Factors Associated with Endothelial Cell Density at One Year in the Diabetes Endothelial Keratoplasty Study.

OBJECTIVE

To evaluate donor, recipient, and operative factors associated with endothelial cell density (ECD) at 1 year after Descemet membrane endothelial keratoplasty (DMEK) in the Diabetes Endothelial Keratoplasty Study (DEKS).

DESIGN

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

PARTICIPANTS

Subjects undergoing DMEK without graft failure and with analyzable endothelial images at 1 year.

METHODS

A central, masked image analysis reading center determined ECD from central endothelial images of corneal grafts from donors without or with diabetes preoperatively and 1 year after DMEK. Associations between ECD at 1 year and donor, recipient, and operative factors were assessed using multivariable linear mixed-effect models adjusting for surgeon (random effect) and accounting for correlation between fellow donor and recipient eyes.

MAIN OUTCOME MEASURE: Post-DMEK ECD at 1 year.

RESULTS

Of 1421 eyes undergoing DMEK, 1274 eyes were included in this analysis; 724 (57%) were in women, 1215 (95%) were in white individuals, and 1229 (96%) had Fuchs endothelial corneal dystrophy (FECD). Lower ECD (estimated effect [99% CI]) at 1 year was associated with lower donor preoperative ECD (-392 [-447 to -336] cells/mm2 per 500 cells/mm2 preoperatively), eye bank-reported donor endothelial cell damage (-161 [-281 to -40] cells/mm2) for 10-20% cell damage by trypan blue staining post lenticule preparation vs. <5% damage, operative complications (-308 [-450 to -166] cells/mm2), and recipient indication other than FECD (-191 [-346 to -36] cells/mm2). One-year endothelial cell loss from preoperative was 26% to 30% across preoperative ECD groups (<2500, 2500 to <2750, 2750 to <3000, ≥3000 cells/mm2), was 36% when there was 10-20% endothelial cell damage after lenticule preparation vs. 29% for <5% cell damage, was 28% when the preoperative indication was FECD vs. 40% when it was not, and was 42% when intraoperative complications occurred vs. 27% when they did not.

CONCLUSIONS

Higher endothelial cell loss at 1 year after DMEK is associated with endothelial cell damage following lenticule preparation, recipient indication other than FECD, and intraoperative complications. Estimating donor endothelial cell damage by trypan blue staining was an independent assessment of donor endothelial health that complemented ECD.