跳至主要内容
临床试验/NCT05967702
NCT05967702已完成不适用

A 3-year Cross-sectional Assessment of the Tianjin Child and Adolescent Large-scale Eye Study

Tianjin Eye Hospital1 个研究点 分布在 1 个国家目标入组 126,810 人开始时间: 2019年7月1日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
126,810
试验地点
1
主要终点
Prevalence of high myopia

研究概览

简要总结

This is a school-based, cross-sectional study to assess the incidence and prevalence, risk factors of myopia among schoolchildren in both eye-use environment, eye-use habits, lifestyle, and family and subjective factors before and during COVID-19. Large population and representative study subjects. Environmental exposure and daily within and out-of-school activities will be evaluated in a random subgroup.

详细描述

Myopia is the most common refractive error and a major reason for reducing uncorrected visual acuity among schoolchildren. It was reported that during COVID-19, home confinement resulted in a significant increase in myopia due to the changed lifestyle of schoolchildren dramatically. However, it is unclear which kind of risk factors should be the first to bear the brunt before and during COVID-19. And which factors should be emphasized and confronted as the optimum strategy for myopia prevention and control? This cohort study aims to determine the risk factors, prevalence, and incidence of myopia, and SE changes among schoolchildren before and during COVID-19, hence identifying the factors that impact the onset and progression of myopia.

This is a 3-year cross-sectional study. This study plans to enroll 126,810 participants (aged 6-18 years) from Tianjin, China. All grade students from 10 regions of Tianjin City, China will be analyzed. Over a 3-year follow-up period, students will receive detailed eye examinations annually and complete questionnaires about eye-use environment, eye-use habits, lifestyle, and family and subjective factors. In a 5% random sample size of this cohort study, outdoor activity, light intensity, eye use habits, and eye use environment data will be obtained using objective measuring devices. Myopia was defined as spherical equivalent refractive (SER) of ≤ -0.5D.

研究设计

研究类型
Observational
观察模型
Case Only
时间视角
Cross Sectional

入排标准

年龄范围
6 Years 至 18 Years(Child, Adult)
性别
All
接受健康志愿者

入选标准

  • All 6-18 years students

排除标准

  • No eye diseases such as cataracts, glaucoma, keratoconus, etc.
  • No psychiatric disorders
  • Astigmatism ≤ -6.00D

结局指标

主要结局

Prevalence of high myopia

时间窗: One day measurement

High myopia was defined as an equivalent spherical refraction ≤ -6.00D in either eye

Prevalence of myopia

时间窗: One day measurement

Myopia was defined as an equivalent spherical refraction ≤ -0.50D in either eye

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)

Loading locations...

相似试验