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Call for 'European Research Area' at ESCRS
Studies of quality-of-life issues such as diseases of aging would be facilitated by cross-border research, EU official says.
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BRUSSELS - European ophthalmology took another large step towards cooperation at this year's meeting of the European Society of Cataract and Refractive Surgeons (ESCRS), held here. Significantly held this millennial year in the "capital of Europe" the meeting focused more than ever on how European ophthalmology can work together to achieve scientific as well as political goals.
ESCRS president José Cunha-Vaz, MD, PhD, of Coimbra, Portugal, spoke of the growing influence of the society, which now has more than 3,000 members worldwide.
"ESCRS is the body best able to offer technical advice to government regulators," he said. He also described leadership roles that ESCRS has adopted in sponsoring specific research projects such as the development of an artificial cornea and in developing a network of clinical research centers across Europe.
"Better funding of research could be obtained through this network of centers with clear targets and rules for large and simple clinical trials and outcomes research," he said.
--- Philippe Busquin, the European Union Commissioner for Research, was the keynote speaker at the opening session of the 2000 meeting of the European Society of Cataract and Refractive Surgeons.
René Trau, MD, president of the Belgian Society of Cataract and Refractive Surgery, thanked Queen Paola of Belgium for her patronage of the meeting. He described the long association of ophthalmology with the royal family in Belgium, which dates back to a 15th century queen whose father was an ophthalmologist.
Dr. Trau introduced the keynote speaker for the opening session, Philippe Busquin, the European Union (EU) commissioner for research, and thanked him for his previous work in reforming the Belgian health care system.
The 19-member European Commission operates in many ways like a national cabinet. Mr. Busquin oversees the operation of all EU research programs for medical and other technologies, which are currently being organized and expanded under the "Fifth Framework Programme." Mr. Busquin began his keynote address by acknowledging the importance of cataract surgery, which almost 2 million Europeans undergo each year, and refractive surgery, which is growing in popularity across Europe.
"My task and hope are to set up the structures for scientific progress in your field and others," Mr. Busquin said in the English-language text of his speech, which he delivered to the ESCRS audience in French. "Only recently did research funding [through the EU] open to ophthalmology."
Mr. Busquin noted that in absolute numbers, Europe has not been funding research to the same degree as other developed economies. Whereas government-funded research currently represents 1.8% of the EU's gross domestic product (GDP), the United States spends about 2.7% and Japan 3.1% of GDP on research.
"That is worrisome," Mr. Busquin said. He noted that the top priorities for the future should be for the EU to increase research funding, adapt the U.S.-style "centers of excellence" model for scientific research and introduce a pan-European patent system to eliminate the high cost of patenting new products country by country.
Mr. Busquin said that an important component of a major research initiative on quality of life issues would be the diseases of aging, particularly age-related macular degeneration. But this research must be carried out across the borders of individual nations, he emphasized. Currently, 95% of scientific research funding in Europe is awarded at a national level.
"I want to sound the alarm to the heads of Europe," Mr. Busquin said.
That alarm apparently is being heard. At a summit last March, the heads of state of the EU member nations endorsed the idea of a European Research Area. Under this approach, research funds and personnel would be pooled in order to achieve more widely applicable results.
"The search for knowledge is inherent in humans," Mr. Busquin reminded the audience. "We are all interested in restoring the faith of the public in science. That is the real meaning and purpose of the European Research Area."
ESCRS secretary Marie-José Tassignon, MD, chairwoman of the Eye Clinic at the University Hospital in Antwerp, looked beyond Europe in welcoming attendees of the meeting to Belgium.
"ESCRS now grows beyond Europe's borders to become an international meeting," she said. Ophthalmologists from more than 70 countries had registered for this year's meeting, she noted.
Outcomes study group
The European Cataract Outcome Study Group was launched to generate a Europe-wide basis for quality assurance in cataract surgery. The outcome study group's long-term goals are to measure the outcomes of cataract surgery in Europe, according to Dr. Cunha-Vaz, who presented the most recently updated information for the group at a special session.
Participating countries include the Czech Republic, Denmark, England, France, Ireland, Italy, Norway, Portugal, Sweden, Netherlands and Yugoslavia.
The study group meets annually to discuss study results from the previous year. Through standardized reporting of results and aggregation of data, Dr. Cunha-Vaz said, the group hopes to promote quality improvements and provide benchmarking for compliance purposes and to demonstrate good practice.
