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)

1 Citation (Scopus)
194 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.

Structured keywords

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

Keywords

  • Cornea
  • immunology

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