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

Sponsor

Klinikum Chemnitz gGmbH (Other)

Overall Status

Unknown status

CT.gov ID

NCT00623584

Collaborator

German Research Foundation (Other), KKS Netzwerk (Other)

Enrollment

Locations

Arms

Duration (Months)

Patients Per Site

1.7

Patients Per Site Per Month

Study Details

Study Description

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

Condition or Disease	Intervention/Treatment	Phase
Fuch's Endothelial Dystrophy Pseudophakic Bullous Keratopathy	Procedure: Corneal transplantation Procedure: Corneal transplantation	N/A

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 Design

Study Type:

Interventional

Anticipated Enrollment :

60 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

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

Study Start Date :

Apr 1, 2011

Anticipated Primary Completion Date :

Apr 1, 2012

Anticipated Study Completion Date :

Oct 1, 2012

Arms and Interventions

Arm	Intervention/Treatment
Experimental: 1 Patients in this arm randomly receive a corneal graft cultured in a serum free culture medium	Procedure: Corneal transplantation Full thickness penetrating keratoplasty
Active Comparator: 2 Patients in this arm randomly receive a corneal graft cultured in a serum supplemented culture medium	Procedure: Corneal transplantation Full thickness penetrating keratoplasty

Arm

Intervention/Treatment

Experimental: 1

Patients in this arm randomly receive a corneal graft cultured in a serum free culture medium

Procedure: Corneal transplantation

Full thickness penetrating keratoplasty

Active Comparator: 2

Patients in this arm randomly receive a corneal graft cultured in a serum supplemented culture medium

Procedure: Corneal transplantation

Full thickness penetrating keratoplasty

Outcome Measures

Primary Outcome Measures

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

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]

Eligibility Criteria

Criteria

Ages Eligible for Study:

50 Years to 85 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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