Comparison with results from past years, said Dr. Cunha-Vaz, shows that there has been improvement in cataract surgery outcomes. Postoperative induced astigmatism decreased from 0.75 D in 1995 to 0.59 D in 1999, he said. Induced stigmatism did not exceed 1 D in 77.9% of patients in 1995, compared with 86.3% in 1999. Average difference between planned and final refraction was 0.79 D in 1995, improving to 0.7 D in 1999.
The management group of the European Cataract Outcome Study Group suggested a new study to take place during October 2000. All cataract extractions performed in participating centers during the month of October will be included in the study. The management group suggested that the same variables and forms from the group's 1999 study be used in the 2000 study.
David Allen, FRCOphth, of the Sunderland Eye Infirmary, Sunderland, United Kingdom, who has been participating in the study for 2 to 3 years, focused on patients' quality of life. Mr. Allen stressed the need for concentration on the personal impact of surgery. He said professionals involved in the study should be disciplined to provide comprehensive data on every patient for the defined period, but he acknowledged that the extent of this information can sometimes be limited.
Initial impact of surgery at a personal level needs to be measured, he said. With this information, surgeons can make valuable comparisons with peers in both the surgeon's own country and elsewhere. Mr. Allen said many aspects of patients' personal benefits from surgery need to be measured by each team member of the study group.
Mr. Allen noted that in the United Kingdom, chief executives and medical directors of National Health Service hospitals are now legally accountable for the quality of care at their facilities. This new concept of clinical governance in the United Kingdom arises as a result of an increased awareness of and need to demonstrate quality of care to the patient, he said. As a result of this new policy, practices have changed and improved, so much so that 80% of cataract patients are now within 1 D of intended refraction, he said.
The next century of surgery
---The Kiewiet de Jonge award was presented by Gabriel van Rij, MD (left), ESCRS national representative from the Netherlands, to Thomas Kohnen, MD, of Frankfurt, Germany. "ESCRS is the platform to learn surgery, to show your surgery to colleagues and to be successful," Dr. Kohnen told the audience.
A symposium titled Cataract Surgery in the New Millennium focused on how European surgeons, eye care providers, governments and patients need to balance greater achievements in ophthalmology with costs and quality of life.
Helen Seward, FRCOphth, of Sussex, England, noted that surgeons must achieve better results in the future than what is currently deemed acceptable.
"We're performing earlier surgeries, and we must require better outcomes," she said. "What was acceptable in the last millennium is no longer acceptable in this millennium; 20/40, 6/12, 0.5 is not good enough, when so many of our patients are starting out seeing better than that [with spectacles]. Complications have not gone away, but over the next years our complication rates must reduce further."
Bengt Jönsson, a professor at the Stockholm School of Economics, explained that no medical procedure can be seen as cost effective in a short-term view. He said the rationale behind surgery, which social medicine needs to understand, is that quality of life is improved for the patient, and this will pay dividends in the future.
He compared the price of cataract surgery of the early 1980s with what it costs today, in both surgeon cost and hospital cost. In Sweden in the 1980s, he said, the surgery cost the health care system several thousand U.S. dollars and required up to an 8-day hospital stay. Now the cost is only a few hundred U.S. dollars and the procedure can be done in an outpatient setting. With that reduction in cost, compounded with the improved quality of life cataract surgery brings, the benefits of the procedure should be without question, Prof. Jönsson said.
In Europe, national health bodies are convinced of the value of first-eye cataract surgery, but less convinced of the value of surgery on the second eye. Mats Lundström, MD, of Karlskrona, Sweden, presented data showing that second-eye cataract surgery might, in fact, be more important than the first.
"Second eye surgery improves visual function and in turn gives more patient satisfaction than the first surgery," said Dr. Lundström. He said data showed that the overall visual function of the patient is greatly improved by having both eyes undergo cataract surgery when necessary.
Safely past the Y2K deadline, Marta Kalas, from the company 3dlogistics.com, suggested that ophthalmology practice can be significantly improved through e-commerce. She said clinics can use the Internet for marketing and advertising, dispensing general information, patient care and education, patient information and to schedule on-line appointments and follow-up.
