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

doi:10.1136/bjophthalmol-2017-311342

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

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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 language	English
Pages (from-to)	132-136
Number of pages	5
Journal	British Journal of Ophthalmology
Volume	103
Issue number	1
Early online date	22 Mar 2018
DOIs	https://doi.org/10.1136/bjophthalmol-2017-311342
Publication status	Published - Jan 2019

Bibliographical note

Structured keywords

Centre for Surgical Research
BTC (Bristol Trials Centre)

Keywords

Cornea
immunology

Access to Document

10.1136/bjophthalmol-2017-311342

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Armitage, W. J., Winton, H. L., Jones, M. N. A., Crewe, J. M., Rogers, C. A., Tole, D. M., & Dick, A. D. (2019). 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. British Journal of Ophthalmology, 103(1), 132-136. https://doi.org/10.1136/bjophthalmol-2017-311342

Armitage, W. John ; Winton, Helen L. ; Jones, Mark N.A. ; Crewe, Julie M. ; Rogers, Chris A. ; Tole, Derek M. ; Dick, Andrew D. / 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. In: British Journal of Ophthalmology. 2019 ; Vol. 103, No. 1. pp. 132-136.

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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.",

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Armitage, WJ, Winton, HL, Jones, MNA, Crewe, JM, Rogers, CA, Tole, DM & Dick, AD 2019, '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', British Journal of Ophthalmology, vol. 103, no. 1, pp. 132-136. https://doi.org/10.1136/bjophthalmol-2017-311342

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

In: British Journal of Ophthalmology, Vol. 103, No. 1, 01.2019, p. 132-136.

Research output: Contribution to journal › Article (Academic Journal)

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AU - Winton, Helen L.

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AU - Dick, Andrew D.

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N2 - 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.

AB - 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.

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Armitage WJ, Winton HL, Jones MNA, Crewe JM, Rogers CA, Tole DM et al. 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. British Journal of Ophthalmology. 2019 Jan;103(1):132-136. https://doi.org/10.1136/bjophthalmol-2017-311342