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

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.

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Key information

Conditions

Corneal Transplantation

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

CHU Besançon, Besançon, France

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

corneal graft

Procedure

Primary outcomes

the primary outcome is the endothelial cell density (ECD) of the corneal grafts.

Time frame: one year after graft

Sponsors and collaborators

Lead sponsor

Centre Hospitalier Universitaire de Saint Etienne

Other

Collaborators

Ministry of Health, France

Registry information

Important dates

Study start: 2012
Primary completion: 2014
Study completion: 2014
First posted: Sep 27, 2012
Registry last updated: Jan 30, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed