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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified December 2010 by Klinikum Chemnitz gGmbH.
Recruitment status was  Not yet recruiting
Sponsor:
Collaborators:
German Research Foundation
KKS Netzwerk
Information provided by:
Klinikum Chemnitz gGmbH
ClinicalTrials.gov Identifier:
NCT00623584
First received: February 13, 2008
Last updated: December 7, 2010
Last verified: December 2010
  Purpose

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


Condition Intervention
Fuch's Endothelial Dystrophy
Pseudophakic Bullous Keratopathy
Procedure: Corneal transplantation

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
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

Resource links provided by NLM:


Further study details as provided by Klinikum Chemnitz gGmbH:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]

Estimated Enrollment: 60
Study Start Date: April 2011
Estimated Study Completion Date: October 2012
Estimated Primary Completion Date: April 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1
Patients in this arm randomly receive a corneal graft cultured in a serum free culture medium
Procedure: Corneal transplantation
Full thickness penetrating keratoplasty
Active Comparator: 2
Patients in this arm randomly receive a corneal graft cultured in a serum supplemented culture medium
Procedure: Corneal transplantation
Full thickness penetrating keratoplasty

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

Ages Eligible for Study:   50 Years to 85 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00623584

Contacts
Contact: Katrin Engelmann, MD + 49 371 333 33230 k.engelmann@skc.de
Contact: Simo Murovski, MD + 49 371 6000020 s.murovski@poliklinik-chemnitz.de

Locations
Germany
Universitäts Augenklinik Not yet recruiting
Halle (Saale), Sachsen-Anhalt, Germany, 06120
Contact: Gernot Duncker, MD    +49 345 557 1878    gernot.duncker@medizin.uni-halle.de   
Contact: Timm Bredehorn, MD    + 49 345 557 1575    timm.bredehorn@dso.de   
Augenklinik, Klinikum Chemnitz gGmbH Not yet recruiting
Chemnitz, Saxony, Germany, 091116
Contact: Katrin Engelmann, MD    + 49 371 333 33230    k.engelmann@skc.de   
Contact: Simo Murovski, MD    + 49 371 6000020    s.murovski@poliklinik-chemnitz.de   
Principal Investigator: Katrin Engelmann, MD         
Sponsors and Collaborators
Klinikum Chemnitz gGmbH
German Research Foundation
KKS Netzwerk
Investigators
Principal Investigator: Katrin Engelmann, MD Klinikum Chemnitz GmbH
  More Information

Publications:
Responsible Party: Prof. Dr. med. Katrin Engelmann, Eye Clinic Chemnitz
ClinicalTrials.gov Identifier: NCT00623584     History of Changes
Other Study ID Numbers: SKC001SFM08
Study First Received: February 13, 2008
Last Updated: December 7, 2010
Health Authority: Germany: Federal Institute for Drugs and Medical Devices

Keywords provided by Klinikum Chemnitz gGmbH:
penetrating keratoplasty
corneal transplantation
corneal grafting
corneal grafts
culture media
corneal culturing
in vitro culturing

Additional relevant MeSH terms:
Fuchs' Endothelial Dystrophy
Corneal Dystrophies, Hereditary
Corneal Diseases
Eye Diseases
Eye Diseases, Hereditary
Genetic Diseases, Inborn

ClinicalTrials.gov processed this record on September 16, 2014