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临床试验/NCT05984758
NCT05984758尚未招募不适用

A Randomised Feasibility Study of Imaging Based Uveitis Screening for Children With Juvenile Idiopathic Arthritis

Institute of Child Health1 个研究点 分布在 1 个国家目标入组 80 人开始时间: 2024年5月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
尚未招募
入组人数
80
试验地点
1
主要终点
Number of eligible patients recruited

研究概览

简要总结

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.

详细描述

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.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Screening
盲法
None

入排标准

年龄范围
2 Years 至 12 Years(Child)
性别
All
接受健康志愿者
否

入选标准

  • •Patients newly diagnosed (within preceding 12 months) with JIA who are eligible for uveitis surveillance
  • •Aged 2-12 years

排除标准

  • •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

研究组 & 干预措施

Standard care

Active Comparator

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

干预措施: Slit lamp examination (Diagnostic Test)

ASOCT imaging

Experimental

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

干预措施: AS-OCT imaging (Diagnostic Test)

结局指标

主要结局

Number of eligible patients recruited

时间窗: 18Months

Feasibility data for larger scale study

Proportion of patients that withdraw due to loss of consent or are lost to follow-up

时间窗: 18Months

Feasibility data for larger scale study

Proportion of patients who meet the eligibility criteria

时间窗: 18Months

Feasibility data for larger scale study

次要结局

  • Visual analogue scoring (VAS) of examination procedures(12Months)
  • Success(12Months)
  • Pediatric quality of life inventory (PedsQL) child self-report(12Months)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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