Real-World Study of Myopia Prevention and Control in Children
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- This is an observational study: the protocol does not assign a study treatment.
- Who it may be relevant to
- Registry conditions: Myopia, Refractive Errors, Children, Cohort. Basic parameters: 6 years — 12 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- China
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
Real-World Study of Myopia Prevention and Control in Children: a Prospective Cohort Study
Overview
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.
Primary outcome measures
- Myopia incidence [Time frame: Assessed at 12 months, 24 months, and 36 months post-baseline.]
- Myopia progression [Time frame: Assessed at 12 months, 24 months, and 36 months post-baseline.]
Secondary outcome measures (1)
- Myopic shift [Time frame: Assessed at 12 months, 24 months, and 36 months post-baseline.]
Eligibility criteria
Inclusion criteria
- 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.
Exclusion criteria
- 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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: Yes
Study design
- Observational model
- Cohort
Study locations
China · 1 center
- Shanghai Eye Disease Prevention and Treatment Center — Shanghai
Identifiers
NCT: NCT06849895 · SIGCMIPCA-2024