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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
122
CHU Besançon
Besançon, France
CHU Clermont-Ferrand
Clermont-Ferrand, France
CHU Grenoble
Grenoble, France
CHU Saint-Etienne
Saint-Etienne, France
the primary outcome is the endothelial cell density (ECD) of the corneal grafts.
Time frame: one year after graft
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