Corneal Transplantation
Conditions
Keywords
Corneal Transplantation, corneal organ culture medium, free animal compound medium
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.
Interventions
PROCEDUREcorneal graft
Sponsors
Ministry of Health, France
Centre Hospitalier Universitaire de Saint Etienne
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| the primary outcome is the endothelial cell density (ECD) of the corneal grafts. | one year after graft |
Countries
France
Outcome results
None listed