ORLANDO, Fla. – IOLs were the stars of the show this year, here at the world’s largest ophthalmology meeting. Whether for cataract or refractive surgery – and increasingly it is hard to tell the difference between the two – novel IOL technologies and applications generated much of the excitement at the joint meeting of the American Academy of Ophthalmology and the Pan-American Association of Ophthalmology.

Of course IOLs were not the only news at the meeting, which now stretches a full week, counting the Subspecialty Days beforehand and the Spanish-language review the day after. The meeting, which drew an estimated 24,000 to central Florida, also saw the first Food and Drug Administration approval of a wavefront-based excimer laser system for refractive surgery, as well as the proposal by an international task force of a new classification system for diabetic retinopathy.

But it was the IOLs that drew sustained interest from the attendees. From the launch of Pharmacia’s much-anticipated Tecnis, with its novel aspheric design, to the growing promise shown by several accommodative and phakic IOL models, to the coffee-break buzz about light-adjustable IOLs and lenses that pass through an incision of less than 2 mm, IOLs were the big news.

On the refractive side, perhaps the title of the keynote lecture by Jorge Alio, MD, during Subspecialty Day said it all: “IOLs and refractive surgery – Ready for prime time?”

Ready or not, IOLs for refractive surgery were everywhere in evidence, with half a morning’s program devoted to them at the RSIG Subspecialty Day and at the International Society of Refractive Surgery meeting held simultaneously across town, as well as more coverage later on during the AAO meeting proper.

On display in the exhibit hall were phakic IOLs old and new, including the recently introduced foldable version of the Ophtec Artisan, dubbed the ArtiFlex, and several new models from European manufacturers.

Refractive lensectomy was discussed by a number of speakers, including I. Howard Fine, MD, who noted that this is the procedure where cataract and refractive surgery come together. The IOL options available and on the horizon for this application – as well as for cataract surgery – are multiplying quickly.

Much talked about, though not represented in the exhibit hall, was the Light-Adjustable Lens from Calhoun Vision. D. Verne Sharma, chief executive officer of Calhoun, said in an interview that there is “tremendous interest” in the lens, which theoretically can be adjusted and “cured” after implantation using a light source. Mr. Sharma said he was presenting the lens in private meetings to groups of surgeons off the meeting site. He said he expects human clinical trials with the lens to begin in the first quarter of next year.

One reason for the increased interest in refractive lensectomy may be the potential for restoring accommodation in presbyopic patients through IOL implantation. Several accommodative IOLs were exhibited and discussed on the podium, including the C&C Vision CrystaLens and the HumanOptics 1CU.

Adding to the options for restoration of near vision, early data on a new multifocal version of the AcrySof acrylic IOL was presented at the Alcon exhibit.

Another trend in IOLs evident at the meeting was the shrinking implant profile. Several IOLs that have the potential for insertion through an incision of less than 2 mm were on display. These include the ThinOptX Rollable thin lens, with its novel concentric optic design; the Acry.Smart IOL from Acry.Tec, made with a high-water-content polymer that can be squeezed through a 1.5-mm incision, and the SmartLens from Medennium, which grows from a 1-mm rod to a bag-filling lens. (Medennium was demonstrating the concept only. Company officials say their lens may be several years from the market yet.)

Most of the new technologies described above are not yet available in the United States, but that did not quell the interest of those at the meeting. A feeling that many new IOL options are just around the corner seemed to inspire presenters and attendees alike.

Following are some of the other highlight of the meeting. Many of these items appeared first on OSNSuperSite.com as part of our daily coverage from the meeting.

Sen. Bradley: get involved

In these times of rapid change, it is important for America to lead by example, said former Senator Bill Bradley. He delivered the keynote address at the official opening session.

Mr. Bradley said the example America can set for the world is that of a pluralistic, democratic society with an improving economy that allows a high standard of living for a large number of people. Ophthalmologists can contribute to this example by voting and by becoming community advocates, he said.

“At least vote. It seems to me that is a basic responsibility. But that doesn’t let you off the hook. You don’t have to be a party activist; you can be a community activist,” he said.

“Think of America as a three-legged stool. There’s the private sector, the public sector and our communities. This is where we worship our God, where we raise our children, where we interact with our friends, the PTA, Mothers Against Drunk Driving, the Boy Scouts, the Sierra Club, etc. Make your contribution there if you don’t want to get involved in politics. But make the contribution,” he said.

Mr. Bradley said the current climate of tremendous change, especially after Sept. 11, 2001, has created a great deal of insecurity. To deal with this insecurity in a rapidly changing world, Sen. Bradley said it is better to try to understanding the forces of change, rather than engage in the vain hope of trying to predict the future. He pointed to three areas of rapid change: globalization, technology and information technology.

“One only needs to walk through the exhibit hall to see how fast technology is changing,” Sen. Bradley said.

Using anecdotes from his days on the U.S. Olympic basketball team, his career with the New York Knicks and his 18 years in the Senate, Sen. Bradley gave his blueprint for individuals to effect positive change.

“The question now becomes, how should America lead in this world, not just how can we expand and extend our military power. We can lead by the power of our example. That example is of a pluralistic democracy with a growing economy that takes more and more people to a higher income.

“How are we doing with this? If you look at our economy things are in a little bit of a downstretch following 10 years of an economic boom. Unemployment has doubled in the last 2 years. We went from a $200 million budget surplus to an almost $200 million budget deficit, the stock market crashed and IRAs and 401Ks lost about 30% of their worth in the last year and a half. And yet, even though this is a difficult time, there still is an underlying consensus, believe it or not, between the two [political] parties, on the basic economic agenda. That is open trade, the free flow of capital, the lowest possible tax rate for the greatest number of people and major investments in education and research. I believe these forces will overwhelm any cyclical downturn and bring us back,” he said.

The goal, he added, is to have a higher quality of life for all Americans.

“Today there are still 42 million Americans without health insurance — 1.4 million more this year than last year. … And yet those who don’t have health insurance today are interspersed among us, and are therefore seemingly invisible. It is an issue we are going to have to deal with if we’re going to be able to lead the world by the power of our example of a society whose quality of life is rich and full for everyone.”

Dr. Tuck: remain active

As the technical, financial and regulatory environment changes, surgeons must remain active in shaping the ophthalmic environment, said Kenneth D. Tuck, MD, FACS, delivering the Parker Heath Lecture.

