Real-World Study of Myopia Prevention and Control in Children

Shanghai Eye Disease Prevention and Treatment Center

Status: Not yet enrolling

Conditions: Myopia; Refractive Errors; Cohort; Children

Study type: Observational

Funder types: Other

Identifiers

NCT06849895

SIGCMIPCA-2024

Details and patient eligibility

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.

Enrollment: 15,000 estimated patients

Sex: All

Ages: 6 to 12 years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

15,000 participants in 4 patient groups

Sufficient hyperopia reserve

Description:

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

Description:

Cycloplegic spherical equivalence is greater than +0.75 diopters but below the recommended value for the corresponding age group.

Premyopia

Description:

-0.50 diopters \< cycloplegic spherical equivalence ≤ +0.75 diopters

Myopia

Description:

Cycloplegic spherical equivalence ≤ -0.50 diopters