UVESCREEN1: Imaging Based Uveitis Screening for Children With Juvenile Idiopathic Arthritis

Sponsor

Institute of Child Health (Other)

Overall Status

Not yet recruiting

CT.gov ID

NCT05984758

Collaborator

Great Ormond Street Hospital for Children NHS Foundation Trust (Other)

Enrollment

Location

Arms

Anticipated Duration (Months)

2.4

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Uveitis, Anterior Juvenile Idiopathic Arthritis	Diagnostic Test: AS-OCT imaging Diagnostic Test: Slit lamp examination	N/A

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 Design

Study Type:

Interventional

Anticipated Enrollment :

80 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Screening

Official Title:

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

Anticipated Study Start Date :

Dec 1, 2023

Anticipated Primary Completion Date :

Jul 1, 2026

Anticipated Study Completion Date :

Oct 1, 2026

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: Standard care Routine examination for uveitis with assessment of visual function followed by slit lamp examination	Diagnostic Test: Slit lamp examination SLE of anterior chamber
Experimental: ASOCT imaging Assessment of visual function followed by image acquisition with the Optovue RTVue OCT and the Heidelberg Spectralis OCT2 machines	Diagnostic Test: AS-OCT imaging Image acquisition with the Optovue RTVue OCT and the Heidelberg Spectralis OCT2 machines

Arm

Intervention/Treatment

Active Comparator: Standard care

Routine examination for uveitis with assessment of visual function followed by slit lamp examination

Diagnostic Test: Slit lamp examination

SLE of anterior chamber

Experimental: ASOCT imaging

Assessment of visual function followed by image acquisition with the Optovue RTVue OCT and the Heidelberg Spectralis OCT2 machines

Diagnostic Test: AS-OCT imaging

Image acquisition with the Optovue RTVue OCT and the Heidelberg Spectralis OCT2 machines

Outcome Measures

Primary Outcome Measures

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

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

Other Outcome Measures

New diagnoses [12months]
Number of new diagnoses of uveitis / Number of new diagnosis of other visual/ocular problems

Eligibility Criteria

Criteria

Ages Eligible for Study:

2 Years to 12 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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