Verisyse lens approved

October 15, 2004

The FDA approval in mid-September of the Verisyse/Artisan phakic IOL [Advanced Medical Optics Inc. (AMO) and Ophtec USA] for use in patients with myopia could be the start of a revolution comparable to the advent of LASIK, according to Eric D. Donnenfeld, MD, FACS, one of the investigators who took part in clinical trials of the lens.

"This is a landmark moment in ophthalmology," said Dr. Donnenfeld, associate professor of ophthalmology, NYU Medical Center, New York, and founding partner of Ophthalmic Consultants of Long Island, NY.

"This is the first phakic IOL approved in the United States, and it opens a new window of opportunity for patients and for doctors to rehabilitate [vision for] patients who in the past were beyond the range of conventional surgery," Dr. Donnenfeld said. "We can now give excellent vision to many of these patients who are most handicapped by their refractive errors."

The Verisyse/Artisan lens is a single-piece, elliptical, PMMA lens with a slight anterior vault. It is designed for implantation into the anterior chamber of the phakic eye and is fixated to the mid-periphery of the iris by incorporation of the iris into a cap in the haptics. Proper fixation requires incorporation of about 1 mm of iris tissue.

"My view of the future is that when we can take these lenses and put multifocal optics on them, we will be able to correct people's distance visual acuity and cure their presbyopia at the same time," Dr. Donnenfeld added. "And that makes this a real advantage over LASIK, which will never be able to cure presbyopia. Phakic IOLs have an exciting future, and we're just seeing the start right now."

Another surgeon involved in the FDA trials, R. Doyle Stulting, MD, PhD, also foresees expanding use of phakic IOLs.

"Today, we think about using phakic IOLs only for people who are severely myopic and are not candidates for LASIK," said Dr. Stulting, professor of ophthalmology, Emory University, Atlanta. "But I suspect that after we become more comfortable and familiar with their use, we will be performing phakic IOL implantation on people with less and less myopia. Indeed, probably soon after approval we'll use a two-stage process where we correct most of the refractive error with the phakic IOL and use the cornea to make small adjustments as needed over the life of the patient."

"If we are to correct fully for myopic astigmatism, we'll need to perform a phakic IOL implant and LASIK or some other corneal surgery for the correction of astigmatism as soon as it's approved," he added.