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

• Sponsor: Centre Hospitalier Universitaire de Saint Etienne (Other)
• Overall Status: Completed
• CT.gov ID: NCT01694914
• Collaborator: Ministry of Health, France (Other)
• Enrollment: 122
• Locations: 4
• Arms: 2
• Duration (Months): 25
• Patients Per Site: 30.5
• Patients Per Site Per Month: 1.2

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Corneal Transplantation	Procedure: corneal graft	Phase 3

Study Design

• Study Type: Interventional
• Actual Enrollment: 122 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
• Primary Purpose: Treatment
• Official Title: Comparative Study of Two Corneal Graft Storage Media: New Animal Compound Free Medium Versus Reference Medium
• Study Start Date: Jan 1, 2012
• Actual Primary Completion Date: Feb 1, 2014
• Actual Study Completion Date: Feb 1, 2014

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Animal Compound Free Medium Patients in this arm receive a corneal graft stored in organ culture in a animal compound free medium	Procedure: corneal graft
Active Comparator: organ culture medium containing 2% of fœtal calf serum Patients in this arm receive a corneal graft stored in organ culture in a commercial organ culture medium containing 2% of fœtal calf serum	Procedure: corneal graft

Outcome Measures

Primary Outcome Measures

1. the primary outcome is the endothelial cell density (ECD) of the corneal grafts. [one year after graft]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts 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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	CHU Besançon	Besancon		France	25000
2	CHU Clermont-Ferrand	Clermont-Ferrand		France	63003
3	CHU Grenoble	Grenoble		France	38043
4	CHU Saint-Etienne	Saint-Etienne		France	42055

Sponsors and Collaborators

• Centre Hospitalier Universitaire de Saint Etienne
• Ministry of Health, France

Investigators

• Principal Investigator: Gilles Thuret, MD-PhD, CHU Saint-Etienne

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Centre Hospitalier Universitaire de Saint Etienne
• ClinicalTrials.gov Identifier: NCT01694914
• Other Study ID Numbers: 0908018; 2010-A00234-35
• First Posted: Sep 27, 2012
• Last Update Posted: Jan 30, 2015
• Last Verified: Jan 1, 2015

• Keywords provided by Centre Hospitalier Universitaire de Saint Etienne: Corneal Transplantation; corneal organ culture medium; free animal compound medium

Study Results

No Results Posted as of Jan 30, 2015