Dr. Tuck said ophthalmologists face many challenges in the current medical environment, and those challenges will increase in the future.

Dr. Tuck, a past president of the AAO, welcomed exciting developments on the horizon, including wavefront technology, confocal microscopy, anti-angiogenesis drugs and neuroprotective agents all in development.

“But these are just the tip of the iceberg of what is to come,” he said. “Ophthalmologists have been inundated with the advances of the past 40 years and look forward to the advances of the next 40.”

Ophthalmologists will be challenged not only to keep up with these advancing technologies and the changing medical environment, but also to integrate new technologies and knowledge into their practices in valid and meaningful ways, Dr. Tuck said.

Regarding the business of ophthalmology, Dr. Tuck said practice will continue to increase in complexity and will require a well-trained and qualified staff. Whatever the needs of the future, he said, “I am confident ophthalmologists will be well-served and well-prepared in our treatments for whatever science and technology send our way.”

As confident as Dr. Tuck is about the future for of ophthalmology, however, he said he is “not so confident about the legislative and regulatory environment.“ He said the expanding scope of practice of optometry and declining reimbursement from Medicare and private insurance will present challenges that ophthalmologists will have to face. He called on the ophthalmic community to band together to help guide regulatory agencies and insurance companies as they develop policies.

“Bad things will only happen to medicine if [we] individually allow them to happen,” he said.

Dr. Abdullah: working for change

Bringing better eye care to the people of Afghanistan is one of the goals of the foreign minister of the new Afghan government.

Abdullah Abdullah, MD, a medical doctor and the foreign minister of Hamid Karzai’s fledgling government, said at the opening session that among his aims is the improvement of what he termed the “very primitive” eye care conditions in his country.

Dr. Abdullah said today in Afghanistan there are only four eye clinics to serve a population of 22 million. For 95% of the populace, he said, cataract means lifelong blindness. For trachoma and other treatable diseases of the eye the prognosis is similar.

He urged the international ophthalmologic community to become involved through education and provision of fellowships for future Afghan ophthalmologists.

As a young man, Dr. Abdullah was forced to abandon his dream of becoming an ophthalmologist because of the Soviet occupation of Afghanistan. Medical schooling in his home country was interrupted, and he fled to Pakistan to complete his training. Before he could study in his chosen specialty of ophthalmology, he became involved with the resistance against the Soviets and then the Taliban. He served as a battlefield surgeon for the Northern Alliance.

Dr. Abdullah said “dealing with patients is important, but it is also just as important for me to deal with politics.” He said he chose to stay in politics to help his country find peace and stability.

Dr. Abdullah said he can now contribute to ophthalmology through his political appointment. “I am committed to making ophthalmology a more important field in Afghanistan,” he said.

At the conclusion of his speech, AAO Executive Vice President H. Dunbar Hoskins Jr., MD, FACS, awarded Dr. Abdullah an honorary membership in the AAO. The recipient was visibly moved by the award and by the standing ovation that followed.

Cataract

Alcon’s multifocal IOL

A new multifocal IOL provides near visual acuity superior to a monofocal IOL without sacrificing distance vision, according to information presented at the Alcon booth by Robert Lehmann, MD.

He discussed early results of a U.S. clinical study comparing Alcon’s multifocal MA60D3 to its monofocal AcrySof MA60BM IOL. The study showed that with bilateral implantation there was no statistically significant difference between distance vision with the multifocal and monofocal IOLs.

In the study, 300 patients were implanted with the MA60D3 and 200 patients were implanted with the AcrySof MA60BM monofocal lens. Dr. Lehmann said analysis is ongoing; the first multifocal lenses were implanted in December 2001. To date, eyes with the MA60D3 have demonstrated no significant glare or halo, and none of the eyes have visual acuity problems in mesopic conditions.

During an audience question and answer period, Dr. Lehmann said at this point, he would recommend against implantation of the multifocal only in eyes with moderate degrees of astigmatism.

Multifocal IOL preference

Hyperopic patients tend to be more satisfied with multifocal IOL implantation than myopes, according to a poster presentation at the International Society of Refractive Surgery meeting.

Gerd Auffarth, MD, and colleagues treated nine hyperopic patients with presbyopic refractive lens exchange (PRELEX) with implantation of an AMO Array SA40N multifocal IOL. Preoperative refraction ranged from +3.5 D to +8.25 D. Results were compared with a group of myopes whose refractions ranged from –3.5 D to –7.5 D.

The hyperopic group had a mean postop refraction of +0.4 D, with uncorrected near acuity of 0.4. The myopic group had a mean uncorrected distance acuity of 0.4 D on the first postop day. After 6 months, distance acuity improved in both groups to 0.7. Near acuity remained stable in the range of 0.4 D to 0.5.

Endophthalmitis and clear cornea

The risk of endophthalmitis may be three or more times greater with clear corneal cataract surgery than with scleral tunnel surgery, according to a meta-analysis.

Robert W. Snyder, MD, and colleagues at the University of Arizona analyzed three large studies of endophthalmitis after clear corneal cataract surgery. The findings were presented at the Ocular Microbiology and Immunology Group Subspecialty Day.

In reviewing the three studies, with more than 1,842 cases of clear corneal cataract surgery, Dr. Snyder performed an analysis based on a binomial probability distribution of what the chances would be of the average surgeon seeing a case of endophthalmitis. Dr. Snyder created a probability table based on an ophthalmologist seeing one case of endophthalmitis for every 350 patients.

Based on that table, for surgeons who perform 200 cataract procedures per year, a little more than half of these surgeons would not see a case of endophthalmitis. One in three physicians would see one case and one in 10 would have two patients develop endophthalmitis. For the surgeon performing 300 cataract cases per year, according to the table, there is a 42% chance that a surgeon would see no cases, a 36% chance that the surgeon would see one case, and a 16% chance of two cases, Dr. Snyder found.

“This is something that needs to be looked at,” Dr. Snyder said. “When we look at the retrospective studies there are a lot of variables that one has to consider with respect to endophthalmitis, including wound location, the closure, the size, IOL materials and insertion, antibiotics and collagen shields to name a few. Because of that, retrospective studies make it very difficult to figure out what the risk factors are.”

Because the risk of endophthalmitis may be three or more times greater with clear corneal cataract surgery, “I think it’s very important to go forward with a prospective study of this issue,” Dr. Snyder said.

Impossible made possible

Advances in technology, including products not yet available in the United States and nontraditional surgical techniques, have made cataract cases that would have been impossible in the past possible today. Surgeons presented difficult cases and how they have managed them at a session called “The Impossible Made Possible in Cataract Surgery.”

Robert H. Osher, MD, discussed implantation of an IOL in a blind eye. The patient had requested the surgeon’s help for cosmetic reasons; she had developed leukocoria in addition to hypotony of 4 mm Hg and phacodonesis. Dr. Osher successfully implanted a black IOL in the eye. He has since used a similar device for intractable diplopia, he said.

Arturo R. Maldonado-Bas, MD, said that although there is controversy over the use of IOLs in children under 3 years of age with cataracts, they can be used successfully.

In the case Dr. Maldonado-Bas presented, the most important part of the procedure was the anterior capsulorrhexis because of the difficulty involved, he said. He performed four paracenteses and used two Lindstrom hooks to dilate the pupil slightly. He then injected viscoelastic and performed the anterior capsulorrhexis, which was difficult in children because the soft lens tended to move. After the anterior capsulorrhexis was safely made, he performed hydrodissection and aspiration of the soft lens as normal.

Although the cases described were unusual, presenters said modern surgical instruments and techniques, combined with a surgeon’s expertise, can make difficult cataract cases possible.

Refractive Surgery

Reviving the market

Technologies soon to be available to ophthalmologists may revive the slumping refractive surgery market. This was the optimistic message delivered by Richard L. Lindstrom, MD, in the Refractive Surgery Interest Group Honorary Lecture.

Dr. Lindstrom said the imminent introduction of wavefront-guided ablation, with its promise of “vision better than we can provide with glasses or contact lenses,” may boost the public’s interest in refractive surgery in 2003. (Alcon received the first U.S. approval for wavefront-guided ablation during the AAO meeting. See related Ophthalmic Business article.)

In addition, he said, the availability of phakic IOLs and other lens-based surgical options will allow surgeons to offer refractive correction to a greater range of myopes.

Ophthalmology’s penetration of the refractive market “has only begun,” Dr. Lindstrom said. He noted that of approximately 275 million Americans, it is estimated that 55% need vision correction of some type. Currently, about 73% of those who need correction use glasses and 23% use contact lenses. Only about 4% have had refractive surgery to date, he said.

Wavefront-guided custom ablation is about to reach the market, Dr. Lindstrom noted, with Alcon’s CustomCornea system approved and other manufacturers’ systems soon to follow.

He predicted that as this technology becomes available, the public’s lagging interest in refractive surgery will be renewed. Citing the results of a trial of the Visx WavePrint system in which 71% of patients had postop uncorrected visual acuity of 20/16 or better, he said impressive visual results like these may spark a revival of attention.

Phakic IOLs, several of which are now in U.S. clinical trials, may allow surgeons to expand the range of myopes to whom they can offer surgery, Dr. Lindstrom said. These devices will be particularly helpful for patients with 8 D or more of myopia, he said.

Other technologies in development hold promise for the smaller market of hyperopes and for the potentially growing market of presbyopes, Dr. Lindstrom said. Many surgeons have not yet decided on a favored approach to hyperopia, he said, and refractive lensectomy seems to hold promise for this application. For presbyopia, small-diameter corneal inlays and accommodating IOLs may be viable options in the near future.

“I would love to have a surgical technique to offer the baby boomers as they reach the presbyopic stage,” Dr. Lindstrom said.

He predicted that the downward trend in refractive surgery will reverse in 2003, and procedure volume will increase, “offering strong growth and opportunity for all of you involved in this field.”

Starting the wave

Daniel S. Durrie, MD, said wavefront-guided laser technology is only the beginning of new technologies that will “drive our understanding of the optics of the eye.” He delivered the Barraquer Lecture during an International Society of Refractive Surgery symposium held during the AAO.

“We are entering the era of quality of vision, not just quantity,” Dr. Durrie said.

“A perfect wavefront is a simple mathematical shape,” Dr. Durrie said. “Spherical aberrations and coma are distortions we all have. These wavefront machines are quite good; they find the problem.”

Dr. Durrie asked the audience, “Why should I think about customized ablation when conventional LASIK works so well?” He explained that with wavefront-guided laser ablation, studies have found that patients experience improvements in night vision, overall vision, glare, halos and night driving.

Dr. Durrie explained that wavefront-guided laser technology is paving the way for wavefront-guided contact lenses and wavefront-adjusted IOLs.

“I’m challenging industry not to think in a phoropter world,” he said.

The Barraquer Lecture, named for the late refractive pioneer Jose Barraquer, MD, recognizes excellence in the field of refractive surgery.

Presbyopia: no perfect option

None of the three approaches currently used to correct presbyopia is an ideal solution; more research is needed before any of them can become a standard, said Michael Knorz, MD.

Dr. Knorz delivered the ISRS Kritzinger Memorial Lecture, named for Michiel Kritzinger, MD, the South African ophthalmologist who died in a helicopter crash in 2000.

Dr. Knorz said there are three current approaches to surgical correction of presbyopia — monovision, pseudoaccommodation and restoration of accommodation.

Monovision can be achieved using any refractive procedure, Dr. Knorz said. He said conductive keratoplasty seems to offer some advantages over other similar hyperopic correction measures.

“Distribution of heat with CK is more homogenous in the tissue. Scars are more predictable, effects more lasting,“ Dr. Knorz said.

While monovision works to correct presbyopia, it involves a compromise, he said. “It reduces stereopsis, reduces distance vision and does not offer perfect near vision.“ He added that in the United States, monovision has a 70% patient acceptance rate, but in Germany, the acceptance rate is “more like 10% to 20%.”

Pseudoaccommodation can be achieved with multifocal IOL implantation, Dr. Knorz said. To date, results with this approach are imperfect, he said. “The compromise is slightly reduced distance vision, not perfect near vision, halos and ghosting. It’s not acceptable to everyone, but it is a feasible option.”

Restoration of accommodation might be achieved with several surgical procedures, “but all the data is experimental,“ Dr. Knorz said.

Steps to customized ablation

Perfect customized ablation depends upon six steps, all of which must work together to produce the right outcome, said Francesco Carones, MD, delivering the Lans Lecture at the ISRS meeting.

