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

Centre Hospitalier Universitaire de Saint Etienne

Status and phase: Completed; Phase 3

Conditions: Corneal Transplantation

Treatments: Procedure: corneal graft

Study type: Interventional

Funder types: Other

Identifiers

NCT01694914

0908018

2010-A00234-35 (Other Identifier)

Details and patient eligibility

About

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.

Enrollment: 122 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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122 participants in 2 patient groups

Animal Compound Free Medium

Experimental group

Description:

Patients in this arm receive a corneal graft stored in organ culture in a animal compound free medium

Treatment:

Procedure: corneal graft

organ culture medium containing 2% of fœtal calf serum

Active Comparator group

Description:

Patients in this arm receive a corneal graft stored in organ culture in a commercial organ culture medium containing 2% of fœtal calf serum

Treatment:

Procedure: corneal graft