Effect of a Myopia Prediction System on Myopia Prevention and Control
NCT ID: NCT06633393
Last Updated: 2024-10-15
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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NOT_YET_RECRUITING
NA
20000 participants
INTERVENTIONAL
2024-11-01
2026-02-28
Brief Summary
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A myopia prediction system based on artificial intelligence was previously developed, accurately predicting future high myopia risk using efficient, robust, and easily accessible predictive factors, including age, spherical equivalent, and the annual progression of spherical equivalent. This study aims to conduct a prospective, one-year, cluster randomized controlled clinical trial to investigate the effectiveness of this prediction system in preventing and controlling myopia in school-aged children.
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
OTHER
SINGLE
Study Groups
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Experimental Arm
At baseline and six months, feedback on ophthalmic examination results and future high myopia risk at 18 years of age using the myopia prediction system
Feedback on Predicted High Myopia Risk at Age 18 Using the Myopia Prediction System
At baseline and six months, participants will be provided with the results of their predicted risk of high myopia at age 18 based on the myopia prediction system.
Feedback on Ophthalmic Examinations
At baseline and six months, participants will be provided with the results of their ophthalmic examinations.
Control Arm
At baseline and six months, feedback on ophthalmic examination results.
Feedback on Ophthalmic Examinations
At baseline and six months, participants will be provided with the results of their ophthalmic examinations.
Interventions
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Feedback on Predicted High Myopia Risk at Age 18 Using the Myopia Prediction System
At baseline and six months, participants will be provided with the results of their predicted risk of high myopia at age 18 based on the myopia prediction system.
Feedback on Ophthalmic Examinations
At baseline and six months, participants will be provided with the results of their ophthalmic examinations.
Eligibility Criteria
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Inclusion Criteria
* Has the record of eye refraction examination in the past year
* Aged 9 to 11 years, regardless of gender
Exclusion Criteria
* Ocular diseases other than myopia (e.g., strabismus, amblyopia, congenital cataract, juvenile glaucoma, retinal diseases).
* Systemic diseases that may affect vision or visual development (e.g., diabetes or other endocrine disorders, cardiovascular or respiratory diseases, Down syndrome)
9 Years
11 Years
ALL
Yes
Sponsors
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Zhongshan Ophthalmic Center, Sun Yat-sen University
OTHER
Responsible Party
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Haotian Lin
Prof.
Principal Investigators
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Haotian Lin, M.D., Ph.D
Role: PRINCIPAL_INVESTIGATOR
Zhongshan Ophthalmic Center, Sun Yat-sen University, Guangzhou, Guangdong
Locations
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Zhongshan Ophthalmic Center, Sun Yat-sen University
Guangzhou, Guangdong, China
Countries
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Central Contacts
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Facility Contacts
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References
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Lin H, Long E, Ding X, Diao H, Chen Z, Liu R, Huang J, Cai J, Xu S, Zhang X, Wang D, Chen K, Yu T, Wu D, Zhao X, Liu Z, Wu X, Jiang Y, Yang X, Cui D, Liu W, Zheng Y, Luo L, Wang H, Chan CC, Morgan IG, He M, Liu Y. Prediction of myopia development among Chinese school-aged children using refraction data from electronic medical records: A retrospective, multicentre machine learning study. PLoS Med. 2018 Nov 6;15(11):e1002674. doi: 10.1371/journal.pmed.1002674. eCollection 2018 Nov.
Other Identifiers
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2024KYPJ102
Identifier Type: -
Identifier Source: org_study_id
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