The six steps, he said, are measurement of aberration, integration of data into an algorithm, registration of the data onto the cornea, laser delivery and tracking, online ablation feedback and adjustment and wound healing control.

The first four steps are technical issues, Dr. Carones said, and will depend upon the laser platform the surgeon chooses. The last two steps involve “real cornea,“ he said.

Dr. Carones described an intraoperative corneal topographer (BioShape) he is investigating that measures the corneal surface shape in three dimensions. “It’s very useful for visualizing small surface irregularities and may help give us information on the corneal healing response,“ Dr. Carones said.

With higher order aberrations, surgeons must start creating and evaluating online feedback, he added.

Recutting, flap lifting

Both recutting the cornea and lifting the flap are safe enhancement procedures after LASIK, but flap complications are more likely in the recutting group, according to Yuval Domniz, MD. He delivered the Troutman Award lecture at the ISRS meeting.

Dr. Domniz described a retrospective study of 318 eyes, in which 263 eyes underwent recutting for enhancement after LASIK and 55 eyes underwent flap lifting. Follow-up was at 1, 3 and 6 months after the enhancement. There were no statistically significant differences between the two groups in spherical equivalent or cylinder after enhancement. No statistically significant differences were found in uncorrected or best corrected visual acuity.

In the recutting group, four eyes lost one line of BCVA. No eye lost two or more lines. Seven eyes in the recutting group had free flap complications. One eye had significant epithelial ingrowth that required removal. Three eyes had loose lamellar tissue that resulted in flap removal. Two eyes required arcuate incisions for residual astigmatism.

In the flap lifting group, two eyes lost one line of BCVA. No eye lost two or more lines. Two eyes had significant epithelial ingrowth, Dr. Domniz said.

The Troutman Award is “meant to stimulate research and development in refractive surgery by a young ophthalmologist.” Dr. Domniz is the youngest recipient of the award to date.

New complication of LASEK

Inadvertently using a stronger concentration of mitomycin during laser epithelial keratomileusis (LASEK) could lead to a toxic endotheliitis and corneal decompensation, according to a poster presentation at ISRS.

Three healthy patients underwent standard LASEK. After ablation, a sponge soaked in mitomycin was placed on the corneal bed for 2 minutes to prevent corneal haze. The concentration of mitomycin was 0.05% instead of the intended 0.02%. On day 3 postop, five eyes of the three patients had diffuse corneal edema and conjunctival injection that was initially diagnosed as tight lens syndrome. The patients’ contact lenses were removed. Intensive topical steroids and hypertonic saline solutions were started as the eyes developed disciform keratitis and iritis. At 9 days postop, two of the three patients’ symptoms had resolved.

The poster authors said they will continue with additional follow-up to determine if there will be any long-term sequelae.

Phakic IOL or LASIK?

A procedure combining both phakic IOLs and LASIK is “where we’re heading,” said George O. Waring III, MD, at ISRS.

Re-treatments after the combined procedure can help lead to an ideal procedure “that eliminates refractive error,” he said.

“If I asked you if LASIK was better a better procedure than phakic IOLs, most people here would raise their hands. But if we look at the published literature, we find that phakic IOLs are a better procedure, because more than 2 lines of BCVA are gained in more patients.”

Dr. Waring said the flexibility of phakic IOLs is greater than that of LASIK.

“Most people think implanting a phakic IOL is more complicated than performing LASIK. With LASIK, we have to deal with a laser we don’t know how to fix if it breaks and a microkeratome, which is a complicated piece of equipment. But a phakic IOL can be implanted by any experienced cataract surgeon.”

He said LASIK alters the cornea and is adjustable but not reversible. Phakic IOLs are more adjustable than LASIK and removable. Both procedures can be performed in an ASC, he noted.

Dr. Waring added, however, that a combined procedure of phakic IOLs and LASIK still needs to be “refined.”

Modified PRK

Photorefractive keratectomy modified to keep corneal tissue cooler seems to improve visual outcomes and reduce complications, according to a poster presentation.

Dieter Dausch, MD, and colleagues treated 50 eyes of 45 patients with myopia of between –1.5 D and –9 D. PRK was performed on the patients using the spot-scanning Asclepion MEL 70 laser, modified so that no increase in temperature resulted within the corneal tissue during the procedure. At 6 months follow-up, 90% had reported no serious pain. The epithelium healed in 2.5 days on average. On the first postoperative day, BCVA was between 20/32 and 20/20. No eye developed more than trace haze.

Dr. Dausch’s poster was presented at ISRS.

Allergies and refractive surgery

Surgeons must identify ocular allergies in their patients before proceeding to refractive surgery, according to one surgeon, because patients taking allergy medications tend to have poor refractive outcomes.

“When you think about it, you wouldn’t think those things would have any influence on each other, but allergy can affect the refractive outcome,” said Deepinder K. Dhaliwal, MD, at the Alcon exhibit.

She cited a study that found that 46% of patients with grade 2 to 3 diffuse lamellar keratitis had a history of ocular allergy. She also quoted information from a laser manufacturer’s training manual, which noted that PRK patients who took Claritin (loratidine, Schering) had an increased mean time to re-epithelialization. The manual stated that patients should be instructed to discontinue loratidine use before refractive surgery.

Surgeons should take a careful patient history, specifically searching out the use of medication.

“Patients taking Claritin or other antihistamines don’t even consider them to be medications, so be specific when you ask about ocular allergy use,” Dr. Dhaliwal said.

She said she gives her refractive surgery candidates a short survey, including the following questions: “Do you take eye drops for ocular allergy, like Visine?” and “Do you take an antihistamine, like Claritin, Allegra or Zyrtec?”

She also recommended against use oral antihistamines for ocular allergies because “it’s best to treat a topical disease topically.”

She recommended that patients use Patanol (olopatidine, Alcon) alone for ocular allergy symptoms, and Patanol with Flonase (fluticasone propionate, GlaxoSmithKline) if nasal symptoms are associated. Patients also should stop wearing contact lenses before refractive surgery, she said.

After 2 to 3 weeks, the ocular surface should be reassessed, Dr. Dhaliwal said.

She said Patanol is effective because it is a “potent antihistamine; it is a mast-cell stabilizer; it is an anti-inflammatory and it is an extremely comfortable agent.”

