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.
J Cataract Refract Surg. 2020 Nov;46(11):1457-1465. doi: 10.1097/j.jcrs.0000000000000351.
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.
Clinical settings in the United States, European Union, and Canada.
Nonrandomized, observational, open-label safety study.
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).
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%).
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.
评估植入 AcrySof L 系列 Cachet 后房型人工晶状体（pIOL）后长达 10 年的患者内皮细胞丢失（ECL）率并收集安全性数据。
美国、欧盟和加拿大的临床环境。
非随机、观察性、开放性标签安全性研究。
评估中央和周边内皮细胞密度，并与植入后 6 个月的基线进行比较。进行非线性分析以确定影响术后 ECL 的因素。其他评估包括未矫正视力（UCVA）、矫正距离视力（CDVA）、不良器械效应（ADE）和严重不良事件（SAE）。
该研究纳入了 1123 只植入眼（平均年龄 37.5 岁）。10 年时，中央和周边 ECL 平均值分别为 16%（年化率 1.7%）。10%的眼（136/1323）行晶状体切除术。由于 ECL 而行 pIOL 摘除的眼（7%），术后 ECL 年化率与因任何原因行晶状体摘除眼的总体率（年化率分别为-1.65%和-2.03%；n=96）和术前 ECL 相比，数值上更低。平均±标准差 CDVA 和 UCVA 分别为-0.12±0.11 和 0.03±0.22 对数最小分辨角。常见眼部 ADE 包括 ECL（10%）、pIOL 取出（9%）、虹膜粘连（7%）和瞳孔变形（2%）。常见 SAE 包括 pIOL 取出（11%）、ECL（9%）和虹膜粘连（8%）。
在某些情况下，Cachet pIOL 与长期 ECL 相关。总体而言，在 10 年随访期间，只有 10%的所有植入眼行晶状体切除术。在因 ECL 而行摘除术的患者中，一些眼在术后 ECL 年化率降低。建议无论是否行晶状体切除术，均应持续监测患者。
