April 08, 2009
1 min read
Save

Good results seen in FDA trial data of phakic IOL for high myopia

SAN FRANCISCO — Six-month data of a phakic IOL show it to be safe and effective in managing high myopia.

"Endothelial cell densities, in terms of losses, were very minimal both centrally and peripherally," Stephen Lane, MD, said here at the American Society of Cataract and Refractive Surgery meeting. "There was no pupil ovalization in the 200-plus patients."

In the study, uncorrected visual acuity of 20/25 or better was achieved in 233 of 253 patients (92.1%) who received the AcrySof phakic angle-supported IOL (Alcon), and best corrected visual acuity of 20/25 or better was achieved in all patients. According to Dr. Lane, postoperative refraction was within 0.5 D of the intended target in 215 of 253 patients (85%).

In terms of patients functionally capable of achieving 20/20 vision, 85% reached that marker, and all were 20/40 or better. BCVA of 20/20 was achieved in 99% of this subset of patients.

"Those capable of seeing 20/20 are getting that, even in an uncorrected visual acuity," Dr. Lane said.

The clinical trial, part of the U.S. Food and Drug Administration-mandated 3-year clinical trial evaluating the AcrySof phakic IOL, is now approaching the 2-year follow-up period, Dr. Lane said. The lens has received a CE Mark in Europe.