Imaging Based Uveitis Screening for Children With Juvenile Idiopathic Arthritis

ConditionsUveitis, Anterior Juvenile Idiopathic Arthritis

Trial statusNot yet recruiting

Trial phaseNot applicable

Trial typeInterventional

Biological sexAll

Age2-12

SponsorInstitute of Child Health

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Patients newly diagnosed (within preceding 12 months) with JIA who are eligible for uveitis surveillance

Aged 2-12 years

Disqualifiers

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

Design model

Parallel

Treatments tested in this trial

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

Treatment groups

80 Participants

are divided into 2 treatment groups

Group A: Standard careActive comparator 1 intervention

Group B: ASOCT imagingExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

Proportion of patients who meet the eligibility criteria

Feasibility data for larger scale study

Time frame

18Months

Number of eligible patients recruited

Feasibility data for larger scale study

Time frame

18Months

Proportion of patients that withdraw due to loss of consent or are lost to follow-up

Feasibility data for larger scale study

Time frame

18Months

Secondary outcomes

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)

Time frame

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)

Time frame

12Months

Visual analogue scoring (VAS) of examination procedures

Scale running from 0 - 100, with higher score meaning better experience as reported by child

Time frame

12Months

Other outcomes

New diagnoses

Number of new diagnoses of uveitis / Number of new diagnosis of other visual/ocular problems

Time frame

12months

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Institute of Child Health

Lead sponsor

Great Ormond Street Hospital for Children NHS Foundation Trust

Collaborator

Source ClinicalTrials.gov

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