Factors Associated with Successful Descemet Membrane Endothelial Keratoplasty in the Diabetes Endothelial Keratoplasty Study.

Abstract

Objective: To identify donor, lenticule preparation, recipient, and operative factors associated with 1-year Descemet membrane endothelial keratoplasty (DMEK) success in the Diabetes Endothelial Keratoplasty Study (DEKS).

Design: This prospective cohort study was a prespecified secondary analysis of the DEKS randomized, double-masked, multicenter clinical trial.

Participants: Individuals undergoing DMEK to treat corneal endothelial dysfunction at 28 clinical sites.

Methods: Recipient eyes were randomized to receive a cornea from a donor without or with diabetes in a 2:1 ratio. Details about donor, tissue preparation, recipient, and operative factors were recorded prospectively. The study excluded eyes with a prior penetrating keratoplasty or glaucoma tube shunt. Graft failures were classified as follows. If the recipient stroma was cloudy in the first postoperative week and did not clear or required a regraft within 8 weeks, it was classified as "primary donor failure" in the absence of operative complications or as "early failure" associated with operative complications. If the recipient stroma cleared in the first postoperative week or cleared after being cloudy in the first postoperative week and later required a regraft or became cloudy without clearing for 90 days, it was classified as "late failure." Proportional hazards and logistic regression were used to estimate risk ratios.

Main outcome measures: Graft success at 1 year.

Results: Of 1421 DMEK grafts, 1374 (97%) were clear at 1 year, 32 were classified as primary donor failures, 12 as early failures, and 3 as late failures. In multivariate analysis, the 78 cases (5.5%) with operative complications had a lower success rate (89%; hazard ratio for graft failure 4.01; 95% confidence interval, 1.86-8.63; P < 0.001). Three additional factors were associated with slightly higher graft success rates without reaching the defined statistical significance threshold of P < 0.01: baseline donor endothelial cell density ≥2500 versus <2500 cells/mm² (97% vs. 95% success; P = 0.03); tissue peeled by surgeon versus eye bank (99% vs. 96% success; P = 0.02); and recipient diabetes status: no versus yes (97% vs. 94% success; P = 0.02).

Conclusions: Descemet membrane endothelial keratoplasty was highly successful across a wide range of donor, recipient, and surgical technique variations. Not surprisingly, graft success was lower in cases with operative complications.

Financial disclosure(s): Proprietary or commercial disclosure may be found in the Footnotes and Disclosures at the end of this article.

Trial registration: NCT05134480, ClinicalTrials.gov.