Preliminary results of a multicenter randomized clinical trial comparing Descemet Membrane Endothelial Keratoplasty (DMEK) with ultrathin Descemet Stripping Automated Endothelial Keratoplasty (UT-DSAEK)

Abstract

Purpose : To compare best corrected visual acuity, endothelial cell density, and complications after Descemet Membrane Endothelial Keratoplasty (DMEK) and ultrathin Descemet Stripping Automated Endothelial Keratoplasty (UT-DSAEK).

Methods : Multicenter prospective randomized clinical trial (RCT). 55 eyes of 55 patients suffering from irreversible corneal endothelial dysfunction due to Fuchs' endothelial corneal dystrophy were randozmized to receive DMEK or UT-DSAEK in six tertiary and secondary eye clinics in the Netherlands. Donor grafts were centrally prepared by the Beverwijk Euro Cornea bank. Patients underwent ophthalmic examinations preoperatively and 3 months postoperatively.

Results : Preoperative BCVA did not differ between both groups (DMEK:0.38±0.18 logMAR vs. UT-DSAEK:0.33±0.21 logMAR, P=0.32). Three months after the operation, BCVA improved significantly (P<0.001). However, there was no statistically significant difference in BCVA between both groups (DMEK: 0.16±0.16 vs. UT-DSAEK: 0.19±0.11 logMAR, P=0.59).
One graft in each group was damaged during preparation. Donor endothelial cell density (ECD) did not differ between both groups (DMEK:2668±168 vs. UT-DSAEK:2638±193 cells/mm^2). Three months after the operation, ECD was significantly higher after DMEK (1868±478 vs. 1295±673 cells/mm^2, P= 0.01). Rebubbling was required in 17% of cases after DMEK, and was not reuquired after UT-DSAEK. Primary graft failure requiring repeated transplantation occurred in 7% of cases after DMEK, but not after UT-DSAEK.

Conclusions : The preliminary results of this multicenter RCT indicate that DMEK and UT-DSAEK achieve a similar improvement in BCVA three months after the operation. However, DMEK was associated with a significantly higher complication rate. To the best of our knowlegde, this is the first report from a RCT comparing both transplantation techniques.

This is an abstract that was submitted for the 2018 ARVO Annual Meeting, held in Honolulu, Hawaii, April 29 - May 3, 2018.