Corneal Transplant Follow-up Study - impact of tissue matching
| ISRCTN | ISRCTN25094892 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN25094892 |
| Protocol serial number | N/A |
| Sponsor | University of Bristol (UK) |
| Funders | Start-up funding: NHS Executive South & West R&D (UK) (ref: R/14/9.96), Subsequent funding: National Eye Research Centre (UK) (ref: SCIAD036) |
- 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
Scientific
Bristol Eye Hospital
Lower maudlin Street
Bristol
BS1 2LX
United Kingdom
| Phone | +44 117 34 24585 |
|---|---|
| w.j.armitage@bristol.ac.uk |
Study information
| Primary study design | Interventional |
|---|---|
| Study design | Multicentre, prospective, longitudinal study using cohort minimisation for patient allocation |
| Secondary study design | Randomised controlled trial |
| Study type | Participant 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(s) |
Time to first rejection |
| Key secondary outcome measure(s) |
Time to graft failure |
| Completion date | 31/12/2014 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Other |
| Sex | All |
| Target sample size at registration | 1200 |
| 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
- United Kingdom
- England
Study participating centre
Bristol Eye Hospital
Bristol
BS1 2LX
United Kingdom
BS1 2LX
United Kingdom
Results and Publications
| Individual participant data (IPD) Intention to share | Yes |
|---|---|
| IPD sharing plan summary | Stored in repository |
| 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? |
|---|---|---|---|---|---|
| Basic results | 27/07/2020 | 27/07/2020 | No | No | |
| Other publications | baseline characteristics | 01/01/2019 | 23/09/2019 | Yes | No |
| Participant information sheet | Participant information sheet | 11/11/2025 | 11/11/2025 | No | Yes |
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.
