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

Phase 3

Completed

• Conditions: Corneal Transplantation
• Interventions: Procedure: corneal graft

• Registration Number: NCT01694914
• Lead Sponsor: Centre Hospitalier Universitaire de Saint Etienne

Brief 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2012-01
• Study First Submitted: 2012-09-25
• Study First Submitted QC: 2012-09-26
• Study First Posted: 2012-09-27
• Primary Completion: 2014-02
• Study Completion: 2014-02
• Status Verified: 2015-01
• Last Update Submitted: 2015-01-29
• Last Update Posted: 2015-01-30

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 122

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
organ culture medium containing 2% of fœtal calf serum	corneal graft	Patients in this arm receive a corneal graft stored in organ culture in a commercial organ culture medium containing 2% of fœtal calf serum
Animal Compound Free Medium	corneal graft	Patients in this arm receive a corneal graft stored in organ culture in a animal compound free medium

Primary Outcome Measures

Name	Time	Method
the primary outcome is the endothelial cell density (ECD) of the corneal grafts.	one year after graft

Trial Locations

Locations (4)

CHU Grenoble; 🇫🇷 Grenoble, France

CHU Besançon; 🇫🇷 Besancon, France

CHU Clermont-Ferrand; 🇫🇷 Clermont-Ferrand, France

CHU Saint-Etienne; 🇫🇷 Saint-Etienne, France