart decision for your future
GLOBAL OPHTHALMOLOGY
Surgery in Sudan
Study shows country’s cataract surgery rate has quadrupled since millennium’s beginning
by Roibeard O’hEineachain in Istanbul Surgeons are impressed with how easy and safe the MICS IOL implantation is using the BLUEMIXS® 180 injector, specially designed for MICS • Covers the complete range of ZEISS preloaded MICS IOLs* • Is a perfect fit for the 1.8 mm MICS incision size For an astigmatism-neutral surgery with rapid visual recovery – the ZEISS BLUEMIXS® 180 injector
Eye-care staff at Sudan Eye Center
T
* For the specific IOLs available in your market, please contact your local sales representative.
Carl Zeiss Meditec AG Goeschwitzer Strasse 51-52 07745 Jena Germany www.meditec.zeiss.com/iol
EUROTIMES | Volume 16 | Issue 7/8
he past decade has seen dramatic improvements in the cataract surgery rate in Sudan, although problems of access to care remain in the more remote parts of the country, according to the findings of a study presented by Kamal Binnawi MD, Khartoum, Sudan. “Sudan’s national cataract surgery rate is good compared to WHO targets and the national plan. The cataract surgery rate has increased from 560 per million population in 2002 to 2025 per million population in 2009. However, there is considerable variation between different states, and there is a need for more outcome data to assess the quality of care the patients receive,” Dr Binnawi said at the 15th ESCRS Winter Meeting. He noted that Sudan has a population of 40 million and is the largest in Africa. It is divided into 25 states and suffers from armed conflict and poverty. Approximately 1.5 per cent of the country’s population is blind. The main cause of blindness is cataract, which accounts for 55 per cent of cases. Other causes include glaucoma, which accounts for 20 per cent of cases, and trachoma, which accounts for 17 per cent. Refractive error and childhood blindness account for six per cent and diabetic retinopathy and onchocerciasis for five per cent of cases. The country has 292 ophthalmologists working in 28 eye hospitals and departments, eight of which are run by non-government organisations (NGOs), four of which are private and 16 of which are government–run hospitals and clinics. Over 10 NGOs provide cataract surgery in Sudan, the most active of which are Albasar, IHH and SIMA (FIMA). Dr Binnawi noted that a retrospective
study that he and his associates conducted showed that 72,024 cataract procedures were performed in Sudan in 2009. Three quarters of patients underwent extracapsular cataract extraction, 23 per cent underwent phacoemulsification, and two per cent of patients received no IOL. Another finding of the study was that 38 per cent of patients were resident in Khartoum, although 52 per cent of patients underwent their surgery in Khartoum, indicating that some patients had travelled from less well-served areas of the country. Moreover, while the cataract surgery rate was 7,073 procedures per million population in Khartoum, it was 1,140 per million population in the rest of the country combined, with rates as low as 50-100 procedures per million population in some areas. Of the total, 56 per cent of cataract surgeries were performed by NGOs, 36 per cent by the government hospitals and eight per cent by private institutions. Around three quarters of procedures were carried out in hospitals, the remainder in eye camps and outreaches. Of the phacoemulsification surgeries, 38 per cent were performed in government hospitals, 37 per cent in NGO clinics and 25 per cent in private institutions. Dr Binnawi noted that government surgeons performed a mean of 171 cataract surgeries per year, NGO surgeons performed 354 per year, and those in private practice performed 206.5 per year. The overall average was 246 cataract surgeries per year.
contact Kamal Binnawi - kamalbinnawi@yahoo.com
contacts
Kuldev Singh - kuldev@yahoo.com Shlomo Melamed - melamed.shlomo@gmail.com Leon Herndon - hernd012@mc.duke.edu Tarek Shaarawy - tshaarawy@yahoo.com
Update
GLOBAL OPHTHALMOLOGY
Encouraging results
Summit seeks solutions to burden of glaucoma in Africa by Cheryl Guttman Krader
EUROTIMES | Volume 16 | Issue 7/8
All indications from highly positive feedback are that the summit meeting was a pivotal turning point Kuldev Singh MD
T
he success of the 1st African Glaucoma Summit marks an important beginning towards reducing the scourge of glaucomarelated vision loss in Western Africa, according to the meeting’s organisers. The unique programme was held in Accra, Ghana, August 6-7, 2010, and was an initiative proposed by the leaders of the World Glaucoma Association (WGA) World Glaucoma Projects Committee, Shlomo Melamed MD, Tarek Shaarawy MD, and Leon Herndon MD, (chairmen). Having been actively involved in medical outreach efforts in Africa, all three glaucoma specialists recognised a dire need to improve glaucoma care in that region. “Glaucoma is truly a curse in Africa, and particularly in West Africa, where there appears to be a genetic pool in the population for a type of early-onset, rapidly progressive primary open-angle glaucoma (POAG). Given the high burden of the disease and the unfortunate health, socioeconomic and political conditions that also exist in this area, we felt formal organised efforts targeting increased public awareness and education of health practitioners to enhance disease screening, diagnosis, and management could have an enormous positive impact,” said Dr Melamed. “However, we also recognised the importance of enlisting the active collaboration of our colleagues in Africa if we hoped to create practical solutions for improving glaucoma care in the continent. There is no way that we, as outsiders spending just a few weeks a year in the region providing care, can have a true understanding of the complexities of the situation and the many challenges that exist. In addition, it would be wrong for us to try to impose strategies based on our limited background. Now that the meeting is over, I am very pleased we chose to make this a joint project.” Dr Shaarawy commented: “I am personally very encouraged by the fact that we have been able to identify a new generation of leaders in glaucoma in subSaharan Africa. This is a generation that is enthusiastic, savvy, well-trained and will be able to change the face of African glaucoma care.” The WGA Board of Governors enthusiastically approved the project,
“
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We’ve established an African National Task Force to focus on better communication among African Glaucoma teams and to improve professional exchange on the continent Leon Herndon MD
and as an expression of their support, the Board voted to provide significant financial resources for the summit, including money to cover the expenses of African delegates. Executive vice-president of the WGA, Kuldev Singh MD, administered the funding. He told EuroTimes that having spent time performing glaucoma surgery in Ghana, he too has been overwhelmed by the level of disconnect between the high disease burden and the paucity of manpower and other resources for its management. “Although glaucoma care is improving worldwide, in Africa there has been little progress and glaucoma remains a devastating disease. The WGA Board of Governors considered the summit an excellent initiative to build momentum towards addressing the needs for greater
