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

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ClinicalTrials.gov Identifier: NCT00623584
Recruitment Status : Unknown
Verified December 2010 by Klinikum Chemnitz gGmbH.
Recruitment status was:  Not yet recruiting
First Posted : February 26, 2008
Last Update Posted : December 8, 2010
Sponsor:
Collaborators:
Information provided by:

February 13, 2008
February 26, 2008
December 8, 2010
April 2011
April 2012   (Final data collection date for primary outcome measure)
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 ]
Same as current
Complete list of historical versions of study NCT00623584 on ClinicalTrials.gov Archive Site
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 ]
Same as current
Not Provided
Not Provided
 
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
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.
Interventional
Not Provided
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
  • Fuch's Endothelial Dystrophy
  • Pseudophakic Bullous Keratopathy
Procedure: Corneal transplantation
Full thickness penetrating keratoplasty
  • Experimental: 1
    Patients in this arm randomly receive a corneal graft cultured in a serum free culture medium
    Intervention: Procedure: Corneal transplantation
  • Active Comparator: 2
    Patients in this arm randomly receive a corneal graft cultured in a serum supplemented culture medium
    Intervention: Procedure: Corneal transplantation

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Unknown status
60
October 2012
April 2012   (Final data collection date for primary outcome measure)

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
Sexes Eligible for Study: All
50 Years to 85 Years   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
Germany
 
 
NCT00623584
SKC001SFM08
Yes
Not Provided
Not Provided
Prof. Dr. med. Katrin Engelmann, Eye Clinic Chemnitz
Klinikum Chemnitz gGmbH
  • German Research Foundation
  • KKS Netzwerk
Principal Investigator: Katrin Engelmann, MD Klinikum Chemnitz GmbH
Klinikum Chemnitz gGmbH
December 2010

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP