Purpose: To compare visual outcomes, complications and vision-related quality-of-life (QoL) following micro-thin Descemet stripping automated endothelial keratoplasty (MT-DSAEK) versus Descemet membrane endothelial keratoplasty (DMEK) for the management of corneal endothelial dysfunction in Fuchs dystrophy. Design: Prospective, double-blinded randomized controlled clinical trial Methods: Patients with visually significant endothelial decompensation from Fuchs dystrophy were prospectively randomized to receive MT-DSAEK or DMEK surgery. The primary outcome was best spectacle-corrected visual acuity (BSCVA) at 12 months. Secondary outcomes included refraction, keratometry, endothelial cell count, complications and vision-related QoL at 6 and 12 months postoperatively.Results: A total of 56 eyes of 56 patients were enrolled, 28 in each group. Post-operatively, LogMAR mean BSCVA in the MT-DSAEK group was 0.17±0.08 and 0.11±0.09 at 6 and 12 months compared to 0.09±0.13 and 0.04±0.13 following DMEK (p=0.03, p=0.002 respectively) with the DMEK cohort achieving 3.5logMAR letters better BSCVA at 1 year compared to MT-DSAEK. Complication rates were similar with 3.5% rebubbling rate in both groups, 1 primary graft failure in DMEK and a single endothelial rejection in the MT-DSAEK arm. Vision-related QoL was comparable at 6 and 12 months post-operatively and no eyes demonstrated loss of vision from pre-operative BSCVA.Conclusion: DMEK surgery resulted in significantly better BSCVA at 1, 3, 6 and 12 months post-operatively compared to MT-DSAEK. Patient satisfaction was similar with no differences reported in vision-related QoL scores, as was the complications profile between groups. Thus, our results favor DMEK as the better choice procedure for eyes with Fuchs-related corneal decompensation without ocular comorbidities.
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