Clinical trial NCT00623584: Comparison of Corneal Grafts Cultured in Serum-free Versus Corneal Grafts Cultured in Serum Supplemented Culture Media
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 type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Fuch's Endothelial Dystrophy
Pseudophakic Bullous Keratopathy
Keywords: penetrating keratoplasty
corneal transplantation
corneal grafting
corneal grafts
culture media
corneal culturing
in vitro culturing
Lead sponsor: Klinikum Chemnitz gGmbH
Sponsor class: OTHER
Collaborators: name: German Research Foundation
name: KKS Netzwerk
First posted: 2008-02-26
Enrollment: 60
Sex: ALL
Minimum age (years): 50
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: The primary outcome is the endothelial cell density of the corneal grafts prior to and after the transplantation procedure
timeFrame: The measurment will be performed prior to and 1, 4, 12, 24, 36, 48 and 60 months after the transplantation
Secondary outcomes:
measure: 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.
timeFrame: 1,4,12, 24, 36, 48 and 60 month after the transplantation
Other outcomes:
Locations:
city: Halle (Saale)
country: Germany
facility: Universitäts Augenklinik
state: Sachsen-Anhalt
city: Chemnitz
country: Germany
facility: Augenklinik, Klinikum Chemnitz gGmbH
state: Saxony
Study officials:
affiliation: Klinikum Chemnitz GmbH
name: Katrin Engelmann, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Hempel B, Bednarz J, Engelmann K. Use of a serum-free medium for long-term storage of human corneas. Influence on endothelial cell density and corneal metabolism. Graefes Arch Clin Exp Ophthalmol. 2001 Oct;239(10):801-5. doi: 10.1007/s004170100364.
citation: Bednarz J, Doubilei V, Wollnik PC, Engelmann K. Effect of three different media on serum free culture of donor corneas and isolated human corneal endothelial cells. Br J Ophthalmol. 2001 Dec;85(12):1416-20. doi: 10.1136/bjo.85.12.1416.
citation: Uphoff J, Bednarz J, Engelmann K. [Follow-up of endothelial cell density after perforating keratoplasty. Effect of donor and recipient-related factors]. Ophthalmologe. 2001 Jun;98(6):550-4. doi: 10.1007/s003470170117. German.
citation: Moller-Pedersen T, Hartmann U, Moller HJ, Ehlers N, Engelmann K. Evaluation of potential organ culture media for eye banking using human donor corneas. Br J Ophthalmol. 2001 Sep;85(9):1075-9. doi: 10.1136/bjo.85.9.1075.
citation: Moller-Pedersen T, Hartmann U, Ehlers N, Engelmann K. Evaluation of potential organ culture media for eye banking using a human corneal endothelial cell growth assay. Graefes Arch Clin Exp Ophthalmol. 2001 Oct;239(10):778-82. doi: 10.1007/s004170100354.