Real-World Study of Myopia Prevention and Control in Children

Not yet recruiting

• Conditions: Myopia; Refractive Errors; Children; Cohort

• Registration Number: NCT06849895
• Lead Sponsor: Shanghai Eye Disease Prevention and Treatment Center

Brief Summary

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

Not available

Study Timeline

• Status Verified: 2025-02
• Study First Submitted: 2025-02-13
• Study First Submitted QC: 2025-02-23
• Last Update Submitted: 2025-02-23
• Study First Posted: 2025-02-27
• Last Update Posted: 2025-02-27
• Study Start: 2025-02-28
• Primary Completion: 2028-02-28
• Study Completion: 2028-02-28

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 15000

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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Myopia incidence	Assessed at 12 months, 24 months, and 36 months post-baseline.	Myopia incidence
Myopia progression	Assessed at 12 months, 24 months, and 36 months post-baseline.	Myopia progression in myopic participants

Secondary Outcome Measures

Name	Time	Method
Myopic shift	Assessed at 12 months, 24 months, and 36 months post-baseline.	Change of spherical equivalence and axial length

Trial Locations

Locations (1)

Shanghai Eye Disease Prevention and Treatment Center; 🇨🇳 Shanghai, Shanghai, China