Ten-year safety follow-up and post-explant analysis of an anterior chamber phakic IOL
Thomas Kohnen1, Andrew Maxwell, Simon Holland
1From the Department of Ophthalmology, Goethe-University (Kohnen), Frankfurt, Germany; California Eye Institute (Maxwell), Fresno, California, USA; Department of Ophthalmology, University of British Columbia (Holland), Vancouver, Pacific Laser Eye Centre (Holland), Vancouver, British Columbia, Canada; Associated Eye Care, University of Minnesota (Lane), Stillwater, Minnesota, and Alcon Research LLC (Lane, Von Tress, Salem, LaFontaine), Fort Worth, Texas, USA.
Purpose:
To assess endothelial cell loss (ECL) rate and collect safety data in patients with AcrySof L-series Cachet phakic intraocular lens (pIOL) up to 10 years post-implantation.
Setting:
Clinical settings in the United States, European Union, and Canada.
Design:
Nonrandomized, observational, open-label safety study.
Methods:
Central and peripheral endothelial cell density was evaluated and compared with 6-month post-implantation baseline. Nonlinear analysis was performed to identify factors affecting post-explantation ECL. Additional evaluations included uncorrected visual acuity (UCVA), corrected distance visual acuity (CDVA), adverse device effects (ADEs), and serious adverse events (SAEs).
Results:
The study included 1123 implanted eyes (mean age, 37.5 years). At 10 years, mean central and peripheral ECL was 16% (1.7% annualized). Explantations were performed in 10% of eyes (n = 136/1323). For eyes with pIOL explantation because of ECL (7%), annualized ECL rate post-explantation was numerically lower compared with the overall rate in eyes that underwent explantation for any reason (annualized rate, -1.65% vs -2.03%, respectively; n = 96) and compared with pre-explantation ECL. Mean ± SD CDVA and UCVA were -0.12 ± 0.11 and 0.03 ± 0.22 logarithm of the minimum angle of resolution, respectively. Common ocular ADEs included ECL (10%), pIOL extraction (9%), iris adhesion (7%), and pupillary deformity (2%). Common SAEs included pIOL extraction (11%), ECL (9%), and iris adhesions (8%).
Conclusions:
Cachet pIOLs were associated with long-term ECL in some cases. Overall, only 10% of all implanted eyes underwent explantation during 10-year follow-up. In patients requiring explantation because of ECL, the annualized ECL rates decreased post-explantation in some eyes. Continued monitoring of patients regardless of explantation is recommended.
