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/mm2 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.
Copyright © 2017 ASCRS and ESCRS. Published by Elsevier Inc. All rights reserved.