Zyoptix results

More than 90% of eyes with myopia up to –7 D and astigmatism up to –3.5 D had uncorrected visual acuity of 20/20 or better, according to data on Bausch & Lomb’s Technolas 217z Zyoptix.

Scott M. MacRae, MD, and Stephen G. Slade, MD, presented these findings at a press conference here.

Dr. Slade said 70.3% of the 340 eyes in the study had UCVA of 20/16. More than 94% of eyes maintained or improved their preop BCVA at 6 months postoperatively.

Dr. MacRae reported that 6 months after surgery with the Zyoptix custom ablation system, 99% of patients said they were satisfied with results. He added that 99.7% indicated improvement in quality of vision, and more than 40% reported improvement in night vision while driving.

Bausch & Lomb officials said this was the first time these findings have been presented publicly in the United States. This data is included in the company’s premarket approval application, which was submitted for review to the Food and Drug Administration in May.

Permavision lens for hyperopia

The Permavision intracorneal lens is effective, predictable, stable and relatively safe for the correction of hyperopia between +1 and +6 D, according to a study.

Dr. Waring presented results on the Permavision lens on behalf of Mohamad Akef El-Maghraby, MD.

The Permavision is a biocompatible, microporous hydrogel lens with properties that mimic that of the stroma, Dr. Waring said. Twenty-nine consecutive eyes with +1 D to +6 D were implanted; 90% of patients were available for follow up.

At 1 year postop follow-up, 44% of eyes were within ±0.5 D, 77.8% were within ±1 D and 100% were within ±1.5 D of target. Thirty-seven percent of patients saw 20/20 or better, and 74% saw 20/40 or better. No eyes lost two or more lines of BCVA.

Lens decentration occurred in 24% of patients; 70% of patients had good centration at 1 year. Seventy-four percent of eyes had no haze, 22% had mild haze and one eye had significant haze. Edge deposits seemed fairly common but not clinically significant.

Dr. Waring said surgical modification may be needed to improve lens centration. Flap haze is the most serous complication, although it occurs rarely. Longer follow-up is needed, he added.

Predicting night vision problems

Night vision disturbances following LASIK are related to some photoablation variables and not to others, said Mihai Pop, MD, during the AAO meeting.

As optical zone goes down and preoperative spherical error goes up, more night vision disturbances occur, according to Dr. Pop. Eyes with myopia greater than –4 D and an optical treatment zone less than 6 mm have a higher chance of night vision disturbances, he said.

He studied 1,488 eyes that underwent LASIK for myopia of up to –9.75 D with the Nidek EC-5000. At 12 months after surgery, 15% of eyes had mild night vision disturbances, 3% had moderate night vision disturbances and 1.3% had “disturbing” night vision disturbances.

Initial sphere and optical zone size could predict the odds of experiencing night vision disturbances with statistical significance, whereas pupil size could not, Dr. Pop said.

There was no correlation of pupil size to complaint of night vision disturbances after surgery at any visit postoperatively, he said. Preoperative sphere and optical zone size predicted night vision disturbances at 3 and 12 months postoperatively.

Post-launch CK results

Patients who have been treated with CK are satisfied with postoperative outcomes according to results released here.

Between the April 2002 Food and Drug Administration approval of conductive keratoplasty (CK) and the first week in October close to 4000 procedures have been performed by surgeons.

According to Refractec’s press release “nearly 95% of patients reported being ‘satisfied’ to ‘extremely satisfied’ with their visual outcome post-CK.”

Refractec purposely limited the technology to a controlled amount of surgeons in order to managed the post-launch data and to “ensure the successful implementation of this new technology by physicians.” Only 54 U.S. surgeons were trained and had access to the technology.

“The demand for CK has grown at a very rapid pace, compared to past vision correction procedures,” said Mitchell B. Campbell, president and CEO of Refractec, Inc. in the press release.

On April 16, 2002, the FDA approved CK for the temporary reduction of spherical hyperopia in patients who have a cycloplegic spherical equivalent refraction of 0.75 D to 3 D and 0.75 D or less of astigmatism.

Glaucoma

IGS awards

Four studies, describing research on normal tension glaucoma, a vaccine for neuroprotection, experimental glaucoma in primates and atrophy of relay neurons, were recognized as among the best research in glaucoma published in 2001.

The International Glaucoma Society presented the authors of these studies with the International Glaucoma Review Award at Glaucoma Subspecialty Day.

Michal Schwartz, MD, PhD, and colleagues received one of the awards for “Vaccination for neuroprotection in the mouse optic nerve: implications for optic neuropathies” (J Neuroscience. 2001;21:136-142).

Two papers shared the other of the two awards. MLJ Crawford and colleagues received the award for “Experimental glaucoma in primates: changes in cytochrome oxidase blobs in V1 cortex” (Inves Ophthalmol Vis Sci. 2001;42:358-364). The award was shared with Robert Weinreb, MD, and colleagues for “Atrophy of relay neurons in magno- and parvocellular layers in the lateral geniculate nucleus in experimental glaucoma” (Inves Ophthalmol Vis Sci. 2001;42:3216-3222).

A Special Recognition Award was given to Douglas Anderson, MD, Stephen Drance, MD, and H. Dunbar Hoskins, MD, for the Collaborative Normal-Tension Glaucoma Study Group, for “Risk factors for progression of visual field abnormalities in normal tension glaucoma” (Am J Ophthalmol. 2001;131:699-708).

The Special Recognition Award is given to a total body of research conducted by a group or groups.

The International Glaucoma Review, a publication of the IGS, presents annual awards to two scientific publications that have the “greatest impact on our understanding of glaucoma,” according to Erik L. Greve, MD, PhD, the IGR editor. “This is truly an international award, and the only true global glaucoma award.”

The awards are given to research that is “original, daring and innovative,” Dr. Greve said. “Both papers are selected based on their outstanding value.” This year, because one of the awards was split, actually three papers were honored.

This was the first time these awards were presented in the United States, according to IGS officials. Ten papers were nominated for the award. Recipients receive a $20,000 prize, a crystal bowl and a diploma.

IOP and ALT failure

Glaucoma patients with intraocular pressure greater than 22 mm Hg before undergoing argon laser trabeculoplasty may have a higher risk of ALT failure, according to a poster presentation. Patients with this and other risk factors may warrant earlier intervention with ALT or other glaucoma filtering surgeries, the poster authors suggested.

