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

Study Overview
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Brief Summary
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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
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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.

Official Title
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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

Conditions
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Fuch's Endothelial Dystrophy, Pseudophakic Bullous Keratopathy

Intervention / Treatment
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* Procedure: Corneal transplantation
* Procedure: Corneal transplantation


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 50 Years
Maximum Age: 85 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

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

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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penetrating keratoplasty, corneal transplantation, corneal grafting, corneal grafts, culture media, corneal culturing, in vitro culturing