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

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• 作者：Mor M. Dickman ; MD¹ ; ^{mor.dickman@mumc.nl" class="auth_mail" title="E-mail the corresponding author} ; Pieter J. Kruit ; MD ; PhD² ; Lies Remeijer ; MD ; PhD³ ; Jeroen van Rooij ; MD³ ; Allegonda Van der Lelij ; MD ; PhD⁴ ; Robert H.J. Wijdh ; MD⁵ ; Frank J.H.M. van den Biggelaar ; PhD¹ ; Tos T.J.M. Berendschot ; PhD¹ ; Rudy M.M.A. Nuijts ; MD ; PhD¹
• 关键词：AS-OCT ; anterior segment optical coherence tomography ; BSCVA ; best spectacle-corrected visual acuity ; CI ; confidence interval ; CME ; cystoid macular edema ; D ; diopter ; DSAEK ; Descemet stripping automated endothelial keratoplasty ; EC ; endothelial cell ; ECD ; endothelial cell density ; EK ; endothelial keratoplasty ; ETDRS ; Early Treatment Diabetic Retinopathy Study ; logMAR ; logarithm of the minimum angle of resolution ; PK ; penetrating keratoplasty ; RCT ; randomized ; controlled clinical trial ; UT ; ultra
• 刊名：Ophthalmology
• 出版年：2016
• 出版时间：November 2016
• 年：2016
• 卷：123
• 期：11
• 页码：2276-2284
• 全文大小：1103 K

文摘

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.