Imaging Based Uveitis Screening for Children With Juvenile Idiopathic Arthritis

NCT05984758 | Not Yet Recruiting DMC

• 2 other identifiers: 21PL04IRAS
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

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.

Conditions

Uveitis, Anterior; Juvenile Idiopathic Arthritis

Keywords

Screening; Surveillance; Imaging; Optical coherence tomography

Outcome Measures

Primary Outcomes (3)

• 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 Outcomes (3)

• Success

  12Months

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

  12Months

• Visual analogue scoring (VAS) of examination procedures

  12Months

Other Outcomes (1)

• New diagnoses

  12months

Study Arms (2)

Standard care

ACTIVE COMPARATOR

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

Diagnostic Test: Slit lamp examination

ASOCT imaging

EXPERIMENTAL

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

Diagnostic Test: AS-OCT imaging

Interventions

AS-OCT imaging DIAGNOSTIC_TEST

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

ASOCT imaging

Slit lamp examination DIAGNOSTIC_TEST

SLE of anterior chamber

Standard care

Eligibility Criteria

• Age: 2 Years - 12 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• Patients newly diagnosed (within preceding 12 months) with JIA who are eligible for uveitis surveillance
• Aged 2-12 years

You may not qualify if:

• 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

Sponsors & Collaborators

• Institute of Child Health: lead
• Great Ormond Street Hospital for Children NHS Foundation Trust: collaborator

Study Sites (1)

Great Ormond Street Hospital

London, WC1n 1DH, United Kingdom

Location

Related Publications (1)

• 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.

  PMID: 39937818 DERIVED

MeSH Terms

Conditions

Uveitis, Anterior; Arthritis, Juvenile

Interventions

Slit Lamp Microscopy

Condition Hierarchy (Ancestors)

Panuveitis; Uveitis; Uveal Diseases; Eye Diseases; Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Connective Tissue Diseases; Skin and Connective Tissue Diseases; Autoimmune Diseases; Immune System Diseases

Intervention Hierarchy (Ancestors)

Diagnostic Techniques, Ophthalmological; Diagnostic Techniques and Procedures; Diagnosis

Central Study Contacts

Ameenat Solebo

CONTACT

+44 20 3987 2162; a.solebo@ucl.ac.uk

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SCREENING
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 25, 2023
• First Posted: August 9, 2023
• Study Start: May 1, 2024
• Primary Completion (Estimated): July 1, 2026
• Study Completion (Estimated): October 1, 2026
• Last Updated: March 12, 2024

Record last verified: 2024-03

Data Sharing

• IPD Sharing: Will not share

Locations

GB (1)