MyopiaNCT06849895
Real-World Study of Myopia Prevention and Control in Children
An observational study of Myopia and Refractive Errors, run by Shanghai Eye Disease Prevention and Treatment Center at 1 site in China.
Trial summary
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… Read more about this study
- Who is it for?
- Ages 6 to 12 yearsHealthy volunteers can take part
- Conditions the study is for
- Myopia, Refractive Errors, Children
- How many people
- 15,000 participants
- Where
- 1 siteChina
- Study dates
- 28 Feb 2025to 28 Feb 2028
- How long will I take part?
- 3 Years
- Phase
- Observational
- 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 6 to 12 years
- All sexes
- Healthy volunteers accepted
- Child
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.
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site
Shanghai Eye Disease Prevention and Treatment Center
Shanghai, Shanghai Municipality, 200336
About this study
Official title: 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.
- Conditions
- Myopia, Refractive Errors, Children, Cohort
- Keywords
- myopia, premyopia, outdoor activities, myopia prevention, myopia control, children, compliance, defocus optical lenses
- Medical subject headings
- Myopia, Refractive Errors, Patient Compliance
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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 being measured
The primary outcome is the main question the study is designed to answer.
Myopia incidence
Myopia incidence
Measured: Assessed at 12 months, 24 months, and 36 months post-baseline.
Myopia progression
Myopia progression in myopic participants
Measured: Assessed at 12 months, 24 months, and 36 months post-baseline.
Secondary outcomes (1)
Myopic shift
Change of spherical equivalence and axial length
Measured: Assessed at 12 months, 24 months, and 36 months post-baseline.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Feb 2025
- Study start28 Feb 2025 (estimated)
- Primary completion28 Feb 2028 (estimated)
- Study completion28 Feb 2028 (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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 15,000 participants (estimated)
- Target duration
- 3 Years
Sponsor and investigators
- Lead sponsor
- Shanghai Eye Disease Prevention and Treatment Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06849895
- Sponsor's protocol ID
- SIGCMIPCA-2024
- Status last verified
- Feb 2025
- First submitted
- 13 Feb 2025
- Last updated
- 27 Feb 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 27 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Real-World Study of Myopia Prevention and Control in Children: a Prospective Cohort Study
- ClinicalTrials.gov ID
- NCT06849895
- Acronym / sponsor ID
- SIGCMIPCA-2024
- Conditions
- Myopia, Refractive Errors, Children, Cohort
- Keywords
- myopia, premyopia, outdoor activities, myopia prevention, myopia control, children, compliance, defocus optical lenses
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 15,000 participants (estimated)
- Lead sponsor
- Shanghai Eye Disease Prevention and Treatment CenterUniversity, hospital or other
- Study start
- 28 Feb 2025 (estimated)
- Primary completion
- 28 Feb 2028 (estimated)
- Study completion
- 28 Feb 2028 (estimated)
- First posted
- 27 Feb 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.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 3 Years
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| 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 |
Who may qualify
- Ages
- 6 to 12 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
- 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.
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (3 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Myopia incidence
Time frame: Assessed at 12 months, 24 months, and 36 months post-baseline.
Myopia incidence
Myopia progression
Time frame: Assessed at 12 months, 24 months, and 36 months post-baseline.
Myopia progression in myopic participants
1 secondary outcome
Myopic shift
Time frame: Assessed at 12 months, 24 months, and 36 months post-baseline.
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 27 Feb 2025.
- Individual participant dataSharing planned: Undecided
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Myopia and Refractive Errors, run by Shanghai Eye Disease Prevention and Treatment Center at 1 site in China.
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 3 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 27 Feb 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
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 Xiangui He, PhD (+86 021-62717733, xianhezi@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Myopia incidence (time frame: Assessed at 12 months, 24 months, and 36 months post-baseline.). The study lists 2 primary outcomes in all. 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 27 Feb 2025; AzTrials last refreshed its copy on 7 Nov 2026.