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ClinicalTrials.gov ID

NCT00623584

Lead Sponsor

Klinikum Chemnitz gGmbHOTHER

Overall Status

Unknown status

Study Type

Interventional

Phase

Not Applicable

Enrollment

60Estimated

Last Update Posted

Dec 8, 2010Estimated

Start Date

Apr 2011

Primary Completion Date

Apr 2012Estimated

Completion Date

Oct 2012Estimated

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 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.

• Fuch's Endothelial Dystrophy
• Pseudophakic Bullous Keratopathy

• Corneal transplantation

Ages Eligible for Study

Adult (18-64)Older Adult (65+)

Sexes Eligible for Study

All

Accepts Healthy Volunteers

No

Eligibility Criteria

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

Primary Purpose

Treatment

Allocation

Randomized

Interventional Model

Parallel Assignment

Masking

None (Open Label)

Lead Sponsor

Klinikum Chemnitz gGmbHOTHER

Collaborators

German Research FoundationOTHER

KKS NetzwerkNETWORK

gernot.duncker@medizin.uni-halle.de+49 345 557 1878