disease awareness, earlier diagnosis, and better treatment. While we look forward to future developments, all indications from highly positive feedback are that the summit meeting was a pivotal turning point,” he said. The meeting had 222 attendees, with representatives from 27 African countries and including the Hon. Robert Joseph Mettle-Nunoo, Ghanaian deputy-minister of health, Dr Anarfi Asamoah-Baah, deputy director general of the WHO, and other WHO, NGO, and industry representatives. Dr Melamed noted he was tremendously impressed by the contributions and enthusiasm of his African colleagues. “Their knowledge and passion for improving glaucoma care in their region were particularly inspiring and left me feeling even more satisfied about the success of the summit,” he said. The programme’s agenda covered eight topics: glaucoma education; best treatment choices; incorporating glaucoma management into existing ophthalmological programmes; screening methodology for advanced glaucoma cases with imminent risk of blindness; centres of excellence for glaucoma in Africa; enhancing awareness in the public, government, and healthcare profession; communication; community and industry support. Each topic was addressed on the first day of the summit with a series of formal presentations given by members of a
dedicated panel and a period of open discussion. On the second day, the panels issued a number of conclusions and action plans defining future steps for achieving the overall goal of improving glaucoma care in Africa. Highlighting some of the recommendations, Dr Melamed noted that the panel on “Best Choices of Treatment for Glaucoma in Africa”, which he moderated, concluded trabeculectomy with an antimetabolite should be the gold standard of treatment, recognising that the tendency for filtering bleb scarring among black people makes surgery without an antifibrotic agent practically futile. The panel on “Centres for Excellence in Glaucoma” decided that five centres of excellence should be established across the continent, and a committee was created to identify existing facilities for housing the centres. As part of the effort to enhance glaucoma awareness, other action plans aim to have glaucoma included in Vision 2020 and to create media campaigns. Also addressed by the action plans of various committees are the needs for more locally conducted clinical research trials and improved communication between professionals in Africa as well as between the Africans and their international colleagues and industry representatives. “To address these issues, we’ve established an African National Task Force to focus on better communication among African Glaucoma teams and to improve professional exchange on the continent,” Dr Herndon said. During the months since the summit, committees have been continuing the dialogue on the various topics through web-based discussion forums as they work to present additional plans at the World Glaucoma Congress in June 2011. “We recognise there are many obstacles to success in improving glaucoma care in Africa. However, we are optimistic about accomplishing our goal and encouraged by the progress already made through our first initiative,” said Dr Melamed. A more detailed report of the 1st African Glaucoma Summit is available online on the WGA website: http://www.worldglaucoma. org/AfricaSummit/index.php.
33
Save the Date
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contacts
Wagih Aclimandos - wagih@macunlimitedworld.net Catherine Creuzot Garcher - catherine.creuzot -garcher@chu-dijon.fr
News
european BOard of ophthalmology
RECORD NUMBERS
EBOD exam reflects European spirit of quality and collaboration by Dermot McGrath in Paris
T
hey came, they saw and most of them conquered. This year a record number of ophthalmology residents converged on the French capital in order to take part in the 2011 European Board of Ophthalmology Diploma (EBOD) examinations. “We are delighted to announce that the 2011 EBOD has once again broken the record for the number of candidates sitting the exam. This year over 330 candidates from 25 European countries came to Paris to sit the EBO Diploma examinations, a figure which continues the steadily upward trend of recent years for this prestigious qualification,” said Wagih Aclimandos FRCS, FRCOphth, FEBO, president of the European Board of Ophthalmology (EBO). Held every year in Paris, the EBOD examination is designed to assess the knowledge and clinical skills requisite to the delivery of a high standard of ophthalmic care both in hospitals and in independent clinical practices. Congratulating the candidates on their achievements, Prof Aclimandos said that it
was heartening to see an increasing number of candidates coming forward to sit the EBOD examination every year. “This is a very important highlight in the calendar of the EBO year, because the EBO is all about attaining high levels of training and experience in ophthalmology across Europe. We are here to celebrate those that have attained that level and also to give credit to those who have contributed to them reaching that level by helping in their training and their teaching,” he said. In this respect, Prof Aclimandos paid tribute to the 190 examiners who travelled from all over Europe to make up the panel of skilled, multilingual EBO examiners, all experts in their various fields. “We are extremely grateful to all those examiners who give up their valuable time and make the effort to join us in Paris every year. It is a fitting example of the European spirit of quality and collaboration and we are deeply appreciative of their efforts to advance the cause of training and education in ophthalmology in Europe,” he said. As in previous years, the EBOD
Andrew Tatham, winner of the EBOD Overall Award for 2011, wih runners-up Panagiotis Salvanos, Sonja Ute Heinzelmann, Marta Hovan, Cord Huchzermeyer, John Somner, Marko Sulak, Despoina Tsamadou and Meghana Anika Varde
examination comprises a multiple choice written exam (MCQ) as well as a fourpart viva-voce exam, the latter seeing each candidate examined on the four key topics of ophthalmology by a team of examiners. Candidates who succeed in passing the examination receive an EBO certificate and earn the right to use FEBO (Fellow of the European Board of Ophthalmology) once they have also completed a recognised training or are registered specialists in a European country. Remarking on the increased number of candidates sitting the EBOD this year, Catherine Creuzot Garcher, Chair of the EBO Education Committee, said that it was encouraging to see that the concept of a European measure of quality in education and training was slowly but surely gaining
traction in member countries. “Countries such as Austria, Belgium, Finland, France, The Netherlands, Slovenia and Switzerland have accepted the EBO exam as the equivalent to their own examination, which is something we would like to see spread to other countries as well. We would therefore urge national delegates and all the candidates who passed the examination in 2011 to further promote in their own countries the ongoing recognition of the EBO mission,” she said. Special awards were also presented this year to Christoph Raum from Germany, who received the 2011 Alan Ridgway Award of a certificate and a €1000 exchange grant for best MCQs result. Another grant of €1000 for Best Overall EBOD result went to Andrew Tatham from the UK.
