A Randomised Feasibility Study of Imaging Based Uveitis Screening for Children With Juvenile Idiopathic Arthritis
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Uveitis, Anterior
- Sponsor
- Institute of Child Health
- Enrollment
- 80
- Locations
- 1
- Primary Endpoint
- Proportion of patients who meet the eligibility criteria
- Status
- Not yet recruiting
- Last Updated
- 2 years ago
Overview
Brief Summary
This study seeks to describe, for children undergoing uveitis surveillance following a new diagnosis of juvenile idiopathic arthritis, the feasibility metrics of undertaking a randomised comparative study of routine slit lamp examination (SLE) versus imaging based (anterior segment optical coherence tomography, OCT) surveillance in order to inform the development of a larger multi-centre trial.
Detailed Description
This study will compare imaging-based surveillance to routine clinical surveillance for uveitis in children with juvenile idiopathic arthritis (JIA) in order to support the design of a future study. Childhood uveitis is a rare inflammatory eye disease. Half of all children with uveitis also have a joint disorder: juvenile idiopathic arthritis (or JIA). Children with JIA must travel to a specialist centre every three months to have eye examinations in an attempt to pick uveitis up early enough to prevent visual loss. Optical coherence tomography (OCT) is a non-contact non-irradiating imaging modality. The investigators have recently demonstrated that novel application of OCT for uveitis detection in children is feasible, acceptable to families, repeatable, sensitive, and specific. The investigators have also found that families welcome the objectivity of imaging-based diagnosis. Standardised operating protocols for image acquisition and analysis have been developed across three imaging platforms (Optovue, Casia and Heidelberg OCT machines). The investigators will be undertaking a feasibility study which compares routine clinical examination based uveitis surveillance to imaging based surveillance in order to provide the necessary information to address this issue in a larger scale clinical trial of clinical and cost-effectiveness, and explore issues around the impact of objective disease metrics on family perceptions of disease and treatment, as well as the perceptions of children, families and clinical staff on the use of automated diagnostic tools.
Investigators
Eligibility Criteria
Inclusion Criteria
- •Patients newly diagnosed (within preceding 12 months) with JIA who are eligible for uveitis surveillance
- •Aged 2-12 years
Exclusion Criteria
- •A previous / existing diagnosis of uveitis
- •Any co-existing ocular or neurological abnormality which impacts on current corrected visual function, or could impact on future corrected visual function
- •Developmental/learning difficulties that preclude concordance with examination / informed assent
Outcomes
Primary Outcomes
Proportion of patients who meet the eligibility criteria
Time Frame: 18Months
Feasibility data for larger scale study
Number of eligible patients recruited
Time Frame: 18Months
Feasibility data for larger scale study
Proportion of patients that withdraw due to loss of consent or are lost to follow-up
Time Frame: 18Months
Feasibility data for larger scale study
Secondary Outcomes
- Success(12Months)
- Visual analogue scoring (VAS) of examination procedures(12Months)
- Pediatric quality of life inventory (PedsQL) child self-report(12Months)