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Real-World Study of Myopia Prevention and Control in Children

Sponsored by Shanghai Eye Disease Prevention and Treatment Center

About this trial

Last updated a year ago

Study ID

SIGCMIPCA-2024

Status

Not yet recruiting

Type

Observational

Placebo

No

Accepting

6 to 12 Years
All Sexes

Trial Timing

Started a year ago

What is this trial about?

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.

What are the participation requirements?

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.