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超薄式撕囊全自动角膜内皮移植术（DSAEK）与 DSAEK 的随机多中心临床试验

A Randomized Multicenter Clinical Trial of Ultrathin Descemet Stripping Automated Endothelial Keratoplasty (DSAEK) versus DSAEK.

机构信息

University Eye Clinic, Maastricht University Medical Center, the Netherlands.

Euro Tissue Bank, Beverwijk, the Netherlands.

出版信息

Ophthalmology. 2016 Nov;123(11):2276-2284. doi: 10.1016/j.ophtha.2016.07.036.

DOI:10.1016/j.ophtha.2016.07.036

PMID:27659544

Abstract

OBJECTIVE

To compare visual acuity, refraction, endothelial cell density (ECD), and complications after Descemet stripping automated endothelial keratoplasty (DSAEK) and ultrathin DSAEK (UT-DSAEK).

DESIGN

A multicenter, prospective, double-masked, randomized, controlled clinical trial.

PARTICIPANTS

From 66 patients with irreversible corneal endothelial dysfunction dues to Fuchs' dystrophy who enrolled from 4 tertiary medical centers in the Netherlands, 66 eyes were studied.

METHODS

Participants were centrally randomized to undergo either UT-DSAEK or DSAEK, based on preoperative best spectacle-corrected visual acuity (BSCVA), recipient central corneal thickness, patient age, and recruitment center. Donor corneas were precut by a single cornea bank.

PARTICIPANTS

Participants underwent ophthalmic examinations preoperatively and 3, 6, and 12 months after the operation, including manifest refraction, BSCVA using an Early Treatment Diabetic Retinopathy Study chart, and endothelium imaging.

MAIN OUTCOME MEASURES

BSCVA 12 months postoperatively.

RESULTS

Preoperative BSCVA did not differ between patients undergoing DSAEK (0.35 logarithm of the minimum angle of resolution [logMAR] [95% confidence interval {CI} 0.27-0.43]; n = 32) and UT-DSAEK (0.37 logMAR [95% CI 0.31-0.43]; n = 34; P = 0.8). BSCVA was significantly better after UT-DSAEK compared with that after DSAEK at 3 months (0.17 logMAR [95% CI 0.13-0.21], n = 31 vs. 0.28 logMAR [95% CI 0.23-0.33], n = 31; P = 0.001), 6 months (0.14 logMAR [95% CI 0.10-0.18], n = 30 vs. 0.24 logMAR [95% CI 0.20-0.28], n = 30; P = 0.002), and 12 months (0.13 logMAR [95% CI 0.09-0.17], n = 33 vs. 0.20 logMAR [95% CI 0.15-0.25], n = 29; P = 0.03). Refraction, ECD loss (40% at 3 months; P < 0.001), donor loss (DSAEK n = 2 vs. UT-DSAEK n = 3 [relative risk {RR} 1.4 {95% CI 0.24-7.5}; P = 0.7]), and graft dislocation (DSAEK n = 5 vs. UT-DSAEK n = 5 [RR 1.0 {95% CI 0.34-3.33}; P = 0.9]) did not differ between UT-DSAEK and DSAEK. Donor thickness was significantly thinner for UT-DSAEK (101 μm [95% CI 93-110 μm]; range 50-145 μm) than for DSAEK (209 μm [95% CI 196-222 μm]; range 147-289 μm; P < 0.001).

CONCLUSIONS

This study indicates that compared with DSAEK, UT-DSAEK results in faster and better recovery of BSCVA with similar refractive outcomes, endothelial cell loss, and incidence of complications.

摘要

目的

比较撕囊自动化角膜内皮移植术（DSAEK）与超薄 DSAEK（UT-DSAEK）术后的视力、屈光度、内皮细胞密度（ECD）和并发症。

设计

多中心、前瞻性、双盲、随机、对照临床试验。

参与者

从荷兰 4 家三级医疗中心因 Fuchs 角膜内皮营养不良而导致不可逆转的角膜内皮功能障碍的 66 名患者中，共有 66 只眼参与了本研究。

方法

根据术前最佳矫正视力（BCVA）、受者中央角膜厚度、患者年龄和招募中心，对患者进行中央随机分组，分别接受 UT-DSAEK 或 DSAEK。供体角膜由单一角膜库预先切割。

参与者

参与者在术前和术后 3、6 和 12 个月进行眼科检查，包括视力检查、使用早期糖尿病视网膜病变研究图表的 BCVA 检查和内皮成像。

主要观察指标

术后 12 个月的 BCVA。

结果

DSAEK 组（0.35 对数最小角分辨率[logMAR] [95%置信区间 {CI} 0.27-0.43]；n = 32）和 UT-DSAEK 组（0.37 logMAR [95% CI 0.31-0.43]；n = 34）患者的术前 BCVA 无差异（P = 0.8）。与 DSAEK 相比，UT-DSAEK 在术后 3 个月（0.17 logMAR [95% CI 0.13-0.21]，n = 31 与 0.28 logMAR [95% CI 0.23-0.33]，n = 31；P = 0.001）、6 个月（0.14 logMAR [95% CI 0.10-0.18]，n = 30 与 0.24 logMAR [95% CI 0.20-0.28]，n = 30；P = 0.002）和 12 个月（0.13 logMAR [95% CI 0.09-0.17]，n = 33 与 0.20 logMAR [95% CI 0.15-0.25]，n = 29；P = 0.03）时的 BCVA 恢复更好。术后屈光度、ECD 丢失（3 个月时 40%；P < 0.001）、供体丢失（DSAEK 组 n = 2 与 UT-DSAEK 组 n = 3 [相对风险 {RR} 1.4 {95% CI 0.24-7.5}；P = 0.7]）和移植物脱位（DSAEK 组 n = 5 与 UT-DSAEK 组 n = 5 [RR 1.0 {95% CI 0.34-3.33}；P = 0.9]）在 UT-DSAEK 与 DSAEK 之间无差异。UT-DSAEK 的供体厚度明显更薄（101 μm [95% CI 93-110 μm]；范围 50-145 μm），而 DSAEK 的供体厚度为 209 μm [95% CI 196-222 μm]；范围 147-289 μm；P < 0.001）。