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Zhaoqing Myopia Study

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

Status
UNKNOWN
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT04219228
Enrollment
4000
Registered
2020-01-06
Start date
2019-12-14
Completion date
2023-02-02
Last updated
2020-03-17

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Myopia

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.

Interventions

Ophthalmic examinations include visual acuity, cover test and ocular dominance, noncycloplegic autorefraction, cycloplegia, ocular biometric measurements, cycloplegic auto-refraction, subjective refraction, and anterior and posterior segment examination.

DEVICEWearable devices

Physical activity, light intensity, and visual information will be measured with wearable devices.

Sponsors

Sun Yat-sen University
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
6 Years to 7 Years
Healthy volunteers
Yes

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.

Design outcomes

Primary

MeasureTime frameDescription
Incident myopia3 yearsIncident 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

MeasureTime frameDescription
Change in axial length1 year, 2 years, 3 yearsAxial length will be measured with a non-contact optical device.
Prevalence of amblyopia, strabismus and other ocular abnormalitiesbaselineCover-uncover tests will be performed to detect strabismus. Any ocular abnormalities, including corneal opacities, lens opacities, and retinal diseases will be recorded based on slit lamp, direct ophthalmoscopic and/or mobile phone video examination. Participants with an uncorrected visual acuity 6/7.5 or worse with undergo subjective refraction to identify amblyopia.
Area under the receiver operating characteristic curve of the deep learning algorithm for the prediction of incident myopia1 yearThe investigators will estimate the area under the receiver operating characteristic curve of the deep learning algorithm for the prediction of incident myopia.
Sensitivity and specificity of the deep learning algorithm for the prediction of incident myopia1 yearThe investigators will estimate sensitivity and specificity of the deep learning algorithm for the prediction of incident myopia.
Prevalence of myopiabaselineMyopia is defined as any eye's SER (sphere + 1/2 cylinder) of at least -0.5 diopters (D).
Sensitivity and specificity of the deep learning algorithm for the prediction of fast progressing myope1 yearThe investigators will estimate the sensitivity and specificity of the deep learning algorithm for the prediction of fast progressing myope (a change in SER of 0.75D or more per year). Cycloplegic spherical refraction changes measured by an auto-refractometer will be used as the indicator of myopia progression.
Area under the receiver operating characteristic curve of the diagnostic algorithm in identifying abnormal vision screening resultbaselineThe investigators will estimate the area under the receiver operating characteristic curve of the diagnostic algorithm in identifying abnormal vision screening result (e.g., abnormal eye lid, abnormal cornea, and strabismus detected with mobile devices).
Sensitivity and specificity of the diagnostic algorithm in identifying abnormal vision screening resultbaselineThe investigators will estimate the sensitivity and specificity of the diagnostic algorithm in identifying abnormal vision screening result (e.g., abnormal eye lid, abnormal cornea, and strabismus detected with mobile devices).
Post-vision screening referral uptake3 monthsAny referral uptake will be confirmed by telephone follow-up.
Area under the receiver operating characteristic curve of the deep learning algorithm for the prediction of fast progressing myope1 yearThe investigators will estimate the area under the receiver operating characteristic curve of the deep learning algorithm for the prediction of fast progressing myope (a change in SER of 0.75D or more per year).

Countries

China

Contacts

Primary ContactYingfeng Zheng, M.D. Ph.D.
zhyfeng@mail.sysu.edu.cn+8613922286455

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 14, 2026