Imaging Based Uveitis Screening for Children With Juvenile Idiopathic Arthritis

Juvenile Idiopathic Arthritis Clinical Trial

— UVESCREEN1  

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05984758
• Other study ID #: 21PL04
• Secondary ID: IRAS
• Status: Not yet recruiting
• Phase: N/A
• Start date: May 1, 2024
• Est. completion date: October 1, 2026

Study information

• Verified date: March 2024
• Source: Institute of Child Health
• Contact: Ameenat Solebo
• Phone: +44 20 3987 2162
• Email: a.solebo[@]ucl.ac.uk
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 80
• Est. completion date: October 1, 2026
• Est. primary completion date: July 1, 2026
• Accepts healthy volunteers: No
• Gender: All
• Age group: 2 Years to 12 Years

Eligibility

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

Related Conditions & MeSH terms

• Arthritis
• Arthritis, Juvenile
• Juvenile Idiopathic Arthritis
• Uveitis
• Uveitis, Anterior

Intervention

Diagnostic Test:
• AS-OCT imaging
Image acquisition with the Optovue RTVue OCT and the Heidelberg Spectralis OCT2 machines
• Slit lamp examination
SLE of anterior chamber

Locations

Country	Name	City	State
United Kingdom	Great Ormond Street Hospital	London

Sponsors (2)

Lead Sponsor	Collaborator
Institute of Child Health	Great Ormond Street Hospital for Children NHS Foundation Trust

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	New diagnoses	Number of new diagnoses of uveitis / Number of new diagnosis of other visual/ocular problems	12months
Primary	Proportion of patients who meet the eligibility criteria	Feasibility data for larger scale study	18Months
Primary	Number of eligible patients recruited	Feasibility data for larger scale study	18Months
Primary	Proportion of patients that withdraw due to loss of consent or are lost to follow-up	Feasibility data for larger scale study	18Months
Secondary	Success	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)	12Months
Secondary	Pediatric quality of life inventory (PedsQL) child self-report	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)	12Months
Secondary	Visual analogue scoring (VAS) of examination procedures	Scale running from 0 - 100, with higher score meaning better experience as reported by child	12Months