Downloaded from http://journals.lww.com/jcrs by BhDMf5ePHKbH4TTImqenVA+lpWIIBvonhQl60Etgtdnn9T1vLQWJq/+R2O4Kjt58 on 11/05/2020 ARTICLE Ten-year safety follow-up and post-explant analysis of an anterior chamber phakic IOL Thomas Kohnen, MD, PhD, FEBO, Andrew Maxwell, MD, PhD, Simon Holland, MD, FRCSC, Stephen Lane, MD, Mark Von Tress, PhD, Craig Salem, OD, Laura LaFontaine, MPH Purpose: To assess endothelial cell loss (ECL) rate and collect safety data in patients with AcrySof L-series Cachet phakic in- traocular 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 de- formity (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 ex- plantation because of ECL, the annualized ECL rates decreased post-explantation in some eyes. Continued monitoring of patients regardless of explantation is recommended. J Cataract Refract Surg 2020; 46:1457–1465 Copyright © 2020 Published by Wolters Kluwer on behalf of ASCRS and ESCRS P atients with myopia have a number of options for corrective procedures to treat refractive errors, in- cluding laser corneal refractive surgery and im- plantation of phakic intraocular lenses (pIOLs). 1 Phakic IOLs, including iris-fixated, angle-supported, and posterior chamber pIOLs, provide good refractive results in patients with mod- erate to high myopia and may be a valid option for patients who wish to reduce or eliminate reliance on spectacles but are not eligible for refractive surgery. 2–4 However, there are concerns about adverse effects, particularly endothelial cell loss (ECL) and pIOL explantation associated with angle-supported pIOLs. 3,5 Recent studies suggest that pIOLs can provide improved visual outcomes with low complications rates in some patients with myopia, but additional long-term studies are needed to develop evidence-based recommendations. 6 Endothelial cells are known to be important for main- taining a healthy cornea and stromal deturgescence. 7 En- dothelial cell density (ECD) is 2500 to 3000 cells/mm 2 in most adults and has been shown to decrease throughout lifetime at a rate of about 0.5% to 0.6% per year. 8–11 In addition to a normal age-related decrease in ECD, ECL can result from trauma or surgery. Severe loss of corneal en- dothelium (ie, ECD of 400 to 700 cells/mm 2 ) can lead to corneal endothelial decompensation and may result in Submitted: November 6, 2019 | Final revision submitted: April 3, 2020 | Accepted: April 13, 2020 From 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. Sponsored by Alcon Research LLC, Fort Worth, Texas, USA. Medical writing assistance was provided by Natalia Zhukovskaya, PhD, of ICON (North Wales, Pennsylvania, USA), and was funded by Alcon Research LLC (Fort Worth, Texas). The authors thank Val Injev of Alcon Vision LLC for facilitated development of this manuscript. Corresponding author: Thomas Kohnen, MD, PhD, FEBO, Department of Ophthalmology, Goethe-University, Theodor-Stern-Kai 7, 60590, Frankfurt, Germany. Email: kohnen@em.uni-frankfurtde. 1457 Copyright © 2020 Published by Wolters Kluwer on behalf of ASCRS and ESCRS Published by Wolters Kluwer Health, Inc. 0886-3350/$ - see frontmatter https://doi.org/10.1097/j.jcrs.0000000000000351 Copyright © 2020 Published by Wolters Kluwer on behalf of ASCRS and ESCRS. Unauthorized reproduction of this article is prohibited.