- ICH GCP
- 미국 임상 시험 레지스트리
- 임상시험 NCT07813598
PANDA-ASOCT: Paediatric Anterior Uveitis Detection With Automated Image Analysis Using ASOCT (PANDA)
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
상태
정황
상세 설명
연구 유형
등록 (추정된)
연락처 및 위치
연구 연락처
- 이름: Research and Development Manager
- 전화번호: 01142260748
- 이메일: research.sheffchild@nhs.net
연구 장소
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South Yorkshire
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Sheffield, South Yorkshire, 영국, S10 2TH
- 모병
- Sheffield Children's Hospital
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연락하다:
- Research and Development Manager
- 전화번호: 01142260748
- 이메일: research.sheffchild@nhs.net
-
-
참여기준
자격 기준
공부할 수 있는 나이
- 어린이
건강한 자원 봉사자를 받아들입니다
샘플링 방법
연구 인구
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
연구는 어떻게 설계됩니까?
디자인 세부사항
코호트 및 개입
그룹/코호트 |
개입 / 치료 |
|---|---|
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Patients attending uveitis clinic
Patients attending uveitis screening clinic, or those attending Jeuvenile Ideopathic Arthritis Uveitis screening clinic.
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Standard of care slit lamp examination for Uveitis.
ASOCT provides high-resolution cross-sectional imaging of the anterior chamber of the eye.
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연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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Index test (ASOCT) images
기간: At time of enrolment visit
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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).
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At time of enrolment visit
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Reference Test (slit lamp examination)
기간: At time of enrolment visit.
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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).
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At time of enrolment visit.
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2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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Demographic data
기간: At time of enrolment visit.
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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.
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At time of enrolment visit.
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Iris colour
기간: At time of enrolment visit.
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Iris colour as matched to a reference sheet.
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At time of enrolment visit.
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공동 작업자 및 조사자
연구 기록 날짜
연구 주요 날짜
연구 시작 (실제)
기본 완료 (추정된)
연구 완료 (추정된)
연구 등록 날짜
최초 제출
QC 기준을 충족하는 최초 제출
처음 게시됨 (실제)
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
QC 기준을 충족하는 마지막 업데이트 제출
마지막으로 확인됨
추가 정보
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. .