Evaluating Safety and Effectiveness of Non-cultured Endothelial Cell Injection Therapy for Adults with Corneal Endothelial Dysfunction

What this Trial Is About

Researchers are evaluating the safety and effectiveness of a cell injection therapy using non-cultured human corneal endothelial cells to treat corneal endothelial dysfunction, including conditions like bullous keratopathy and corneal endothelial dystrophy. This trial is a phase 1 interventional study aiming to assess clinical outcomes and safety of this novel treatment approach. Participants will receive a direct injection of non-cultured corneal endothelial cells as the study treatment. This single-group trial involves monitoring patients after the cell injection to observe treatment effects and any complications. The therapy specifically targets patients with mild to moderate corneal endothelial decompensation or bullous keratopathy with minimal stromal scarring. Throughout the study, participants will undergo various clinical assessments such as best spectacle-corrected visual acuity BSCVA, intraocular pressure, keratometric astigmatism, spherical equivalent, endothelial cell density, anterior segment optical coherence tomography ASOCT, and contrast sensitivity at multiple time points up to 12 months post-operation. Researchers will also track any postoperative complications like graft dislocation or graft failure to evaluate safety and effectiveness.

Simple Non-cultured Endothelial Cell Therapy for Corneal Endothelial Dysfunction