Validation of the Eye Screeningtest GoCheckKids (GCK) for the Detection of Amblyopia Risk Factors in Toddlers in Flanders.
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 460
- 试验地点
- 1
- 主要终点
- Negative predictive value
研究概览
简要总结
The aim is to validate the new GoCheck Kids application as automatic eye screener for preschool children (<3 years of age) at 'Child and Family' agency. Sensitivity, specificity, positive and negative predictive value of the GoCheck Kids screening tool are the endpoints of this study.
详细描述
Comparison of the results of the GoCheck Kids application on iPhone with a complete eye examination (gold standard) including cycloplegic refraction with retinoscopy, performed by an ophthalmologist.
研究设计
- 研究类型
- Observational
- 观察模型
- Other
- 时间视角
- Prospective
入排标准
- 年龄范围
- 11 Months 至 16 Months（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •GoCheck Kids (GCK) evaluation at Child and Family Agency at the age between 11-16 months.
排除标准
- •Allergy for the used cycloplegia cyclopentolate 0.5%.
- •Any history of ocular surgery
- •The time window between GCK measurement and the complete eye examination may not exceed 2 months.
- •The parents or legal representatives of the child do not understand or speak Dutch, French or English.
结局指标
主要结局
Negative predictive value
时间窗: Day 1
Negative predictive value of GCK eye screener
Sensitivity
时间窗: Day 1
Sensitivity of GCK eye screener
Specificity
时间窗: Day 1
Specificity of GCK eye screener
Positive predictive value
时间窗: Day 1
Positive predictive value of GCK eye screener
次要结局
未报告次要终点