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

2026년 9월 10일 업데이트: 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.

연구 개요

상세 설명

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.

연구 유형

관찰

등록 (추정된)

300

연락처 및 위치

이 섹션에서는 연구를 수행하는 사람들의 연락처 정보와 이 연구가 수행되는 장소에 대한 정보를 제공합니다.

연구 연락처

연구 장소

    • South Yorkshire
      • Sheffield, South Yorkshire, 영국, S10 2TH
        • 모병
        • Sheffield Children's Hospital
        • 연락하다:

참여기준

연구원은 적격성 기준이라는 특정 설명에 맞는 사람을 찾습니다. 이러한 기준의 몇 가지 예는 개인의 일반적인 건강 상태 또는 이전 치료입니다.

자격 기준

공부할 수 있는 나이

  • 어린이

건강한 자원 봉사자를 받아들입니다

아니

샘플링 방법

비확률 샘플

연구 인구

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

설명

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

공부 계획

이 섹션에서는 연구 설계 방법과 연구가 측정하는 내용을 포함하여 연구 계획에 대한 세부 정보를 제공합니다.

연구는 어떻게 설계됩니까?

디자인 세부사항

코호트 및 개입

그룹/코호트
개입 / 치료
Patients attending uveitis clinic
Patients attending uveitis screening clinic, or those attending Jeuvenile Ideopathic Arthritis Uveitis screening clinic.
Standard of care slit lamp examination for Uveitis.
ASOCT provides high-resolution cross-sectional imaging of the anterior chamber of the eye.

연구는 무엇을 측정합니까?

주요 결과 측정

결과 측정
측정값 설명
기간
Index test (ASOCT) images
기간: 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)
기간: 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.

2차 결과 측정

결과 측정
측정값 설명
기간
Demographic data
기간: 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
기간: At time of enrolment visit.
Iris colour as matched to a reference sheet.
At time of enrolment visit.

공동 작업자 및 조사자

여기에서 이 연구와 관련된 사람과 조직을 찾을 수 있습니다.

연구 기록 날짜

이 날짜는 ClinicalTrials.gov에 대한 연구 기록 및 요약 결과 제출의 진행 상황을 추적합니다. 연구 기록 및 보고된 결과는 공개 웹사이트에 게시되기 전에 특정 품질 관리 기준을 충족하는지 확인하기 위해 국립 의학 도서관(NLM)에서 검토합니다.

연구 주요 날짜

연구 시작 (실제)

2026년 9월 9일

기본 완료 (추정된)

2027년 2월 1일

연구 완료 (추정된)

2027년 2월 1일

연구 등록 날짜

최초 제출

2026년 9월 4일

QC 기준을 충족하는 최초 제출

2026년 9월 4일

처음 게시됨 (실제)

2026년 9월 10일

연구 기록 업데이트

마지막 업데이트 게시됨 (실제)

2026년 9월 15일

QC 기준을 충족하는 마지막 업데이트 제출

2026년 9월 10일

마지막으로 확인됨

2026년 9월 1일

추가 정보

이 연구와 관련된 용어

기타 연구 ID 번호

  • SCH-2925
  • 351221 (기타 식별자: IRAS Number)

개별 참가자 데이터(IPD) 계획

개별 참가자 데이터(IPD)를 공유할 계획입니까?

아니요

약물 및 장치 정보, 연구 문서

미국 FDA 규제 의약품 연구

아니

미국 FDA 규제 기기 제품 연구

아니

이 정보는 변경 없이 clinicaltrials.gov 웹사이트에서 직접 가져온 것입니다. 귀하의 연구 세부 정보를 변경, 제거 또는 업데이트하도록 요청하는 경우 register@clinicaltrials.gov. 문의하십시오. 변경 사항이 clinicaltrials.gov에 구현되는 즉시 저희 웹사이트에도 자동으로 업데이트됩니다. .

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