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

Klinikum Chemnitz gGmbH

Status: Unknown

Conditions: Fuch's Endothelial Dystrophy; Pseudophakic Bullous Keratopathy

Treatments: Procedure: Corneal transplantation

Study type: Interventional

Funder types: Other; NETWORK

Identifiers

NCT00623584

SKC001SFM08

Details and patient eligibility

About

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

Full 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.

Enrollment: 60 estimated patients

Sex: All

Ages: 50 to 85 years old

Volunteers: No 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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60 participants in 2 patient groups

1

Experimental group

Description:

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

Treatment:

Procedure: Corneal transplantation

Procedure: Corneal transplantation

2

Active Comparator group

Description:

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

Treatment:

Procedure: Corneal transplantation

Procedure: Corneal transplantation