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Not Yet RecruitingNCT05984758

Imaging Based Uveitis Screening for Children With Juvenile Idiopathic Arthritis

A Randomised Feasibility Study of Imaging Based Uveitis Screening for Children With Juvenile Idiopathic Arthritis

Status
Not Yet Recruiting
Phase
N/A
Study type
Interventional
Enrollment
80 (estimated)
Sponsor
Institute of Child Health · Academic / Other
Sex
All
Age
2 Years – 12 Years
Healthy volunteers
Not accepted

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.

Conditions

Interventions

TypeNameDescription
DIAGNOSTIC_TESTAS-OCT imagingImage acquisition with the Optovue RTVue OCT and the Heidelberg Spectralis OCT2 machines
DIAGNOSTIC_TESTSlit lamp examinationSLE of anterior chamber

Timeline

Start date
2024-05-01
Primary completion
2026-07-01
Completion
2026-10-01
First posted
2023-08-09
Last updated
2024-03-12

Locations

1 site across 1 country: United Kingdom

Source: ClinicalTrials.gov record NCT05984758. Inclusion in this directory is not an endorsement.