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 Details — Status: Completed

Administrative data

• NCT number: NCT01694914
• Other study ID #: 0908018
• Secondary ID: 2010-A00234-35
• Status: Completed
• Phase: Phase 3
• First received: September 25, 2012
• Last updated: January 29, 2015
• Start date: January 2012
• Est. completion date: February 2014

Study information

• Verified date: January 2015
• Source: Centre Hospitalier Universitaire de Saint Etienne
• Contact: n/a
• Is FDA regulated: No
• Health authority: France: Agence Nationale de Sécurité du Médicament et des produits de santé
• Study type: Interventional

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 122
• Est. completion date: February 2014
• Est. primary completion date: February 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

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

• Corneal Transplantation

Intervention

Procedure:
• corneal graft

Locations

Country	Name	City	State
France	CHU Besançon	Besancon
France	CHU Clermont-Ferrand	Clermont-Ferrand
France	CHU Grenoble	Grenoble
France	CHU Saint-Etienne	Saint-Etienne

Sponsors (2)

Lead Sponsor	Collaborator
Centre Hospitalier Universitaire de Saint Etienne	Ministry of Health, France

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	the primary outcome is the endothelial cell density (ECD) of the corneal grafts.		one year after graft	No