Prof Soubrane receives inaugural award Described variously as an “institution,” a “crusader for education and training” and a “staunch supporter of EBO values”, Gisèle Soubrane MD, PhD, was honoured at this year’s European Board of Ophthalmology (EBO) examination as the first recipient of the Peter Eustace Medal for her contribution to education in ophthalmology in Europe. “It is hard to think of a more deserving person for the first Peter Eustace Medal than Prof Gisèle Soubrane,” said Wagih Aclimandos FRCS, FRCOphth, FEBO, president of the EBO. “Gisèle is a pastpresident of the EBO and her belief and support for this cause has been unwavering, continuous and indeed enormous,” he said. Prof Aclimandos said that the Peter Eustace Medal had been established by the EBO as a token of appreciation of the tireless work of Prof Peter Eustace from Ireland who established the first EBO Diploma examination in Milan in 1995. Paying tribute to Prof Soubrane, Prof Aclimandos said that her own contribution EUROTIMES | Volume 16 | Issue 7/8
to European ophthalmology over many years had made her a worthy recipient of the Peter Eustace Medal. “Prof Soubrane is professor of ophthalmology and Chair Emeritus at the University of Paris East-Creteil. Her training in France, as well as at the Wilmer Eye Institute at Johns Hopkins and the Institute of Ophthalmology in London, have resulted in a truly open-minded individual,” he said. Acknowledging her attributes as a researcher and scientist, Prof Aclimandos said that Prof Soubrane’s success also owes much to her vibrant and outgoing character. “Prof Soubrane has always remained very level-headed and approachable and a true crusader for education and training. We must remind ourselves that while we now have to fight for men’s rights, Gisèle managed to shine in a world that was at the time dominated by men. She has, and remains, a very strong proponent of women in ophthalmology,” he said. Speaking on behalf of Prof Peter Eustace,
L-R: Prof Peter Ringens, general secretary of EBO, Dr Marie Hickey-Dwyer, Prof Wagih Aclimandos, president of EBO, Prof Gisele Soubrane, recipient of the first Peter Eustace Medal, and Marko Hawlina, ex president of EBO
who was unable to attend the award ceremony in Paris, Dr Marie Hickey-Dwyer, honorary treasurer of the Irish College of Ophthalmologists, said that Prof Eustace was delighted to have his name associated with such a prestigious award. She added that Prof Eustace, who served as consultant ophthalmic surgeon at the Mater Hospital for over 30 years with a special
interest in neuro-ophthalmology, believed passionately in the mission of the EBO. “He recognised the excellent training ophthalmologists were receiving all over Europe and wanted to put a definitive mark on it for all of them which would be recognised throughout Europe and beyond,” she said.
35
News
YOUNG OPHTHALMOLOGISTS
the balancing act
What does it mean to be a good ophthalmology resident? by Leigh Spielberg MD
W
hat does it mean to be a good ophthalmology resident? What does it take? Hard work, dedication and enthusiasm for the field are the big three essentials, but these are just the starting points. Our dedication is evident in our four-tofive-year commitment to residency. Further, enthusiasm is more or less assured, since we were all free to choose ophthalmology out of many possibilities. Many of us chose to specialise in ophthalmology for similar reasons: the fascinating microsurgery, the nearly endless range of pathology, the chance to sub-specialise, and the fact that ophthalmology patients find their own vision so important. Not to mention the generally benign workload, the relatively painless call duties and the high job satisfaction. But more is needed than the big three. Dr G Venkataswamy, founder of the Aravind Eye Hospital in Madurai, India realised this early on. In the Aravind hospital hangs a plaque with his inspiring quote: “Intelligence and capability are not enough. There must be the joy of doing something beautiful.” But can we translate this notion into something more concrete? “Dr V,” as he is known in Aravind, did so by founding an eye care centre that treats more than 2.4 million patients per year, many of them impoverished patients who could otherwise never have afforded to be cured of their blindness. Short of this earthly miracle, which includes 300,000 surgeries per year, what should a
resident be striving for? That depends on whom you ask. For example, a staff ophthalmologist who supervises residents in the emergency room might focus on a resident’s basic clinical knowledge, diligence of examination and patience with patients and colleagues. What’s the differential diagnosis for this high IOP? Did you prescribe the correct medications for this corneal ulcer? Did you remember to check the angle for microhyphemae in the unlucky tennis player’s left eye? A sub-specialist might demand more in-depth and detail-oriented knowledge. Which patients are not eligible for refractive surgery? What are the potential complications of this corneal transplant? A research professor will look for academically oriented residents who are involved in setting up studies, seeing them through, and getting them published. Any professor would be thrilled with a resident who could help set up a confocal microscopy study of endothelial involvement in HSV keratitis. A resident’s peers expect their colleagues to help out, pick up the slack and generally be a decent person to work with. How annoying would it be to work with someone who always selected the easy patients to treat, leaving his or her colleagues with the complicated multi-pathology late on a Friday afternoon? And it doesn’t end there – further afield, those in charge of fellowship programme admissions will likely look for good letters of recommendation and a
EUROTIMES
ESCRS
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“
The more we learn, the better we will be able to treat our patients later on and that is ultimately what will give us the joy of doing something beautiful Leigh Spielberg MD
strong résumé. Has this applicant published serious work? Has he or she presented at international conferences? Will he or she contribute to my department? But a resident can’t be the best in everything. If the resident spends a lot of time working on cutting-edge research, basic clinical knowledge will suffer. On the other hand, a single-minded obsession with detailed learning might threaten to overshadow patient care, research opportunities and collegiality. So where do we begin? How do we know that we’re making the most of our short time in training? Niels Hoevenaars, a first-year resident in Rotterdam, finds that “a good resident must be very critical regarding his or her knowledge and clinical work. On the other hand, young residents have to be able to put their abilities into perspective, to realise that older, more experienced residents
and attendings will simply know more, and that this should be a source of learning and inspiration, rather than frustration.” The senior staff isn’t looking for a resident to be an instant expert in every field – it takes years of experience to be able to interpret fluorescein angiography – but rather for a resident who is eager to learn. Ideally, a residency programme will provide all that is needed to become a good resident and, by extension, a good ophthalmologist: a large and varied clinical case load, knowledgeable and enthusiastic mentors, surgical experience, research opportunities, useful and focused teaching moments, the opportunity to spend time working abroad in a less fortunate region, time for self-study and also a little time to let it all sink in. But maybe the most important person to decide what makes a good resident is the resident him – or herself. He or she is the one who will have to function as an ophthalmologist until retirement, and will have to launch a practice with the knowledge, competencies and experiences gained during what was hopefully a fruitful and satisfying residency. Dr Marijke Wefers-Bettink, a neuroophthalmologist who supervises first-year residents in the emergency room in my hospital, agrees. “Simply becoming a good ophthalmologist is not enough. Nonophthalmic education is crucial, including training to become a good team player and a good practice manager.” Dr Wefers-Bettink offered this optimistic advice: “You will learn quickly, and if you keep your eyes and ears open, you will succeed in becoming a good ophthalmologist.” We should see our residency as a period of freedom to learn as much as we can, because the more we learn, the better we will be able to treat our patients later on and that is ultimately what will give us the joy of doing something beautiful.