Manvi Prakash, MD, and colleagues reviewed the records of 458 consecutive patients with primary open-angle glaucoma who underwent ALT. Mean follow-up was 26.9 months. Patients included in the study had uncontrolled IOP despite medical treatment with maximum tolerated IOP-lowering medications.

Of nine risk factors evaluated, the following were statistically significantly associated with ALT failure: an IOP of greater than 22 mm Hg before ALT (P <.0001), systemic hypertension (P =.0006), age over 60 years (P =.0035), and IOP greater than 17 mm Hg 1 hour following ALT.

Bimatoprost and latanoprost

In a 6-month study, bimatoprost 0.03% was more effective than latanoprost 0.5% at lowering intraocular pressure. However, some adverse events occurred more frequently with bimatoprost than latanoprost.

Robert Noecker, MD, an associate professor at the University of Arizona in Tucson, presented the study, which compared Lumigan (bimatoprost 0.03%, Allergan) to Xalatan (latanoprost 0.5%). In the randomized, multi-center, investigator-masked study, 133 patients received bimatoprost and 136 patients received latanoprost.

For inclusion patients had to be over 18 years of age, have a diagnosis of ocular hypertension or primary open-angle glaucoma and have an IOP between 22 mm Hg and 34 mm Hg. Patients were excluded if they had progressive disease or recent intraocular surgery. Patients were randomized to receive either Lumigan or Xalatan and then followed for 6 months. The washout period varied depending on the patient’s prior medication. Patients were instructed to dose once in the evening. Patients were followed up at 1 week, 1 month, 3 months and 6 months.

“In this study the data is extremely consistent at every time point at every single visit; Lumigan outperforms Xalatan by a statistically significant margin,” Dr. Noecker said. “In addition, when we looked at the other measures, usually it was statistically positive, but there was a trend that Lumigan did better as far as hitting lower numbers in IOP reduction, percent chance of hitting a target pressure or having high responder rates.”

Adverse events included hyperemia (44.4% with Lumigan vs. 20.6% with Xalatan), eyelash growth (10.5% vs. 0%), ocular itching (9.8% vs. 2.9%) and ocular burning (5.3% vs. 5.9%); adverse events occasionally resulted in discontinuation (4.5% with Lumigan vs. 3.7% with Xalatan).

“This is consistent with what we see clinically,” said Dr. Noecker.

The study, which was sponsored by Allergan, is scheduled to be published in the January 2003 issue of American Journal of Ophthalmology.

SLT as first line treatment

Selective laser trabeculoplasty (SLT) is a safe and effective treatment for patients with either open-angle glaucoma or ocular hypertension, according to Madhu Nagar, MBBS, FRCS. Patients with uncontrolled ocular hypertension responded slightly better to the treatment than those with open-angle glaucoma, she added.

Mrs. Nagar enrolled 207 patients in a study and divided them into two groups. One group had medically uncontrolled OAG or ocular hypertension; a second group consisted of patients newly diagnosed with OAG or ocular hypertension. The patients received SLT around 90°, 180° or 360° using the Lumenis Selecta 7000.

“On day 1, there was about a 40% reduction in intraocular pressure. The pressure creeps up a bit at week 1 but stabilizes after that,“ she said. Results with SLT were “slightly better” for hypertensive patients (33%) than for OAG patients (25.6%) in the first group. The newly diagnosed group also responded well to treatment, with a 28.5% drop of IOP in patients with OAG and a 29.5% drop of IOP in patients with ocular hypertension, Mrs. Nagar said.

A second study was initiated, comparing the three types of shots; about 31 eyes were enrolled in each of three groups. Follow-up to date is about 6 months, Mrs. Nagar said. All three groups showed a drop in IOP.

"As the treatment area increased, the failure rate was reduced,” she said. “But the adverse events increased as the treatment area increased." She attributed this to her own discomfort with the procedure at the time of treatment delivery.

As discussant of Mrs. Nagar’s paper, Michael Stiles, MD, identified some areas of concern with the second part of the study. “It lacks a control group, it lacks well-defined outcome criteria, details of patients excluded or treatment failures and it lacks protocol changes," he said. In addition, baseline characteristics of the patients were not included, so results may be difficult to generalize to the population at large.

Retina

Task force proposes universal DR stages

Much attention was paid at this year’s meeting to diabetic retinopathy (DR), in recognition of the fact that diabetes has reached such unprecedented levels in the U.S. population.

The most important DR initiative announced at the meeting was a simplified system for classifying the disease, prepared and proposed by an international task force of specialists. The complexity and number of existing classification systems prompted the international effort to standardize the classification of DR, according to members of the task force.

Juan Verdaguer T., MD, said there is a need for a “unified scheme“ because the Early Treatment Diabetic Retinopathy Study (ETDRS) staging system is not easy to use. Dr. Verdaguer is part of the task force that released its recommendations here during the meeting.

The task force designed a five-point scale: no DR, mild DR, moderate DR, severe DR and proliferative DR. Details of the scheme are available on the AAO Web site (www.aao.org).

Control of diabetes

A theme at a number of sessions was the need to control systemic diabetes in order to prevent vision loss from DR. Patients need to be advised that early, intense control of diabetes can retard the progression of DR, several speakers said.

Although this is not news to clinicians, it is worth re-emphasis as the developed world experiences a veritable epidemic of diabetes, said speakers at an Update on Diabetic Retinopathy symposium.

Tight control of glucose and cholesterol levels in patients with diabetes mellitus assists in reducing the incidence of DR, said Emily Y. Chew, MD. She reviewed the effectiveness of intense glucose control vs. conventional glucose control as outlined in the Early Treatment of Diabetic Retinopathy Study (ETDRS). The study showed that there was a 34% to 76% reduction of DR with intense glucose control.

Lowering serum cholesterol levels can also be beneficial in managing diabetic macular edema, Dr. Chew said. She said the ETDRS and the Wisconsin Epidemiological Study of Diabetic Retinopathy showed that serum cholesterol may have an effect on the number of hard exudates in diabetic patients. According to Dr. Chew, the studies found elevated levels of serum cholesterol were associated with as much as a 50% increased risk of developing hard exudates, which can double the risk of vision loss after 5 years.

