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.
Br J Ophthalmol
; 103(1): 132-136, 2019 01.
Article
en En
| MEDLINE
| ID: mdl-29567793
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.Palabras clave
Texto completo:
1
Base de datos:
MEDLINE
Asunto principal:
Prueba de Histocompatibilidad
/
Antígenos HLA-A
/
Antígenos HLA-B
/
Antígenos HLA-DR
/
Trasplante de Córnea
Tipo de estudio:
Clinical_trials
/
Observational_studies
/
Prognostic_studies
/
Risk_factors_studies
Límite:
Adult
/
Aged
/
Female
/
Humans
/
Male
/
Middle aged
Idioma:
En
Revista:
Br J Ophthalmol
Año:
2019
Tipo del documento:
Article
País de afiliación:
Reino Unido