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NCT07813598

PANDA-ASOCT: Paediatric Anterior Uveitis Detection With Automated Image Analysis Using ASOCT

Sponsor: Sheffield Children's NHS Foundation Trust

View on ClinicalTrials.gov

Summary

Uveitis, an inflammation inside the eye. Although rare, it is an important auto-inflammatory eye condition that affect children and young people (CYP). If not identified and treated promptly, it can lead to permanent vision loss. Uveitis is estimated to affect around 4-5 in every 100,000 children, and up to 26% of those with childhood-onset disease may develop severe visual impairment. Because uveitis often causes no symptoms, even when it is advanced, it is sometimes described as a "silent blinding disease" Uveitis can occur on its own or together with other immune-related conditions. It is the most common non-joint (extra-articular) complication of Juvenile Idiopathic Arthritis (JIA), the most frequent childhood auto-inflammatory joint disorder, which affects about 5.6 per 100,000 children in the UK. National guidelines from the Royal Colleges recommend regular uveitis screening for all children and young people with JIA. This study aims to assess whether a high-resolution, non-irradiating eye imaging system can accurately detect inflammatory cells inside the eye objectively. The scan is non-invasive, non-contact, painless, and well tolerated by children. It can take 50,000 images per second, allowing the front of the eye to be captured in seconds. These images will be analysed using validated automated algorithms to identify and measure signals from inflammatory cells objectively, without influence of human factor. The qualitative and quantitative information may help predict disease activity and monitor treatment response. We aim to compare the imaging results with the current standard slit-lamp eye examination in 300 children and young people (600 eyes). Both the imaging operators and the senior clinical examiners will be not know what each other's findings. The primary aim is to determine how AS-OCT imaging system is in detecting uveitis in children and if the results is the same as the standard eye test. The measurement data will also support early-phase deep-learning development to create a cost-effective, automated tool for diagnosing, grading, and crucially monitoring uveitis over time, particularly during treatments that involve complex immunosuppressive medications.

Official title: An Observational Longitudinal Cohort Study on the Clinical Application of Anterior Segment Ocular Coherence Tomography (AS-OCT) as an Imaging Tool in Detecting, Grading and Monitoring Non-infectious Anterior Uveitis, in Age 2 to 16 Years Old, in a Single Regional Multi-disciplinary Paediatric Uveitis Service, Comparing With the Standard Slit Lamp Examination, and Development of Deep Learning in Automated Analysis

Key Details

Gender

All

Age Range

2 Years - 16 Years

Study Type

OBSERVATIONAL

Enrollment

300

Start Date

2026-09

Completion Date

2027-02

Last Updated

2026-09-10

Healthy Volunteers

No

Conditions

Interventions

DIAGNOSTIC_TEST

Slit Lamp Examination

Standard of care slit lamp examination for Uveitis.

DIAGNOSTIC_TEST

Anterior segment ocular coherence tomography (ASOCT)

ASOCT provides high-resolution cross-sectional imaging of the anterior chamber of the eye.

Locations (1)

Sheffield Children's Hospital

Sheffield, South Yorkshire, United Kingdom