跳至主要内容
临床试验/NCT04344652
NCT04344652撤回不适用

Prospective Evaluation of a Smartphone Application, GoCheckKids TM, as a Screening Tool for Leukocoria in the Infant and Pediatric Population

Phoenix Children's Hospital0 个研究点目标入组 76 人开始时间: 2022年6月1日最近更新:
适应症

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

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

研究者

申办方类型
Other
责任方
Sponsor

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