UVESCREEN1: A randomised feasibility study of imaging-based uveitis screening for children with juvenile idiopathic arthritis- Study Protocol
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Children with Juvenile Idiopathic Arthritis (JIA) are at a currently unpredictable risk of a blinding, often asymptomatic, co-existent eye disorder, anterior uveitis which requires prompt treatment. The unpredictability of this insidious disorder commits children with JIA to three-monthly expert clinical examination in specialist eye centres often located far from their homes. Optical coherence tomography of the ocular anterior segment (AS-OCT) has been shown to be an acceptable, repeatable and sensitive modality for uveitis detection, but is not standard care. This feasibility randomised controlled trial (RCT) aims to inform a future full-scale RCT comparing current routine practice (expert slit lamp examination, SLE) to AS-OCT for the surveillance of uveitis in children at risk.
Eighty children aged between 2 and 12 years old and diagnosed with JIA within the preceding year will be included. Participants with an existing diagnosis of uveitis, other ocular co-morbidities or those unable to complete examinations or provide informed assent will be excluded. Participants will be randomised to SLE (control) or AS-OCT (intervention) examination at a frequency consistent with the current national programme for childhood uveitis surveillance. Children in the intervention arm will also have standard examination at 6 and 12 months after study entrance. Outcomes of interest will be feasibility (recruitment and attrition rates), clinical metrics (proportion diagnosed with uveitis or other ocular disorders at 12 months after study entrance), quality of life outcomes (PedsQL), and resource use. Additionally, comparative analysis of AS-OCT versus SLE (‘gold standard’ reference testing) findings at 6 and 12 months for those in the intervention arm will provide the proof-of-concept data necessary to develop and undertake a larger scale trial.
Trial registration: This trial has been registered with clinicaltrails.gov ( NCT05984758 ).
Summary
Anterior uveitis is a rare form of eye disease that is commonly associated with Juvenile Idiopathic Arthritis (JIA). Childhood uveitis is potentially blinding, so children with JIA must travel to a specialist centre every two to three months for an eye examination to pick up signs of uveitis. This feasibility study will compare routine Slit Lamp Examination (SLE) with imaging-based surveillance using Optical Coherence Tomography of the Anterior Segment (AS-OCT) to support the design of a future study. Eighty children between the ages of two and twelve years old who have been diagnosed with JIA in the past year will be invited to take part. Children will be randomised into one of two arms (SLE or AS-OCT) and will have their routine uveitis screening appointments over one year using either of the screening modalities. This study will provide the proof-of-concept data necessary to develop and undertake a larger scale trial.
