Descemet Membrane Endothelial Keratoplasty versus Ultrathin Descemet Stripping Automated Endothelial Keratoplasty: A Multicenter Randomized Controlled Clinical Trial
Dunker, Suryan L; Dickman, Mor M; Wisse, Robert P L; Nobacht, Siamak; Wijdh, Robert H J; Bartels, Marjolijn C; Tang, Mei L; van den Biggelaar, Frank J H M; Kruit, Pieter J; Nuijts, Rudy M M A
(2020) Ophthalmology, volume 127, issue 9, pp. 1152 - 1159
(Article)
Abstract
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
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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.
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Keywords: Aged, Cell Count, Corneal Endothelial Cell Loss/physiopathology, Descemet Membrane/surgery, Descemet Stripping Endothelial Keratoplasty/methods, Endothelium, Corneal/pathology, Female, Fuchs' Endothelial Dystrophy/physiopathology, Humans, Male, Postoperative Complications, Prospective Studies, Refraction, Ocular/physiology, Visual Acuity/physiology, Ophthalmology, Journal Article, Research Support, Non-U.S. Gov't, Randomized Controlled Trial, Multicenter Study, Comparative Study
ISSN: 0161-6420
Publisher: Elsevier
Note: Funding Information: Supported by The Netherlands Association for Health Research and Development , The Hague, The Netherlands; Algemene Nederlandse Vereniging Ter Voorkoming Van Blindheid , Doorn, The Netherlands; Dutch Eyefund , Utrecht, The Netherlands; Dr. F.P. Fischer-Stichting , Utrecht, The Netherlands; and Landelijke Stichting Blinden en Slechtzienden (LSBS), Ede, The Netherlands. The sponsor or funding organization had no role in the design or conduct of this research. No conflicting relationship exists for any author. None of the authors has any proprietary/financial interests to disclose with regard to this study Funding Information: In this study, a larger sample size might have yielded statistically significant differences. However, the observed effect size was 0.08 logMAR at 12 months, which is less than half of what can be considered a clinically relevant improvement. 31 Moreover, the loss to follow-up rate was much smaller than anticipated, which increases the power. Similar to our study, the DETECT study also included 50 eyes. Six corneal clinics participated in this study to increase generalizability. These were academic and nonacademic centers, as requested by The Netherlands Association for Health Research and Development, which provided financial support for this study. Publisher Copyright: © 2020 American Academy of Ophthalmology
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