™
российский выпуск
RUSSIAN language edition now online EUROTIMES | Volume 16 | Issue 7/8
Visit: www.eurotimesrussian.org
37
News
esaso
GLOBAL INITIATIVE
The ESASO campuses at Lugano are attended by students of all ages and nationalities by Giuseppe Guarnaccia
E
SASO aims to improve the clinical and surgical practice of specialists in ophthalmology in order to promote and enhance their professional skills. Its objective is to provide ophthalmologists with postgraduate education and hands-on training from an internationally renowned faculty. The school promotes scientific research, organises meetings and seminars, and manages publications with the purpose of improving scientific knowledge within the ophthalmic community and thereby benefiting eye care and cures for patients. With campuses at the University of Lugano, Switzerland and the Medical Center in Singapore, one of the reasons so many students are enrolling for the ESASO courses is that they are receiving an academic education with an academic degree. The basic training system envisaged by the Bologna Process is currently offered by universities, but there is an almost complete lack of effective post university training across Europe. Programme courses at ESASO are taught by a distinguished international faculty and the medically oriented subjects are lectured by renowned practitioners invited for each specific domain. ESASO offers three programmes, each leading to a separate certificate. Students who wish to attend only single modules receive a certificate of attendance. Students who complete all five modules receive the Diploma of Specialist Superior in Ophthalmology (DiSSO), which is equivalent to the Certificate of Advanced Studies (CAS). Students who complete all the modules plus a one-year fellowship programme at one of a number of prestigious institutions receive the Master of Advanced Studies in Ophthalmology (MAS). Each module has the same structure. ESASO conducts regular surveys after each module to guarantee quality and steadily improve the programmes. The modules consist of: a total of eight days of personal preparation and classes/labs assisted and coordinated by the respective faculty members. Students attending the school were predominantly from Western European countries, but now students from Eastern Europe, South America, Russia, the Middle East, and Asia are enrolling in the courses.
EUROTIMES | Volume 16 | Issue 7/8
Fourth Module 2011
Fifth Module 2011
Cataract and intraocular refractive surgery
Glaucoma
Lugano, Switzerland 5 – 10 September 2011
Lugano, Switzerland 12 – 16 September 2011
Faculty
Faculty
B.S. Aslan, R. Bellucci, F. Malecaze, I. Prieto, P. Rosen, F. Simona, M-J. Tassignon, V. Trubilin
K. Barton, O. Bernasconi, B. Cvenkel, F. Grehn, P. Khaw, H. Lemij, N. Pfeiffer, T. Shaarawy, I. Stalmans, J. Thygesen, C.E. Traverso, A. Viswanathan
“
The campus at Lugano is very well organised, attended by students of all ages and of all nationalities, with the possibility ‘of interesting intercultural exchanges’ Giuseppe Guarnaccia
The upcoming Retina I module in Lugano will be attended by 41 students and the adjacent module Retina II by over 30 students.
Achieving fellowship So what do the students taking part in ESASO think of the programme? “One of the most enjoyable aspects of the ESASO course is the chance to meet eminent surgeons and teachers of ophthalmology,” said Maria Caterina Cascella. Dr Cascella has been working since 1990 at the Center of Excellence in Ophthalmology, Eye Unit, Putignano, Bari (Italy) and is responsible for diagnostic medical and surgical treatment of retinal diseases. “The campus at Lugano is very well organised, attended by students of all ages and of all nationalities, with the possibility ‘of interesting intercultural exchanges’. I also like the fact that the campus is located in a valley full of trees at the edge of a beautiful lake surrounded by mountains with a mild and sunny climate. I had the chance to take part in interesting classes of clinical and ophthalmic surgery (in particular of retinal disease, my main interest, along with glaucoma and corneal diseases), followed by internships and wetlab with some of the great teachers in world ophthalmology,” Dr Cascella said. Giuseppe Guarnaccia is ESASO global executive director
contact
Under the auspices of ESCRS (European Society of Cataract and Refractive Surgeons)
Under the auspices of EGS (European Glaucoma Society)
ESASO c/o Università della Svizzera italiana (USI) Via Giuseppe Buffi 13 6904 Lugano, Switzerland Tel. +41 (0)58 666 4629 Fax +41 (0)58 666 4619 Email info@esaso.ch
www.esaso.ch
Gabriella Skala - gabriella.skala@esaso.org ES_10-11 ESASO_Anz_120x300_RZ.indd 1
20.4.2011 9:01:46 Uhr
pub EKC 120/300 Angl 2011:Mise en page 1
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EKC EurokeratoConus II
Feature
industry news
Recent developments in the vision care industry
September 23 - 24 2011
New pupil camera optic
BORDEAUX - FRANCE Cité Mondiale – Centre des Congrès - Parvis des Chartrons - 33080 Bordeaux - France
Official Language : English OCULUS Pentacam pupil camera
CE Mark approval
Honorary Chairman : Pr Yves POULIQUEN
Chairmen : Pr Joseph COLIN, Pr François MALECAZE
Join us for the 2nd European Congress on Keratoconus World renowned faculty members will provide updates on the rapidly evolving technologies in the management of keratoconus
Download the programme on the web site :
www.keratocone.eu Register now Submit abstract by July 30, 2011
joseph.colin@chu-bordeaux.fr Information : JBH Santé - ye@jbhsante.fr
EUROTIMES | Volume 16 | Issue 7/8
STAAR Surgical has announced CE Mark approval for two of its products. Approval has been granted for Visian(R) Implantable Collamer(R) Lens (ICL(TM)) V4c design. The V4c design incorporates a proprietary port in the centre of the ICL optic of a size determined to optimise the flow of fluid within the eye, and eliminates the need for the surgeon to perform a YAG peripheral iridotomy procedure days before the ICL implant, said a company spokesperson. Approval has also been granted for the nanoFLEX(TM) Collamer(R) Single Piece IOL which can be injected through a 2.2mm incision with the nanoPOINT(TM) Injector System. The nanoFLEX IOL incorporates the company’s proprietary aspheric optic design (patent pending), which is optimised for the naturally curved anatomy of the eye.
