Clinical trial NCT05984758: Imaging Based Uveitis Screening for Children With Juvenile Idiopathic Arthritis
Official title: A Randomised Feasibility Study of Imaging Based Uveitis Screening for Children With Juvenile Idiopathic Arthritis
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Uveitis, Anterior
Juvenile Idiopathic Arthritis
Keywords: Screening
Surveillance
Imaging
Optical coherence tomography
Lead sponsor: Institute of Child Health
Sponsor class: OTHER
Collaborators: name: Great Ormond Street Hospital for Children NHS Foundation Trust
First posted: 2023-08-09
Enrollment: 80
Sex: ALL
Minimum age (years): 2
Maximum age (years): 12
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SCREENING

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.

Eligibility criteria: 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

Primary outcomes:
measure: Proportion of patients who meet the eligibility criteria
timeFrame: 18Months
measure: Number of eligible patients recruited
timeFrame: 18Months
measure: Proportion of patients that withdraw due to loss of consent or are lost to follow-up
timeFrame: 18Months
Secondary outcomes:
measure: Success
timeFrame: 12Months
measure: Pediatric quality of life inventory (PedsQL) child self-report
timeFrame: 12Months
measure: Visual analogue scoring (VAS) of examination procedures
timeFrame: 12Months
Other outcomes:
measure: New diagnoses
timeFrame: 12months
Locations:
city: London
country: United Kingdom
facility: Great Ormond Street Hospital
Study officials:
References: