Uveitis, AnteriorUVESCREEN1NCT05984758
Imaging Based Uveitis Screening for Children With Juvenile Idiopathic Arthritis
A study testing AS-OCT imaging and Slit lamp examination in people with Uveitis, Anterior and Juvenile Idiopathic Arthritis, run by Institute of Child Health at 1 site in United Kingdom.
Trial 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)… Read more about this study
- Who is it for?
- Ages 2 to 12 years
- Conditions the study is for
- Uveitis, Anterior, Juvenile Idiopathic Arthritis
- What is being tested?
- AS-OCT imaging and Slit lamp examination
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 1 May 2024to 1 Oct 2026
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 2 to 12 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Patients newly diagnosed (within preceding 12 months) with JIA who are eligible for uveitis surveillance
- Aged 2-12 years
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
Great Ormond Street Hospital
London, WC1n 1DH
Ameenat Lola Solebo, PhD FRCOphth, +44 20 3987 2162, lola.solebo@gosh.nhs.uk
About this study
Official title: 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.
Read the 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.
- Conditions
- Uveitis, Anterior, Juvenile Idiopathic Arthritis
- Being tested
- AS-OCT imaging, Slit lamp examination
- Keywords
- Screening, Surveillance, Imaging, Optical coherence tomography
- Medical subject headings
- Uveitis, Anterior, Arthritis, Juvenile
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AS-OCT imagingDiagnostic test
Image acquisition with the Optovue RTVue OCT and the Heidelberg Spectralis OCT2 machines
Slit lamp examinationDiagnostic test
SLE of anterior chamber
| Study group | Role | What they receive |
|---|---|---|
| Standard care | Active comparator | Routine examination for uveitis with assessment of visual function followed by slit lamp examination Receives: 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 Receives: Diagnostic Test: AS-OCT imaging |
What is being measured
The primary outcome is the main question the study is designed to answer.
Proportion of patients who meet the eligibility criteria
Feasibility data for larger scale study
Measured: 18Months
Number of eligible patients recruited
Feasibility data for larger scale study
Measured: 18Months
Proportion of patients that withdraw due to loss of consent or are lost to follow-up
Feasibility data for larger scale study
Measured: 18Months
Secondary outcomes (3)
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)
Measured: 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)
Measured: 12Months
Visual analogue scoring (VAS) of examination procedures
Scale running from 0 - 100, with higher score meaning better experience as reported by child
Measured: 12Months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Aug 2023
- Study start1 May 2024 (estimated)
- Primary completion1 Jul 2026 (estimated)
- Study completion1 Oct 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Uveitis, AnteriorStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Screening
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Institute of Child Health
- Sponsor type
- University, hospital or other
- Collaborators
- Great Ormond Street Hospital for Children NHS Foundation Trust
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05984758
- Sponsor's protocol ID
- 21PL04
- Other IDs
- IRAS
- Acronym
- UVESCREEN1
- Status last verified
- Mar 2024
- First submitted
- 25 Jul 2023
- Last updated
- 12 Mar 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: IPD shared only after dissemination of study findings and only on reasonable request
Publications
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.
PubMed 39937818
Study at a glance
From the registry record, last updated by the sponsor on 12 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomised Feasibility Study of Imaging Based Uveitis Screening for Children With Juvenile Idiopathic Arthritis
- ClinicalTrials.gov ID
- NCT05984758
- Acronym / sponsor ID
- UVESCREEN1 / 21PL04
- Conditions
- Uveitis, Anterior, Juvenile Idiopathic Arthritis
- Keywords
- Screening, Surveillance, Imaging, Optical coherence tomography
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- Institute of Child HealthUniversity, hospital or other
- Collaborators
- Great Ormond Street Hospital for Children NHS Foundation Trust
- Study start
- 1 May 2024 (estimated)
- Primary completion
- 1 Jul 2026 (estimated)
- Study completion
- 1 Oct 2026 (estimated)
- First posted
- 9 Aug 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Screening
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Standard care | Active comparator | Diagnostic Test: Slit lamp examinationRoutine examination for uveitis with assessment of visual function followed by slit lamp examination |
| ASOCT imaging | Experimental | Diagnostic Test: AS-OCT imagingAssessment of visual function followed by image acquisition with the Optovue RTVue OCT and the Heidelberg Spectralis OCT2 machines |
Who may qualify
- Ages
- 2 to 12 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (2 listed)
- Patients newly diagnosed (within preceding 12 months) with JIA who are eligible for uveitis surveillance
- Aged 2-12 years
Key exclusion criteria (3 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| AS-OCT imagingImage acquisition with the Optovue RTVue OCT and the Heidelberg Spectralis OCT2 machines | Diagnostic test | ASOCT imaging |
| Slit lamp examinationSLE of anterior chamber | Diagnostic test | Standard care |
Primary outcome
Proportion of patients who meet the eligibility criteria
Time frame: 18Months
Feasibility data for larger scale study
Number of eligible patients recruited
Time frame: 18Months
Feasibility data for larger scale study
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
3 secondary outcomes
Success
Time frame: 12Months
Pediatric quality of life inventory (PedsQL) child self-report
Time frame: 12Months
Visual analogue scoring (VAS) of examination procedures
Time frame: 12Months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Mar 2024.
- Derived from this study: PubMed 39937818Dave 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.
- Individual participant dataSharing planned: No. IPD shared only after dissemination of study findings and only on reasonable request
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing AS-OCT imaging and Slit lamp examination in people with Uveitis, Anterior and Juvenile Idiopathic Arthritis, run by Institute of Child Health at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 12 Mar 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Ameenat Solebo (+44 20 3987 2162, a.solebo@ucl.ac.uk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Proportion of patients who meet the eligibility criteria (time frame: 18Months). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05984758, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Mar 2024.