Elucidating Perifoveal Vasculature Development in Infants
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 16
- 试验地点
- 2
- 主要终点
- Change in vascular density of intermediate and deep vascular plexus at the fovea and perifovea
研究概览
简要总结
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.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- — 至 2 Months（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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)
结局指标
主要结局
Change in vascular density of intermediate and deep vascular plexus at the fovea and perifovea
时间窗: During hospitalization (at approximately 32-44 weeks post menstrual age, PMA)
Measured by retinal OCTA imaging.
次要结局
- Change in vascular density of superficial vascular plexus at the fovea and perifovea(During hospitalization (at approximately 32-44 weeks post menstrual age, PMA))
- Change in avascular zone size of superficial, intermediate and deep vascular plexus(During hospitalization (at approximately 32-44 weeks post menstrual age, PMA))
- Change in network length of intermediate and deep vascular plexus(During hospitalization (at approximately 32-44 weeks post menstrual age, PMA))