Clinical Research Directory

Safety and Efficacy of Corneal Preservation Solution for Corneal Transplantation

Sponsor: Shandong Branden Med.Device Co.,Ltd

Summary

The goal of this clinical trial is to learn if a corneal preservation solution can safely and effectively preserve donor corneas for corneal transplantation in patients who need penetrating keratoplasty (PKP) or endothelial keratoplasty (EK). It will also learn about the safety of this corneal preservation solution. The main questions it aims to answer are: What is the donor viability rate on the day of transplantation, defined as the proportion of donor corneas with endothelial cell density (ECD) ≥2,000 cells/mm²? What is the corneal graft transparency rate 14 days after transplantation? What medical problems do participants have after transplantation? This is a single-center, prospective, single-arm study. Researchers will enroll 60 patients at Shandong Provincial Eye Hospital (Affiliated Eye Hospital of Shandong First Medical University). All participants will receive a donor cornea preserved in the corneal preservation solution for 2-7 days. Donor corneal ECD and hexagonality will be measured at the time of donor retrieval and on the day of transplantation. Donors with ECD ≥2,000 cells/mm² can be used for transplantation. Participants will be followed for 14 days after transplantation. There is no comparison group. Participants will: Undergo PKP or EK using a donor cornea preserved in the corneal preservation solution for 2-7 days. Have donor corneal ECD and hexagonality measured before transplantation. Be followed for 14 days after transplantation for graft transparency, ECD, graft thickness, epithelial healing, visual acuity recovery, secondary surgery, and adverse events. The results will provide evidence for the formal clinical use of this corneal preservation solution in China.

Official title: A Single-Center, Prospective, Single-Arm Clinical Study Evaluating the Safety and Efficacy of Corneal Preservation Solution

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