Real-World Study of Myopia Prevention and Control in Children

NCT ID: NCT06849895

Last Updated: 2025-02-27

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

Total Enrollment

15000 participants

Study Classification

OBSERVATIONAL

Study Start Date

2025-02-28

Study Completion Date

2028-02-28

Brief Summary

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This prospective, school-based cohort study aims to enroll approximately 15,000 primary school students from multiple districts in Shanghai, China and to observe the outcomes on myopia prevention and control in children with varying refractive status (including sufficient hyperopia reserve, relative insufficiency in hyperopia reserve, pre-myopia and myopia) who are exposed to a school-based categorized and integrated interventions strategy in real-world settings.

The primary objective of this study is to observe the change in the incidence and prevalence of myopia as well as the the progression of myopia among primary school students population under a school-based interventions, including increasing outdoor activities and wearing special designed optical lenses. The second objective is to identify factors influencing the outcomes and assess the compliance of different intervention methods. Additionally, a cost-effectiveness analysis will be conducted to assess the implementation process, providing technical solutions and operational models for wider application.

Detailed Description

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Conditions

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Myopia Refractive Errors Children Cohort

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Sufficient hyperopia reserve

Cycloplegic spherical equivalence is higher than the recommended values and falls within the normal range for the corresponding age group.

No interventions assigned to this group

Relative insufficiency in hyperopia reserve

Cycloplegic spherical equivalence is greater than +0.75 diopters but below the recommended value for the corresponding age group.

No interventions assigned to this group

Premyopia

-0.50 diopters \< cycloplegic spherical equivalence ≤ +0.75 diopters

No interventions assigned to this group

Myopia

Cycloplegic spherical equivalence ≤ -0.50 diopters

No interventions assigned to this group

Eligibility Criteria

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Inclusion Criteria

1. All students from the enrolled schools;
2. Participants must be able to cooperate with and complete all required ophthalmic examinations;
3. Written informed consent must be obtained from their parents or legal guardians.

Exclusion Criteria

1. Ocular abnormalities (e.g., strabismus, amblyopia, or other significant eye diseases);
2. Systemic diseases that may affect ocular health;
3. Current participation in other myopia intervention programs.
Minimum Eligible Age

6 Years

Maximum Eligible Age

12 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Shanghai Eye Disease Prevention and Treatment Center

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Shanghai Eye Disease Prevention and Treatment Center

Shanghai, Shanghai Municipality, China

Site Status

Countries

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China

Central Contacts

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Xiangui He, PhD

Role: CONTACT

+86 021-62717733

Other Identifiers

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SIGCMIPCA-2024

Identifier Type: -

Identifier Source: org_study_id

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