The following is a summary of “Descemet Endothelial Thickness Comparison Trial 1 (DETECT 1): outcome masked, placebo-controlled trial comparing two types of corneal transplant surgeries and effect of rho kinase inhibitors on endothelial cell loss protocol,” published in the January 2024 issue of Ophthalmology by Chamberlain et al.

Adjuvant ripasudil, a rho kinase inhibitor, is promising to mitigate endothelial cell loss (ECL) and improve long-term graft survival in endothelial keratoplasty (EK) for corneal transplantation.

Researchers conducted a prospective study to assess the efficacy of a protocol for Descemet Endothelial Thickness Comparison Trial 1 (DETECT 1)through a multicentre, outcome-masked, randomized, placebo-controlled, four-arm clinical trial.

They enrolled 160 eligible patients with endothelial dysfunction from five participating sites in the USA. These patients will be assigned randomly in a 2×2 factorial design to one of the specified treatment groups, group 1—ultrathin Descemet stripping endothelial keratoplasty (UT-DSAEK) plus topical ripasudil 0.4% (n=40); group 2—UT-DSAEK plus topical placebo (n=40); group 3—Descemet membrane endothelial keratoplasty (DMEK) plus topical ripasudil 0.4% (n=40); and group 4—DMEK plus topical placebo (n=40). Primary outcomes, assessed at 12 months, include the best spectacle-corrected visual acuity and endothelial cell loss. Secondary outcomes included visual acuity at different time points, vision-related QoL, endothelial cell morphology, and cost-effectiveness.

The results demonstrated that the study outcomes would undergo analysis through mixed effects linear regression models, considering both treatment arms and pertinent covariates. The documentation and analysis of adverse events, encompassing rebubble procedures, graft failure, and graft rejection, would be conducted using suitable statistical methods.

Investigators concluded that DETECT 1 seeks to optimize corneal transplantation by comparing UT-DSAEK vs DMEK, evaluating ripasudil’s potential to reduce endothelial cell loss, and informing cost-effectiveness for improved clinical practice.

Source: bmjophth.bmj.com/content/9/1/e001454