Clinical Trial: Comparison of Corneal Grafts Cultured in Serum-free Versus Corneal Grafts Cultured in Serum Supplemented Culture Media

Study Status: Completed
Recruit Status: Unknown status
Study Type: Interventional

Official Title: In Vitro and Clinical Comparison of Corneal Grafts Cultured in Serum Free Medium or Standard Serum Supplemented Medium in Patients With Degeneration of the Corneal Endothelium

Brief Summary: The goal of this clinical trial is to compare the quality of corneal grafts cultured in a serum-free culture medium with a defined composition versus corneal grafts cultured in a standard serum supplemented culture medium transplanted in patients with decompensated corneal dystrophy

Detailed Summary: The primary objective of this clinical trial is to test the equivalence of the quality of the corneal grafts cultured under serum free conditions to corneal grafts cultured in the Minimal Essential Medium supplemented with 2% fetal calf serum, based on a parallel comparison of the endothelial cell density of paired corneal grafts deriving from single donors at different time points before and after the grafting procedure. In addition, the safety of the clinical use of corneal grafts cultured in both media will be determined. The graft survival rate during the follow-up period will be quantified in regard to immune mediated graft rejection and non-immune mediated graft failure, as well as the incidence of corneal edema, corneal opacities and corneal neovascularisation.
Sponsor: Klinikum Chemnitz gGmbH

Current Primary Outcome: The primary outcome is the endothelial cell density of the corneal grafts prior to and after the transplantation procedure [ Time Frame: The measurment will be performed prior to and 1, 4, 12, 24, 36, 48 and 60 months after the transplantation ]

Original Primary Outcome: Same as current

Current Secondary Outcome: Secondary study outcomes are immune mediated graft rejection, non-immune mediated graft failure, as well as the incidence of corneal edema, corneal opacities and corneal neovascularisation. [ Time Frame: 1,4,12, 24, 36, 48 and 60 month after the transplantation ]

Original Secondary Outcome: Same as current

Information By: Klinikum Chemnitz gGmbH

Dates:
Date Received: February 13, 2008
Date Started: April 2011
Date Completion: October 2012
Last Updated: December 7, 2010
Last Verified: December 2010