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NCT Number: NCT05984758

Imaging Based Uveitis Screening for Children With Juvenile Idiopathic Arthritis

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.

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Key information

Age range

2 year–12 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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

Primary outcomes

  1. Proportion of patients who meet the eligibility criteria

    Time frame: 18Months

    Feasibility data for larger scale study

  2. Number of eligible patients recruited

    Time frame: 18Months

    Feasibility data for larger scale study

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

    Time frame: 18Months

    Feasibility data for larger scale study

Secondary outcomes

  1. Success

    Time frame: 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)

  2. Pediatric quality of life inventory (PedsQL) child self-report

    Time frame: 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)

  3. Visual analogue scoring (VAS) of examination procedures

    Time frame: 12Months

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

Other outcomes

  1. New diagnoses

    Time frame: 12months

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

Study contacts

Contact information is provided by the study sponsor or research team.

Ameenat Solebo

CONTACT

[email protected]

+44 20 3987 2162

Sponsors and collaborators

Lead sponsor

Institute of Child Health

Other

Collaborators

  • Great Ormond Street Hospital for Children NHS Foundation Trust

Registry information

Official study title

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

Acronym: UVESCREEN1

Important dates

Study start
2024
Primary completion
2026
Study completion
2026
First posted
Aug 9, 2023
Registry last updated
Mar 12, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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