An interventional study of AS-OCT imaging and Slit lamp examination in Uveitis, Anterior and Juvenile Idiopathic Arthritis, sponsored by Institute of Child Health. Not yet recruiting at 1 site in United Kingdom. Open to participants aged 2 Years to 12 Years. Per ClinicalTrials.gov, last updated 2024-03-12.
Sponsored by Institute of Child Health · Not applicable, Interventional, and Screening
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.
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.
56 studies on the registry are indexed under Uveitis, Anterior; 9 are open to participants now.
This study's planned enrollment of 80 is above the median of 50 across 45 interventional studies indexed under Uveitis, Anterior.
Browse Uveitis, Anterior studies →Institute of Child Health is the lead sponsor of 40 studies on the registry; 4 are open to participants now.
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Exclusion Criteria:
Routine examination for uveitis with assessment of visual function followed by slit lamp examination
Diagnostic Test: Slit lamp examination
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
SLE of anterior chamber
Proportion of patients who meet the eligibility criteria
Feasibility data for larger scale study
Time frame: 18Months
Number of eligible patients recruited
Feasibility data for larger scale study
Time frame: 18Months
Proportion of patients that withdraw due to loss of consent or are lost to follow-up
Feasibility data for larger scale study
Time frame: 18Months
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)
Time frame: 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)
Time frame: 12Months
Visual analogue scoring (VAS) of examination procedures
Scale running from 0 - 100, with higher score meaning better experience as reported by child
Time frame: 12Months
New diagnoses
Number of new diagnoses of uveitis / Number of new diagnosis of other visual/ocular problems
Time frame: 12months
Plan to share: No — IPD shared only after dissemination of study findings and only on reasonable request
No publications or documents are linked to this record.
Start is estimated for May 2024; primary completion for Jul 2026, 26 months later.
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This study is not yet recruiting, as verified in Mar 2024. You cannot join it, but the record below documents what was studied.
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Institute of Child Health