Imaging Based Uveitis Screening for Children With Juvenile Idiopathic Arthritis (UVESCREEN1)

Institute of Child Health

Status: Not yet enrolling

Conditions: Uveitis, Anterior; Juvenile Idiopathic Arthritis

Treatments: Diagnostic Test: AS-OCT imaging; Diagnostic Test: Slit lamp examination

Study type: Interventional

Funder types: Other

Identifiers

NCT05984758

IRAS (Other Identifier)

21PL04

Details and patient eligibility

About

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.

Full 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.

Enrollment: 80 estimated patients

Sex: All

Ages: 2 to 12 years old

Volunteers: No 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

Trial design

Primary purpose: Screening

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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80 participants in 2 patient groups

Standard care

Active Comparator group

Description:

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

Treatment:

Diagnostic Test: Slit lamp examination

ASOCT imaging

Experimental group

Description:

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

Treatment:

Diagnostic Test: AS-OCT imaging