Cornea Image Analysis Reading Center, University Hospitals Eye Institute, Department of Ophthalmology and Visual Sciences, Case Western Reserve University, Cleveland, Ohio, USA.
Alcon Research, LLC, Fort Worth, Texas, USA.
Am J Ophthalmol. 2019 Dec;208:211-218. doi: 10.1016/j.ajo.2019.07.016. Epub 2019 Aug 1.
To characterize long-term changes in corneal endothelial cells after phacoemulsification with or without supraciliary Micro-Stent (Alcon) implantation in eyes with open-angle glaucoma (OAG) and visually significant cataract.
Three-year safety extension of a 2-year randomized clinical trial.
Patients from the multicenter Study of an Implantable Device for Lowering Intraocular Pressure in Glaucoma Patients Undergoing Cataract Surgery (COMPASS) trial who underwent Micro-Stent implantation plus phacoemulsification (n = 282) or phacoemulsification alone (n = 67) were analyzed post hoc. Specular microscopy was used to assess endothelial cell loss (ECL), including changes from baseline in endothelial cell density (ECD), coefficient of variation, and percentage of hexagonal cells.
Preoperative ECDs in the microstent group (2,432.6 cells/mm [95% confidence interval [CI], 2,382.8-2,482.4 cells/mm]) were similar to those in the control group (2,434.5 cells/mm [95% CI, 2,356.5-2,512.4 cells/mm]) groups. ECL at months 48 and 60 was greater in the Micro-Stent group than in the control group. At month 60, the mean percent of changes in ECD was -20.4% (95% CI, -23.5% to -17.5%) in the Micro-Stent group and -10.1% (95% CI, -13.9% to -6.3%) in the control group. No statistically significant between-group changes from baseline in cellular morphology were observed. Nine adverse events were possibly related to ECL, including 3 eyes with transient focal corneal edema and 4 eyes that required Micro-Stent trimming due to protrusion.
In eyes with OAG, ECL after phacoemulsification is acute and stabilizes after 3 months, whereas ECL after phacoemulsification plus Micro-Stent implantation proceeds for at least 5 years. Clinical findings associated with ECL in these eyes were uncommon (3.3% of implanted eyes), suggesting that ECL is generally a subclinical phenomenon.
研究超声乳化白内障吸除术联合或不联合睫状体上腔微型支架（Alcon）植入治疗开角型青光眼（OAG）合并有临床意义白内障患者的长期角膜内皮细胞变化。
2 年随机临床试验的 3 年安全性扩展研究。
对接受微型支架植入联合超声乳化白内障吸除术（n=282）或单纯超声乳化白内障吸除术（n=67）的多中心青光眼白内障手术患者的植入装置降低眼压研究（COMPASS）试验患者进行回顾性分析。采用共焦显微镜评估内皮细胞丢失（ECL），包括内皮细胞密度（ECD）、变异系数和六角形细胞百分比的基线变化。
微型支架组（2432.6 个细胞/mm[95%置信区间（CI），2382.8-2482.4 个细胞/mm]）术前 ECD 与对照组（2434.5 个细胞/mm[95%CI，2356.5-2512.4 个细胞/mm]）相似。微型支架组在 48 个月和 60 个月时 ECL 大于对照组。在 60 个月时，微型支架组 ECD 的平均变化百分比为-20.4%（95%CI，-23.5%至-17.5%），对照组为-10.1%（95%CI，-13.9%至-6.3%）。未观察到两组间细胞形态的统计学显著变化。9 项不良事件可能与 ECL 有关，包括 3 只眼短暂性局灶性角膜水肿和 4 只眼因突出需要微型支架修剪。
在 OAG 眼中，超声乳化白内障吸除术后的 ECL 是急性的，在 3 个月后稳定，而超声乳化白内障吸除术联合微型支架植入术后的 ECL 至少持续 5 年。这些眼中与 ECL 相关的临床发现并不常见（植入眼中的 3.3%），这表明 ECL 通常是一种亚临床现象。
