跳至主要内容
临床试验/NCT05691296
NCT05691296进行中(未招募)不适用

The Monitoring and Intervention of Refractive Changes in Children and Teenagers in Tianjin

Tianjin Eye Hospital1 个研究点 分布在 1 个国家目标入组 4,000 人开始时间: 2020年5月1日最近更新:
适应症

试验速览

阶段
不适用
状态
进行中(未招募)
入组人数
4,000
试验地点
1
主要终点
The changes of axial length

研究概览

简要总结

The study aimed to collect multi-factor information on school-age children with pre-clinical myopia, and to identify the initial factors and warning signs of myopia.

详细描述

The incidence of myopia is high in China. At present, the mechanism of myopia is unclear, and the main theories are genetic and environmental aspects. Many factors may affect the occurrence and development of myopia in students, such as ocular biological parameters, peripheral refractive state, differences in binocular vision function, eye habits, and outdoor time. In this study, the multi-factor information on pre-clinical myopia in school-age children was collected to find out the initial factors and warning signals of myopia.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Prevention
盲法
None

入排标准

年龄范围
5 Years 至 12 Years(Child)
性别
All
接受健康志愿者

入选标准

  • All students in grades 1 to 4
  • Can cooperate with the examination of students

排除标准

  • Obvious strabismus and amblyopia
  • Eye diseases that affect vision, such as congenital cataracts, glaucoma, and retinal diseases
  • History of ocular surgery

结局指标

主要结局

The changes of axial length

时间窗: Every 6 months, up to 3 years

The axial length was measured by a biological measuring instrument.

The rate of new-onset myopia

时间窗: Through study completion, an average of 1 year

The number of new children with myopia was counted

The changes of refractive error

时间窗: Every 6 months, up to 3 years

The changes of refractive error between visit time and baseline which was obtained with a computer refractometer.

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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