Refractive surgery for presbyopia: a promising treatment option

Issue: January 2005

ByJennifer Byrne

Although LASIK, PRK and LASEK are not yet ready for widespread use to treat presbyopia, several clinical trials have shown promising results, creating cautious optimism among major ophthalmic companies.

“The development of these ablations is still in the early stages,” said Robin Hughes, head of Bausch & Lomb’s refractive surgery division, in an interview with Primary Care Optometry News. “However, a lot of surgeons out there are doing these types of presbyopic treatments and say they are getting excellent outcomes. We are trying to determine what these outcomes are and how consistent they are.”

Studies at University of Ottawa

One significant study on presbyopic refractive surgery was conducted at the University of Ottawa Eye Institute by W. Bruce Jackson, MD.

This study involved eight myopes and six hyperopes. The myopes, with an average age of 52 years, had a mean refractive spherical equivalent of –3.30 D and a mean add requirement of 2.31 D. The hyperopes, with a mean age of 55 years, had an MRSE of 2.26 D and a mean add requirement of 2.29 D. All subjects received bilateral treatments targeting improvements in both distance and near vision.

At the 3-month follow-up, all eyes achieved 20/40 distance uncorrected acuity, with 80% reaching 20/40 near acuity. The mean near add requirement dropped in both groups.

Bausch & Lomb studies

Mr. Hughes discussed Bausch & Lomb’s clinical trials in this area. “There are two types of patients, the hyperopes and the myopes/emmetropes,” he said. “Based on the way in which the ablations are performed, it is much easier to treat hyperopes than myopes. And if you do any type of hyperopic correction, you can get some sort of multifocality.”

In terms of ablation patterns, Mr. Hughes said researchers have found that central additions and additions in the periphery seem to yield equally effective acuity results. “Both options seem to provide good near vision. It is quite easy to get to a level of J2 with these treatments. But to what extent does it compromise distance vision?” he said.

“Most practitioners who work in this area have a limited cohort of data,” he said. “The success rate ranges anywhere from 80% to 90% with hyperopes to around 50% to 60% with myopes and emmetropes.”

Mr. Hughes said he believes it is too soon to draw any conclusions based on the currently available data. “A lot of individual surgeons are convinced they have algorithms and approaches to treat the condition, but I think it is early to draw any conclusions,” he said.

Visx hyperopia trials

Visx has also been conducting clinical trials on refractive surgery for presbyopia. According to Sondra Black, OD, of TLC Laser Centers in Ontario, the hyperopic results have been quite promising.

Eighty percent of the hyperopes, with a binocular bifocal, ended up at 20/30 and J3, she said. “Preoperatively, most of the mild hyperopes walk around without a distance correction,” she said. “Postoperatively, if they are able to function for 85% of their day without glasses, they’re generally thrilled.”

Dr. Black said the myopic group is still in the trial phase and is likely to be more of a challenge, due to the good near vision they experience without their glasses and the desire for “perfect” distance vision.

“While the majority of myopes have been happy with their outcome, counseling will be the key,” she continued. The most difficult patients are those with less than 2 D of myopia. Ideally, they will have previously tried monovision or a multifocal contact lens to simulate the result, she said.

Dr. Black said while she agrees that refractive corneal surgery for presbyopia is still not ready for widespread use, she feels it is promising. “It’s going to be the way of the future,” she said.

Alcon’s current status

Although Alcon was unable to supply specific data from its presbyopic refractive surgery clinical trials, a company spokesperson issued a statement on the current findings.

“Various industry research and data presented at recent meetings regarding laser ablation profiles and algorithms suggest that excimer lasers alone may not provide a comprehensive solution to presbyopia and therefore may not be the optimal technology to address this condition,” said Holly Cross, senior product manager for Alcon. “Alcon … is applying the complete range of its broad technology portfolio to the presbyopia question ... using various modalities, including excimer laser technology and intraocular lenses.”

Presbyopic LASIK trial

The first multifocal LASIK procedure was recently performed by Colman Kraff, MD, founder and president of the Kraff Eye Institute in Chicago. Dr. Kraff said this is an FDA clinical trial sponsored by Visx using the Visx S4 CustomVue and iris registration tracking system. “We're recruiting patients who are low hyperopes and also presbyopes, and we are doing hyperopic presbyopic treatment on them,” he said.

Dr. Kraff said the results so far are quite encouraging, but are still preliminary at this point. “So far, only a few patients have been treated,” he said. “At this point, we have no quantitative data to share, but anecdotally, the early results we are seeing are exciting.

“The CustomVue technology involves putting a proprietary shape on the eye with a LASIK procedure,” he continued. “It’s a true presbyopic treatment.” n

For Your Information:

Robin Hughes can be reached at Bausch & Lomb World Headquarters, One Bausch & Lomb Place, Rochester, NY 14604-2701; (585) 338-6000; fax: (585) 338-6007.

Sondra Black, OD, can be reached at TLC Laser Vision Center, 4101 Yonge St. #100, Toronto, ON M2P1N6; (866) 223-2020; fax: (416) 733-0316.

Holly Cross can be reached at Alcon Laboratories, 6201 South Freeway, Fort Worth, TX 76134; (817) 551-8696; fax: (817) 568-7531.

Colman Kraff, MD, can be reached at the Kraff Eye Institute, 25 E. Washington St., Chicago, IL 60602; (312) 444-1111; fax (312) 444-1953.