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

NCT07813598 | Recruiting

• 2 other identifiers: SCH-2925351221
• Study Type: observational
• Target: 300
• Locations: 1 country
• Sites: 1

Brief Summary

Uveitis is 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.

Conditions

Uveitis

Keywords

ASOCT; Uveitis; Ophthalmology

Outcome Measures

Primary Outcomes (2)

• Index test (ASOCT) images

  The ASOCT device will be used to image the eyes of the patient. Pseudo-anonymised cross-sectional scans will be analysed using application Image J (National Institutes of Health, United States).

  At time of enrolment visit

• Reference Test (slit lamp examination)

  The slit-lamp is the standard clinical examination with a bright light beam of 1x1mm, at high magnification by the ophthalmologists and screening optometrists. The number of visible cellular dots in the anterior chamber will be scored according to the international standard SUN criteria, as 0, ½+ (1-5 cells), 1+ (6-15 cells), 2+ (16-25 cells), 3+ (26-50 cells) and 4+ (\> 50 cells).

  At time of enrolment visit.

Secondary Outcomes (2)

• Demographic data

  At time of enrolment visit.

• Iris colour

  At time of enrolment visit.

Study Arms (1)

Patients attending uveitis clinic

Patients attending uveitis screening clinic, or those attending Jeuvenile Ideopathic Arthritis Uveitis screening clinic.

Diagnostic Test: Slit Lamp Examination; Diagnostic Test: Anterior segment ocular coherence tomography (ASOCT)

Interventions

Anterior segment ocular coherence tomography (ASOCT) DIAGNOSTIC_TEST

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

Patients attending uveitis clinic

Slit Lamp Examination DIAGNOSTIC_TEST

Standard of care slit lamp examination for Uveitis.

Patients attending uveitis clinic

Eligibility Criteria

• Age: 2 Years - 16 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)
• Sampling Method: Non-Probability Sample

Study Population

Paediatric patients at Sheffield Children's Hospital, who have been referred to the clinics for uveitis and JIA-uveitis.

You may qualify if:

• Aged between 2 and 16 years
• Attending uveitis and JIA-uveitis clinic at Sheffield Children's Hospital
• Parents/carers give informed written consent and CYP give age-appropriate assent

You may not qualify if:

• Unable to obtain parental/carer written consent
• CYP does not want to be recruited

Sponsors & Collaborators

• Sheffield Children's NHS Foundation Trust: lead

Study Sites (1)

Sheffield Children's Hospital

Sheffield, South Yorkshire, S10 2TH, United Kingdom

RECRUITING

MeSH Terms

Conditions

Uveitis

Interventions

Slit Lamp Microscopy

Condition Hierarchy (Ancestors)

Uveal Diseases; Eye Diseases

Intervention Hierarchy (Ancestors)

Diagnostic Techniques, Ophthalmological; Diagnostic Techniques and Procedures; Diagnosis

Central Study Contacts

Research and Development Manager

CONTACT

01142260748; research.sheffchild@nhs.net

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 4, 2026
• First Posted: September 10, 2026
• Study Start: September 9, 2026
• Primary Completion (Estimated): February 1, 2027
• Study Completion (Estimated): February 1, 2027
• Last Updated: September 15, 2026

Record last verified: 2026-09

Data Sharing

• IPD Sharing: Will not share

Locations

GB (1)