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

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

3 Citations (Scopus)

229 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 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

BTC (Bristol Trials Centre)
Centre for Surgical Research

Keywords

Cornea
immunology

Access to Document

10.1136/bjophthalmol-2017-311342

Full-text PDF (accepted author manuscript)
This is the author accepted manuscript (AAM). The final published version (version of record) is available online via BMJ at http://bjo.bmj.com/content/early/2018/03/22/bjophthalmol-2017-311342.info . Please refer to any applicable terms of use of the publisher.
Accepted author manuscript, 271 KB

Fingerprint

Dive into the research topics of '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'. Together they form a unique fingerprint.

Cite this

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.

@article{4d9ea6189c0740a8b3b4269a4bb748d6,

title = "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",

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.",

keywords = "Cornea, immunology",

author = "Armitage, {W. John} and Winton, {Helen L.} and Jones, {Mark N.A.} and Crewe, {Julie M.} and Rogers, {Chris A.} and Tole, {Derek M.} and Dick, {Andrew D.}",

note = "{\textcopyright} 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.",

year = "2019",

month = jan,

doi = "10.1136/bjophthalmol-2017-311342",

language = "English",

volume = "103",

pages = "132--136",

journal = "British Journal of Ophthalmology",

issn = "0007-1161",

publisher = "BMJ Publishing Group",

number = "1",

}

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) › peer-review

TY - JOUR

T1 - Corneal transplant follow-up study II (CTFS II)

T2 - A prospective clinical trial to determine the influence of HLA class II matching on corneal transplant rejection: Baseline donor and recipient characteristics

AU - Armitage, W. John

AU - Winton, Helen L.

AU - Jones, Mark N.A.

AU - Crewe, Julie M.

AU - Rogers, Chris A.

AU - Tole, Derek M.

AU - Dick, Andrew D.

PY - 2019/1

Y1 - 2019/1

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.

KW - Cornea

KW - immunology

UR - http://www.scopus.com/inward/record.url?scp=85058773736&partnerID=8YFLogxK

U2 - 10.1136/bjophthalmol-2017-311342

DO - 10.1136/bjophthalmol-2017-311342

M3 - Article (Academic Journal)

C2 - 29567793

VL - 103

SP - 132

EP - 136

JO - British Journal of Ophthalmology

JF - British Journal of Ophthalmology

SN - 0007-1161

IS - 1

ER -

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

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

Abstract

Bibliographical note

Structured keywords

Keywords

Access to Document

Other files and links

Fingerprint

Cite this