NCT01694914

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

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 122 (actual)
• Sponsor: Centre Hospitalier Universitaire de Saint Etienne · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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.

Conditions

• Corneal Transplantation

Interventions

Type	Name	Description
PROCEDURE	corneal graft

Timeline

• Start date: 2012-01-01
• Primary completion: 2014-02-01
• Completion: 2014-02-01
• First posted: 2012-09-27
• Last updated: 2015-01-30

Locations

4 sites across 1 country: France