Ms. Kalas explained that it was in practitioners' best interests to use e-commerce as a way to communicate with the general public. She said physicians should make sure they define clearly what the want from e-commerce, look at it from an outsider's point of view, keep things simple, and most important, devote time and money to its ongoing management.
ESCRS ponders questionnaire
Calling it "the most important part of this year's ESCRS meeting," Phillippe Sourdille, MD, of Nantes, France, led a discussion regarding the need to develop a comprehensive questionnaire for surgical outcomes.
The object of the questionnaire is to gauge the quality of vision, quality of life and overall care of patients so that surgeons have a better way to evaluate surgical outcomes and keep track of patient follow-up.
Eugenio Leite, MD, noted the difficulty of a multilingual and multicultural organization attempting to agree on one questionnaire. He said there could be problems in translating the form into several languages. But he acknowledged the importance of measuring outcomes and said the essence of the questionnaire process is valid. Dr. Leite said the combination of questionnaire data along with the input of surgeons, patients and healthcare authorities could go a long way in improving the quality of health care policies.
During the presentations several questionnaires that currently exist were discussed, but Jack Holladay, MD, of Bellaire, Texas, explained that the global questionnaire "must blend ease of use and completeness." He said it is unlikely that surgeons could expect a single questionnaire to cover all surgeries, for example, because of the large age difference between patients undergoing cataract and refractive surgeries.
The panel of surgeons also discussed whether or not the survey should include subjective and objective questions, a particularly hard decision since "questionnaires on quality of life are inherently subjective," Dr. Holladay said.
Preoperative questionnaires were also discussed. These would include questionnaires designed to lead surgeons to choose patients most likely to accept certain kinds of surgery better than other patients - for instance patients who might be more apt to adjust to their new refractive acuities better than others after a year's time.
In the end no major decisions regarding questionnaires were made, but the hope that the discussion would continue and lead eventually to a conclusive and comprehensive global questionnaire was evident.
Prismatic IOL for AMD
Piggybacking a prismatic IOL with a normal IOL to help reduce the effects of age-related macular degeneration (AMD) was discussed by Joseph Colin, MD, of Brest, France. He presented 1-year clinical results of patients who were implanted with piggybacked prismatic IOLs.
To determine whether patients could be helped by a prismatic IOL, microperimetry with a scanning laser ophthalmocope was used to determine the residual function in various regions of the retina, and the best angle for the prismatic IOL to redirect light in the proper direction.
The prismatic IOLs were implanted in front of conventional PMMA posterior chamber IOLs.
In Dr. Colin's results both near and distance visual acuity improved in all patients. He concluded that the prismatic IOL was effective in shifting images away from the non-functional fovea to enhance visual performance. In his studies, reading speed doubled in all patients and in some patients as much as quintupled.
He said all patients tolerated the prismatic IOL, and some changes in the lens design are being made to create more space between the IOL and the iris.
Glaucoma surgery
Although the ESCRS, as the organization's name implies, has traditionally concentrated on cataract and refractive surgery, the past few years have seen increasing inclusion of glaucoma surgical topics on the scientific program. Specifically, non-penetrating deep sclerectomy techniques have drawn great interest as more anterior segment surgeons adopt one of the several variations of this procedure.
Andre Mermoud, MD, of Lausanne, Switzerland, described 5-year results with his technique, which includes use of a collagen implant to keep the scleral reservoir patent.
Dr. Mermoud said that in 105 eyes of 105 patients, 61% achieved compete success – intraocular pressure (IOP) reduction to less than 21 mm Hg without need for postoperative medications – while 95% achieved success with postop medications. In addition, he said, 81% maintained their visual fields with no progression of damage for the duration of follow-up. The other 19% showed deterioration of their visual fields, though with IOPs still lower than 15 mm Hg, he said.
In some patients that had IOP rises during the course of follow-up, Dr. Mermoud performed goniopuncture to bring the pressure down. In 48 such cases, goniopuncture at an average time of 13 months postop reduced IOPs in those patients from a mean of 20 mm Hg to 10 mm Hg.
Elie Dahan, MD, of Johannesburg, South Africa, said non-penetrating glaucoma surgery can successfully be combined with cataract surgery in elderly patients. In fact, he said, his results have been better with combined surgery than with non-penetrating glaucoma surgery alone. He said that in combined procedures, the rate of successful filtration declines from 93% in the first year to 63% still controlled without medications in the seventh year, while in non-penetrating surgery alone his success rate declined from 80% to 11% over the same period.
