Great Ormond Street Hospital
London, WC1n 1DH, United Kingdom
NCT Number: NCT05984758
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.
Trial opening soon.
Get Notified2 year–12 year
All sexes
Interventional
Not applicable
London, WC1n 1DH, United Kingdom
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Image acquisition with the Optovue RTVue OCT and the Heidelberg Spectralis OCT2 machines
SLE of anterior chamber
Time frame: 18Months
Feasibility data for larger scale study
Time frame: 18Months
Feasibility data for larger scale study
Time frame: 18Months
Feasibility data for larger scale study
Time frame: 12Months
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
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
Scale running from 0 - 100, with higher score meaning better experience as reported by child
Time frame: 12months
Number of new diagnoses of uveitis / Number of new diagnosis of other visual/ocular problems
Contact information is provided by the study sponsor or research team.
Institute of Child Health
Other
A Randomised Feasibility Study of Imaging Based Uveitis Screening for Children With Juvenile Idiopathic Arthritis
Acronym: UVESCREEN1
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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