University Eye Clinic, Maastricht University Medical Center, Maastricht, the Netherlands.
University Eye Clinic, Maastricht University Medical Center, Maastricht, the Netherlands; Department of Ophthalmology, Amsterdam University Medical Center, Vrije Universiteit Amsterdam, Amsterdam Public Health, Amsterdam, the Netherlands.
Am J Ophthalmol. 2021 Feb;222:218-225. doi: 10.1016/j.ajo.2020.06.023. Epub 2020 Jul 2.
This study analyzed real-world practice patterns, graft survival, and outcomes of Descemet membrane endothelial keratoplasty (DMEK) in the Netherlands.
Population-based interventional clinical study.
In this prospective registry study, all consecutive primary DMEK procedures registered in the Netherlands Organ Transplant Registry were identified. Short-term graft survival and outcomes of primary transplants for Fuchs' endothelial dystrophy (FED) were analyzed using Kaplan-Meier survival curves with log-rank test and Cox regression. Linear mixed model analyses were used for best spectacle-corrected visual acuity (BSCVA), spherical equivalent, hyperopic shift, and endothelial cell density.
752 DMEKs were identified between 2011 and 2018. In 90% of cases, the indication for DMEK was FED. Graft survival measured 87% at 3 months, 85% at 6 months, 85% at 1 year, and 78% at 2 years. DMEK procedures after 2015 showed better survival compared to previous years (Hazard ratio = 0.4; P < .001). Baseline BSCVA in primary transplants with FED measured on average 0.45 logarithm of the minimum angle of resolution (logMAR) (95% confidence interval [CI], 0.41-0.49), and significantly improved (overall P < .001) to 0.17 logMAR (95% CI, 0.14-0.21) at 3 months, 0.15 logMAR (95% CI, 0.11-0.18) at 6 months, 0.12 logMAR (95% CI, 0.08-0.16) at 1 year, and 0.08 (95% CI, 0.05-0.12) at 2 years. At 3 months, a hyperopic shift of +0.36 diopters (P < .001) was observed and endothelial cell loss measured 33%.
Our findings provide real-world support that DMEK is an effective treatment for FED with respect to vision restoration, inducing a small hyperopic shift with an acceptable endothelial cell loss. Graft survival improved over time, suggesting a learning curve on a national level.
本研究分析了荷兰真实世界中 Descemet 膜内皮角膜移植术（DMEK）的手术实践模式、移植物存活率和结果。
基于人群的干预性临床研究。
在这项前瞻性登记研究中，确定了荷兰器官移植登记处登记的所有连续原发性 DMEK 手术。使用 Kaplan-Meier 生存曲线和对数秩检验及 Cox 回归分析原发性 Fuchs 内皮营养不良（FED）移植的短期移植物存活率和结果。线性混合模型分析用于最佳矫正视力（BSCVA）、等效球镜、远视漂移和内皮细胞密度。
2011 年至 2018 年期间共发现 752 例 DMEK。90%的病例的适应证为 FED。术后 3 个月、6 个月、1 年和 2 年的移植物存活率分别为 87%、85%、85%和 78%。与前几年相比，2015 年后的 DMEK 手术存活率更高（风险比=0.4；P<.001）。原发性 FED 移植的基线 BSCVA 平均为 0.45 对数最小分辨角（logMAR）（95%置信区间[CI]，0.41-0.49），且显著改善（总体 P<.001）至术后 3 个月的 0.17 logMAR（95%CI，0.14-0.21）、术后 6 个月的 0.15 logMAR（95%CI，0.11-0.18）、术后 1 年的 0.12 logMAR（95%CI，0.08-0.16）和术后 2 年的 0.08（95%CI，0.05-0.12）。术后 3 个月时，观察到远视漂移+0.36 屈光度（P<.001），内皮细胞丢失 33%。
本研究结果为 DMEK 治疗 FED 可恢复视力提供了真实世界证据，且引起小的远视漂移，内皮细胞丢失可接受。移植物存活率随时间推移而提高，表明在全国范围内存在学习曲线。
