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NCT Number: NCT06849895

Real-World Study of Myopia Prevention and Control in Children

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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Key information

Conditions

Myopia Behavior Children Cohort Eye Diseases Health Behavior Patient Acceptance of Health Care Patient Compliance Refractive Errors Treatment Adherence and Compliance

Age range

6 year–12 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Shanghai Eye Disease Prevention and Treatment Center

Shanghai, Shanghai Municipality, 200336, China

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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.

Exclusion criteria

  • 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.

Treatment and study plan

Primary outcomes

  1. Myopia incidence

    Time frame: Assessed at 12 months, 24 months, and 36 months post-baseline.

    Myopia incidence

  2. Myopia progression

    Time frame: Assessed at 12 months, 24 months, and 36 months post-baseline.

    Myopia progression in myopic participants

Secondary outcomes

  1. Myopic shift

    Time frame: Assessed at 12 months, 24 months, and 36 months post-baseline.

    Change of spherical equivalence and axial length

Study contacts

Contact information is provided by the study sponsor or research team.

Xiangui He, PhD

CONTACT

[email protected]

+86 021-62717733

Sponsors and collaborators

Lead sponsor

Shanghai Eye Disease Prevention and Treatment Center

Other

Registry information

Official study title

Real-World Study of Myopia Prevention and Control in Children: a Prospective Cohort Study

Important dates

Study start
2025
Primary completion
2028
Study completion
2028
First posted
Feb 27, 2025
Registry last updated
Feb 27, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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