Corneal Transplant Follow-up Study - impact of tissue matching

ISRCTN	ISRCTN25094892
DOI	https://doi.org/10.1186/ISRCTN25094892
Secondary identifying numbers	N/A

Submission date: 23/09/2008
Registration date: 06/10/2008
Last edited: 27/07/2020

Recruitment status: No longer recruiting
Overall study status: Completed
Condition category: Injury, Occupational Diseases, Poisoning

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Plain English summary of protocol

Not provided at time of registration

Contact information

Prof John Armitage
Scientific

Bristol Eye Hospital
Lower maudlin Street
Bristol
BS1 2LX
United Kingdom

Phone	+44 117 34 24585
Email	w.j.armitage@bristol.ac.uk

Study information

Study design	Multicentre, prospective, longitudinal study using cohort minimisation for patient allocation
Primary study design	Interventional
Secondary study design	Randomised controlled trial
Study setting(s)	Hospital
Study type	Treatment
Participant information sheet	Not available in web format, please use the contact details to request a patient information sheet
Scientific title	Evaluation of HLA class II histocompatibility matching and cytokine polymorphisms in corneal transplantation
Study acronym	CTFS II
Study objectives	Primary hypothesis: HLA class II tissue matching between donors and recipients decreases the risk of cell-mediated rejection in high risk corneal transplants. Secondary hypothesis: Cytokine polymorphisms modulate the cell-mediated rejection response in high risk corneal transplants.
Ethics approval(s)	South West Research Ethics Committee: Original study approved on 11/12/1997 (ref: MREC/97/6/8) Study extension approved on 13/9/2001 (ref: MREC/01/6/77)
Health condition(s) or problem(s) studied	Corneal transplantation
Intervention	Patients receive a corneal transplant from a donor matched for HLA class I antigens (not more than two HLA-A and/or HLA-B mismatches combined) with 0, 1 or 2 HLA class II (HLA-DR) mismatches. The level of HLA-DR mismatching defines the study group and is allocated by cohort minimisation. Data are submitted at the time of surgery and the patients are followed up at 6 months, 1, 2, 3, 4 and 5 years postoperatively. Follow-up data include whether the graft has failed, occurrence of rejection episodes, postoperative interventions and medication (including topical steroids and systemic immunosuppressives).
Intervention type	Other
Primary outcome measure	Time to first rejection
Secondary outcome measures	Time to graft failure
Overall study start date	01/09/1998
Completion date	31/12/2014

Eligibility

Participant type(s)	Patient
Age group	Other
Sex	Both
Target number of participants	1,200
Total final enrolment	1077
Key inclusion criteria	Patients of any age or sex tissue typed by polymerase chain reaction using sequence-specific primers (PCR-SSP) or PCR using sequence-specific oligonucleotides (PCR-SSO) with corneal disease requiring a corneal transplant and with the following conditions that increase the risk of cell-mediated rejection: 1. Previously failed corneal transplant 2. Vascularised cornea 3. Ocular inflammatory disease 4. Bullous keratopathy consequent to previous ocular surgery
Key exclusion criteria	Patients requiring corneal transplants where the risk of rejection is low (e.g., keratoconus and Fuchs' endothelial dystrophy) and where there are no known pre-operative risk factors for rejection.
Date of first enrolment	01/09/1998
Date of final enrolment	31/12/2014

Locations

Countries of recruitment

England
United Kingdom

Study participating centre

Bristol Eye Hospital

Bristol
BS1 2LX
United Kingdom

Sponsor information

University of Bristol (UK)
University/education

Research and Enterprise Development
Senate House
Tyndall Avenue
Bristol
BS8 1TH
England
United Kingdom

Phone	+44 117 928 8676
Email	Red-Office@bristol.ac.uk
Website	http://www.bris.ac.uk
"ROR"	https://ror.org/0524sp257

Funders

Funder type

Charity

Start-up funding: NHS Executive South & West R&D (UK) (ref: R/14/9.96)

No information available

Subsequent funding: National Eye Research Centre (UK) (ref: SCIAD036)

No information available

Results and Publications

Intention to publish date	01/08/2020
Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Stored in repository
Publication and dissemination plan	Presentation at international eye research meetings and publication in medical journals. The study aims and design, and the donor and recipient cohort demographics have been published (see publications list).
IPD sharing plan	The data collected for this trial are stored and maintained by NHS Blood and Transplant (NHSBT) in the UK Transplant Registry (UKTR). Corneal transplants in the UK are routinely followed for 5 years by NHSBT and this mechanism was used for the capture of follow-up data for the CTFS II transplants at the following time points: time of transplant, then postoperatively at 6, 12, 24, 36, 48 and 60 months. The UKTR contains patient identifiable data (compliant with GDPR) and is not therefore publicly available.

Study outputs

Output type	Details	Date created	Date added	Peer reviewed?	Patient-facing?
Other publications	baseline characteristics	01/01/2019	23/09/2019	Yes	No
Basic results		27/07/2020	27/07/2020	No	No

Additional files

ISRCTN25094892_BasicResults_27Jul20.pdf: Uploaded 27/07/2020

Editorial Notes

27/07/2020: The following changes were made to the trial record:
1. Publication and dissemination plan and IPD sharing statement added.
2. The basic results of this trial have been uploaded as an additional file.
3. The study design was changed from 'Multicentre, prospective, longitudinal study using cohort minimisation for patient allocation (non-randomised controlled trial)' to ''Multicentre, prospective, longitudinal study using cohort minimisation for patient allocation'.
23/09/2019: Publication reference and total final enrolment number added.
18/11/2016: No publications found in PubMed, verifying study status with principal investigator.