Real-World Study of Myopia Prevention and Control in Children
1 other identifier
observational
15,000
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Feb 2025
Typical duration for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
February 13, 2025
CompletedFirst Posted
Study publicly available on registry
February 27, 2025
CompletedStudy Start
First participant enrolled
February 28, 2025
CompletedPrimary Completion
Last participant's last visit for primary outcome
February 28, 2028
ExpectedStudy Completion
Last participant's last visit for all outcomes
February 28, 2028
February 27, 2025
February 1, 2025
3 years
February 13, 2025
February 23, 2025
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
Myopia incidence
Myopia incidence
Assessed at 12 months, 24 months, and 36 months post-baseline.
Myopia progression
Myopia progression in myopic participants
Assessed at 12 months, 24 months, and 36 months post-baseline.
Secondary Outcomes (1)
Myopic shift
Assessed at 12 months, 24 months, and 36 months post-baseline.
Study Arms (4)
Sufficient hyperopia reserve
Cycloplegic spherical equivalence is higher than the recommended values and falls within the normal range for the corresponding age 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.
Premyopia
-0.50 diopters \< cycloplegic spherical equivalence ≤ +0.75 diopters
Myopia
Cycloplegic spherical equivalence ≤ -0.50 diopters
Eligibility Criteria
All students in the enrolled schools can participate in the project and receive tiered interventions after obtaining informed consent from their guardians. After professional examination, students with conditions such as strabismus, amblyopia, other significant ocular abnormalities, systemic diseases, or those currently undergoing other myopia interventions will generally not be fitted with specially designed myopia control spectacles.
You may qualify if:
- All students from the enrolled schools;
- Participants must be able to cooperate with and complete all required ophthalmic examinations;
- Written informed consent must be obtained from their parents or legal guardians.
You may not qualify if:
- Ocular abnormalities (e.g., strabismus, amblyopia, or other significant eye diseases);
- Systemic diseases that may affect ocular health;
- Current participation in other myopia intervention programs.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Shanghai Eye Disease Prevention and Treatment Center
Shanghai, Shanghai Municipality, 200336, China
Biospecimen
Saliva
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Target Duration
- 3 Years
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
February 13, 2025
First Posted
February 27, 2025
Study Start
February 28, 2025
Primary Completion (Estimated)
February 28, 2028
Study Completion (Estimated)
February 28, 2028
Last Updated
February 27, 2025
Record last verified: 2025-02