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

ConditionUveitis
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age2-16
SponsorSheffield Children's NHS Foundation Trust

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

Unable to obtain parental/carer written consent

CYP does not want to be recruited

Trial population

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

Trial design

Design model

Cohort

Time perspective

Cross-sectional

Treatments tested in this trial

  • Slit Lamp Examination

    Diagnostic test

    Standard of care slit lamp examination for Uveitis.

  • Anterior segment ocular coherence tomography (ASOCT)

    Diagnostic test

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

Treatment groups

300 Participants
are divided into 1 treatment group
Group A: Patients attending uveitis clinic2 interventions

Trial outcomes

Primary outcomes

1

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).

Time frame
At time of enrolment visit
2

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).

Time frame
At time of enrolment visit.

Secondary outcomes

1

Demographic data

Age, biological sex, ethnicity, co-morbidities, ocular history, systemic history, ocular diagnosis, visual acuity, intraocular pressure, current and previous treatments including topical and systemic medication.

Time frame
At time of enrolment visit.
2

Iris colour

Iris colour as matched to a reference sheet.

Time frame
At time of enrolment visit.

Other outcomes

Sponsors and contacts

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