Imaging Based Uveitis Screening for Children With Juvenile Idiopathic Arthritis

NCT ID: NCT05984758

Last Updated: 2024-03-12

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

NOT_YET_RECRUITING

Clinical Phase

NA

Total Enrollment

80 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-05-01

Study Completion Date

2026-10-01

Brief Summary

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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

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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.

Conditions

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Uveitis, Anterior Juvenile Idiopathic Arthritis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

SCREENING

Blinding Strategy

NONE

Study Groups

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Standard care

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

Group Type ACTIVE_COMPARATOR

Slit lamp examination

Intervention Type DIAGNOSTIC_TEST

SLE of anterior chamber

ASOCT imaging

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

Group Type EXPERIMENTAL

AS-OCT imaging

Intervention Type DIAGNOSTIC_TEST

Image acquisition with the Optovue RTVue OCT and the Heidelberg Spectralis OCT2 machines

Interventions

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AS-OCT imaging

Image acquisition with the Optovue RTVue OCT and the Heidelberg Spectralis OCT2 machines

Intervention Type DIAGNOSTIC_TEST

Slit lamp examination

SLE of anterior chamber

Intervention Type DIAGNOSTIC_TEST

Eligibility Criteria

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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
Minimum Eligible Age

2 Years

Maximum Eligible Age

12 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Great Ormond Street Hospital for Children NHS Foundation Trust

OTHER

Sponsor Role collaborator

Institute of Child Health

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Great Ormond Street Hospital

London, , United Kingdom

Site Status

Countries

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United Kingdom

Central Contacts

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Ameenat Solebo

Role: CONTACT

+44 20 3987 2162

Facility Contacts

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Ameenat Lola Solebo, PhD FRCOphth

Role: primary

+44 20 3987 2162

References

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Dave S, Rahi JS, Petrushkin H, Testi I, Patel DE, Solebo AL. UVESCREEN1: A randomised feasibility study of imaging-based uveitis screening for children with juvenile idiopathic arthritis- Study Protocol. PLoS One. 2025 Feb 12;20(2):e0316410. doi: 10.1371/journal.pone.0316410. eCollection 2025.

Reference Type DERIVED
PMID: 39937818 (View on PubMed)

Other Identifiers

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IRAS

Identifier Type: OTHER

Identifier Source: secondary_id

21PL04

Identifier Type: -

Identifier Source: org_study_id

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