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Completed

NCT Number: NCT00810472

Functional Antigen Matching in Corneal Transplantation

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.

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Key information

Conditions

Corneal Diseases Eye Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University Eye Hospital Freiburg

Freiburg im Breisgau, Baden-Wurttemberg, 79106, Germany

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Predicted waiting time for a 4/6 match lower than 6 months.

Exclusion criteria

  • Minority
  • Legal incapacity

Treatment and study plan

HLA Matching

Other

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.

penetrating keratoplasty

Procedure

Corneal transplantation.

Primary outcomes

  1. Time to first endothelial graft rejection.

    Time frame: Mostly within the first six months.

Sponsors and collaborators

Lead sponsor

University Hospital Freiburg

Other

Collaborators

  • German Research Foundation

Registry information

Official study 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.

Acronym: FANCY

Important dates

Study start
2009
Primary completion
2015
Study completion
2015
First posted
Dec 18, 2008
Registry last updated
Oct 25, 2016

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

View the official ClinicalTrials.gov record (opens in a new tab)

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.

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