Imaging Based Uveitis Screening for Children With Juvenile Idiopathic Arthritis
Ориентир для пациента и семьи
Простыми словами
Автоматическая сводка по структурированным данным реестра. Она помогает сориентироваться, но не заменяет официальный протокол или оценку врача.
- Что изучают
- В протоколе указаны: AS-OCT imaging, Slit lamp examination.
- Кому может быть актуально
- Состояния в реестре: Uveitis, Anterior, Juvenile Idiopathic Arthritis. Базовые параметры: 2 лет — 12 лет · Все.
- Что важно проверить
- Возраст, диагноз и пол — только базовые ориентиры. Предыдущее лечение, анализы и другие обязательные условия указаны ниже в критериях участия.
- Где проводится
- Великобритания
- Следующий шаг
- Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →
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Официальное название
A Randomised Feasibility Study of Imaging Based Uveitis Screening for Children With Juvenile Idiopathic Arthritis
Обзор
This study seeks to describe, for children undergoing uveitis surveillance following a new diagnosis of juvenile idiopathic arthritis, the feasibility metrics of undertaking a randomised comparative study of routine slit lamp examination (SLE) versus imaging based (anterior segment optical coherence tomography, OCT) surveillance in order to inform the development of a larger multi-centre trial.
Подробное описание
This study will compare imaging-based surveillance to routine clinical surveillance for uveitis in children with juvenile idiopathic arthritis (JIA) in order to support the design of a future study.
Childhood uveitis is a rare inflammatory eye disease. Half of all children with uveitis also have a joint disorder: juvenile idiopathic arthritis (or JIA). Children with JIA must travel to a specialist centre every three months to have eye examinations in an attempt to pick uveitis up early enough to prevent visual loss.
Optical coherence tomography (OCT) is a non-contact non-irradiating imaging modality. The investigators have recently demonstrated that novel application of OCT for uveitis detection in children is feasible, acceptable to families, repeatable, sensitive, and specific. The investigators have also found that families welcome the objectivity of imaging-based diagnosis. Standardised operating protocols for image acquisition and analysis have been developed across three imaging platforms (Optovue, Casia and Heidelberg OCT machines).
The investigators will be undertaking a feasibility study which compares routine clinical examination based uveitis surveillance to imaging based surveillance in order to provide the necessary information to address this issue in a larger scale clinical trial of clinical and cost-effectiveness, and explore issues around the impact of objective disease metrics on family perceptions of disease and treatment, as well as the perceptions of children, families and clinical staff on the use of automated diagnostic tools.
Вмешательства
- Диагностический тест AS-OCT imaging
Image acquisition with the Optovue RTVue OCT and the Heidelberg Spectralis OCT2 machines - Диагностический тест Slit lamp examination
SLE of anterior chamber
Первичные конечные точки
- Proportion of patients who meet the eligibility criteria [Срок оценки: 18Months]
- Number of eligible patients recruited [Срок оценки: 18Months]
- Proportion of patients that withdraw due to loss of consent or are lost to follow-up [Срок оценки: 18Months]
Вторичные конечные точки (3)
- Success [Срок оценки: 12Months]
- Pediatric quality of life inventory (PedsQL) child self-report [Срок оценки: 12Months]
- Visual analogue scoring (VAS) of examination procedures [Срок оценки: 12Months]
Критерии участия
Критерии включения
- Patients newly diagnosed (within preceding 12 months) with JIA who are eligible for uveitis surveillance
- Aged 2-12 years
Критерии исключения
- A previous / existing diagnosis of uveitis
- Any co-existing ocular or neurological abnormality which impacts on current corrected visual function, or could impact on future corrected visual function
- Developmental/learning difficulties that preclude concordance with examination / informed assent
Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.
Здоровые добровольцы: Нет
Дизайн исследования
- Распределение
- Рандомизированное
- Модель
- Параллельные группы
- Маскирование
- Открытое
- Основная цель
- Скрининг
Центры проведения
Великобритания · 1 центр
- Great Ormond Street Hospital — London
Публикации
- Dave S, Rahi JS, Petrushkin H, Testi I, Patel DE, Solebo AL. UVESCREEN1: A randomised feasibility study of imaging-based uveitis screening for children with juvenile idiopathic arthritis- Study Protocol. PLoS One. 2025 Feb 12;20(2):e0316410. doi: 10.1371/journal.pone.0316410. eCollection 2025. PMID 39937818
Идентификаторы
NCT: NCT05984758 · 21PL04 · IRAS