Effect of a Myopia Prediction System on Myopia Prevention and Control

NCT ID: NCT06633393

Last Updated: 2024-10-15

Study Results

Results pending

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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Recruitment Status

NOT_YET_RECRUITING

Clinical Phase

NA

Total Enrollment

20000 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-11-01

Study Completion Date

2026-02-28

Brief Summary

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The global rise in myopia, particularly among children and adolescents in China, underscores the inadequacy of current prevention strategies, indicating that conventional screening and education alone are insufficient to curb the prevalence. Integrating personalized myopia prediction into routine care may enhance risk awareness, promote proactive prevention, and improve adherence to medical advice, ultimately reducing the future burden of high myopia.

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.

Detailed Description

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Conditions

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Myopia Randomized Controlled Trials Artificial Intelligence (AI)

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

OTHER

Blinding Strategy

SINGLE

Outcome Assessors

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

Group Type EXPERIMENTAL

Feedback on Predicted High Myopia Risk at Age 18 Using the Myopia Prediction System

Intervention Type OTHER

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

Intervention Type OTHER

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.

Group Type ACTIVE_COMPARATOR

Feedback on Ophthalmic Examinations

Intervention Type OTHER

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.

Intervention Type OTHER

Feedback on Ophthalmic Examinations

At baseline and six months, participants will be provided with the results of their ophthalmic examinations.

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* The participant and their guardian voluntarily signed the informed consent form
* Has the record of eye refraction examination in the past year
* Aged 9 to 11 years, regardless of gender

Exclusion Criteria

* High myopia(spherical equivalent ≤ -6.00 D)
* 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)
Minimum Eligible Age

9 Years

Maximum Eligible Age

11 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Zhongshan Ophthalmic Center, Sun Yat-sen University

OTHER

Sponsor Role lead

Responsible Party

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Haotian Lin

Prof.

Responsibility Role PRINCIPAL_INVESTIGATOR

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

Site Status

Countries

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China

Central Contacts

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Yahan Yang, M.D., Ph.D

Role: CONTACT

+86 15521013933

Xinwei Chen, M.D.

Role: CONTACT

+86 13535382011

Facility Contacts

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Haotian Lin, M.D., Ph.D

Role: primary

+86 13802793086

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.

Reference Type BACKGROUND
PMID: 30399150 (View on PubMed)

Other Identifiers

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2024KYPJ102

Identifier Type: -

Identifier Source: org_study_id

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