Purpose

To compare best spectacle-corrected visual acuity (BSCVA), endothelial cell density (ECD), refractive astigmatism, and complications after Descemet membrane endothelial keratoplasty (DMEK) and ultrathin Descemet stripping automated endothelial keratoplasty (UT-DSAEK).

Design

Prospective, multicenter randomized controlled trial.

Participants

Fifty-four pseudophakic eyes of 54 patients with corneal endothelial dysfunction resulting from Fuchs endothelial corneal dystrophy were enrolled in 6 corneal centers in The Netherlands.

Methods

Participants were allocated to DMEK (n = 29) or UT-DSAEK (n = 25) using minimization randomization based on preoperative BSCVA, recipient central corneal thickness, gender, age, and institution. Donor corneas were prestripped and precut for DMEK and UT-DSAEK, respectively. Six corneal surgeons participated in this study.

Main Outcome Measures

The primary outcome measure was BSCVA at 12 months after surgery.

Results

Central graft thickness of UT-DSAEK lamellae measured 101 μm (95% confidence interval [CI], 90–112 μm). Best spectacle-corrected visual acuity did not differ significantly between DMEK and UT-DSAEK groups at 3 months (0.15 logarithm of the minimum angle of resolution [logMAR] [95% CI 0.08–0.22 logMAR] vs. 0.22 logMAR [95% CI 0.16–0.27 logMAR]; P = 0.15), 6 months (0.11 logMAR [95% CI 0.05–0.17 logMAR] vs. 0.16 logMAR [95% CI 0.12–0.21 logMAR]; P = 0.20), and 12 months (0.08 logMAR [95% CI 0.03–0.14 logMAR] vs. 0.15 logMAR [95% CI 0.10–0.19 logMAR]; P = 0.06). Twelve months after surgery, the percentage of eyes reaching 20/25 Snellen BSCVA was higher in DMEK compared with UT-DSAEK (66% vs. 33%; P = 0.02). Endothelial cell density did not differ significantly 12 months after DMEK and UT-DSAEK (1870 cells/mm² [95% CI 1670–2069 cells/mm²] vs. 1612 cells/mm² [95% CI 1326–1898 cells/mm²]; P = 0.12). Both techniques induced a mild hyperopic shift (12 months: +0.22 diopter [D; 95% CI –0.23 to 0.68 D] for DMEK vs. +0.58 D [95% CI 0.13–1.03 D] for UT-DSAEK; P = 0.34).

Conclusions

Descemet membrane endothelial keratoplasty and UT-DSAEK did not differ significantly in mean BSCVA, but the percentage of eyes achieving 20/25 Snellen vision was significantly higher with DMEK. Endothelial cell loss did not differ significantly between the treatment groups, and both techniques induced a minimal hyperopic shift.

中文翻译：

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Descemet膜内皮角膜移植术与超薄Descemet剥离自动内皮膜角膜移植术：多中心随机对照临床试验。

目的

为了比较最佳的眼镜矫正视力（BSCVA），内皮细胞密度（ECD），屈光散光和Descemet膜上皮角膜移植术（DMEK）和超薄Descemet剥离自动内皮膜角膜移植术（UT-DSAEK）后的并发症。

设计

前瞻性，多中心随机对照试验。

参加者

在荷兰的6个角膜中心研究了54例因Fuchs内皮角膜营养不良而导致的角膜内皮功能障碍的54只假晶状体眼。

方法

根据术前BSCVA，接受者中央角膜厚度，性别，年龄和机构，使用最小化随机分配参与者至DMEK（n = 29）或UT-DSAEK（n = 25）。分别对供体角膜进行DMEK和UT-DSAEK预剥离和预切割。六名角膜外科医生参加了这项研究。

主要观察指标

主要结局指标是术后12个月的BSCVA。

结果

UT-DSAEK薄片的中央移植物厚度为101μm（95％置信区间[CI]为90-112μm）。DMEK组和UT-DSAEK组在3个月时的最佳眼镜矫正视力没有显着差异（最小分辨角0.15对数[logMAR] [95％CI 0.08–0.22 logMAR]与0.22 logMAR [95％CI 0.16] –0.27 logMAR]；P  = 0.15），6个月（0.11 logMAR [95％CI 0.05–0.17 logMAR]和0.16 logMAR [95％CI 0.12-0.21 logMAR]；P  = 0.20）和12个月（0.08 logMAR [ 95％CI 0.03–0.14 logMAR]与0.15 logMAR [95％CI 0.10–0.19 logMAR]；P  = 0.06）。手术十二个月后，DMEK中，达到Snellen BSCVA的20/25的眼睛百分比高于UT-DSAEK（66％比33％；P = 0.02）。DMEK和UT-DSAEK后12个月的内皮细胞密度没有显着差异（1870个细胞/ mm ² [95％CI 1670-2069细胞/ mm ² ]与1612个细胞/ mm ² [95％CI 1326-1898个细胞/ mm ² ]；P  = 0.12）。两种技术均引起轻度的远视移位（12个月：DMEK为+0.22屈光度[D； 95％CI –0.23至0.68 D]，而UT-DSAEK为+0.58 D [95％CI 0.13–1.03 D]；P  = 0.34 ）。

结论

Descemet膜内皮角膜移植术和UT-DSAEK在平均BSCVA方面无显着差异，但使用DMEK时达到20/25 Snellen视力的眼睛百分比明显更高。治疗组之间内皮细胞的损失没有显着差异，并且两种技术均引起最小的远视转变。