TY - JOUR
T1 - Descemet Endothelial Thickness Comparison Trial
T2 - A Randomized Trial Comparing Ultrathin Descemet Stripping Automated Endothelial Keratoplasty with Descemet Membrane Endothelial Keratoplasty
AU - Chamberlain, Winston
AU - Lin, Charles C.
AU - Austin, Ariana
AU - Schubach, Nicholas
AU - Clover, Jameson
AU - McLeod, Stephen D.
AU - Porco, Travis C.
AU - Lietman, Thomas M.
AU - Rose-Nussbaumer, Jennifer
N1 - Publisher Copyright:
© 2018
PY - 2019/1
Y1 - 2019/1
N2 - Purpose: To compare clinical outcomes of ultrathin Descemet stripping automated endothelial keratoplasty (UT-DSAEK) and Descemet membrane endothelial keratoplasty (DMEK) in the treatment of corneal endothelial dysfunction. Design: Patient and outcome-masked, randomized controlled clinical trial. Participants: Patients with damaged or diseased endothelium from Fuchs endothelial dystrophy or pseudophakic bullous keratopathy who were considered good candidates for DMEK or UT-DSAEK. Methods: Study eyes were randomized by the eye bank to UT-DSAEK or DMEK 1 to 2 days before surgery. Main Outcome Measures: The primary outcome of the trial was best spectacle-corrected visual acuity (BSCVA) at 6 months. Secondary outcomes included 3- and 12-month BSCVA; 3-, 6-, and 12-month endothelial cell counts; intraoperative and postoperative complications; and change in pachymetry. Results: A total of 216 patients with endothelial dysfunction were screened, and 50 eyes of 38 patients were enrolled by 2 surgeons at Casey Eye Institute at Oregon Health & Science University in Portland, Oregon, and at Byers Eye Institute at Stanford University in Palo Alto, California. Overall, we found DMEK to have better visual acuity outcomes compared with UT-DSAEK after correcting for baseline visual acuity: compared with UT-DSAEK, those randomized to DMEK had 1.5 lines better BSCVA at 3 months (95% confidence interval [CI], 2.5–0.6 lines better; P = 0.002), 1.8 lines better BSCVA at 6 months (95% CI, 2.8–1.0 lines better; P < 0.001), and 1.4 lines better BSCVA at 12 months (95% CI, 2.2–0.7 lines better; P < 0.001). Average endothelial cell counts were 1963 cells/mm2 in DMEK and 2113 cells/mm2 in UT-DSAEK at 6 months (P = 0.17) and 1855 cells/mm2 in DMEK and 2070 cells/mm2 in UT-DSAEK at 12 months (P = 0.051). Intraoperative and postoperative complication rates were similar between groups. Conclusions: Descemet membrane endothelial keratoplasty had superior visual acuity results compared with UT-DSAEK at 3, 6, and 12 months in patients with isolated endothelial dysfunction with similar complication rates.
AB - Purpose: To compare clinical outcomes of ultrathin Descemet stripping automated endothelial keratoplasty (UT-DSAEK) and Descemet membrane endothelial keratoplasty (DMEK) in the treatment of corneal endothelial dysfunction. Design: Patient and outcome-masked, randomized controlled clinical trial. Participants: Patients with damaged or diseased endothelium from Fuchs endothelial dystrophy or pseudophakic bullous keratopathy who were considered good candidates for DMEK or UT-DSAEK. Methods: Study eyes were randomized by the eye bank to UT-DSAEK or DMEK 1 to 2 days before surgery. Main Outcome Measures: The primary outcome of the trial was best spectacle-corrected visual acuity (BSCVA) at 6 months. Secondary outcomes included 3- and 12-month BSCVA; 3-, 6-, and 12-month endothelial cell counts; intraoperative and postoperative complications; and change in pachymetry. Results: A total of 216 patients with endothelial dysfunction were screened, and 50 eyes of 38 patients were enrolled by 2 surgeons at Casey Eye Institute at Oregon Health & Science University in Portland, Oregon, and at Byers Eye Institute at Stanford University in Palo Alto, California. Overall, we found DMEK to have better visual acuity outcomes compared with UT-DSAEK after correcting for baseline visual acuity: compared with UT-DSAEK, those randomized to DMEK had 1.5 lines better BSCVA at 3 months (95% confidence interval [CI], 2.5–0.6 lines better; P = 0.002), 1.8 lines better BSCVA at 6 months (95% CI, 2.8–1.0 lines better; P < 0.001), and 1.4 lines better BSCVA at 12 months (95% CI, 2.2–0.7 lines better; P < 0.001). Average endothelial cell counts were 1963 cells/mm2 in DMEK and 2113 cells/mm2 in UT-DSAEK at 6 months (P = 0.17) and 1855 cells/mm2 in DMEK and 2070 cells/mm2 in UT-DSAEK at 12 months (P = 0.051). Intraoperative and postoperative complication rates were similar between groups. Conclusions: Descemet membrane endothelial keratoplasty had superior visual acuity results compared with UT-DSAEK at 3, 6, and 12 months in patients with isolated endothelial dysfunction with similar complication rates.
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U2 - 10.1016/j.ophtha.2018.05.019
DO - 10.1016/j.ophtha.2018.05.019
M3 - Article
C2 - 29945801
AN - SCOPUS:85048856626
SN - 0161-6420
VL - 126
SP - 19
EP - 26
JO - Ophthalmology
JF - Ophthalmology
IS - 1
ER -