Imaging Based Uveitis Screening for Children With Juvenile Idiopathic Arthritis

Study Overview
=================
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.

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

Conditions
-----------------
Uveitis, Anterior, Juvenile Idiopathic Arthritis

Intervention / Treatment
-----------------
* Diagnostic Test: AS-OCT imaging
* Diagnostic Test: Slit lamp examination


Participation Criteria
=================
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

Ages Eligible for Study
-----------------
Minimum Age: 2 Years
Maximum Age: 12 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Screening
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

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

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Proportion of patients who meet the eligibility criteria | Feasibility data for larger scale study | 18Months | 
| Number of eligible patients recruited | Feasibility data for larger scale study | 18Months | 
| Proportion of patients that withdraw due to loss of consent or are lost to follow-up | Feasibility data for larger scale study | 18Months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 
| 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 | 
| Visual analogue scoring (VAS) of examination procedures | Scale running from 0 - 100, with higher score meaning better experience as reported by child | 12Months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Screening, Surveillance, Imaging, Optical coherence tomography