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July/August 2005

News in Review
A Look at Today’s Ideas and Trends
By Linda Roach, Contributing Writer
Edited by Brian A. Francis, MD

New IOL Ruling, Same Standards

Long-Term NSAIDs Therapy May Prevent AMD

Gender May Affect Treatment for DME

The Risks of Clear Corneal Cataract Surgery

New IOL Ruling, Same Standards

A recent ruling by the CMS that gives Medicare patients access to presbyopia-correcting IOLs could enhance vision after cataract surgery. But it shouldn’t change practice patterns. “The same ethical standards that applied prior to this ruling still apply,” said William W. Culbertson, MD, a member of the Academy’s ethics committee.

Before the May ruling, Medicare reimbursed for IOLs (including the Array multifocal lens, which received new technology, or NTIOL, status several years ago) at rates of $150 to $200 but wouldn’t pay a penny toward the latest high-tech lenses intended for correction of vision at all distances. These IOLs are designed to treat two conditions: cataract removal with lens replacement, which is covered by Medicare; and presbyopia, a noncovered service. Now cataract patients willing to pay the difference will have access for the first time to Crystalens, AcrySof ReStor, ReZoom or any of the other presbyopia-correcting IOLs likely to be marketed in the wake of this unusual ruling.

Dr. Culbertson called the ruling “a novel thing for ophthalmology in terms of economics and Medicare law.”

But the ruling also has the potential to needlessly change practice patterns. Since the ruling, questions have arisen over whether surgeons might be tempted to lower their indications for cataract surgery in their Medicare patients and therefore do more surgeries. Such speculation relates to the fact that over the years reimbursement for cataract surgery has been ratcheted down to the point where physicians may be underpaid for their services; meanwhile, IOL payments have not risen.

Now the potential exists to recoup that underpayment by billing for postoperative refractive services that are noncovered by Medicare. “But the criteria that we have traditionally used to recommend surgery should not change, and the complete examination that we always perform in every cataract patient still applies,” said Dr. Culbertson, professor of ophthalmology at Bascom Palmer. “When ophthalmologists bill for these services, it’s important that they be reasonable with the extra charges they pass along to the patient.”

Dr. Culbertson added that doctors now have an obligation to inform patients about the option for high-tech lenses. “The patient always needs to know what’s going on,” whether it’s about side effects or extra charges. At the same time, the ophthalmologist must be competent to perform these procedures and must understand the advantages and disadvantages of the various lenses. And he or she must perform the appropriate pretreatment assessment to determine indications or contraindications for their use. Finally, he noted that advertisements must be accurate and not create unreasonable expectations. "So overall there's going to be additional responsibility on the doctor to apprise their patients," he said.

Ultimately, everyone stands to win.  As Dr. Culbertson put it: "Ass ling as the patient is properly enlightened as to the medical and financial implications of these IOLs, 'presbyopic cataract surgery' should prove beneficial to both patient and doctor."

Retina Report

Long-Term NSAIDs Therapy May Prevent AMD

Cutting down on age-related macular degeneration among older patients might be as simple as prescribing long-term use of nonsteroidal inflammatory drugs, a study of AMD incidence among rheumatoid arthritis patients has suggested.¹

This conclusion contrasts with those of the population-based Beaver Dam and Rotterdam eye studies, which could find no impact from NSAIDs. But the difference between the AMD incidence in those studies and the rate found in the arthritis study was so large—a tenfold decrease—that it adds a strong, independent underpinning to other clues about the importance of inflammation in AMD.

“This is very interesting,” said AMD epidemiology researcher Johanna M. Seddon, MD, ScM, of the group’s findings. “This is very plausible and deserves increased attention.”

Dr. Seddon, associate professor of ophthalmology at the Massachusetts Eye and Ear Infirmary, coauthored a study that showed an association between AMD and a blood marker of inflammation, C-reactive protein.²

The lead author of the NSAID study, Patrick L. McGeer, MD, PhD, professor emeritus at Kinsmen Laboratory of Neurological Research, University of British Columbia, noted that the study’s findings also dovetail nicely with the recent discovery, reported this spring in the journal Science, of an inflammation-related gene defect that increases the risk of AMD threefold to sevenfold. (For more about this, see page 3 of this month’s EyeNet Extra supplement AMD Research: An Update, which arrived with this issue of EyeNet.)

