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

Not Applicable

• Conditions: Fuch's Endothelial Dystrophy; Pseudophakic Bullous Keratopathy
• Interventions: Procedure: Corneal transplantation

• Registration Number: NCT00623584
• Lead Sponsor: Klinikum Chemnitz gGmbH

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 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 Timeline

• Study First Submitted: 2008-02-13
• Study First Submitted QC: 2008-02-25
• Study First Posted: 2008-02-26
• Status Verified: 2010-12
• Last Update Submitted: 2010-12-07
• Last Update Posted: 2010-12-08
• Study Start: 2011-04
• Primary Completion: 2012-04
• Study Completion: 2012-10

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 60

Inclusion Criteria

• Male and female patients between 50 and 85 years of age
• Clinically proven Fuchs corneal dystrophy or secondary decompensation the corneal endothelium (e. g. after surgical intervention in the anterior segment of the eye)
• Patient informed consent

Exclusion Criteria

• Previous penetrating keratoplasty
• Corneal neovascularisation
• Pathologic changes in the anterior segment of the eye (anterior / posterior synechiae, uveitis)
• Glaucoma
• Aphakia
• Infectious diseases of the cornea
• Neurodermitis
• Participation of the patient in another clinical trial within the last four weeks that precede the recruitment
• The patient is unlikely to comply with the requirements of the protocol
• Previous or current abuse of medications, narcotics or alcohol
• Pregnancy

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
1	Corneal transplantation	Patients in this arm randomly receive a corneal graft cultured in a serum free culture medium
2	Corneal transplantation	Patients in this arm randomly receive a corneal graft cultured in a serum supplemented culture medium

Primary Outcome Measures

Name	Time	Method
The primary outcome is the endothelial cell density of the corneal grafts prior to and after the transplantation procedure	The measurment will be performed prior to and 1, 4, 12, 24, 36, 48 and 60 months after the transplantation

Secondary Outcome Measures

Name	Time	Method
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.	1,4,12, 24, 36, 48 and 60 month after the transplantation

Trial Locations

Locations (2)

Augenklinik, Klinikum Chemnitz gGmbH; 🇩🇪 Chemnitz, Saxony, Germany

Universitäts Augenklinik; 🇩🇪 Halle (Saale), Sachsen-Anhalt, Germany