Functional Antigen Matching in Corneal Transplantation
Not Applicable
Completed
- Conditions
- Corneal Diseases
- Interventions
- Procedure: Penetrating keratoplastyOther: HLA Matching
- Registration Number
- NCT00810472
- Lead Sponsor
- University Hospital Freiburg
- Brief Summary
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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 650
Inclusion Criteria
- Predicted waiting time for a 4/6 match lower than 6 months.
Exclusion Criteria
- Minority
- Legal incapacity
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Random graft assignment Penetrating keratoplasty - HLA Matching Penetrating keratoplasty HLA matching is exerted by selecting the donor with least-most additional HLA alleles. We will predict the waiting time for such a donor in order to assess eligibility for the trial \[8\]. In addition, we will dynamically adopt the degree of matching that is aimed at depending on the predicted time interval and actual waiting time: the first donors not exerting more than 7 mismatches at the triplet-amino-acid-residue-level (HLAMatchmaker method \[6\]) is accepted if the patient is waiting less than half of his predicted waiting time. The next available donor exerting a 2/6 match (or better) is assigned thereafter. The next graft will be assigned, regardless of HLA matching after 6 months. HLA Matching HLA Matching HLA matching is exerted by selecting the donor with least-most additional HLA alleles. We will predict the waiting time for such a donor in order to assess eligibility for the trial \[8\]. In addition, we will dynamically adopt the degree of matching that is aimed at depending on the predicted time interval and actual waiting time: the first donors not exerting more than 7 mismatches at the triplet-amino-acid-residue-level (HLAMatchmaker method \[6\]) is accepted if the patient is waiting less than half of his predicted waiting time. The next available donor exerting a 2/6 match (or better) is assigned thereafter. The next graft will be assigned, regardless of HLA matching after 6 months.
- Primary Outcome Measures
Name Time Method Time to first endothelial graft rejection. Mostly within the first six months.
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (1)
University Eye Hospital Freiburg
🇩🇪Freiburg, Baden-Württemberg, Germany