A Randomized Controlled Trial Comparing Microthin Descemet Stripping Automated Endothelial Keratoplasty (Mt-Dsaek) With Descemet Membrane Endothelial Keratoplasty: 2 Year Report

To report the 2 year outcomes of a double blind randomised controlled trial comparing DMEK (Descemet Membrane Endothelial Keratoplasty) and MT- DSAEK. (Microthin- Descemet Stripping Automated Endothelial Keratoplasty)

Debated still exists whether DMEK is superior to MT-DSAEK in uncomplicated eyes. We therefore performed a randomised controlled trial to investigate the long term outcomes comparing the two techniques.

56 eyes of 56 patients with Fuchs Endothelial Dystrophy were randomised to DMEK or the MT-DSAEK, with 28 patients randomised to each arm. The main outcome measure was Best Spectacle Corrected Visual Acuity (BSCVA) at 24 months. Other secondary outcomes included complications, endothelial cell density and vision related Quality of Life scores (vQoL).  An intention to treat analysis was adopted.  Linear regression analysis was undertaken on BSCVA, ECC and VFQ scores at 1 and 2 years controlling for baseline values including all 56 patients in the study. Complication rates were anaylsed through the Fisher exact test. 

There was no statistically significant difference in BSCVA between the DMEK and the MT-DSAEK group at 2-year time point (mean ± SD; 0.04±0.14 vs 0.12± 0.19, p=0.061) in contrast to the 1-year results (mean ± SD; 0.04 ± 0.13 vs 0.11 ± 0.09, p=0.002) previously reported. Endothelial cell density did not show a statistically significant difference at 24 months between DMEK and MT-DSAEK groups (1522 ± 293cell/mm² vs 1432 ± 327 cells/mm², p=0.27). There were 2 additional graft rejection episodes in the MT-DSAEK group between the one and two years follow up period, but this did not result in graft failure. The mean vQoL scores between DMEK and MT-DSAEK indicated similar patient satisfaction between the groups. (97.1 ± 4.0 vs 92.6 ± 10.2, p=0.13).

In summary, the trial showed no significant difference in BSCVA at 24 months between the DMEK and MT-DSAEK groups. Both techniques continued to demonstrate comparable outcomes in terms of complication rates, endothelial cell loss and patient reported vQoL scores.