跳至主要内容
临床试验/NCT03479021
NCT03479021Unknown不适用

Accuracy of Welch Allyn Spot™ Vision Screener to Detect Amblyogenic Factors in Developmentally Delayed Children

Children's Hospital Colorado1 个研究点 分布在 1 个国家目标入组 100 人开始时间: 2017年5月11日最近更新:
适应症

试验速览

阶段
不适用
入组人数
100
试验地点
1
主要终点
the SPOT will be effective in screening for amblyogenic risk factors

研究概览

简要总结

The purpose of this protocol is to determine if the Welch-Allyn Spot Vision Screener (SPOT) is effective at detecting various risk factors for poor vision in developmentally delayed children. These children have a higher percentage of vision disorders than the average population. The SPOT screen itself takes about six seconds to complete. It produces a photograph of the eye and a print out with amount of hyperopia, myopia, astigmatism and pupil size. The subject will have three SPOT screens around the time of their standard of care eye exam. The data obtained from the three SPOT screens will be compared among themselves for accuracy and to the findings of the clinical eye exam.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

入排标准

年龄范围
4 Years 至 17 Years(Child)
性别
All
接受健康志愿者

入选标准

  • child over 4 months of age social, behavioral, physical, or other handicap unable to complete age-appropriate vision screening

排除标准

  • glaucoma post intraocular surgery microphthalmia other serious eye disorder inability to complete SPOT screener

结局指标

主要结局

the SPOT will be effective in screening for amblyogenic risk factors

时间窗: 12 months

the Spot has a sensitivity, specificity, positive predictive value (PPV) and negative predictive value (NPV) necessary to appropriately perform visual triage in developmentally delayed children

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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