跳至主要内容
临床试验/NCT03533647
NCT03533647Unknown不适用

A Longitudinal Study on the Development and Pathological Changes Among Children and Adolescents With High Myopia in China

Zhongshan Ophthalmic Center, Sun Yat-sen University1 个研究点 分布在 1 个国家目标入组 1,400 人开始时间: 2018年5月14日最近更新:
适应症

试验速览

阶段
不适用
入组人数
1,400
试验地点
1
主要终点
To observe the relationship between the changes of ocular structure parameters and pathological changes among children with high myopia.

研究概览

简要总结

The study aims to observe the relationship between the changes of ocular structure parameters and pathological changes among children and adolescents with high myopia. Environmental factors and family history will also be collected to explore their impacts on high myopia progression.

详细描述

This study aims to observe children and adolescents with high myopia for 3 years, and to collect data of ocular pathological changes, family history and environmental factors so as to understand the natural course and internal laws of the development of high myopia.

研究设计

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

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

  • 9 to 18 years old school students in Guangzhou, with either eye had myopia equal or greater than 6.0D
  • Or 6 to 8 years old school students in Guangzhou, with either eye had myopia equal or greater than 3.0D
  • Written informed consent for study participation
  • Be willing to cooperate with the relevant ophthalmological examination and complete the questionnaire.

排除标准

  • None school students in Guangzhou
  • Other contraindications
  • A history of allergy to tropicamide or topical anesthetics
  • Missing ability to give informed consent

结局指标

主要结局

To observe the relationship between the changes of ocular structure parameters and pathological changes among children with high myopia.

时间窗: examine every 12 months, follow up 3 years

examine the ocular pathological changes

次要结局

  • To explore the impact of environmental factors and genetic factors on the progression among children and adolescents with high myopia(examine every 12 months, follow up 3 years)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Yizhi Liu

Clinical Professor,director of Zhongshan Ophthalmic Center

Zhongshan Ophthalmic Center, Sun Yat-sen University

研究点 (1)

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