An observational study in Myopia, Refractive Errors and Children, sponsored by Shanghai Eye Disease Prevention and Treatment Center. Not yet recruiting at 1 site in China. Open to participants aged 6 Years to 12 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2025-02-27.
Sponsored by Shanghai Eye Disease Prevention and Treatment Center · Observational
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.
1,159 studies on the registry are indexed under Myopia; 225 are open to participants now.
This study's planned enrollment of 15,000 is above the median of 150 across 204 observational studies indexed under Myopia.
Browse Myopia studies →Shanghai Eye Disease Prevention and Treatment Center is the lead sponsor of 66 studies on the registry; 30 are open to participants now.
Counted across the registry records on this site, refreshed daily.
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.
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Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Cycloplegic spherical equivalence is higher than the recommended values and falls within the normal range for the corresponding age group.
Cycloplegic spherical equivalence is greater than +0.75 diopters but below the recommended value for the corresponding age group.
-0.50 diopters \< cycloplegic spherical equivalence ≤ +0.75 diopters
Cycloplegic spherical equivalence ≤ -0.50 diopters
Myopia incidence
Myopia incidence
Time frame: Assessed at 12 months, 24 months, and 36 months post-baseline.
Myopia progression
Myopia progression in myopic participants
Time frame: Assessed at 12 months, 24 months, and 36 months post-baseline.
Myopic shift
Change of spherical equivalence and axial length
Time frame: Assessed at 12 months, 24 months, and 36 months post-baseline.
Plan to share: Undecided
No publications or documents are linked to this record.
This study is not yet recruiting, as verified in Feb 2025. You cannot join it, but the record below documents what was studied.
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Shanghai Eye Disease Prevention and Treatment Center