Suryan L Dunker1, Mor M Dickman2, Robert P L Wisse3, Siamak Nobacht4, Robert H J Wijdh5, Marjolijn C Bartels6, Mei L Tang7, Frank J H M van den Biggelaar8, Pieter J Kruit9, Rudy M M A Nuijts2. 1. University Eye Clinic, Maastricht University Medical Center, Maastricht, The Netherlands. Electronic address: suryan.dunker@mumc.nl. 2. University Eye Clinic, Maastricht University Medical Center, Maastricht, The Netherlands; Department of Ophthalmology, Zuyderland Medical Center, Heerlen, The Netherlands. 3. Department of Ophthalmology, University Medical Center Utrecht, Utrecht, The Netherlands. 4. Department of Ophthalmology, Radboud University Medical Centre, Nijmegen, The Netherlands. 5. Department of Ophthalmology, University Medical Center Groningen, Groningen, The Netherlands. 6. Department of Ophthalmology, Deventer Hospital, Deventer, The Netherlands. 7. Department of Ophthalmology, Gelre Hospitals, Apeldoorn, The Netherlands. 8. University Eye Clinic, Maastricht University Medical Center, Maastricht, The Netherlands. 9. Euro Tissue Bank - Bio Implant Service (ETB-BISLIFE), Leiden, The Netherlands.
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 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.
RCT Entities:
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 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.
Authors: Francesco Aiello; Federico Genzano Besso; Giulio Pocobelli; Gabriele Gallo Afflitto; Rossella Anna Maria Colabelli Gisoldi; Carlo Nucci; Diego Ponzin Journal: Cell Tissue Bank Date: 2021-05-24 Impact factor: 1.522
Authors: Michele Lanza; Rosa Boccia; Adriano Ruggiero; Paolo Melillo; Mario Bifani Sconocchia; Francesca Simonelli; Sandro Sbordone Journal: Front Med (Lausanne) Date: 2021-04-12
Authors: Suryan L Dunker; Mor M Dickman; Robert P L Wisse; Siamak Nobacht; Robert H J Wijdh; Marjolijn C Bartels; N E Mei-Lie Tang; Frank J H M van den Biggelaar; Pieter J Kruit; Bjorn Winkens; Rudy M M A Nuijts Journal: Acta Ophthalmol Date: 2021-01-12 Impact factor: 3.761