Continued follow-up reinforces efficacy, safety of myopic phakic IOL

October 23, 2004

Up-to-date results from participants in the FDA clinical trial of the recently approved phakic myopic IOL (Verisyse, Advanced Medical Optics) demonstrate that implant provides excellent refractive outcomes with a good safety profile, said R. Doyle Stulting, MD, PhD, at the refractive surgery subspecialty day meeting.

New Orleans-Up-to-date results from participants in the FDA clinical trial of the recently approved phakic myopic IOL (Verisyse, Advanced Medical Optics) demonstrate that implant provides excellent refractive outcomes with a good safety profile, said R. Doyle Stulting, MD, PhD, at the refractive surgery subspecialty day meeting.

"The excellent results achieved with this technology are translating into high patient and surgeon satisfaction," commented Dr. Stulting, professor of ophthalmology, Emory University, Atlanta.

The study enrolled patients with axial myopia that could be addressed with -5 to -20 D of correction. Participants had to have a minimum anterior chamber depth of 3.2-mm and a minimum endothelial cell count of 2,000 cells/mm². Eyes with up to 2.5 D of cylinder were allowed, although no cylinder correction was performed.

Analyses based on 662 first eyes with a mean preoperative myopia of -12.6 D showed two-thirds achieved one or more lines of improvement in BSCVA, while the proportion of eyes reaching BSCVA of 20/15 increased over time, reaching 24% at 3 years.

"We think that phenomenon is due to more than magnification because it continued to increase as time goes on," Dr. Stulting noted.

Considering eyes with preoperative BSCVA 20/20 or better, 92% had UCVA of 20/40 or better at 3 years and 61.7% were seeing 20/25 or better uncorrected.

"Remember the implant was available in only 1-D increments and there was no cylinder correction. Therefore, we anticipate even better results in postmarketing clinical use," Dr Stulting said.

Various analyses of endothelial cell count data provided no reason for alarm. There have been four cataracts, of which three were late nuclear sclerosis in older patients. Six retinal detachments have occurred among a total of nearly 1,200 implanted eyes, which represents a rate consistent with that expected for an unoperated population predominated by high myopes, Dr. Stulting said.

A number of the IOLs were removed the reasons included cataract and repositioning.

"In a number of eyes, it was felt that there was insufficient iris enclavation and so re-attachment was performed prophylactically. There is a learning curve for Verisyse implantation, but it is short with adequate training. Our study analyses showed that at each center, the number of repositionings dropped after the first ten implants," Dr. Stulting said.