Imaging Based Uveitis Screening for Children With Juvenile Idiopathic Arthritis
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: AS-OCT imaging, Slit lamp examination.
- Who it may be relevant to
- Registry conditions: Uveitis, Anterior, Juvenile Idiopathic Arthritis. Basic parameters: 2 years — 12 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United Kingdom
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
A Randomised Feasibility Study of Imaging Based Uveitis Screening for Children With Juvenile Idiopathic Arthritis
Overview
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 test AS-OCT imaging
Image acquisition with the Optovue RTVue OCT and the Heidelberg Spectralis OCT2 machines - Diagnostic test Slit lamp examination
SLE of anterior chamber
Primary outcome measures
- Proportion of patients who meet the eligibility criteria [Time frame: 18Months]
- Number of eligible patients recruited [Time frame: 18Months]
- Proportion of patients that withdraw due to loss of consent or are lost to follow-up [Time frame: 18Months]
Secondary outcome measures (3)
- Success [Time frame: 12Months]
- Pediatric quality of life inventory (PedsQL) child self-report [Time frame: 12Months]
- Visual analogue scoring (VAS) of examination procedures [Time frame: 12Months]
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Open label
- Primary purpose
- Screening
Study locations
United Kingdom · 1 center
- Great Ormond Street Hospital — London
Publications
- Dave S, Rahi JS, Petrushkin H, Testi I, Patel DE, Solebo AL. UVESCREEN1: A randomised feasibility study of imaging-based uveitis screening for children with juvenile idiopathic arthritis- Study Protocol. PLoS One. 2025 Feb 12;20(2):e0316410. doi: 10.1371/journal.pone.0316410. eCollection 2025. PMID 39937818
Identifiers
NCT: NCT05984758 · 21PL04 · IRAS