Study to Evaluate Safety and Tolerability of the PVEK Corneal Implant in Adults with Corneal Edema from Fuchs Endothelial Dystrophy or Pseudophakic Bullous Keratopathy

What this Trial Is About

Researchers are evaluating the safety and tolerability of PVEK, a tissue-engineered corneal implant, for people with corneal swelling caused by Fuchs endothelial dystrophy or pseudophakic bullous keratopathy who need endothelial keratoplasty. This Phase 1 study aims to identify possible side effects after the implant and how many participants can complete 6 months after surgery without needing another treatment due to implant intolerance or ineffectiveness. About 15 participants will be involved and followed for up to 12 months after surgery. Participants will undergo implantation of the PVEK corneal endothelial implant in a single surgery. The implant combines a human collagen scaffold and corneal endothelial cells and is delivered into the eye during endothelial keratoplasty using a sterile injector system. After surgery, participants will use prescribed eye drops and attend scheduled follow-up visits for up to 12 months to monitor eye health and implant performance. During the study, participants will complete initial screening including eye exams and health checks before implantation. Follow-up visits will include vision tests, eye pressure measurements, and eye scans to assess corneal thickness and endothelial cell density. Researchers will track the incidence of adverse events for 12 months, monitor eye pressure, and evaluate visual acuity and corneal health. The main outcomes focus on safety and implant tolerability during the first 6 months and continued monitoring up to one year.

PVEK Corneal Implant For Treatment of Corneal Edema