Long-term safety follow-up of an anterior chamber angle-supported phakic intraocular lens.

PURPOSE

To report adverse device effects and annualized endothelial cell loss rate for up to 10 years after implantation of the Acrysof L-series Cachet phakic intraocular lens (pIOL).

SETTING

Clinical centers in the United States, European Union, and Canada.

DESIGN

Nonrandomized clinical trial.

METHODS

After implantation of the pIOL, the endothelial cell density (ECD) at follow-up evaluations was compared with the 6-month postoperative baseline. Adverse device effects were assessed.

RESULTS

This study assessed 638 patients (1087 eyes) from previous clinical trials. The mean central ECD change from baseline was -9.6% ± 8.3% (SD) (-1.7% annualized; 623 eyes) and -11.0% ± 9.9% (-1.7% annualized; 703 eyes) at 6 years and 7 years, respectively. The mean peripheral ECD change from baseline was -10.8% ± 8.7% (-2.0% annualized; 615 eyes) and -11.9% ± 10.0% (-1.8% annualized; 680 eyes), respectively. Endothelial cell loss greater than 30% from the preoperative baseline at any time after implantation affected 8.0% of all eyes. An ECD of 1500 cells/mm or less at any time after implantation affected 2.7% of all eyes. The most common adverse device effects were peripheral iris adhesions (57 eyes [5.2%]), corneal endothelial cell loss (42 eyes [3.9%]), and pIOL explantation (37 eyes [3.4%]).

CONCLUSIONS

Long-term evaluation of the pIOL showed a persistent ECD decrease in some eyes that was numerically larger than the annual rate expected with aging. Endothelial cell loss resulted in explantation in 3.1% of all eyes with the pIOL. Patients had no permanent vision loss. The manufacturer recommends that patients continue to be monitored and their corneal endothelium evaluated semiannually.