Clinical trial NCT04219228: Zhaoqing Myopia Study
Official title: A Prospective School-based Study of Myopia in Children in Southern China
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Myopia
Lead sponsor: Sun Yat-sen University
Sponsor class: OTHER
First posted: 2020-01-06
Enrollment: 4000
Sex: ALL
Minimum age (years): 6
Maximum age (years): 7
Standard ages: CHILD
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: All first-grade students from 10 primary schools in urban counties, and from 10 primary schools in rural counties, Zhaoqing city.

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.

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:

* No.

Primary outcomes:
measure: Incident myopia
timeFrame: 3 years
Secondary outcomes:
measure: Prevalence of myopia
timeFrame: baseline
measure: Change in axial length
timeFrame: 1 year, 2 years, 3 years
measure: Prevalence of amblyopia, strabismus and other ocular abnormalities
timeFrame: baseline
measure: Area under the receiver operating characteristic curve of the deep learning algorithm for the prediction of incident myopia
timeFrame: 1 year
measure: Sensitivity and specificity of the deep learning algorithm for the prediction of incident myopia
timeFrame: 1 year
measure: Area under the receiver operating characteristic curve of the deep learning algorithm for the prediction of fast progressing myope
timeFrame: 1 year
measure: Sensitivity and specificity of the deep learning algorithm for the prediction of fast progressing myope
timeFrame: 1 year
measure: Area under the receiver operating characteristic curve of the diagnostic algorithm in identifying abnormal vision screening result
timeFrame: baseline
measure: Sensitivity and specificity of the diagnostic algorithm in identifying abnormal vision screening result
timeFrame: baseline
measure: Post-vision screening referral uptake
timeFrame: 3 months
Other outcomes:
Locations:
city: Guangzhou
country: China
facility: Zhognshan Ophthalmic Center, Sun Yat-sen University
state: Guangdong
city: Zhaoqing
country: China
facility: Schools
state: Guangdong
Study officials:
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