Children, Cohort, Myopia, Refractive Errors
Conditions
Keywords
myopia, premyopia, outdoor activities, myopia prevention, myopia control, children, compliance, defocus optical lenses
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.
Interventions
None listed
Sponsors
Shanghai Eye Disease Prevention and Treatment Center
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
6 Years to 12 Years
Healthy volunteers
Yes
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| Myopic shift | Assessed at 12 months, 24 months, and 36 months post-baseline. | Change of spherical equivalence and axial length |
Countries
China
Contacts
Primary ContactXiangui He, PhD
Outcome results
None listed