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

NCT ID: NCT01694914

Last Updated: 2015-01-30

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

122 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-01-31

Study Completion Date

2014-02-28

Brief Summary

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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.

Detailed Description

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Conditions

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Corneal Transplantation

Keywords

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Corneal Transplantation corneal organ culture medium free animal compound medium

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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Animal Compound Free Medium

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

Group Type EXPERIMENTAL

corneal graft

Intervention Type PROCEDURE

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

Group Type ACTIVE_COMPARATOR

corneal graft

Intervention Type PROCEDURE

Interventions

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corneal graft

Intervention Type PROCEDURE

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Ministry of Health, France

OTHER_GOV

Sponsor Role collaborator

Centre Hospitalier Universitaire de Saint Etienne

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Gilles Thuret, MD-PhD

Role: PRINCIPAL_INVESTIGATOR

CHU SAINT-ETIENNE

Locations

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CHU Besançon

Besançon, , France

Site Status

CHU Clermont-Ferrand

Clermont-Ferrand, , France

Site Status

CHU Grenoble

Grenoble, , France

Site Status

CHU Saint-Etienne

Saint-Etienne, , France

Site Status

Countries

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France

Other Identifiers

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2010-A00234-35

Identifier Type: OTHER

Identifier Source: secondary_id

0908018

Identifier Type: -

Identifier Source: org_study_id