Lawrence I. Rand, MD, spoke on lessons learned from the Diabetes Control and Complications Trial. The goal of the study was to verify whether controlling blood glucose levels reduces the risk of blindness. The study monitored 1,422 patients randomized into two groups.

He and colleagues concluded that intensive therapy and control of glucose level does prevent proliferation. It also reduces the risk of nonophthalmic complications from advanced stages of the disease, such as renal failure.

Currently, there are 11 million Americans — 6.2% of the population — diagnosed with diabetes mellitus. That number is expected to climb to 25 million by 2025, Dr. Chew said.

Also at the symposium, Frederick L. Ferris, MD, said the ETDRS found that early application of scatter photocoagulation can preserve vision in up to 30% of previously untreated eyes with DR.

An interesting side finding of the study was that use of aspirin by patients with cardiovascular disease did not increase retinal hemorrhaging, Dr. Ferris said.

At a separate session, Peter Hamilton, MD, spoke about how physically taxing DR can be to a patient. As an example, he showed a photograph of two women seemingly unrelated. He said the two women were identical twin sisters, but one had been blinded by DR in childhood.

He, like others presenters, expressed hope that DR may effectively be treated with compounds currently being investigated, such as protein kinase C inhibitors and anti-vascular endothelial growth factor.

Anastomosis for CRVO

Bypassing the central retinal vein with anastomosis of a retinal vein to a choroidal vein may be an option for patients with central retinal vein occlusion (CRVO), according to presentation given during Retina Subspecialty Day.

Ian L. McAllister, MD, said he would not recommend the procedure until results of the Central Retinal Vein Bypass Study become available. But the poor prognosis of CRVO and the success of the anastomosis technique to date warrant further scientific evaluation, he said.

Creating an anastomosis involves the use of a high-intensity argon laser. Dr. McAllister said using the technique he has been able to effectively create anastomoses in 61% of patients.

The main risk of the technique is neovascularization of the shunt site, but this can be controlled with close follow-up and proper control of areas of ischemia, Dr. McAllister said. Ischemic eyes and eyes likely to progress to ischemia are not good candidates for the technique, he said.

5-FU for PVR

Intravitreal injection of 5-fluorouracil may be effective in preventing proliferative vitreoretinopathy (PVR) in high-risk patients, said G. William Aylward, FRCS, MD.

PVR is the most common cause of retinal detachment following vitrectomy, said Dr. Aylward, speaking at Retina Subspecialty Day. He said the use of 5-FU presents a "simple, cheap and effective way" of preventing PVR in these patients.

Dr. Aylward described a clinical trial including 174 patients, conducted at Moorfields Eye Hospital in London, which evaluated the efficacy of 5-FU in reducing the incidence of PVR in high-risk patients. Postoperative incidence of PVR was reduced by “roughly half" in the treatment group, he said.

Dr. Aylward said additional study is still needed, and a trial is currently evaluating the efficacy of 5-FU for treating established PVR. Another trial is planned to evaluate the use of 5-FU in all patients undergoing vitrectomy for retinal detachment, rather than only those deemed high-risk.

Photocoagulation for retinal tumors

Laser photocoagulation may be a treatment option for vasoproliferative retinal tumors, according to Alain Gaudric, MD.

Dr. Gaudric said several methods of treatment have been tried, including cryotherapy and plaque radiotherapy. Laser photocoagulation seems to be effective for occluding the vascular component of the vasoproliferative retinal tumors, rather than eradication of the tumor itself, which is the main goal of other treatments, he said.

Dr. Gaudric treated eight consecutive patients using either argon laser photocoagulation at the slit lamp or endolaser photocoagulation in conjunction with vitrectomy. Patient follow-up ranged from 7 months to 10 years.

All patients showed complete regression of subretinal fluid and had a significant regression of subretinal exudates, he said.

Best corrected visual acuity improved 3 or more lines in two patients, and the other six patients maintained vision.

Retinal cells and circadian rhythms

Blind children with retinal ganglion cell dysfunction exhibit greater variation in sleep patterns than other children, blind or sighted, according to Russell N. Van Gelder, MD, PhD.

Dr. Van Gelder and colleagues performed a prospective field study including 42 children and young adults between the ages of 12 and 20 years. Participants were grouped according to visual function: those with retinal ganglion cell dysfunction, those blind but with intact retinal ganglion cells and those with normal sight.

Wrist actigraphy was used to monitor participants’ sleep patterns, including waking hours and daytime napping. Dr. Van Gelder noted that normal individuals have a circadian rhythm cycle of 24.3 hours, and that each day individuals must “reset” their rhythm with the day/night cycle.

Sleep times varied among the groups, and individuals with retinal ganglion cell disease exhibited the greatest variance in sleep patterns. Dr. van Gelder said patients with retinal ganglion cell disease had the greatest incidence of daytime napping (P < .0008), sleep latency (P < .0007) and circadian desynchronization (P < .004).

Dr. Van Gelder said these findings support earlier research indicating that a second set of retinal cells is responsible for regulating sleep patterns in humans. He said melatonin could possibly be used as a therapeutic option for patients with ganglion cell disease, but this remains to be evaluated.

Macular translocation in pathological myopia

Eyes that undergo full macular translocation for pathological myopia recover with better visual acuity than eyes that undergo limited macular translocation, said Yasuo Tano, MD, of Osaka University Medical School, who delivered the Jackson Memorial Lecture.

Dr. Tano said he was honored to be giving the prestigious lecture because he felt it was awarded to him not for his accomplishments alone, but because of the accomplishments and progress of his fellow Japanese ophthalmologists who have drawn international attention to ophthalmologic achievements there.

He said he focused his research on macular translocation and submacular surgery because pathological myopia is one of the most common afflictions in Asia, the Middle East and especially Japan.

Endophthalmitis after retinal surgery

Exogenous endophthalmitis is rare after vitrectomy retinal surgery, according to Magdalena Shuler, MD. She said the study she presented here is the largest series from a single institution evaluating the occurrence of endophthalmitis.

Of 1,052 patients enrolled, only 17 developed endophthalmitis after surgery. The patients successfully underwent vitrectomy for various reasons. The most commonly found organism was Staphylococcus.

Harry Flynn, MD, who discussed Dr. Shuler’s paper, commented on the limitations of a retrospective study. He noted that there were no incidence data, and the inclusion criteria may have allowed other reasons for endophthalmitis. The question of how often endophthalmitis occurs after pars plana vitrectomy is still unanswered, he said.