OCULUS have announced that the OCULUS Pentacam® is now equipped with a new optic for the pupil camera. "As of now the new camera optic is included within all new Pentacam® and Pentacam® HR devices without extra costs," said a company spokesperson. "With the aid of the new camera, the whiteto-white measurement is performed automatically. The high-res photo of the iris enables the user to new opportunities of evaluation. In addition to that the brilliant image is the basis for further data determination," she said.
Retinal disease management
Critical Health, a provider of ophthalmology-specific software solutions for Clinical Decision Support and Electronic Medical Record, attended the recent 11th EURETINA Congress where the company showcased its latest innovations in retinal disease management. These included the Retmarker suite, a certified Medical Device software solution (CE0197) and recipient of an European IT Excellence Award. The Retmarker suite, developed in partnership with the leading research institute AIBILI (Association for Biomedical Research and Innovation in Light and Image), is based on the latest research on Microaneurysm Turnover, a new biomarker for diabetic retinopathy progression.
Twice-daily ocular NSAID approved by European Commission
CROMA Pharma and Bausch + Lomb have announced the approval of Yellox ™ (Bromfenac sodium sesquihydrate) by the European commission. This news follows the positive opinion issued earlier in March by the Committee for Medicinal Products for Human Use (CHMP), part of the European Medicines Agency (EMA). Yellox, a non-steroidal anti-inflammatory drug (NSAID), is now approved for the treatment of postoperative ocular inflammation following cataract extraction in adults. “We are extremely pleased with marketing authorisation from the European Medicines Agency,” said Andreas Prinz, managing director of CROMA Pharma GmbH. “Yellox is an innovative advance for the millions of post-cataract surgical patients and offers physicians a new, powerful and convenient choice for helping to put a stop to ocular inflammation after cataract surgery.” “Yellox is very promising for cataract surgery patients,” said Dr Cal Roberts, chief medical officer, Bausch + Lomb. “The drug helps meet the unmet needs of both patients and physicians alike across a number of European markets, offering them a new choice to treat postoperative ocular inflammation following cataract extraction.”
Feature
39
Book review
School of hard knocks Experience of real-world ophthalmic practice supplies answers
One of the more humbling realisations about becoming a fully fledged specialist is that the actual clinical work is the least of your worries. Dealing with colleagues, managing time, managing junior staff, interacting with administrators of a bewildering variety of stripes, juggling one’s own personal life with the demands that the role places – all are challenges which can vex far more than the more intractable clinical case. Tom Harbin MD, MBA is a cataract surgeon with more than 30 years of clinical – and practical – experience. It is that practical experience that puts this book into a genre of its own: the whatthey-don’t-teach-you-in-school genre. The first of these was the management bestseller, What They Don’t Teach You in Harvard Business School. This set the template for a style of book that promises to tell it as it is. Generally these books make a virtue of their no-nonsense, thisis-how-it-is style.
This set the template for a style of book that promises to tell it as it is. Dr Harbin has written an engaging book, full of lively advice for doctors of all specialities. He covers a wide range of topics, most notably planning, deciding on what specialty or area a medical graduate wishes to pursue, and how to get along with colleagues and co-workers. There are some elements of quasi-clinical advice – such as not performing procedures unless confident that they will be of benefit – but generally the tone is looking at all those things that are not (or barely) included in the average medical school curriculum, but that become among the most pressing issues of a career. The book is obviously aimed at the American market, and sometimes the observations reflect this. European practitioners work in a variety of settings, including private and for-profit practice, but a much more sizeable chunk are working in public sector healthcare than among Dr Harbin’s target readership. Occasionally, this gives a slightly odd tone to the advice – especially in the section on colleagues to watch out for, where he discusses the “lazy” doctors who don’t bring enough income into a practice. The book is divided into five sections, to correspond to career stages; getting EUROTIMES | Volume 16 | Issue 7/8
started, learning business, early career, mid career, and late career. Dr Harbin covers a lot of ground as can be seen from the titles of his subsections – from dealing with the sociopathic doctor to drawing up a life plan. There is a question which the title of this book begs: Should these things be part of the medical school curriculum? Concerns that medical schools aren’t producing technically competent or fully ethical doctors are prevalent throughout the medical educational literature. It is less often considered how, for want of better words, business-savvy and life-savvy they are. Of course, the focus of medical education is on producing safe, competent, and reliable clinicians. And it would be short-sighted to overload an already groaningly daunting curriculum with further material, some of which should be perhaps considered more part of our general education. Having said that, perhaps a model akin to that adopted by PhD programmes in many universities in recent years could be considered, such as including modules aimed at making the graduate “business aware”. Even in the European context, where the medical marketplace is dominated by the state and not private practice, an awareness of the financial realities of life and of practice is highly important.
