Real-World Study of Myopia Prevention and Control in Children
Trial statusNot yet recruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age6-12
SponsorShanghai Eye Disease Prevention and Treatment Center
About this trial
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.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
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.
Disqualifiers
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.
Trial population
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.
Trial design
Design model
Cohort
Time perspective
Prospective
Treatments tested in this trial
Not listed
Trial groups
15,000 Participants
are grouped into 4 trial groupsGroup A: Sufficient hyperopia reserve
Group B: Relative insufficiency in hyperopia reserve
Group C: Premyopia
Group D: Myopia
Trial outcomes
Primary outcomes
1
Myopia incidence
Myopia incidence
Time frame
Assessed at 12 months, 24 months, and 36 months post-baseline.2
Myopia progression
Myopia progression in myopic participants
Time frame
Assessed at 12 months, 24 months, and 36 months post-baseline.Secondary outcomes
1
Myopic shift
Change of spherical equivalence and axial length
Time frame
Assessed at 12 months, 24 months, and 36 months post-baseline.Sponsors and contacts
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Source ClinicalTrials.gov
This trial is not recruiting at the moment. You can still explore other options: