Safety and Effectiveness of Tissue-Engineered Endothelial Keratoplasty for Corneal Endothelial Disorders

What this Trial Is About

Researchers are evaluating the safety and effectiveness of a new tissue-engineered corneal endothelial graft material made from cultured human corneal endothelial cells. This treatment is aimed at patients with mild to moderate corneal endothelial problems, such as Fuchs endothelial dystrophy, bullous keratopathy, or irreversible post-surgical corneal decompensation. The study is a Phase 1 clinical trial led by the Singapore Eye Research Institute to assess outcomes after this specific type of corneal transplant called Tissue-Engineered Endothelial Keratoplasty TE-EK. The trial involves undergoing the TE-EK surgery, where the tissue-engineered endothelial graft is transplanted using a standard Descemet Stripping Automated Endothelial Keratoplasty DSAEK technique. The surgery will be performed by an experienced principal investigator who has completed over 300 EK surgeries. The treatment approach will not differ whether or not a patient participates in the study. Participants will have regular follow-up visits following current EK protocols, including assessments of visual acuity, eye pressure, corneal shape and thickness, endothelial cell density, and contrast sensitivity. Researchers will also monitor for any complications such as graft dislocation or failure. The main outcome is best spectacle-corrected visual acuity measured at 3 months, along with other eye health measures tracked up to 6 months. The total participation period and safety monitoring extend through these follow-ups.

Safety and Efficacy of Tissue Engineered Endothelial Keratoplasty