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

Primary Purpose

Uveitis, Anterior, Juvenile Idiopathic Arthritis

Status
Not yet recruiting
Phase
Not Applicable
Locations
United Kingdom
Study Type
Interventional
Intervention
AS-OCT imaging
Slit lamp examination
Sponsored by
Institute of Child Health
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional screening trial for Uveitis, Anterior focused on measuring Screening, Surveillance, Imaging, Optical coherence tomography

Eligibility Criteria

2 Years - 12 Years (Child)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Great Ormond Street Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

Standard care

ASOCT imaging

Arm Description

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

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

Outcomes

Primary Outcome Measures

Proportion of patients who meet the eligibility criteria
Feasibility data for larger scale study
Number of eligible patients recruited
Feasibility data for larger scale study
Proportion of patients that withdraw due to loss of consent or are lost to follow-up
Feasibility data for larger scale study

Secondary Outcome Measures

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)
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)
Visual analogue scoring (VAS) of examination procedures
Scale running from 0 - 100, with higher score meaning better experience as reported by child

Full Information

First Posted
July 25, 2023
Last Updated
August 2, 2023
Sponsor
Institute of Child Health
Collaborators
Great Ormond Street Hospital for Children NHS Foundation Trust
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1. Study Identification

Unique Protocol Identification Number
NCT05984758
Brief Title
Imaging Based Uveitis Screening for Children With Juvenile Idiopathic Arthritis
Acronym
UVESCREEN1
Official Title
A Randomised Feasibility Study of Imaging Based Uveitis Screening for Children With Juvenile Idiopathic Arthritis
Study Type
Interventional

2. Study Status

Record Verification Date
August 2023
Overall Recruitment Status
Not yet recruiting
Study Start Date
December 1, 2023 (Anticipated)
Primary Completion Date
July 1, 2026 (Anticipated)
Study Completion Date
October 1, 2026 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Institute of Child Health
Collaborators
Great Ormond Street Hospital for Children NHS Foundation Trust

4. Oversight

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
Data Monitoring Committee
Yes

5. Study Description

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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Uveitis, Anterior, Juvenile Idiopathic Arthritis
Keywords
Screening, Surveillance, Imaging, Optical coherence tomography

7. Study Design

Primary Purpose
Screening
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
80 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Standard care
Arm Type
Active Comparator
Arm Description
Routine examination for uveitis with assessment of visual function followed by slit lamp examination
Arm Title
ASOCT imaging
Arm Type
Experimental
Arm Description
Assessment of visual function followed by image acquisition with the Optovue RTVue OCT and the Heidelberg Spectralis OCT2 machines
Intervention Type
Diagnostic Test
Intervention Name(s)
AS-OCT imaging
Intervention Description
Image acquisition with the Optovue RTVue OCT and the Heidelberg Spectralis OCT2 machines
Intervention Type
Diagnostic Test
Intervention Name(s)
Slit lamp examination
Intervention Description
SLE of anterior chamber
Primary Outcome Measure Information:
Title
Proportion of patients who meet the eligibility criteria
Description
Feasibility data for larger scale study
Time Frame
18Months
Title
Number of eligible patients recruited
Description
Feasibility data for larger scale study
Time Frame
18Months
Title
Proportion of patients that withdraw due to loss of consent or are lost to follow-up
Description
Feasibility data for larger scale study
Time Frame
18Months
Secondary Outcome Measure Information:
Title
Success
Description
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
Title
Pediatric quality of life inventory (PedsQL) child self-report
Description
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
Title
Visual analogue scoring (VAS) of examination procedures
Description
Scale running from 0 - 100, with higher score meaning better experience as reported by child
Time Frame
12Months
Other Pre-specified Outcome Measures:
Title
New diagnoses
Description
Number of new diagnoses of uveitis / Number of new diagnosis of other visual/ocular problems
Time Frame
12months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
2 Years
Maximum Age & Unit of Time
12 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Ameenat Solebo
Phone
+44 20 3987 2162
Email
a.solebo@ucl.ac.uk
Facility Information:
Facility Name
Great Ormond Street Hospital
City
London
ZIP/Postal Code
WC1n 1DH
Country
United Kingdom
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Ameenat Lola Solebo, PhD FRCOphth
Phone
+44 20 3987 2162
Email
lola.solebo@gosh.nhs.uk

12. IPD Sharing Statement

Plan to Share IPD
No
IPD Sharing Plan Description
IPD shared only after dissemination of study findings and only on reasonable request

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Imaging Based Uveitis Screening for Children With Juvenile Idiopathic Arthritis

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