Young patients with CRVO

Young patients with central retinal vein occlusion can have variable disease outcomes, including loss of vision even after significant improvement, said Franco Recchia, MD.

He conducted a study to evaluate the clinical course in young patients with CRVO. Most studies have evaluated the disease course in older patients, he said.

Dr. Recchia said initial visual acuity may not be indicative of final treatment outcome. Those who initially present with good vision have the tendency to deteriorate, and the converse was also seen in the study.

Thomas Friberg, MD, who discussed Dr. Recchia’s study, noted that a previous study had shown that patients with CRVO who present with poor vision may improve slowly. He called for further study focusing on different predictive factors.

Plastics and more

Cancer therapy and duct obstruction

Radiation injury may occur in the lacrimal outflow system following a common iodine thyroid cancer treatment, according to John A. Burns, MD, FACS. This can result in scarring and symptomatic epiphora, he said.

Dr. Burns presented his findings on I¹³¹ treatment, a common radioactive iodine therapy for thyroid cancer patients, at the American Society of Ophthalmic Plastic and Reconstructive Surgeons meeting, held in conjunction with the AAO. According to Dr. Burns, I¹³¹ has not been previously reported to cause nasolacrimal duct obstruction. He reported on 17 patients whose lacrimal systems were obstructed by I¹³¹.

The treatment of choice for metastatic differentiated thyroid carcinoma is mega-doses of I¹³¹, he said. Mega-doses of I¹³¹are considered to be 100 mCi to 1,000 mCi delivered in one or more treatments.

From May 2000 and September 2002, 423 patients with thyroid cancer were seen in an outpatient thyroid clinic, Dr. Burns said. Of those patients, 92% had received I¹³¹ as therapy. Seventeen patients with reported epiphora were referred for evaluation of their lacrimal structure.

Unilateral obstruction was observed in five patients and bilateral obstruction was observed in 12 patients. The mean dosage of I¹³¹ was 180 mCi. None of these patients received dosages less than 150 mCi.

The obstructions were most frequently in the puncta or canaliculus.

Symptoms occurred from 3 to 16 months after I¹³¹ therapy. Time from the onset of symptoms to correct diagnosis was an average 18 months. Prior to accurate diagnosis, 70% of the patients were treated by a physician with at least one medication for their ophthalmic symptoms.

Dr. Burns recommends that endocrinologists be properly educated on I¹³¹-related risk factors with high doses of 150 mCi or more. They should counsel patients about the possible association with nasolacrimal duct obstruction. Standard lacrimal procedures are effective in managing the obstructions, he said.

Endoscopy for duct obstruction

Endoscopy-assisted balloon dacryoplasty appears to be a safe and effective procedure for treating incomplete nasolacrimal duct obstruction, according to a poster presentation.

Steven M. Couch, MD, and William L. White, MD, retrospectively analyzed records of 103 patients with 142 incomplete nasolacrimal duct obstructions who underwent endoscopy-assisted balloon dacryoplasty using a 3-mm diameter, 15-mm-long balloon catheter. They presented their results in a poster.

The researchers evaluated subjective improvement in epiphora, dye disappearance testing and lacrimal system patency to irrigation. Follow-up was 7.5 months on average.

According to the report, overall 90% of patients experienced an improvement in epiphora. Symptoms completely resolved in 56% of occlusions, and improvement was noted in an additional 34% of occlusions. Patients noting an improvement experienced occasional epiphora. No improvement was seen in 10% of eyes.

Depression among ophthalmologists

An ophthalmologist’s caseload and experience level may be directly related to the amount of stress he or she feels, a study presented here indicates.

Kenneth C. Dhimitri, MS, PT, Paul Lee, JD, and colleagues conducted a mail survey of ophthalmologists in the northeast region of the United States to evaluate 1-month prevalence rates of self-reported depression and stress. Results of the survey were detailed in a poster.

Of 697 respondents, 4.8% reported experiencing depression. According to the study, depression was correlated with increasing years of practice (P = .0001). Of those who responded, 5.9% reported feeling stressed. Stress correlated with increasing numbers of patients seen per week (P = .0001), the number of surgeries performed per week (P = .006) and the number of laser procedures performed per week (P = .0001).

Surgeons who have been practicing less than 20 years were 2.7 times more likely to report stress (P < .0001). Stress levels increased to maximum values at 12 and 17 years of practice.

Surgeons who saw more than 100 patients each week were nearly 1.5 times more likely to report feeling stressed (P = .0038) than those who saw fewer than 100 patients weekly.

Ilomastat reduces effect of ulcerative keratitis

The new drug Ilomastat is effective against corneal ulcers and may have applications in treating chemical warfare injuries, according to a researcher.

Several studies show that Ilomastat inhibits the converting enzyme that causes perforation in ulcerative keratitis, said Gregory Schultz, PhD, delivering the Thygeson Lecture at the Ocular Microbiology and Immunology Group Subspecialty Day.

Ilomastat, in development by Arriva Pharmaceuticals, is a synthetic matrix metalloprotease inhibitor.

Dr. Schultz used a broad definition of ulcerative keratitis. He described it as any inflammation of the cornea that leads to the formation of an ulcer, including chemical injuries, bacterial keratitis and viral keratitis in his definition of ulcerative keratitis. In all three conditions, he said, Ilomastat in topical treatment has shown the ability to block the TNF-alpha enzyme that causes corneal ulceration.

One year ago, prompted by the threat of chemical terrorism, Dr. Schultz began animal studies with the U.S. Army Institute for Chemical Defense on the treatment of sulphur mustard injuries to the eye. Use of topical Ilomastat on sulphur mustard injured rabbit eyes showed that Ilomastat had similar results as in treating alkali injuries. The eyes did not ulcerate when treated with Ilomastat, Dr. Schultz said.

In a phase 2 clinical study of 556 patients with infected corneal ulcers, Ilomastat significantly reduced the incidence of perforation, Dr. Schultz said. He added that it had no effect on production of minor ulcers because powerful antibiotics kill most of the bacteria.

Since Ilomastat has not yet been approved by the Food and Drug Administration, Dr. Schultz recommended doxycycline as a reasonable alternative. Doxycycline also inhibits the TNF-alpha converting enzyme, but to a lesser degree than Ilomastat, according to Dr. Schultz.