Purpose

To compare clinical outcomes of ultrathin Descemet stripping automated endothelial keratoplasty (UT-DSAEK) and Descemet membrane endothelial keratoplasty (DMEK) in the treatment of corneal endothelial dysfunction.

Design

Patient and outcome-masked, randomized controlled clinical trial.

Participants

Patients with damaged or diseased endothelium from Fuchs endothelial dystrophy or pseudophakic bullous keratopathy who were considered good candidates for DMEK or UT-DSAEK.

Methods

Study eyes were randomized by the eye bank to UT-DSAEK or DMEK 1 to 2 days before surgery.

Main Outcome Measures

The primary outcome of the trial was best spectacle-corrected visual acuity (BSCVA) at 6 months. Secondary outcomes included 3- and 12-month BSCVA; 3-, 6-, and 12-month endothelial cell counts; intraoperative and postoperative complications; and change in pachymetry.

Results

A total of 216 patients with endothelial dysfunction were screened, and 50 eyes of 38 patients were enrolled by 2 surgeons at Casey Eye Institute at Oregon Health & Science University in Portland, Oregon, and at Byers Eye Institute at Stanford University in Palo Alto, California. Overall, we found DMEK to have better visual acuity outcomes compared with UT-DSAEK after correcting for baseline visual acuity: compared with UT-DSAEK, those randomized to DMEK had 1.5 lines better BSCVA at 3 months (95% confidence interval [CI], 2.5–0.6 lines better; P = 0.002), 1.8 lines better BSCVA at 6 months (95% CI, 2.8–1.0 lines better; P < 0.001), and 1.4 lines better BSCVA at 12 months (95% CI, 2.2–0.7 lines better; P < 0.001). Average endothelial cell counts were 1963 cells/mm² in DMEK and 2113 cells/mm² in UT-DSAEK at 6 months (P = 0.17) and 1855 cells/mm² in DMEK and 2070 cells/mm² in UT-DSAEK at 12 months (P = 0.051). Intraoperative and postoperative complication rates were similar between groups.

Conclusions

Descemet membrane endothelial keratoplasty had superior visual acuity results compared with UT-DSAEK at 3, 6, and 12 months in patients with isolated endothelial dysfunction with similar complication rates.

中文翻译：

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Descemet内皮厚度比较试验

目的

为了比较超薄Descemet剥离自动内皮角膜移植术（UT-DSAEK）和Descemet膜内皮角膜移植术（DMEK）在角膜内皮功能障碍治疗中的临床效果。

设计

患者和具有结果掩盖性的随机对照临床试验。

参加者

因Fuchs内皮营养不良或假晶状体大疱性角膜病变而导致内皮受损或患病的患者被认为是DMEK或UT-DSAEK的良好候选者。

方法

在手术前1至2天，研究人员将研究眼睛的眼库随机分为UT-DSAEK或DMEK。

主要观察指标

该试验的主要结果是6个月时的最佳眼镜矫正视力（BSCVA）。次要结果包括3个月和12个月的BSCVA；3、6和12个月的内皮细胞计数；术中和术后并发症；并改变测厚法。

结果

筛查了总共216例具有内皮功能障碍的患者，并在俄勒冈州波特兰市俄勒冈健康与科学大学的Casey眼科研究所和加利福尼亚州帕洛阿尔托的斯坦福大学的Byers眼科研究所由两名外科医生招募了38名患者的50只眼。总体而言，我们发现校正基线视敏度后，DMEK的视敏度较UT-DSAEK好：与UT-DSAEK相比，随机分入DMEK的患者在3个月时的BSCVA改善1.5倍（95％置信区间[CI]，改善2.5–0.6线；P = 0.002），6个月时BSCVA改善1.8线（95％CI，改善2.8–1.0线；P < 0.001）和12个月时BSCVA改善1.4线（95％CI，2.2–0.7）行更好；P <0.001）。在6个月时，平均内皮细胞计数在DMEK中为1963个细胞/ mm ²，在UT-DSAEK中为2113个细胞/ mm ²（P = 0.17），在DMEK中为1855个细胞/ mm ²，在UT-DSAEK中为1270个/ mm ²月（P = 0.051）。两组之间的术中和术后并发症发生率相似。

结论

在合并的内皮功能障碍，并发症发生率相似的患者中，在3、6和12个月时，Descemet膜内皮角膜移植术的视敏度优于UT-DSAEK。