Prospective Evaluation of a Smartphone Application, GoCheckKids TM, as a Screening Tool for Leukocoria in the Infant and Pediatric Population
试验速览
- 阶段
- 不适用
- 状态
- 撤回
- 入组人数
- 76
- 主要终点
- Reliability to detect leukocoria
研究概览
简要总结
Retinoblastoma is the most common pediatric eye malignancy and manifests between 1 and 5 years of age. The tumor is most often diagnosed by leukocoria ( white reflex in the pupil). There is often a significant delay in diagnosis and early diagnosis enables good life prognosis and better vision outcome.There is currently not a standardized screening protocol for detection of retinoblastoma. Vision screening methods are recommended for children 3-5 years of age. The investigators are attempting to use instrument based screening started from birth to detect leukocoria.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Diagnostic
- 盲法
- None
入排标准
- 年龄范围
- 0 Years 至 10 Years(Child)
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Age birth to 10 years
- •Informed consent given by parent or legal guardian
排除标准
- 未提供
结局指标
主要结局
Reliability to detect leukocoria
时间窗: 1 year
Testing the reliability of the app to detect leukocoria with good sensitivity and specificity
次要结局
未报告次要终点
