Pujari Rathin, Matsou Artemis, Kean Jane, Zhang Jufen, Rajan Madhavan S
Department of Ophthalmology, Cambridge Eye Research Centre, Cambridge University Hospitals, Cambridge, United Kingdom ; and.
Faculty of Health, Education, Medicine and Social Care, School of Medicine, Anglia Ruskin University, Vision and Eye Research Institute.
Cornea. 2022 Dec 1;41(12):1519-1524. doi: 10.1097/ICO.0000000000003024. Epub 2022 Apr 8.
The purpose of this study was to report the 2-year outcomes of a double-blinded randomized controlled trial comparing Descemet membrane endothelial keratoplasty (DMEK) and microthin Descemet stripping automated endothelial keratoplasty (MT-DSAEK).
Fifty-six eyes of 56 patients were randomized to DMEK or microthin DSAEK (MT-DSAEK). The main outcome measure was best spectacle-corrected visual acuity (BSCVA) at 24 months. Other secondary outcomes included complications, endothelial cell density, and vision-related quality-of-life (vQoL) scores.
There was no statistically significant difference in BSCVA between the DMEK and MT-DSAEK groups at the 2-year time point (mean ± SD; 0.04 ± 0.14 vs. 0.12± 0.19, P = 0.061) in contrast to the 1-year results (mean ± SD; 0.04 ± 0.13 vs. 0.11 ± 0.09, P = 0.002) previously reported. Endothelial cell density did not show a statistically significant difference at 24 months between the DMEK and MT-DSAEK groups (1522 ± 293 cell/mm2 vs. 1432 ± 327 cells/mm2, P = 0.27). There were 2 additional graft rejection episodes in the MT-DSAEK group between the 1- and 2-year follow-up periods, but this did not result in graft failure. The mean vQoL scores between DMEK and MT-DSAEK indicated similar patient satisfaction between the groups (97.1 ± 4.0 vs. 92.6 ± 10.2, P = 0.13).
In summary, the trial showed no significant difference in BSCVA at 24 months between the DMEK and MT-DSAEK groups. Both techniques continued to demonstrate comparable outcomes for complication rates, endothelial cell loss, and patient-reported vQoL scores.
ISRCTN10578843.
本研究旨在报告一项双盲随机对照试验的2年结果，该试验比较了Descemet膜内皮角膜移植术（DMEK）和超薄Descemet膜剥除自动内皮角膜移植术（MT-DSAEK）。
56例患者的56只眼被随机分为DMEK组或超薄DSAEK（MT-DSAEK）组。主要观察指标是24个月时的最佳矫正视力（BSCVA）。其他次要观察指标包括并发症、内皮细胞密度和视力相关生活质量（vQoL）评分。
与之前报道的1年结果（平均值±标准差；0.04±0.13对0.11±0.09，P = 0.002）相比，在2年时间点，DMEK组和MT-DSAEK组之间的BSCVA无统计学显著差异（平均值±标准差；0.04±0.14对0.12±0.19，P = 0.061）。DMEK组和MT-DSAEK组在24个月时的内皮细胞密度无统计学显著差异（1522±293个细胞/mm²对1432±327个细胞/mm²，P = 0.27）。在1年和2年随访期之间，MT-DSAEK组又出现了2次移植排斥反应，但这并未导致移植失败。DMEK组和MT-DSAEK组之间的平均vQoL评分表明两组患者的满意度相似（97.1±4.0对92.6±10.2），P = 0.13）。
总之，该试验表明DMEK组和MT-DSAEK组在24个月时的BSCVA无显著差异。两种技术在并发症发生率、内皮细胞丢失和患者报告的vQoL评分方面继续显示出可比的结果。
ISRCTN10578843。
