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Zhaoqing Myopia Study

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ClinicalTrials.gov Identifier: NCT04219228
Recruitment Status : Recruiting
First Posted : January 6, 2020
Last Update Posted : March 17, 2020
Sponsor:
Information provided by (Responsible Party):
Yingfeng Zheng, Sun Yat-sen University

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.

Condition or disease Intervention/treatment
Myopia Diagnostic Test: Ophthalmic examinations Device: Wearable devices

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.

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Study Type : Observational
Estimated Enrollment : 4000 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: A Prospective School-based Study of Myopia in Children in Southern China
Actual Study Start Date : December 14, 2019
Estimated Primary Completion Date : February 2, 2023
Estimated Study Completion Date : February 2, 2023

Resource links provided by the National Library of Medicine


Group/Cohort Intervention/treatment
Students in urban counties
All first-grade students in urban counties will undergo anthropometry and ophthalmic examination, and be required to complete questionnaires and wear wearable devices to collect environmental information and daily activities.
Diagnostic Test: Ophthalmic examinations
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.

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

Students in rural counties
All first-grade students in rural counties will undergo anthropometry and ophthalmic examination, and be required to complete questionnaires and wear wearable devices to collect environmental information and daily activities.
Diagnostic Test: Ophthalmic examinations
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.

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




Primary Outcome Measures :
  1. 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 Outcome Measures :
  1. Prevalence of myopia [ Time Frame: baseline ]
    Myopia is defined as any eye's SER (sphere + 1/2 cylinder) of at least -0.5 diopters (D).

  2. Change in axial length [ Time Frame: 1 year, 2 years, 3 years ]
    Axial length will be measured with a non-contact optical device.

  3. Prevalence of amblyopia, strabismus and other ocular abnormalities [ Time Frame: baseline ]
    Cover-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.

  4. Area under the receiver operating characteristic curve of the deep learning algorithm for the prediction of incident myopia [ Time Frame: 1 year ]
    The investigators will estimate the area under the receiver operating characteristic curve of the deep learning algorithm for the prediction of incident myopia.

  5. Sensitivity and specificity of the deep learning algorithm for the prediction of incident myopia [ Time Frame: 1 year ]
    The investigators will estimate sensitivity and specificity of the deep learning algorithm for the prediction of incident myopia.

  6. Area under the receiver operating characteristic curve of the deep learning algorithm for the prediction of fast progressing myope [ Time Frame: 1 year ]
    The 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).

  7. Sensitivity and specificity of the deep learning algorithm for the prediction of fast progressing myope [ Time Frame: 1 year ]
    The 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.

  8. Area under the receiver operating characteristic curve of the diagnostic algorithm in identifying abnormal vision screening result [ Time Frame: baseline ]
    The 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).

  9. Sensitivity and specificity of the diagnostic algorithm in identifying abnormal vision screening result [ Time Frame: baseline ]
    The 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).

  10. Post-vision screening referral uptake [ Time Frame: 3 months ]
    Any referral uptake will be confirmed by telephone follow-up.



Information from the National Library of Medicine

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Ages Eligible for Study:   6 Years to 7 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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.
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04219228


Contacts
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Contact: Yingfeng Zheng, M.D. Ph.D. +8613922286455 zhyfeng@mail.sysu.edu.cn

Locations
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China, Guangdong
Zhognshan Ophthalmic Center, Sun Yat-sen University Recruiting
Guangzhou, Guangdong, China, 510000
Contact: Yingfeng Zheng, M.D, Ph.D    +8613922286455    zhyfeng@mail.sysu.edu.cn   
Schools Recruiting
Zhaoqing, Guangdong, China
Contact: Yingfeng Zheng       zhyfeng@mail.sysu.edu.cn   
Sponsors and Collaborators
Sun Yat-sen University
Publications of Results:
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Responsible Party: Yingfeng Zheng, Clinical investigator, Sun Yat-sen University
ClinicalTrials.gov Identifier: NCT04219228    
Other Study ID Numbers: 2019KYPJ171
First Posted: January 6, 2020    Key Record Dates
Last Update Posted: March 17, 2020
Last Verified: March 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Myopia
Refractive Errors
Eye Diseases