Descemet Membrane Endothelial Keratoplasty versus Ultrathin Descemet Stripping Automated Endothelial Keratoplasty: A Multicenter Randomized Controlled Clinical Trial.

摘要: Purpose To compare best spectacle-corrected visual acuity (BSCVA), endothelial cell density (ECD), refractive astigmatism, and complications after Descemet membrane keratoplasty (DMEK) ultrathin stripping automated (UT-DSAEK). Design Prospective, multicenter randomized controlled trial. Participants Fifty-four pseudophakic eyes of 54 patients with corneal dysfunction resulting from Fuchs dystrophy were enrolled in 6 centers The Netherlands. Methods allocated to DMEK (n = 29) or UT-DSAEK 25) using minimization randomization based on preoperative BSCVA, recipient central thickness, gender, age, institution. Donor corneas prestripped precut for UT-DSAEK, respectively. Six surgeons participated this study. Main Outcome Measures primary outcome measure was BSCVA at 12 months surgery. Results Central graft thickness lamellae measured 101 μm (95% confidence interval [CI], 90–112 μm). Best did not differ significantly between groups 3 (0.15 logarithm the minimum angle resolution [logMAR] [95% CI 0.08–0.22 logMAR] vs. 0.22 logMAR 0.16–0.27 logMAR]; P = 0.15), (0.11 0.05–0.17 0.16 logMAR [95% 0.12–0.21 0.20), (0.08 0.03–0.14 0.15 0.10–0.19 0.06). Twelve surgery, percentage reaching 20/25 Snellen higher compared (66% 33%; 0.02). Endothelial (1870 cells/mm2 1670–2069 cells/mm2] 1612 1326–1898 cells/mm2]; 0.12). Both techniques induced a mild hyperopic shift (12 months: +0.22 diopter [D; 95% –0.23 0.68 D] vs. +0.58 D 0.13–1.03 UT-DSAEK; 0.34). Conclusions mean but achieving vision DMEK. loss treatment groups, both minimal shift.