Michael Belkin, MD, of Tel Hashomer, Israel, described his use of the Ex-Press mini-shunt for glaucoma in a trial to evaluate safety and efficacy of the device. The shunt is implanted in a simple, brief procedure, under the conjunctiva and through the sclera. It is 2 mm long, has an external diameter of 27 gauge and an internal lumen of 20 µm, 30 µm or 50 µm.
In a series of 90 patients receiving the shunt, average IOP was reduced successfully to below 20 mm Hg with up to 3 years follow-up.
PCO symposium
At the Clinical Research Symposia that traditionally kick off the ESCRS, Dr. Sourdille led a discussion on the state of current knowledge about posterior capsular opacification (PCO).
"We read in the scientific literature that the PCO rate is low," Dr. Sourdille said, "and yet in the United States it is the most commonly performed procedure after cataract surgery."
He presented his work on a questionnaire designed to record intraoperative and follow-up data to keep track of PCO progression, with the idea of relating long-term PCO results to elements of operative technique and perioperative care.
Okihiro Nishi, MD, spoke about the effects of IOL design and material on PCO. Dr. Nishi has previously described the preventive effect that capsular "bending" has on posterior capsular epithelial cell proliferation. He said that "sharp and fast is best" – in other words, that cataract cases using IOLs with sharp edges, in which the anterior and posterior capsules seal together quickly, are the least likely to develop cell proliferation on the posterior capsule.
New lenses introduced
CIBA Vision held a users' meeting to announce the re-launch of their MemoryLens IOL. Hans Blickensdorfer, commercial director for Europe, Middle East and Africa at CIBA Vision AG (Bulach, Switzerland), explained that soon after the company acquired the MemoryLens from Mentor Ophthalmics, scattered reports of inflammation associated with the lens emerged. The company voluntarily withdrew the lens from circulation in order to check over the manufacturing process, Mr. Blickensdorfer said. They tentatively identified the source of inflammation in some of the reports as an aluminum polishing compound used in finishing the lenses.
After a thorough refurbishing of the manufacturing process, new batches of the MemoryLens were subjected to new multicenter clinical trials at 9 centers across Europe, said Thomas Neuhann, MD, of Munich, who discussed the study design at the meeting. The trials are ongoing, but results to date showed no adverse events in 82 implants. In 30 patients with 1 month follow-up, 60% are seeing 20/20, Dr. Neuhann said.
In addition to the MemoryLens re-launch, CIBA also announced that it has not one but two foldable phakic IOLs in development.
Georges Baïkoff, MD, of Marseilles, presented the details of his three-point fixation anterior chamber phakic IOL, dubbed the Vivarte. The technique of selective polymerization, he said, has allowed CIBA to make the haptics rigid and the optic flexible on this one-piece hydrophilic acrylic lens, making it capable of fitting through a small incision.
Dr. Baïkoff, presented preliminary results of a multifocal version of the Vivarte he has used to correct presbyopia. In his 5-patient, 6-eye pilot study, the patients were all 55 or older, were plano before surgery and were seeking at least 2.5 D of near vision. At 6 months, he said, acceptance by patients was good. He said more study was needed, and that worldwide clinical trials would begin soon.
Dimitri Dementiev, MD, of Arese, Italy, presented CIBA's other new phakic foldable lens, the PRL (Posterior Refractive Lens). This lens is made of an extremely flexible silicone material and is implanted through a small incision with no folding device needed. The IOL "floats" over the natural lens, according to the manufacturer.
Dr. Dementiev said that in several hundred cases performed to date in Italy and Mexico with up to 5 years' follow-up, there was an overall incidence of lens opacification of about 2%. No surgical intervention has been needed in any of the cases of opacification, he said. A U.S. study in legally blind eyes has also been performed, he said, and phase 2 studies in the States have currently enrolled 66 patients.
Donald D. Ferguson, executive director for global marketing in CIBA's Surgical Business Unit, said CIBA had acquired worldwide marketing and distribution rights for both lenses, both of which are manufactured by other companies. He said the company decided to investigate two phakic IOLs simultaneously because they want to give surgeons the choice between an anterior and posterior segment approach. The CE mark, which allows distribution in Europe, is expected for the lenses in January 2001, Mr. Ferguson said.