Comparison of Corneal Grafts Cultured in Serum-free Versus Corneal Grafts Cultured in Serum Supplemented Culture Media — SFM

Pseudophakic Bullous Keratopathy Clinical Trial

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

Status Not yet recruiting

Clinical Trial 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

Clinical Trial Description

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. ;

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT00623584
Study type	Interventional
Source	Klinikum Chemnitz gGmbH
Contact	Katrin Engelmann, MD
Phone	+ 49 371 333 33230
Email	k.engelmann@skc.de
Status	Not yet recruiting
Phase	N/A
Start date	April 2011
Completion date	October 2012

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