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Clinical Trials/NCT03533647
NCT03533647
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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 site in 1 country1,400 target enrollmentMay 14, 2018
ConditionsHigh Myopia

Overview

Phase
N/A
Intervention
Not specified
Conditions
High Myopia
Sponsor
Zhongshan Ophthalmic Center, Sun Yat-sen University
Enrollment
1400
Locations
1
Primary Endpoint
To observe the relationship between the changes of ocular structure parameters and pathological changes among children with high myopia.
Last Updated
7 years ago

Overview

Brief Summary

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.

Detailed Description

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.

Registry
clinicaltrials.gov
Start Date
May 14, 2018
End Date
May 31, 2021
Last Updated
7 years ago
Study Type
Observational
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Yizhi Liu

Clinical Professor,director of Zhongshan Ophthalmic Center

Zhongshan Ophthalmic Center, Sun Yat-sen University

Eligibility Criteria

Inclusion Criteria

  • 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.

Exclusion Criteria

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

Outcomes

Primary Outcomes

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

Time Frame: examine every 12 months, follow up 3 years

examine the ocular pathological changes

Secondary Outcomes

  • 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)

Study Sites (1)

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