Uveitis, Anterior, Juvenile Idiopathic Arthritis
Conditions
Keywords
Screening, Surveillance, Imaging, Optical coherence tomography
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.
Interventions
DIAGNOSTIC_TESTAS-OCT imaging
Image acquisition with the Optovue RTVue OCT and the Heidelberg Spectralis OCT2 machines
DIAGNOSTIC_TESTSlit lamp examination
SLE of anterior chamber
Sponsors
Great Ormond Street Hospital for Children NHS Foundation Trust
Institute of Child Health
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SCREENING
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
2 Years to 12 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Proportion of patients that withdraw due to loss of consent or are lost to follow-up | 18Months | Feasibility data for larger scale study |
| Proportion of patients who meet the eligibility criteria | 18Months | Feasibility data for larger scale study |
| Number of eligible patients recruited | 18Months | Feasibility data for larger scale study |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Visual analogue scoring (VAS) of examination procedures | 12Months | Scale running from 0 - 100, with higher score meaning better experience as reported by child |
| Success | 12Months | Success rates (ie agreement with routine clinical examination, set at 100% for routine examination arm, and analysed at 6 months and 12 months milestones for OCT arm) |
| Pediatric quality of life inventory (PedsQL) child self-report | 12Months | Health related quality of life, through child self-report, items linearly score on 0-100 scale, so that higher scores indicate better HRQOL (Health-Related Quality of Life) |
Other
| Measure | Time frame | Description |
|---|---|---|
| New diagnoses | 12months | Number of new diagnoses of uveitis / Number of new diagnosis of other visual/ocular problems |
Countries
United Kingdom
Contacts
Primary ContactAmeenat Solebo
Outcome results
None listed