Original articleDescemet Endothelial Thickness Comparison Trial: A Randomized Trial Comparing Ultrathin Descemet Stripping Automated Endothelial Keratoplasty with Descemet Membrane Endothelial Keratoplasty
Section snippets
Trial Design
The Descemet Endothelial Thickness Comparison Trial was an institutionally funded, randomized, patient and outcome-masked, controlled clinical trial comparing the clinical outcomes of 2 types of endothelial keratoplasty. Eyes with endothelial dysfunction from Fuchs endothelial dystrophy or pseudophakic bullous keratopathy were independently randomized in a 1:1 fashion to UT-DSAEK or DMEK.
Primary Outcome
The primary outcome of the trial was best spectacle-corrected visual acuity (BSCVA) at 6 months.
Study Participants
Enrollment
Results
A total of 216 patients with endothelial dysfunction were screened between January 20, 2015, and April 26, 2017, and 50 eyes from 38 patients were randomized to UT-DSAEK or DMEK (Fig 1). Enrollment sites included Casey Eye Institute at OHSU (N = 43 eyes, N = 31 patients; 86%) and Byers Eye Institute at Stanford University, which joined the study September 20, 2016 (N = 7 eyes, N = 7 patients; 14%). Most patients who were screened but not enrolled were excluded because they had complex anterior
Discussion
In this study, we found that DMEK provides superior visual acuity results compared with UT-DSAEK for patients with isolated endothelial dysfunction. Patients receiving DMEK had more rapid visual acuity improvement, and although those randomized to UT-DSAEK improved with time, there remained approximately 1.5 lines difference at 12 months. Several large series of DMEK outcomes have reported excellent visual acuity with low reoperation rates similar to ours; however, the majority of corneal
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Financial Disclosure(s): The author(s) made the following disclosures:
Supported by Grants K23 EY025025 (J.R.-N.) from the National Eye Institute and Research to Prevent Blindness. The eye bank Lions VisionGift of Portland, Oregon, contributed to the design and implementation of the study, providing all of the tissue for the study and randomizing all eyes to treatment arm.
HUMAN SUBJECTS: Human subject/tissues were included. Study protocol was approved by the Human Research Committees at University of California, San Francisco, OHSU, and Stanford University. The trial conformed to the Declaration of Helsinki. Written informed consent was obtained from all participants.
No animal subjects were used in this study.
Trial Registration: NCT02373137.
Author Contributions:
Conception and design: Chamberlain, Shubach, Clover, McLeod, Lietman, Rose-Nussbaumer
Data collection: Chamberlain, Lin, Austin, Shubach, Clover, Lietman, Rose-Nussbaumer
Analysis and interpretation: Austin, Porco, Rose-Nussbaumer
Obtained funding: N/A
Overall responsibility: Chamberlain, Lin, Austin, Shubach, Clover, McLeod, Porco, Lietman, Rose-Nussbaumer