books editor: Seamus Sweeney publication What Every Doctor Should Know... but was Never Taught in Medical School Editor Tom Harbin MD, MBA published by F E P International, 2010 If you a have a book you would like to have reviewed please send it to: EuroTimes, Temple House, Temple Road, Blackrock, Co Dublin, Ireland ad-eye-cee one 120x300 1105v1 jmo Eurotimes jmo.indd 3
23.05.11 16:37
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Feature
LEGAL matters
MORE SATISFIED PATIENTS
Cataract surgeons at low risk of being sued for malpractice by Paul McGinn
C
ataract surgeons take heart. If the world’s largest-ever study of cataract surgery lawsuits is any indication, you may never find yourself in court for medical negligence. The study, authored by two consultant ophthalmic surgeons at Moorfields Hospital in London, found that of the estimated four million patients who underwent cataract surgery in the UK between 1995 and 2008, only 324 sued their ophthalmologist for medical negligence. That figure translates to about 23 lawsuits per year for the whole of the UK National Health Service or about one lawsuit for every 12,000 operations. The ophthalmologists attributed the low risk of being sued to a number of factors. For one, cataract surgery carries a relatively low risk of complications when compared to other operations. Also, many UK patients who might otherwise sue their ophthalmologist in court make complaints directly to local and national health authorities and agencies. When a patient did sue an ophthalmologist over a cataract operation, the most likely reason was because of a mistake during surgery. That said, the study also found a raft of errors that led patients to sue: ineffective anaesthetic, erroneous biometry measurements, inaccurate refraction calculation, and delayed response to postoperative complications. Interestingly, the findings also showed that while consent is an important part of the preoperative process, it does not prevent a patient from suing or receiving compensation. The study, which appeared in the April issue of the British Journal of Ophthalmology, found more than onethird of all claims and more than two-fifths of the compensation paid out arose over allegations involving the ophthalmologist’s negligence during the surgery. In most cases, such negligence was proved despite the patients having signed consent forms that acknowledged the complications of cataract surgery, including such risks as posterior capsule tears and dropped nuclei. “This is of interest as it is part of routine consent for cataract surgery to warn of the risk of the standard intraoperative complications and postoperative reduced vision. Nevertheless, this does not prevent EUROTIMES | Volume 16 | Issue 7/8
Perhaps the best defence to lawsuits is one of the oldest ones – make friends with your patients, the surgeons advised. claims arising, nor from being successful in many cases,” wrote the authors, Nadeem Ali FRCSEd(Ophth), and Brian C Little FRCS. “This highlights the fact that, just because a complication is known to occur on a regular basis and is consented for, does not imply that there is no fault attributable in the individual case,” the surgeons added. “It also highlights the need for surgeons to take every precaution available to reduce the chance of the predictable complications of cataract surgery. In addition, it is necessary to discuss preoperatively with patients potentially unavoidable complications which may occur without surgery being negligent.” The study also found that lawsuits may arise because a patient’s expectations of
the outcome are too high or misguided. “This is despite the fact that visual outcomes may be excellent. This underlines the critical importance of accurate biometry and the need for robust systems for ensuring the biometry data in the notes match the patient, the power of the IOL inserted matches that documented in the notes, and that any preoperative anomalies or concerns are flagged up and acted upon.”
Costliest claims Somewhat surprisingly, the costliest claims were those involving inadequate anaesthetic. “The psychological distress caused to a patient who suffered pain while awake during an operation clearly has a strong resonance in a sympathetic court of law. This is a pertinent finding as there is a
trend towards lighter forms of ocular anaesthesia, such as topical only. However, perhaps we should welcome this trend since the second most likely cause to result in damages is globe perforation from anaesthetic injection, a well-described medico-legal scenario.” Endophthalmitis, too, produced costly claims. The surgeons noted that while the condition has an incidence of between 0.05 per cent and 0.25 per cent, it accounted for four per cent of all cataract surgery claims. “Part of this may reflect the devastating nature of the condition and the affected patient’s feeling of the need for compensation. There is also heightened public awareness about the risk of hospital-acquired infections,” the authors noted. They added that a number of lawsuits involving endophthalmitis arose because of the delay in diagnosing and treating the condition. “This might be reduced by better education of front-line staff, ophthalmic or non-ophthalmic, to whom these cases first present,” the surgeons observed. Despite the overall good news from the study, the authors cautioned against complacency, noting that the study did not incorporate any information about near-misses, undetected adverse events, or cases in which patients did not sue. “From a risk management perspective, it is also important to recognise that negligence claims represent just the tip of the risk iceberg,” they wrote. In the end, few patients sued their ophthalmologists just because of mistakes on the operating table. Rather, what motivates patients to sue has more to do with how they treat the patient before and after the operation than what they do inside the operating theatre. “The factors that motivate patients to sue centre more around behaviour than around clinical competence,” the surgeons wrote. What that means is that if an ophthalmic surgeon shows respect and empathy for a patient, communicates well and shows a real interest in the patient’s condition, the ophthalmologist may avoid a lawsuit despite an adverse outcome, injury, or even mistake. Perhaps the best defence to lawsuits is one of the oldest ones – make friends with your patients, the surgeons advised. “People are reluctant to sue someone that they like.”
For details of the study, see British Journal of Ophthalmology 2011;95:490-492.
42
Review
JCRS Highlights
JCRS Symposium
CONTROVERSIES in Cataract and Refractive Surgery
2011
Sunday, September 18, 2011 14.00 –16.00 Chairs:
Emanuel S. Rosen, MD, FRCSEd Thomas Kohnen, MD, PhD, FEBO
Will femtosecond-assisted cataract surgery supersede microincision phaco cataract surgery?
Zoltan Nagy, MD, Takayuki Akahoshi, MD
Will the advantages of modern phakic intraocular lenses reduce the applications of laser vision correction?
Thomas Kohnen, MD, PhD, FEBO Julian D. Stevens, MD
If I were having cataract and IOL surgery today, my choice of IOL would be . . .
