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

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

Status

UNKNOWN

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00623584

Acronym

SFM

Enrollment

Registered

2008-02-26

Start date

2011-04-30

Completion date

2012-10-31

Last updated

2010-12-08

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Fuch's Endothelial Dystrophy, Pseudophakic Bullous Keratopathy

Keywords

penetrating keratoplasty, corneal transplantation, corneal grafting, corneal grafts, culture media, corneal culturing, in vitro culturing

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.

Interventions

PROCEDURECorneal transplantation

Full thickness penetrating keratoplasty

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

50 Years to 85 Years

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

Design outcomes

Primary

Measure	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

Measure	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

Countries

Germany

Contacts

Primary ContactKatrin Engelmann, MD

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

Backup ContactSimo Murovski, MD

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

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026