Corneal transplant follow-up study II (CTFS II): A prospective clinical trial to determine the influence of HLA class II matching on corneal transplant rejection: Baseline donor and recipient characteristics

W. John Armitage, Helen L. Winton, Mark N.A. Jones, Julie M. Crewe, Chris A. Rogers, Derek M. Tole, Andrew D. Dick*

*Corresponding author for this work

Research output: Contribution to journalArticle (Academic Journal)peer-review

11 Citations (Scopus)
419 Downloads (Pure)

Abstract

PURPOSE: To describe a study to determine the influence of HLA class II matching on allograft rejection of high-risk, full-thickness corneal transplants.

METHODS: A prospective, longitudinal, clinical trial (ISRCTN25094892) with a primary outcome measure of time to first clinically determined rejection episode. Tissue typing used DNA-based techniques. Corneas were allocated to patients with ≤2 human leucocyte antigen (HLA) class I antigen mismatches by cohort minimisation to achieve 0, 1 or 2 HLA class II (HLA-DR) antigen mismatches. Transplants were to be followed up at 6 months and then annually on the anniversary of surgery for 5 years. Power calculations estimated a sample size of 856 transplants to detect a 0.1 difference in probability of rejection at 1 year between HLA class II matched and mismatched transplants at the 5% level of significance with 80% power.

RESULTS: To allow for loss to follow-up, 1133 transplants in 980 patients were accrued to the study between 3 September 1998 and 2 June 2011. 17% of transplants had 0 HLA-DR mismatches. The most frequent indication was bullous keratopathy, accounting for 27% of transplants and 54% of the transplants were regrafts. Median waiting time for a matched graft was 3 months. Donor and recipient characteristics were distributed evenly across the study groups.

CONCLUSION: Recruitment to the CFS II has closed with 1077/1133 transplants meeting all the study criteria. Follow-up has been completed and final analysis of the data has started.

TRIAL REGISTRATION NUMBER: ISRCTN25094892 andUKCRNID9871, Pre-results.

Original languageEnglish
Pages (from-to)132-136
Number of pages5
JournalBritish Journal of Ophthalmology
Volume103
Issue number1
Early online date22 Mar 2018
DOIs
Publication statusPublished - Jan 2019

Bibliographical note

© Article author(s) (or their employer(s) unless otherwise stated in the text of the article) 2019. All rights reserved. No commercial use is permitted unless otherwise expressly granted.

Research Groups and Themes

  • BTC (Bristol Trials Centre)
  • Centre for Surgical Research

Keywords

  • Cornea
  • immunology

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