A Comparison Of Visual Function After Phacoemulsification Combined With Ultrathin Descemet’S Stripping Automated Endothelial Keratoplasty Or Descemet’S Membrane Endothelial Keratoplasty For Fuchs’ Endothelial Dystrophy: A Randomized Clinical Trial.

The study aimed to compare the best corrected visual acuity (BCVA) and contrast sensitivity (CS) following phacoemulsification with concomitant Ultrathin Descemet’s Stripping Automated Endothelial Keratoplasty (phaco-UT-DSAEK) or Descemet’s Membrane Endothelial Keratoplasty (phaco-DMEK) for Fuchs’ endothelial dystrophy (FED). To our knowledge, a randomized study of phaco-UT-DSAEK and phaco-DMEK has not previously been performed.

The study was conducted at Department of Ophthalmology, Aarhus University Hospital, Denmark. Interim results from 3- and 6-months follow-up will be presented. Included subjects will be followed for 12-months in total. 26 and 32 study subjects have completed the 3- and 6-months follow-up in the phaco-UT-DSAEK and phaco-DMEK group, respectively.

The study is a randomized controlled clinical trial. Only patients suffering from FED and cataract were included. Exclusion criteria were previous ocular surgery or vision-affecting pathology. Included patients were treated with either phaco-UT-DSAEK or phaco-DMEK in a single procedure. UT-DSAEK was defined a graft with a thickness less than 100 µm. BCVA was measured using the standardized chart for early treatment diabetic retinopathy study letters (ETDRS). CS was measured using the Freiburg Acuity and Contrast Test under standardized light conditions. The test provides the contrast threshold in Weber contrast units. The results are presented as the log transformed reciprocal of the Weber contrast (logCS).

Patients treated with phaco-DMEK had a significantly better BCVA compared to patients treated with phaco-UT-DSAEK 3 months postoperatively (p<0.01) with a mean difference of 6.31 ETDRS (95% CI: ETDRS 2.48 to 10.13). This persisted to 6 months postoperatively (p<0.01) with a mean difference of 7.00 ETDRS (95% CI: ETDRS 3.31 to 10.70). No significant difference in logCS was found between patients treated with phaco-DMEK and phaco-UT-DSAEK 3 (p=0.13) and 6 months (p=0.38) postoperatively. Patients treated with phaco-DMEK had a slightly better logCS compared to phaco-UT-DSAEK with a median difference of 0.17 logCS (95% CI: logCS 0.05 to 0.40) and a median difference of 0.12 logCS (95% CI: logCS 0.15 to 0.39) after 3 and 6 months, respectively.

FED patients treated with phaco-DMEK had a significantly better BCVA 3 and 6 months postoperatively compared to phaco-UT-DSAEK. No difference was found in the CS after phaco-DMEK and phaco-UT-DSAEK although the results suggest a slightly better CS after phaco-DMEK compared to phaco-UT-DSAEK 3 months postoperatively.