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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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 |
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| Measure | Description | Time Frame |
|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Myopic shift | Change of spherical equivalence and axial length | Assessed at 12 months, 24 months, and 36 months post-baseline. |
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Inclusion Criteria:
Exclusion Criteria:
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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.
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Xiangui He, PhD | Contact | +86 021-62717733 | xianhezi@163.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Shanghai Eye Disease Prevention and Treatment Center | Shanghai | Shanghai Municipality | 200336 | China |
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| ID | Term |
|---|---|
| D009216 | Myopia |
| D012030 | Refractive Errors |
| D010349 | Patient Compliance |
| ID | Term |
|---|---|
| D005128 | Eye Diseases |
| D010342 | Patient Acceptance of Health Care |
| D000074822 | Treatment Adherence and Compliance |
| D015438 | Health Behavior |
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Saliva
| D001519 | Behavior |