Early Vision Screening With Automated Photorefraction in Pre-term, Low-birth- Weight and Development-delay Children in Far-Eastern Memorial Hospital, Taiwan
试验速览
- 阶段
- 不适用
- 入组人数
- 200
- 试验地点
- 1
- 主要终点
- positive predictive value of vision screening
研究概览
简要总结
To evaluate the effect of early vision screening with automated photorefraction device in high risk children
详细描述
Pre-term, low-birth-weight, and development delay are well-known risk factors related to higher incidence of high refractive error and strabismus, which can potentially lead to amblyopia and is regarded as amblyopia risk factors. This project is a cross-sectional controlled study. Our study includes high-risk group and normal group. High-risk group includes children with birth history of pre-term, low-birth-weight and the diagnosis of development delay in FEMH. Normal group enrolled age-matched children without those risk factors. Vision screening by FDA-approved photorefraction device as well as comprehensive ophthalmic exams for definite diagnosis will be performed on the high-risk group and the normal group.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Control
- 时间视角
- Cross Sectional
入排标准
- 年龄范围
- 1 Year 至 2 Years（Child）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •High risk group: children with gestational age less than 36weeks, birth weight less than 2500g and children diagnosed as develop delay
- •Normal group: children with normal birth history and normal development
排除标准
- •Children with known ophthalmic diseases
- •Children with congenital systemic diseases
结局指标
主要结局
positive predictive value of vision screening
时间窗: one year
positive predictive value
次要结局
- Odds ratio of having amblyopia risk factors(one year)
研究者
Yao-Lin Liu
M.D.
Far Eastern Memorial Hospital