The McGeer study involved 993 people over age 65, who have been followed closely since diagnosis with rheumatoid arthritis at an average age of 51.3. Prevalence for AMD in this Canadian group was compared with published data from the Beaver Dam and Rotterdam eye studies, among others. Only three cases of AMD were found in the arthritis study, one-tenth as many as would be expected based on the incidence found in the population-based studies. Furthermore, two of the three cases occurred in patients who had received therapy with hydroxychloroquine, which is known to cause retinopathy.

“Our paper bounced around a little bit because referees just couldn’t believe it would be true,” Dr. McGeer said with a laugh.  "This is a very spectacular and unexpected finding.  We found a tenfold sparing from AMD in these patients undergoing long-term NSAID therapy.  These people just don't go blind."

1 McGeer P.L. and J. Sibley.  Neurobiol Aging 2005;26(8):1199-1203
2 JAMA 2004;291(6):704-710.

Beware Pirated IOL Software
Free software for calculating IOL power isn’t just unauthorized, it gives erroneous results, too, warned a June 3 press release from Kenneth J. Hoffer, MD, of Santa Monica, Calif.; Wolfgang Haigis, PhD, Würzburg, Germany; Jack T. Holladay, MD, Houston; and Donald R. Sanders, MD, Chicago.

The software pirates copied the Hoffer Q program and added Haigis, SRK/T, SRK II, Holladay II and Holladay I formulas. They are offering it for Palm Pilots at a Russian Web site.

Diabetes Update

Gender May Affect Treatment for DME

Ophthalmologists who use optical coherence tomography to look for early signs of retinal thickening might need to take body-mass index, axial length and—especially —gender into account, according to new research from China.

Using OCT, the Hong Kong–based researchers examined 60 male and 57 female subjects, all healthy. They found that, on average, the central 1 millimeter of the fovea was 14 micrometers thicker in men than women (P = 0.001).

Greater foveal thickness also correlated, though less strongly, with higher BMI and longer axial length.¹

Retinal specialists have begun over the last several years to investigate the highly sensitive technique of OCT to monitor retinal changes in patients at high risk for conditions such as diabetic macular edema.

A recent study advises clinicians to account for gender

Caption: A recent study advises clinicians
to account for gender as well as body mass
index and axial length when assesing
patients with diabetic macular edema
for laser therapy.

Browning et al. reported last year that OCT detected DME earlier than the current standard of care, stereoscopic slit-lamp examination of the fundus.² This would make earlier treatment with focal laser photocoagulation possible.

A foveal thickness of about 180 µm has generally been used as the cutoff point between normal and DME-affected eyes. But this value may not be appropriate for all patients, the new study suggests.

It measured mean foveal thickness in the 117 subjects at 171 ± 22µm. However, males tended to have a thicker fovea (174 ± 21 µm) compared with females (168 ± 23 µm). In the central 1 mm, the gender difference was even more marked: 203 ± 23 µm for the men and 189 ± 20 µm for the women.

These findings, the researchers say, mean that gender, BMI and axial length should be considered when assessing a patient’s need for laser treatment.

1 Wong A. C. et al. Eye 2005; 19(3):292–297.
2 Ophthalmology 2004;111(4): 712–715.

Cornea Research

The Risks of Clear Corneal Cataract Surgery

Clear corneal incisions have raised the risk of endophthalmitis among cataract patients since 1992, while the risk of this serious complication has declined for the more invasive procedure of penetrating keratoplasty, according to two meta-analyses of research papers published worldwide.

Endophthalmitis still is three times more likely to occur after PK than cataract surgery, the authors note in papers published simultaneously in the May Archives of Ophthalmology.¹ But the rise in this potentially devastating complication since clear corneal incisions were introduced in 1992 should concern cataract surgeons as they perform ever-increasing numbers of cataract surgeries, the researchers suggest.

“Considering a current (2002) volume of more than 2.5 and 10 million cataract surgeries performed annually in the United States and worldwide, the recent increase in endophthalmitis occurrence (0.265 percent from 2000 and later vs. 0.109 percent in 1963 to 1999) can equate to approximately 4,000 and 16,000 additional cases of endophthalmitis annually in the United States and worldwide, respectively,” they say.

The two meta-analyses pooled data on more than 3 million cataract patients (215 papers) and 90,000 corneal transplant recipients (66 papers) to reach their conclusions.

They speculated that the higher infection risk with clear corneal incisions is related to leaking of the unsutured wounds, possibly because of poorly constructed corneal tunnels, undetected gaping of unsutured wounds, or IOP changes that cause a pressure gradient drawing fluid into the eye after surgery.

1 Taban, M. et al. Arch Ophthalmol 2005;123(5):613-620 and 605-609.