MyopiaNCT07211893
Effect of MyopiaEd Messaging on Improving Eye-use Behavior and Myopia Control Among Primary School Students in China
A study testing Send myopia-related health education message in people with Myopia, run by Zhongshan Ophthalmic Center, Sun Yat-sen University.
Trial 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… Read more about this study
- Who is it for?
- Ages 8 to 12 yearsHealthy volunteers can take part
- Conditions the study is for
- Myopia
- What is being tested?
- Send myopia-related health education message
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,330 participants
- Where
- No sites listed yet
- Study dates
- 5 Dec 2025to 31 Dec 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 8 to 12 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- 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.
Who cannot join
- with other ocular diseases that severely affect vision
- with systematic diseases or mental disorders, inability to understand or cooperate with the study
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Effect of MyopiaEd Messaging on Improving Eye-use Behavior and Myopia Control Among Primary School Students in China: A Randomized Controlled Trial
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.
- Conditions
- Myopia
- Being tested
- Send myopia-related health education message
- Medical subject headings
- Myopia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Send myopia-related health education messageOther
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.
| Study group | Role | What they receive |
|---|---|---|
| MyopiaEd Messaging | Experimental | send myopia-related health education message from the MyopiaEd information repository Receives: Other: Send myopia-related health education message |
| Control | No intervention | no myopia-related health education message from the MyopiaEd information repository |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 12 months
Secondary outcomes (4)
Change in myopia-related knowledge score of students' guardians between baseline and 12 months
Change in myopia-related knowledge score of students' guardians between baseline and 12 months, assessed via questionnaire. The score ranged from 1 to 20, with higher scores indicating better knowledge.
Measured: 12 months
Difference in incidence of myopia between the two groups after 12 months
Difference in incidence of myopia between the two groups after 12 months
Measured: 12 months
Difference in the change of spherical equivalence between baseline and 12 months in the two groups
Difference in the change of spherical equivalence between baseline and 12 months in the two groups. Spherical equivalence is calculated as sphere plus half of cylindrical power, as assessed by auto-refraction.
Measured: 12 months
The satisfaction of the MyopiaEd information by the guardians
The satisfaction of the MyopiaEd information by the guardians, assessed by a study questionnaire. Satisfaction score ranges from 1 to 5, with higher scores indicating better satisfaction.
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Oct 2025
- Study start5 Dec 2025 (estimated)
- Primary completion1 Nov 2026 (estimated)
- Study completion31 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for MyopiaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 1,330 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Zhongshan Ophthalmic Center, Sun Yat-sen University
- Sponsor type
- University, hospital or other
- Collaborators
- National Health Commission of the People's Republic of China
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07211893
- Sponsor's protocol ID
- 2025KYPJ113
- Status last verified
- Sep 2025
- First submitted
- 18 Sep 2025
- Last updated
- 10 Dec 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of MyopiaEd Messaging on Improving Eye-use Behavior and Myopia Control Among Primary School Students in China: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT07211893
- Acronym / sponsor ID
- 2025KYPJ113
- Conditions
- Myopia
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 1,330 participants (estimated)
- Lead sponsor
- Zhongshan Ophthalmic Center, Sun Yat-sen UniversityUniversity, hospital or other
- Collaborators
- National Health Commission of the People's Republic of China
- Study start
- 5 Dec 2025 (estimated)
- Primary completion
- 1 Nov 2026 (estimated)
- Study completion
- 31 Dec 2026 (estimated)
- First posted
- 8 Oct 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| MyopiaEd Messaging | Experimental | Other: Send myopia-related health education messagesend myopia-related health education message from the MyopiaEd information repository |
| Control | No intervention | –no myopia-related health education message from the MyopiaEd information repository |
Who may qualify
- Ages
- 8 to 12 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (2 listed)
- with other ocular diseases that severely affect vision
- with systematic diseases or mental disorders, inability to understand or cooperate with the study
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Send myopia-related health education messageGuardians 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. | Other | MyopiaEd Messaging |
Primary outcome
The proportion of children having improved eye-use behaviors after 1 year.
Time frame: 12 months
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.
4 secondary outcomes
Change in myopia-related knowledge score of students' guardians between baseline and 12 months
Time frame: 12 months
Difference in incidence of myopia between the two groups after 12 months
Time frame: 12 months
Difference in the change of spherical equivalence between baseline and 12 months in the two groups
Time frame: 12 months
The satisfaction of the MyopiaEd information by the guardians
Time frame: 12 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Dec 2025.
- Individual participant dataSharing planned: No
Related trials for Myopia
Not yet recruitingObservational study
Corneal Biomechanics and Stromal Tissue Characteristics in Patients Undergoing SMILE
Myopia
Enrolling by invitation
Therapeutic Efficacy of Different Repeated Low-Intensity Red Light Devices and Different Usage Frequencies
Myopia
Not yet recruiting
Clinical Performance and Outcomes After Toric Lens Transition
Astigmatism
Active, not recruitingPhase 4
Odyssey Evaluation in Post LASIK Patients
Cataract
RecruitingPhase 3
A RCT of Spectacles With Aspherical Lenslets or 0.05% Atropine for Myopia Control
Myopia
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Questions about this trial
What is this clinical trial studying?
A study testing Send myopia-related health education message in people with Myopia, run by Zhongshan Ophthalmic Center, Sun Yat-sen University.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 10 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Lingyi Liang (+8602087330487, lianglingyi@gzzoc.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The proportion of children having improved eye-use behaviors after 1 year. (time frame: 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Dec 2025.