Trial Comparing Two Eye Surgery Methods and Treatments for Fuchs Endothelial Dystrophy in Adults

What this Trial Is About

The trial investigates treatments for Fuchs endothelial dystrophy, a condition affecting the corneas inner layer. It is a Phase 3, multi-center, randomized clinical trial comparing two surgical approaches for this condition. The goal is to better understand how different procedures affect vision and eye health in adults with this disease. The study is led by Stanford University and includes 60 participants who will be randomly assigned to treatment groups with masked outcome assessors to reduce bias. Participants will be randomly assigned to one of two groups one receiving Descemet Membrane Endothelial Keratoplasty DMEK with a topical placebo, and the other undergoing Descemet Stripping Only DSO combined with topical Ripasudil 0.4%. The study is triple-masked, meaning patients, surgeons, and outcome assessors are unaware of the treatment assignments. Both treatments are delivered as eye procedures, and the Ripasudil is administered topically to the eye in the DSO group. During the 24-month study period, participants will undergo regular assessments including measuring their best spectacle-corrected visual acuity BSCVA at 3, 6, 12, and 24 months. Endothelial cell density will also be measured at 3, 6, and 24 months to monitor the corneas cell health. Safety and adherence to the protocol will be monitored throughout to ensure accurate evaluation of each treatments outcomes. Participants will be followed closely to assess the impact of treatments on vision and corneal health over time.

Descemet Endothelial Thickness Comparison Trial II