Imaging Retinal Vasculature in Infant Eyes
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: Handheld Optical Coherence Tomography with OCT Angiography.
- Кому может быть актуально
- Состояния в реестре: Retinopathy of Prematurity. Базовые параметры: до 2 мес. · 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
- США
- Следующий шаг
- Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →
Не всё понятно в терминах? Прочитайте наш гид для пациентов →
Официальное название
Elucidating Perifoveal Vasculature Development in Infants
Обзор
Retinopathy of prematurity is a leading cause of childhood blindness worldwide. The fovea, a critical location in the retina determining visual acuity and visual function, and the blood vessels around it, are abnormally developed in infants with retinopathy of prematurity. However, how these blood vessels form during development of the human fovea remains unclear. This research will advance our understanding of the fundamental knowledge of how the blood vessels around the fovea form in infants, and how they change in diseased states such as preterm birth or retinopathy of prematurity.
Вмешательства
- Устройство Handheld Optical Coherence Tomography with OCT Angiography
OCT systems are in vivo optical imaging technology that allows non-contact imaging of early-stage ocular pathology. They create real-time, non-invasive images of ocular microstructure and have become standard-of-care instruments in ophthalmic imaging in clinics and operating rooms. In contrast to the visible light used in clinical eye examinations, because infrared light is not visible, the participant is not disturbed by the light. OCT imaging allows the capture of hundreds of B-scan (cross-sec
Первичные конечные точки
- Change in vascular density of intermediate and deep vascular plexus at the fovea and perifovea [Срок оценки: During hospitalization (at approximately 32-44 weeks post menstrual age, PMA)]
Вторичные конечные точки (3)
- Change in vascular density of superficial vascular plexus at the fovea and perifovea [Срок оценки: During hospitalization (at approximately 32-44 weeks post menstrual age, PMA)]
- Change in avascular zone size of superficial, intermediate and deep vascular plexus [Срок оценки: During hospitalization (at approximately 32-44 weeks post menstrual age, PMA)]
- Change in network length of intermediate and deep vascular plexus [Срок оценки: During hospitalization (at approximately 32-44 weeks post menstrual age, PMA)]
Критерии участия
Критерии включения
- Health care provider, knowledgeable of protocol, agrees that study personnel could contact the Parent/Legal guardian
- Parent/Legal Guardian is able and willing to consent to study participation for the infant
- Infant meets the American Association of Pediatrics eligibility of ROP screening, and is age less than 34 6/7 weeks postmenstrual age at first visit
Критерии исключения
- Participant or Parent/Legal Guardian unwilling or unable to provide consent
- Infant has a health or eye condition that preclude eye examination or retinal imaging (e.g. corneal opacity such as with Peter's anomaly or cataract)
- Infant has a health condition, other than prematurity, that has a profound impact on brain development (e.g. anencephaly)
Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.
Здоровые добровольцы: Нет
Дизайн исследования
- Модель наблюдения
- Когортное
Центры проведения
США · 2 центра
- Duke University — Durham
- University of Pennsylvania — Philadelphia
Идентификаторы
NCT: NCT05558059 · Pro00111105 · 1R01EY03413401