Real-World Study of Myopia Prevention and Control in Children

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

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Refractive Errors; Children; Myopia; Cohort

• Study Type: Observational
• Enrollment (Estimated): 15000

Contacts and Locations

• Study Contact: Name: Xiangui He, PhD; Phone Number: +86 021-62717733; Email: xianhezi@163.com

Study Locations

• China
  • Shanghai
    • Shanghai, Shanghai, China, 200336
      • Shanghai Eye Disease Prevention and Treatment Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child
• Accepts Healthy Volunteers: Yes

• Sampling Method: Non-Probability Sample

Study 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.

Description

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.

Study Plan

How is the study designed?

Number of groups / cohorts

4

Cohorts and Interventions

Group / Cohort
Sufficient hyperopia reserve; 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; Cycloplegic spherical equivalence is greater than +0.75 diopters but below the recommended value for the corresponding age group.
Premyopia; -0.50 diopters < cycloplegic spherical equivalence ≤ +0.75 diopters
Myopia; Cycloplegic spherical equivalence ≤ -0.50 diopters

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Myopia incidence	Myopia incidence	Assessed at 12 months, 24 months, and 36 months post-baseline.
Myopia progression	Myopia progression in myopic participants	Assessed at 12 months, 24 months, and 36 months post-baseline.

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Myopic shift	Change of spherical equivalence and axial length	Assessed at 12 months, 24 months, and 36 months post-baseline.

Collaborators and Investigators

• Sponsor: Shanghai Eye Disease Prevention and Treatment Center

Study record dates

Study Major Dates

• Study Start (Estimated): February 28, 2025
• Primary Completion (Estimated): February 28, 2028
• Study Completion (Estimated): February 28, 2028

Study Registration Dates

• First Submitted: February 13, 2025
• First Submitted That Met QC Criteria: February 23, 2025
• First Posted (Actual): March 25, 2025

Study Record Updates

• Last Update Posted (Actual): March 25, 2025
• Last Update Submitted That Met QC Criteria: February 23, 2025
• Last Verified: February 1, 2025

More Information

Terms related to this study

• Keywords: compliance; children; myopia control; myopia; premyopia; outdoor activities; myopia prevention; defocus optical lenses
• Additional Relevant MeSH Terms: Eye Diseases; Myopia; Refractive Errors
• Other Study ID Numbers: SIGCMIPCA-2024

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No