Imaging Based Uveitis Screening for Children With Juvenile Idiopathic Arthritis

Not Applicable

Not yet recruiting

• Conditions: Uveitis, Anterior; Juvenile Idiopathic Arthritis
• Interventions: Diagnostic Test: Slit lamp examination; Diagnostic Test: AS-OCT imaging

• Registration Number: NCT05984758
• Lead Sponsor: Institute of Child Health

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.

Study Timeline

• Study First Submitted: 2023-07-25
• Study First Submitted QC: 2023-08-02
• Study First Posted: 2023-08-09
• Status Verified: 2024-03
• Last Update Submitted: 2024-03-11
• Last Update Posted: 2024-03-12
• Study Start: 2024-05-01
• Primary Completion: 2026-07-01
• Study Completion: 2026-10-01

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 80

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Standard care	Slit lamp examination	Routine examination for uveitis with assessment of visual function followed by slit lamp examination
ASOCT imaging	AS-OCT imaging	Assessment of visual function followed by image acquisition with the Optovue RTVue OCT and the Heidelberg Spectralis OCT2 machines

Primary Outcome Measures

Name	Time	Method
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
Proportion of patients that withdraw due to loss of consent or are lost to follow-up	18Months	Feasibility data for larger scale study

Secondary Outcome Measures

Name	Time	Method
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)
Visual analogue scoring (VAS) of examination procedures	12Months	Scale running from 0 - 100, with higher score meaning better experience as reported by child
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)

Trial Locations

Locations (1)

Great Ormond Street Hospital; 🇬🇧 London, United Kingdom