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Clinical Trials/NCT04219228
NCT04219228
Unknown
Not Applicable

A Prospective School-based Study of Myopia in Children in Southern China

Sun Yat-sen University2 sites in 1 country4,000 target enrollmentDecember 14, 2019
ConditionsMyopia

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Myopia
Sponsor
Sun Yat-sen University
Enrollment
4000
Locations
2
Primary Endpoint
Incident myopia
Last Updated
6 years ago

Overview

Brief Summary

Myopia is a common cause of vision loss, being particularly prevalent in children in East and Southeast Asia. The investigators will assess prevalence and incidence of myopia, identify digital biomarkers associated with myopia, and validate algorithms for the detection and/or predition of myopia and other ocular abnormalities in school-aged children in both urban and rural settings in Southern China.

Detailed Description

Myopia is a common cause of vision loss, being particularly prevalent in East and Southeast Asia. It is still not entirely clear whether and how visual experience in an urban environment with less outdoor exposure could have an impact on the development and progression of myopia. Zhaoqing has a relatively stable population of 4,084,600, which are representative of the Chinese population in term of demographic and socioeconomic characteristics. Therefore, the investigators will conduct a longitudinal cohort study in both urban and rural settings to examine prevalence and incidence of myopia, identify digital biomarkers associated with myopia, and validate algorithms for the detection and/or predition of incidence and progression of myopia and other ocular abnormalities in school-aged children in Zhaoqing.

Registry
clinicaltrials.gov
Start Date
December 14, 2019
End Date
February 2, 2023
Last Updated
6 years ago
Study Type
Observational
Sex
All

Investigators

Sponsor
Sun Yat-sen University
Responsible Party
Principal Investigator
Principal Investigator

Yingfeng Zheng

Clinical investigator

Sun Yat-sen University

Eligibility Criteria

Inclusion Criteria

  • All first-grade students from 10 primary schools in urban counties, and from 10 primary schools in rural counties, Zhaoqing city.

Exclusion Criteria

  • Not provided

Outcomes

Primary Outcomes

Incident myopia

Time Frame: 3 years

Incident myopia is defined as myopia detected during follow up among those without myopia at baseline. Myopia is defined as any eye's SER (sphere + 1/2 cylinder) of at least -0.5 diopters (D).

Secondary Outcomes

  • Prevalence of myopia(baseline)
  • Area under the receiver operating characteristic curve of the deep learning algorithm for the prediction of fast progressing myope(1 year)
  • Area under the receiver operating characteristic curve of the diagnostic algorithm in identifying abnormal vision screening result(baseline)
  • Change in axial length(1 year, 2 years, 3 years)
  • Sensitivity and specificity of the deep learning algorithm for the prediction of fast progressing myope(1 year)
  • Sensitivity and specificity of the diagnostic algorithm in identifying abnormal vision screening result(baseline)
  • Area under the receiver operating characteristic curve of the deep learning algorithm for the prediction of incident myopia(1 year)
  • Prevalence of amblyopia, strabismus and other ocular abnormalities(baseline)
  • Sensitivity and specificity of the deep learning algorithm for the prediction of incident myopia(1 year)
  • Post-vision screening referral uptake(3 months)

Study Sites (2)

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