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Comparative Study of Two Corneal Graft Storage Media: New Animal Compound Free Medium Versus Reference Medium

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01694914
First Posted: September 27, 2012
Last Update Posted: January 30, 2015
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
Ministry of Health, France
Information provided by (Responsible Party):
Centre Hospitalier Universitaire de Saint Etienne
  Purpose
At present, all commercially available corneal organ culture media contain foetal calf serum (FCS) and sometimes other compounds extracted from animals. These compounds are necessary for corneal cell survival but are problematic because they theoretically have risk of anthropozoonosis transmission, especially for new variant of CJD and the variability between FCS batches influence graft quality. Our laboratory research allowed in vitro and ex vivo validation of a new medium free compound animal. We proved its superiority over conventional medium containing 2% FCS for endothelial cell survival during the storage time. The goal of this clinical trial is now to assess its superiority in patients.

Condition Intervention Phase
Corneal Transplantation Procedure: corneal graft Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Comparative Study of Two Corneal Graft Storage Media: New Animal Compound Free Medium Versus Reference Medium

Further study details as provided by Centre Hospitalier Universitaire de Saint Etienne:

Primary Outcome Measures:
  • the primary outcome is the endothelial cell density (ECD) of the corneal grafts. [ Time Frame: one year after graft ]

Enrollment: 122
Study Start Date: January 2012
Study Completion Date: February 2014
Primary Completion Date: February 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Animal Compound Free Medium
Patients in this arm receive a corneal graft stored in organ culture in a animal compound free medium
Procedure: corneal graft
Active Comparator: organ culture medium containing 2% of fœtal calf serum
Patients in this arm receive a corneal graft stored in organ culture in a commercial organ culture medium containing 2% of fœtal calf serum
Procedure: corneal graft

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Male and female patients
  • over 18 years of age
  • Clinically proven corneal disease
  • Registered on the French National waiting list (GLAC)
  • Patient informed consent
  • Patient who needs a 8.25mm of diameter perforating keratoplasty, either isolated or combined with lens surgery
  • Low immune rejection risk (< 2 quadrants of neovascularization, no previous history of herpetic keratitis nor graft rejection)
  • No previous history of glaucoma or elevated intra ocular pressure (>22 mm

Exclusion Criteria:

  • Patient is unlikely to comply with the requirements of the protocol
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01694914


Locations
France
CHU Besançon
Besancon, France, 25000
CHU Clermont-Ferrand
Clermont-Ferrand, France, 63003
CHU Grenoble
Grenoble, France, 38043
CHU Saint-Etienne
Saint-Etienne, France, 42055
Sponsors and Collaborators
Centre Hospitalier Universitaire de Saint Etienne
Ministry of Health, France
Investigators
Principal Investigator: Gilles Thuret, MD-PhD CHU Saint-Etienne
  More Information

Responsible Party: Centre Hospitalier Universitaire de Saint Etienne
ClinicalTrials.gov Identifier: NCT01694914     History of Changes
Other Study ID Numbers: 0908018
2010-A00234-35 ( Other Identifier: AFSSAPS )
First Submitted: September 25, 2012
First Posted: September 27, 2012
Last Update Posted: January 30, 2015
Last Verified: January 2015

Keywords provided by Centre Hospitalier Universitaire de Saint Etienne:
Corneal Transplantation
corneal organ culture medium
free animal compound medium