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

Corneal Transplantation Clinical Trial

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

Clinical Trial 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.

Clinical Trial Description

n/a

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT01694914
Study type Interventional
Source Centre Hospitalier Universitaire de Saint Etienne
Contact
Status Completed
Phase Phase 3
Start date January 2012
Completion date February 2014
View Details
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