Emanuel S. Rosen, MD, FRCSEd Thomas F. Neuhann, MD Richard B. Packard, MD Douglas D. Koch, MD Hiroko Bissen-Miyajima, MD Gerd U. Auffarth, MD
Journal of Cataract and Refractive Surgery Simultaneous bilateral vs sequential bilateral cataract surgery Cataract extraction is now the most common surgery performed in the world, and demand is expected to continue to increase with the ageing population in the developed world and better access to care in the developing world. The economics favour the idea of simultaneous bilateral surgery, but is this approach as safe as the standard sequential approach? The Helsinki Simultaneous Bilateral Cataract Surgery Study evaluated the refractive outcomes, complication rates, and changes in patients' functional state and satisfaction with simultaneous compared with sequential bilateral cataract surgery. In this study 493 (247 patients) had bilateral surgery in one session and 506 (257 patients) in separate sessions. The postoperative refraction was within ±0.50 dioptre of the target in 67.2 per cent of eyes in the study group and 69.2 per cent of eyes in the control group and within ±1.00 D in 91.0 per cent and 90.3 per cent, respectively (P=.92). The only complication that affected postoperative visual acuity was chronic cystoid macular oedema, which occurred in one eye in the study group (0.2 per cent) and in two eyes (0.4 per cent) of one patient in the control group (P=.57). Ninety-five per cent of patients in both groups reported being very satisfied with surgery. When planning simultaneous bilateral cataract surgery, the major concerns include the risk for endophthalmitis, corneal oedema, and CME, as well as for retinal detachment in patients with high axial myopia. In the present study, those concerns were taken into consideration by using appropriate inclusion criteria for enrolment. Staff also received additional training on endophthalmitis prevention. Therefore, while this study suggests no difference in outcomes between the two approaches, the results cannot be extrapolated to patients who would not fulfil the inclusion criteria used in this study, the researchers note.
years postoperatively in contralateral eyes with a single-piece hydrophobic acrylic (AcrySof, Alcon) and one of two singlepiece hydrophilic acrylic intraocular lenses (Akreos Adapt or C-flex ). Although there was no significant difference at one month, the median EPCO score was statistically significantly lower in the hydrophobic group than in hydrophilic groups at three years. Nine eyes in hydrophilic groups required Nd:YAG capsulotomy, while no eye in the hydrophobic group required a capsulotomy. n AR Vasavada
et al., JCRS, “Comparison of posterior capsule opacification with hydrophobic acrylic and hydrophilic acrylic intraocular lenses”, June 2011, Volume 37, Issue 6, 1050-1059.
Vision quality after LASEK
How good is patients’ quality of vision after laser-assisted subepithelial keratectomy (LASEK)? A study employing the Quality of Vision (QoV) questionnaire indicated that the quality of vision worsened in the early postoperative period but returned to preoperative levels after one month and was better than preoperative levels by three months. The researchers note that quality of vision may be largely governed by epithelial cover, which usually occurs within three to seven days of surgery, but may take as long as two weeks. This may contribute to the high QoV scores in the early postoperative period. These findings may also be attributable to general wound healing, tear-film disruption, and the use of topical medication. n C
McAlinden et al., JCRS, “Quality of vision after myopic and hyperopic laser-assisted subepithelial keratectomy”, June 2011, Volume 37, Issue 6,1097-1100.
n A
Sarikkola et al., JCRS, “Simultaneous bilateral versus sequential bilateral cataract surgery: Helsinki Simultaneous Bilateral Cataract Surgery Study Report 1”, June 2011, Volume 37, Issue 6, 992-1002.
DURING THE XXIX CONGRESS OF THE ESCRS, VIENNA, AUSTRIA
EUROTIMES | Volume 16 | Issue 7/8
Comparing PCO rates
How do single-piece hydrophobic acrylic IOLs compare with singlepiece hydrophilic acrylic IOLs with a 360-degree square edge in terms of PCO formation? Vasavada and colleagues conducted a prospective randomised clinical trial comparing PCO rates three
Thomas Kohnen associate editor of jcrs FURTHER STUDY Become a member of ESCRS to receive a copy of EuroTimes and JCRS journal
contact
Janet Kettels - kettels_janet@allergan.com
Feature
outlook on industry
new treatment options
Panel recommends broader indication for Allergan’s time-release retinal anti-inflammatory implant by Howard Larkin
A
s the population of Europe ages, retinal disease has become a growing problem, and Allergan is committed to supplying ophthalmologists with advanced medications and delivery devices needed to treat it, says Douglas Ingram, president, Allergan Ltd., Europe, Africa and the Middle East. Allergan’s latest move toward realising that goal came in mid-April. The Committee for Medicinal Products for Human Use (CHMP), recommended that the European Medicines Agency (EMEA), expand marketing authorisation for OZURDEX® to include non-infectious uveitis. The EMEA usually accepts CHMP recommendations within a few months, which clears the way for national health agencies and insurance plans to pay for the treatment in the 27 member states of the EU, Mr Ingram notes. A biodegradable timerelease anti-inflammatory corticosteroid implant, OZURDEX was approved by the EMEA last year for treating macular oedema related to both central and branch retinal vein occlusion. If EMEA follows form with the expanded authorisation, Allergan will be ready to launch OZURDEX for uveitis in Germany and the UK this autumn, followed by rollout in other countries. “We are pleased with the committee’s positive opinion supporting the licensure of OZURDEX for treating non-infectious intermediate and posterior uveitis. This is also an important milestone for Allergan’s retina franchise and demonstrates our continuing commitment to developing innovative new treatments that can help preserve vision for patients suffering from retinal diseases,” Mr Ingram says. OZURDEX is already clinically approved for RVO in Germany, the UK, France, Spain, Sweden and Italy. Allergan is working with national health agencies to ensure payment for OZURDEX, which may increase patient compliance and reduce costs by cutting back on the number of treatments required to control retinal conditions. “Acceptance has been great throughout the region. It has outperformed our expectations,” Mr Ingram adds.
