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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
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
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.
Age
50 - 85 years
Sex
ALL
Healthy Volunteers
No
Augenklinik, Klinikum Chemnitz gGmbH
Chemnitz, Saxony, Germany
Universitäts Augenklinik
Halle, Saxony-Anhalt, Germany
Start Date
April 1, 2011
Primary Completion Date
April 1, 2012
Completion Date
October 1, 2012
Last Updated
December 8, 2010
60
ESTIMATED participants
Corneal transplantation
PROCEDURE
Corneal transplantation
PROCEDURE
Lead Sponsor
Klinikum Chemnitz gGmbH
Collaborators
NCT05436665
NCT05531760
Data Source & Attribution
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