Functional Antigen Matching in Corneal Transplantation
This trial is active, not recruiting.
|Treatments||hla matching, penetrating keratoplasty|
|Sponsor||University Hospital Freiburg|
|Collaborator||German Research Foundation|
|Start date||September 2009|
|End date||May 2015|
|Trial size||650 participants|
|Trial identifier||NCT00810472, FR-2008-FANCY|
Penetrating keratoplasty is one of the most commonly performed transplantation surgeries. Graft rejection is a major complication. HLA compatibility has already been demonstrated an effective prophylaxis in several retrospective investigations. The purpose of the investigators randomized clinical trial is to demonstrate superiority of HLA matching in comparison to random graft assignment with respect to the endpoint 'time to first endothelial graft rejection' in penetrating keratoplasty. The investigators will perform DNA-based allele resolution typing.
|Endpoint classification||efficacy study|
|Intervention model||parallel assignment|
|Masking||single blind (subject)|
Time to first endothelial graft rejection.
time frame: Mostly within the first six months.
Male or female participants at least 18 years old.
Inclusion Criteria: - Predicted waiting time for a 4/6 match lower than 6 months. Exclusion Criteria: - Minority - Legal incapacity
|Official title||Clinical Trial to Investigate Superiority of HLA Matching in Comparison to Random Graft Assignment With Respect to the Endpoint 'Time to First Endothelial Graft Rejection' in Penetrating Keratoplasty.|
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