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

Klinikum Chemnitz gGmbH60 enrolled

Overview

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

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 Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Fuch's Endothelial Dystrophy Pseudophakic Bullous Keratopathy

Interventions

Corneal transplantationPROCEDURE

Full thickness penetrating keratoplasty

Corneal transplantationPROCEDURE

Full thickness penetrating keratoplasty

Eligibility

Sex: ALLMin age: 50 YearsMax age: 85 Years

Medical Language ↔ Plain English

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

Locations (2)

Augenklinik, Klinikum Chemnitz gGmbH

Chemnitz, Saxony, Germany

Universitäts Augenklinik

Halle, Saxony-Anhalt, Germany

Outcomes

Primary Outcomes

The primary outcome is the endothelial cell density of the corneal grafts prior to and after the transplantation procedure

Time frame: The measurment will be performed prior to and 1, 4, 12, 24, 36, 48 and 60 months after the transplantation

Secondary Outcomes

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.

Time frame: 1,4,12, 24, 36, 48 and 60 month after the transplantation

Central Contacts

Katrin Engelmann, MD

CONTACT

+ 49 371 333 33230 k.engelmann@skc.de

Simo Murovski, MD

CONTACT

+ 49 371 6000020 s.murovski@poliklinik-chemnitz.de

Data from ClinicalTrials.gov

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