PresbyLASIK an attractive alternative for presbyopia management

However, data are sparse, and the procedure is not FDA approved.

Colman R. Kraff

LASIK is becoming more popular as a way to manage presbyopia, with the most common treatment being blended vision correction. While there is no approved method for giving patients a full presbyopic correction without compromising distance visual acuity using multifocality, presbyopic LASIK has emerged as a viable treatment option but poses some challenges.

Unlike trying to achieve monovision, in which the dominant eye is treated to focus on objects at distance and the nondominant eye is treated to focus on near objects, with presbyLASIK, a multifocal treatment is used so that each eye can focus both near and far.

“The ability to correct presbyopia is the holy grail of refractive surgery,” Colman R. Kraff, MD, director of refractive surgery at the Kraff Eye Institute, Chicago, said. “The benefit of any presbyopic procedure is to give people distance and near vision simultaneously, so they can have complete freedom from spectacles.”

Although some studies indicate a benefit of presbyLASIK, limited data are available in large populations and on the long-term benefits. In addition, presbyLASIK is not approved by the U.S. Food and Drug Administration.

Results limited but indicate benefit

The first attempts to put a multifocal surface on the cornea were conducted in the mid-1990s, Dr. Kraff said at OSN New York 2010. Since then, study results have been mixed, he told Ocular Surgery News in a subsequent interview.

Dr. Kraff highlighted three methods for implementing presbyopic multifocal LASIK. The central method involves increasing the central near add; the peripheral method, which most of the laser manufacturers are now doing, involves increasing the peripheral add for near; and the translational approach, which is similar to the peripheral method, creates an aspheric surface to increase depth of focus.

Dr. Kraff highlighted results of a retrospective study published in the Journal of Refractive Surgery that showed progressive multifocal LASIK performed with the WaveLight Allegretto platform (Alcon) is a safe and effective treatment.

Progressive multifocal LASIK is a corneal surgical technique that is based on the principles of LASIK to create a multifocal or aspheric corneal surface. The study enrolled 178 patients, of which 102 had at least 3 months of follow-up. After surgery, 81% had 20/20 or better binocular uncorrected distance visual acuity and 98% had 20/25 or better binocular uncorrected distance visual acuity. In addition, results showed that 44% had J1 binocular near visual acuity, 60% had J2 and 96% had J3.

“This is probably the best study done of all systems in the United States with off-label use and appropriate informed consent,” Dr. Kraff said. “The results were quite good, none of the patients complained of glare or halos, and there was no loss of best spectacle corrected visual acuity.”

The results are comparable to Dr. Kraff’s early, unpublished FDA clinical study results that evaluated multifocality and benefit of use. Those results showed that 75% of patients had 20/20 vision or better at 3 months and 97% had 20/40 or better; 89% had near visual acuity of J3 or better.

“What I experienced was there were limitations in amount of near add,” he said. “When you treat these patients that are in their mid- to late-40s, within a couple years they lose some of the near effect and became less happy.”

The study made it to phase 2 trial but was halted by the laser manufacturer.

“Delivering enough near correction proved to be difficult without compromising distance vision,” he said of the results.

The future of presbyLASIK

Currently, presbyLASIK for the management of presbyopia is not the standard of care; therefore, the only option for ophthalmologists in the United States who are interested in this treatment method is off-label use. As with any off-label use, patient selection needs to considered carefully and Dr. Kraff suggested that ophthalmologists should proceed cautiously.

“While the trend is using intraocular lenses for this type of correction, I believe preliminary study results of presbyLASIK for management showed promise, and this warrants another look,” he said. “We need controlled FDA-clinical trials to ensure safety and effectiveness.”

Dr. Kraff believes that if presbyLASIK were available for the management of presbyopia in the United States there would be a market for it, pending appropriate patient selection.

“The future of presbyLASIK is limited,” he said. “Unless medical device laser manufacturers get on board, the reality is, it’s not going to happen.” – by Tara Grassia

Reference:

• Gordon M. Presbyopia corrections with the WaveLight Allegretto: 3-month results. J Refract Surg. 2010;26(10):S824-S826.

• Colman R. Kraff, MD, can be reached at Kraff Eye Institute, 25 E. Washington St., Suite 606, Chicago, IL 60602; 312-444-1111; fax: 312-444-1953; email: ckraff@kraffeye.com.
• Disclosure: Dr. Kraff is a consultant to AMO and a clinical investigator for Alcon.