NCT01706991已完成不适用
MEPEDS New Device Pediatric Vision Scanner
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 32
- 试验地点
- 1
- 主要终点
- Binocularity score
研究概览
简要总结
The purpose of this project is to compare the performance of the Pediatric Vision Scanner (PVS) with the Gold Standard Examination to determine the effectiveness of the PVS at detecting amblyopia and strabismus. All tests and observations will be done at a single visit over the course of approximately 30 minutes.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Control
- 时间视角
- Prospective
入排标准
- 年龄范围
- 6 Months 至 6 Years（Child）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Children aged 6 months to 6 years
- •Signed Informed consent by parent or guardian
- •Meet all inclusion criteria.
排除标准
- •Children with a history of developmental delay or cognitive deficit
- •Children unable to complete the GSE (including visual acuity testing)
结局指标
主要结局
Binocularity score
时间窗: Day 1
次要结局
- Presence of amblyopia risk factors(Day 1)
研究者
研究点 (1)
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