From the John A. Moran Eye Center (I.I.K.A.), University of Utah, Salt Lake City, Utah, USA; Department of Ophthalmology and Vision Sciences (I.I.K.A., T.D.F.), University of Toronto, Toronto, Ontario, Canada.
From the John A. Moran Eye Center (I.I.K.A.), University of Utah, Salt Lake City, Utah, USA; Department of Ophthalmology and Visual Sciences (A.S.), Washington University in St. Louis School of Medicine, St. Louis, Missouri, USA.
Am J Ophthalmol. 2023 Aug;252:17-25. doi: 10.1016/j.ajo.2023.02.014. Epub 2023 Mar 1.
To report 5-year postoperative safety data of iStent inject, including overall stability, endothelial cell density (ECD), and endothelial cell loss (ECL) in patients with mild-to-moderate primary open-angle glaucoma (POAG).
5-year follow-up safety study of the prospective, randomized, single-masked, concurrently controlled, multicenter iStent inject pivotal trial.
In this 5-year follow-up safety study of the 2-year iStent inject pivotal randomized controlled trial, patients receiving iStent inject placement and phacoemulsification or phacoemulsification alone were studied for the incidence of clinically relevant complications associated with iStent inject placement and stability. Corneal endothelial endpoints were mean change in ECD from screening and proportion of patients with >30% ECL from screening, from analysis of central specular endothelial images by a central image analysis reading center at several time points through 60 months postoperatively.
Of the 505 original randomized patients, 227 elected to participate (iStent inject and phacoemulsification group, n = 178; phacoemulsification-alone control group, n = 49). No specific device-related adverse events or complications were reported through month 60. No significant differences were observed in mean ECD, mean percentage change in ECD, or proportion of eyes with >30% ECL between the iStent inject and control groups at any time point; mean percentage decrease in ECD at 60 months was 14.3% ± 13.4% in the iStent inject group and 14.8% ± 10.3% in the control group (P = .8112). The annualized rate of ECD change from 3 to 60 months was neither clinically nor statistically significant between groups.
Implantation of iStent inject during phacoemulsification in patients with mild-to-moderate POAG did not produce any device-related complications or ECD safety concerns compared to phacoemulsification alone through 60 months.
报告 iStent inject 的 5 年术后安全性数据，包括轻度至中度原发性开角型青光眼（POAG）患者的总体稳定性、内皮细胞密度（ECD）和内皮细胞丢失（ECL）。
前瞻性、随机、单盲、同期对照、多中心 iStent inject 关键试验的 5 年随访安全性研究。
在这项为期 2 年的 iStent inject 关键随机对照试验的 5 年随访安全性研究中，对接受 iStent inject 植入和超声乳化术或仅超声乳化术的患者进行了与 iStent inject 植入和稳定性相关的临床相关并发症发生率的研究。角膜内皮终点是从筛查开始时 ECD 的平均变化和从筛查开始时 ECL 超过 30%的患者比例，从术后 60 个月通过中央图像分析阅读中心对中央镜面内皮图像进行分析得出。
在最初的 505 名随机患者中，有 227 名患者选择参与（iStent inject 和超声乳化术组，n=178；超声乳化术对照组，n=49）。在第 60 个月之前，没有报告任何特定的与设备相关的不良事件或并发症。在任何时间点，iStent inject 组和对照组之间 ECD 的平均值、ECD 的平均百分比变化或 ECL 超过 30%的眼睛比例均无显著差异；在 60 个月时，iStent inject 组 ECD 的平均百分比下降为 14.3%±13.4%，对照组为 14.8%±10.3%（P=0.8112）。从 3 个月到 60 个月的 ECD 变化的年化率在两组之间既无临床意义也无统计学意义。
与单独进行超声乳化术相比，在轻度至中度 POAG 患者进行超声乳化术时植入 iStent inject 在 60 个月内没有产生任何与设备相关的并发症或 ECD 安全性问题。
