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

10. september 2026 oppdatert av: Sheffield Children's NHS Foundation Trust

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

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.

Studieoversikt

Status

Rekruttering

Forhold

Intervensjon / Behandling

Detaljert beskrivelse

Uveitis, an inflammation inside the eye, is a rare auto-inflammatory eye condition in children and young people (CYP). It is a potentially blinding disorder if left untreated. Uveitis is a preventable blindness in CYP, estimated 4-5 per 100,000 children developing it. Blindness was reported in 26% of childhood onset uveitis. Children with uveitis do not always have symptoms, even in the most severe end-stage, and often labelled as 'silent blinding disease'. Uveitis can occur in association with systemic auto-immune disorder and is the main extra-articular manifestation of juvenile idiopathic arthritis (JIA). JIA is the most common auto-inflammatory joints disease in children, affecting 5.6 per 100,000 children in the United Kingdom. Guidelines published by the Royal Colleges recommend uveitis screening for all CYP with JIA. This study aims to evaluate the clinical application of a high-resolution non-irradiating imaging system to detect inflammatory cells inside the eye. The camera is non-invasive, non-contact and well tolerated in children. It has a scan-speed of 50,000 images per second. The entire front of the eye can be scanned in 1.2 seconds. The images will be analysed using an appropriately calibrated automated algorithms to detect signals from inflammatory cells objectively. The qualitative and quantitative measurements can be used to predict disease and monitor treatment response. The imaging data will be compared with current standard eye examination in 300 children (600 eyes), masking both the scanner operators and the senior examiners in clinics. The primary objective is to assess sensitivity of the automated imaging system in detecting and predicting uveitis in children. The quantification data will contribute to early phase of deep learning in developing a cost-effective automated diagnostic tool in detecting, grading and most importantly monitoring of uveitis objectively during treatment(s) which often involve complex immunosuppressive agents.

Studietype

Observasjonsmessig

Registrering (Antatt)

300

Kontakter og plasseringer

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Studiekontakt

Studiesteder

  • Storbritannia
    • South Yorkshire
      • Sheffield, South Yorkshire, Storbritannia, S10 2TH
        • Rekruttering
        • Sheffield Children's Hospital
        • Ta kontakt med:

Deltakelseskriterier

Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.

Kvalifikasjonskriterier

Alder som er kvalifisert for studier

  • Barn

Tar imot friske frivillige

Nei

Prøvetakingsmetode

Ikke-sannsynlighetsprøve

Studiepopulasjon

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

Beskrivelse

Inclusion Criteria:

  • 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

Exclusion Criteria:

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

Studieplan

Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.

Hvordan er studiet utformet?

Designdetaljer

Kohorter og intervensjoner

Gruppe / Kohort
Intervensjon / Behandling
Patients attending uveitis clinic
Patients attending uveitis screening clinic, or those attending Jeuvenile Ideopathic Arthritis Uveitis screening clinic.
Diagnostisk test: Slit Lamp Examination
Standard of care slit lamp examination for Uveitis.
Diagnostisk test: Anterior segment ocular coherence tomography (ASOCT)
ASOCT provides high-resolution cross-sectional imaging of the anterior chamber of the eye.

Hva måler studien?

Primære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
Index test (ASOCT) images
Tidsramme: At time of enrolment visit
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)
Tidsramme: At time of enrolment visit.
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.

Sekundære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
Demographic data
Tidsramme: At time of enrolment visit.
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.
At time of enrolment visit.
Iris colour
Tidsramme: At time of enrolment visit.
Iris colour as matched to a reference sheet.
At time of enrolment visit.

Samarbeidspartnere og etterforskere

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Sponsor

Sheffield Children's NHS Foundation Trust

Studierekorddatoer

Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.

Studer hoveddatoer

Studiestart (Faktiske)

9. september 2026

Primær fullføring (Antatt)

1. februar 2027

Studiet fullført (Antatt)

1. februar 2027

Datoer for studieregistrering

Først innsendt

4. september 2026

Først innsendt som oppfylte QC-kriteriene

4. september 2026

Først lagt ut (Faktiske)

10. september 2026

Oppdateringer av studieposter

Sist oppdatering lagt ut (Faktiske)

15. september 2026

Siste oppdatering sendt inn som oppfylte QC-kriteriene

10. september 2026

Sist bekreftet

1. september 2026

Mer informasjon

Begreper knyttet til denne studien

Nøkkelord

Ytterligere relevante MeSH-vilkår

Andre studie-ID-numre

  • SCH-2925
  • 351221 (Annen identifikator: IRAS Number)

Plan for individuelle deltakerdata (IPD)

Planlegger du å dele individuelle deltakerdata (IPD)?

NEI

Legemiddel- og utstyrsinformasjon, studiedokumenter

Studerer et amerikansk FDA-regulert medikamentprodukt

Nei

Studerer et amerikansk FDA-regulert enhetsprodukt

Nei

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