Imaging Based Uveitis Screening for Children With Juvenile Idiopathic Arthritis (UVESCREEN1)

A Randomised Feasibility Study of 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.

Study Overview

• Status: Not yet recruiting
• Conditions: Uveitis, Anterior; Juvenile Idiopathic Arthritis
• Intervention / Treatment: Diagnostic test: Slit lamp examination; Diagnostic test: AS-OCT imaging

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.

• Study Type: Interventional
• Enrollment (Estimated): 80
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Ameenat Solebo; Phone Number: +44 20 3987 2162; Email: a.solebo@ucl.ac.uk

Study Locations

• United Kingdom
  • London, United Kingdom, WC1n 1DH
    • Great Ormond Street Hospital
    • Contact: Ameenat Lola Solebo, PhD FRCOphth; Phone Number: +44 20 3987 2162; Email: lola.solebo@gosh.nhs.uk

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

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

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

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
New diagnoses	Number of new diagnoses of uveitis / Number of new diagnosis of other visual/ocular problems	12months

Collaborators and Investigators

• Sponsor: Institute of Child Health
• Collaborators: Great Ormond Street Hospital for Children NHS Foundation Trust

Study record dates

Study Major Dates

• Study Start (Estimated): May 1, 2024
• Primary Completion (Estimated): July 1, 2026
• Study Completion (Estimated): October 1, 2026

Study Registration Dates

• First Submitted: July 25, 2023
• First Submitted That Met QC Criteria: August 2, 2023
• First Posted (Actual): August 9, 2023

Study Record Updates

• Last Update Posted (Actual): March 12, 2024
• Last Update Submitted That Met QC Criteria: March 11, 2024
• Last Verified: March 1, 2024

More Information

Terms related to this study

• Keywords: Imaging; Optical coherence tomography; Screening; Surveillance
• Additional Relevant MeSH Terms: Immune System Diseases; Autoimmune Diseases; Eye Diseases; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Connective Tissue Diseases; Panuveitis; Uveal Diseases; Arthritis; Arthritis, Juvenile; Uveitis; Uveitis, Anterior
• Other Study ID Numbers: 21PL04; IRAS (Other Identifier: 348528)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: IPD shared only after dissemination of study findings and only on reasonable request

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No