NCT07211893

Brief Summary

Myopia represents a significant global public health challenge, with China experiencing particularly high myopia prevalence among children and adolescents. The World Health Organization (WHO) acknowledges the critical role of health education in eye care and has collaborated with the International Telecommunication Union (ITU) to launch the Be He@lthy, Be Mobile (BHBM) initiative, which includes MyopiaEd-a mobile health project specifically designed to address myopia. Developed in partnership with international experts and informed by evidence-based guidelines, MyopiaEd provides standardized, scientifically validated content for effective myopia control. The MyopiaEd library has been translated and adapted by the Zhongshan Ophthalmic Center for use in China. Therefore, we aim to investigate whether the Chinese version of MyopiaEd can improve eye care behaviors among primary school students and enhance parental knowledge regarding myopia prevention and control in China.

Trial Health

65
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Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
1,330

participants targeted

Target at P75+ for not_applicable

Timeline
8mo left

Started Dec 2025

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress39%
Dec 2025Dec 2026

First Submitted

Initial submission to the registry

September 18, 2025

Completed
20 days until next milestone

First Posted

Study publicly available on registry

October 8, 2025

Completed
2 months until next milestone

Study Start

First participant enrolled

December 5, 2025

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2026

Expected
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2026

Last Updated

December 10, 2025

Status Verified

September 1, 2025

Enrollment Period

11 months

First QC Date

September 18, 2025

Last Update Submit

December 3, 2025

Conditions

Outcome Measures

Primary Outcomes (1)

  • The proportion of children having improved eye-use behaviors after 1 year.

    Children are considered to have improved behaviors if they meet three or more of the following criteria after 12 months: Outdoor Time: Increase of ≥ 30 minutes for those initially \< 2 hours; maintain ≥ 2 hours for those initially ≥ 2 hours. Near Work Time: Reduce ≥ 30 minutes for those initially ≥ 1 hour; maintain \< 1 hour for those initially \< 1 hour. Screen Time: Reduce ≥ 30 minutes for those initially ≥ 1 hour; maintain \< 1 hour for those initially \< 1 hour. Eye Exam Frequency: Increase of ≥ 1 exam for those with \< 2 exams initially; maintain ≥ 2 for those with ≥ 2 exams. Sitting Posture: Increase of ≥ 1 point for those with ≤ 3; maintain ≥ 4 for those with ≥ 4. Resting Behavior During Near Work: Increase of ≥ 1 point for those with ≤ 3; maintain ≥ 4 for those with ≥ 4. Spectacle-Wearing: Children not wearing glasses begin after 12 months. Daily Spectacle Wear for Myopic Children: Increase of ≥ 1 hour for those wearing ≤ 8 hours; maintain \> 8 hours for those wearing \> 8 hour.

    12 months

Secondary Outcomes (4)

  • Change in myopia-related knowledge score of students' guardians between baseline and 12 months

    12 months

  • Difference in incidence of myopia between the two groups after 12 months

    12 months

  • Difference in the change of spherical equivalence between baseline and 12 months in the two groups

    12 months

  • The satisfaction of the MyopiaEd information by the guardians

    12 months

Study Arms (2)

MyopiaEd Messaging

EXPERIMENTAL

send myopia-related health education message from the MyopiaEd information repository

Other: Send myopia-related health education message

Control

NO INTERVENTION

no myopia-related health education message from the MyopiaEd information repository

Interventions

Guardians of students in the intervention group will receive regular myopia-related health education messages, comprising text and images, from the MyopiaEd information repository via class-based WeChat groups. The intervention will last for 12 months.

MyopiaEd Messaging

Eligibility Criteria

Age8 Years - 12 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)

You may qualify if:

  • primary school students in the third grade;
  • the guardians of students can receive, read, and understand multimedia (image-text) messages via WeChat on their mobile phones;
  • voluntary participation in this study, with guardians' consent and a signed informed consent form.

You may not qualify if:

  • with other ocular diseases that severely affect vision
  • with systematic diseases or mental disorders, inability to understand or cooperate with the study

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Myopia

Condition Hierarchy (Ancestors)

Refractive ErrorsEye Diseases

Central Study Contacts

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 18, 2025

First Posted

October 8, 2025

Study Start

December 5, 2025

Primary Completion (Estimated)

November 1, 2026

Study Completion (Estimated)

December 31, 2026

Last Updated

December 10, 2025

Record last verified: 2025-09

Data Sharing

IPD Sharing
Will not share