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临床试验/NCT06148519
NCT06148519终止不适用

Comparing Preschool-Aged Refractive Measurements and Amblyopia Risks Using the 2WIN-S Portable Refractor with Vision Screening by Cycloplegic Refraction in Bangkok

Rajavithi Hospital2 个研究点 分布在 1 个国家目标入组 250 人开始时间: 2023年8月23日最近更新:
适应症

试验速览

阶段
不适用
状态
终止
入组人数
250
试验地点
2
主要终点
Significant refractive errors defined by AAPOS

研究概览

简要总结

The goal of this diagnostic test is to compare the results of refraction and amblyopia risks between using 2WIN-S portable refractor and cycloplegic refraction in pre-school age.

All participants will be tested by 2WIN-S portable refractor.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Screening
盲法
None

入排标准

年龄范围
3 Years 至 6 Years(Child)
性别
All
接受健康志愿者

入选标准

  • corrected visual acuity 0.1 logMAR (Snellen 20/25) or better
  • Age 3-6 years old who studies in the kindergarten school that joins the study
  • Parents sign informed consent form about allowing their child to join the study

排除标准

  • other eye conditions causing visual and 2WIN-S portable refractor working disturbance such as media opacity, history of ocular surgery, strabismus, etc.

结局指标

主要结局

Significant refractive errors defined by AAPOS

时间窗: At baseline.

Measuring spherical equivalent(SE) and cylinder(Cy), and axis to detect specific target levels of ARFs and visually significant refractive errors, as defined by AAPOS.

次要结局

  • Diagnostic accuracy for Amblyopia(At baseline.)

研究者

申办方类型
Other Gov
责任方
Sponsor

研究点 (2)

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