Six months between injections
Like many retinal diseases, non-infectious posterior segment uveitis can be chronic and difficult to treat, Mr Ingram notes. EUROTIMES | Volume 16 | Issue 7/8
OZURDEX is a biodegradable intravitreal implant of dexamethasone, a highly potent corticosteroid, and is supplied in a specially designed, single use applicator
Blurred vision
Spots or threads
Decreased visual acquity
Floaters
Straight lines appear wavy Metamorphopsia (image distortion)
What a patient with intermediate and posterior uveitis may see due to impaired vision
While less common than anterior segment uveitis, it is more likely to result in vision loss. The majority of cases occur in people between ages 20 to 50, and can cause vision loss due to vitreous haze and macular oedema. Severe cases are typically treated with local and systemic steroids. However, long-term systemic treatment may not be suitable due to the adverse systemic side effects of steroids, and local treatments can require frequent intraocular injections, with related pain, risk of infection, and cost and inconvenience for both patient and surgeon. Treating retinal vein occlusion and other retinal diseases present similar challenges. OZURDEX was developed to minimise these issues by providing 0.7mg intravitreal dexamethasone that is gradually released over a period of up to six months. The implant is made of Allergan’s proprietary Novadur, a solid polymer that dissolves
over time. OZURDEX is FDA approved for treating retinal vein occlusion, and is in trials in Europe and the US for other indications, including diabetic macular oedema. The safety and efficacy of OZURDEX for managing patients with non-infectious intermediate or posterior uveitis was demonstrated in Allergan’s phase III HURON trial. In this 26-week, multicentre, double masked clinical study, 229 patients were randomised to receive either OZURDEX 0.35mg or 0.7mg or simulated sham injections. Eligible patients had non-infectious ocular inflammation of the posterior segment with intermediate or posterior uveitis, best corrected visual acuity of 10 to 75 Snellen letters, a vitreous haze grade of >+1.5 on the 0-4 classification scale. At the eight-week primary end point, 47 per cent of patients receiving OZURDEX had a vitreous haze score of zero, or about four
times the 12 per cent rate observed in the sham group. The treated group maintained statistical superiority through the 26-week study. The treatment group also saw a statistically significant improvement in visual acuity from week three through week 26, and achieved significantly higher scores on clinically relevant visual function and healthrelated quality of life as measured by the NEI VFQ-25 survey. OZURDEX was also welltolerated with manageable adverse effects, Mr Ingram says. Since OZURDEX directly targets inflammation, it may be more suitable for treating retinal diseases that are more inflammatory in nature, such as RVO and uveitis, than anti-VEGF dugs, which may be more useful for diseases such as wet AMD that involve neovascularisation, Mr Ingram points out. The two drug classes may well complement each other, he says. OZURDEX is also undergoing Phase III trials for diabetic macular oedema. Mr Ingram is hopeful about the outcomes, which are being unmasked this summer and could pave the way for yet another indication. “These are the early days for OZURDEX. The response has been great from physicians. At our last quarterly meeting we had a patient describing their experience with OZURDEX. We are bringing a product to the market that addresses significant unmet need.” Mr Ingram also sees broad potential for the Novadur extended delivery system, which is key to reducing frequent intravitreal injections and keeping vitreal drug concentrations more constant over time. Other drugs in Allergan’s pipeline will make use of the technology, he says. “It is the platform that makes OZURDEX such an exciting opportunity for us and a good tool for physicians.” Allergan currently invests more than $800m annually in research and development, Mr Ingram notes. Much of this goes toward ophthalmology, which represents about half of Allergan’s sales in the Europe-Africa-Middle East region. Ophthalmic products include Alphagan P 0.1 per cent, Lumigan 0.01 per cent and Combigan for glaucoma, and Restasis, which is approved for dry eye in the US but not Europe. Other high-profile products include Botox for therapeutic and cosmetic uses, Latisse for eyelash thickening, and various obesity treatments and breast and facial aesthetic devices. Allergan’s sales worldwide for FY 2010 totalled $4.8bn, up from $4.4bn in 2009. Mr Ingram sees ophthalmology as a strong growth area. “We are committed to all areas of ophthalmology for the future as we have been for the last 50 years. We’ve been there and we are going to be there for the ophthalmologist. Not many companies can say that.”
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Reference
Calendar of events Dates for your Diary
July 2011
1-3
July
Leuven, Belgium
Leuven Retina Meeting www.leuvenretinameeting.eu
8-10
2011
21-23 Israel
Dead Sea,
Fifth International Symposium on Refractive Surgery, Cataract and Cornea www.dead-sea2011.co.il/
Crete, Greece
12th Aegean Retina Meeting www.aegeanretina.gr
September
October
5-8 Porto Alegre, Brazil
6-7 DUBLIN, IRELAND
2011
XXXVI Ophthalmology Brazilian Congress www.cbo2011.com.br/
September vienna, austria
16-17 17-21
www.surgicon.org
www.apacrs.org
23-24 Bordeaux, France
22-25 ORLANDO, FL, USA
January
February
Eurokeratoconus II www.jbhsante.fr
XXIX Congress of the ESCRS www.escrs.org
November 2011
23-26
13th International Paediatric Ophthalmology Meeting Dublin
Gothenburg, Sweden 13-16 SEOUL, KOREA 8-9 1st World Congress on Surgical Training 2011 APACRS-KSCRS Annual Meeting
2011
2nd EuCornea Congress www.eucornea.org
2011
MILAN, ITALY
91st SOI National Congress www.soiweb.com
December
1-4
2011
vienna, austria
International Symposium on Ocular Pharmacology and Therapeutics www.isopt.net
2012
13-15
Athens, Greece
7th Pan-Hellenic Vitreo-Retinal Meeting www.gvrs.gr
28
American Academy of Ophthalmology Annual Meeting www.aao.org
3-5
2012
prague,
czech republic
16th ESCRS Winter Meeting www.escrs.org
rome, ITALY
2nd EURETINA Winter Meeting www.euretina.org
April
2012
21
Belgrade, Serbia
International Symposium on Glaucoma – New Insights and Updates www.glaucoma –belgrade2012.org
July 2012
22-27
berlin,
germany
ISER 2012 XX Biennial Meeting of the International Society for Eye Research www2.kenes.com/iser/pages/home.aspx
September
September
MILAN, ITALY
MILAN, ITALY
6-7 7-9
2012
3rd EuCornea Congress www.eucornea.org
2nd World Congress of Paediatric Ophthalmology and Strabismus www.wcpos.org
2012
6-9 8-12
12th EURETINA Congress www.euretina.org
XXX Congress of the ESCRS www.escrs.org
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Please visit us at booth B312 at the ESCRS congress, Vienna, 17-21 September
RAYNER IOL experts, the world over.
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Sulcoflex ® Pseudophakic Supplementary IOLs are exclusively designed in collaboration with Professor Michael Amon (Vienna, Austria). Note: Sulcoflex® Pseudophakic Supplementary IOLs are not yet approved for sale in the US and Canada. 05/11 Copyright Rayner Intraocular Lenses Limited.
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