Phakic IOL shows good safety, efficacy profile in multicenter study

Patients implanted with a phakic IOL to correct high levels of myopia showed excellent refractive outcomes at 3 years follow-up, according to the results of a U.S. Food and Drug Administration clinical trial of the lens published in the March issue of Ophthalmology.

R. Doyle Stulting, MD, PhD, and colleagues assessed outcomes for the first eyes of 662 patients enrolled in the prospective, multicenter study of the Artisan phakic IOL (Ophtec). All eyes had axial myopia ranging between 4.5 D and 22 D.

At 3 years follow-up for 231 eyes, investigators found that uncorrected visual acuity averaged 20/40 or better in 194 eyes (84%) and 20/25 or better in 120 eyes (51.9%).

Beginning at 6 months after implantation, between 71.7% and 76.7% of eyes were within 0.5 D of target refraction and between 93.1% and 95% were within 1 D. Also, from 1 month to 3 years follow-up, best corrected visual acuity had improved to 20/40 or better in 99% to 100% of eyes, according to the study.

At 3 years, 54% of eyes had gained at least one line of BCVA and only 7.5% had lost one line or more of best corrected vision, the authors reported.

The change in endothelial cell density over the 3-year follow-up period averaged –4.8%, with a 2.4% loss occurring between 2 years and 3 years. One investigative site had a mean endothelial cell loss of 5% (P = .023), while all other sites combined had an average endothelial cell loss of 1.7%, the researchers noted.

Among 57 eyes with endothelial cell density data available for all follow-up examinations, the change in cell density averaged –3.8% over the 3 years of follow-up.

"Approximately half (31/59) of the adverse events and preventative repositioning were among the first 10 cases performed by each investigator," the study authors said.

Advanced Medical Optics markets the Artisan IOL in the United States under the trade name Verisyse.