MyopiaNCT05715424
Community Intervention and Demonstration Area Construction
A study testing Six interventions for children and adolescents in people with Myopia and Refractive Errors, run by Anhui Medical University at 1 site in China.
Trial summary
The objective of this intervention study was to understand the visual health status of nearly one million children and adolescents in ten provinces in China, and then to conduct intervention and evaluate the effect of intervention measures with the development of myopia as the outcome indicator. Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Myopia, Refractive Errors
- What is being tested?
- Six interventions for children and adolescents
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,000,000 participants
- Where
- 1 siteChina
- Study dates
- 1 Dec 2022to Dec 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 Any age
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- ● Kindergarten kids.
- Grade of 1 to 6 in elementary schools.
- Grade of 1 to 3 in middle schools.
- Grade of 1 to 3 in high schools.
- Sign the informed consent.
Who cannot join
- ●Visual defect or other eye diseases.
- wearing orthokeratology; refractive surgery history.
- Not considered suitable for inclusion in the study by the investigator.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Anqing myopia scene
Anqing, Anhui, 246000
XiangLin Zhang, 19966513010, 1696061680@qq.com
About this study
Official title: Research on Precise Myopia Prevention and Control Technology and Demonstration Application for Children and Adolescent
The objective of this intervention study was to understand the visual health status of nearly one million children and adolescents in ten provinces in China, and then to conduct intervention and evaluate the effect of intervention measures with the development of myopia as the outcome indicator. The study will be conducted in the form of a stepped intervention and will answer the following questions.
Current China children and adolescent's vision health, including the different degrees of myopia prevalence, and farsightedness reserve status. To evaluate the implementation and effect of eight appropriate technologies and six interventions developed in this study, to reduce the incidence of myopia among children and adolescents in China, to achieve the purpose of nationwide application.
In the early stage of this study, a baseline survey will be conducted on participants. In the middle stage, participants will be required to adjust the seat height regularly and increase the time for outdoor activities, etc. In the later stage, intervention measures will be evaluated based on the overall research situation to consider national promotion.
- Conditions
- Myopia, Refractive Errors
- Being tested
- Six interventions for children and adolescents
- Medical subject headings
- Myopia, Refractive Errors
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Six interventions for children and adolescentsOther
- Vision Health Record Establishment and Myopia Risk Assessment.
- Evaluation of vision care behavior and development of reasonable eye use behavior.
- Health education for teachers and parents.
- Action to improve the reading and writing environment at home and school.
- One hour of outdoor activities in and out of school during the day.
- Myopia grading management and medical correction action.
| Study group | Role | What they receive |
|---|---|---|
| Cluster A | Experimental | The study population (school-based) was divided into four clusters.Each cluster will receive the same intervention.and one cluster was randomly selected as Cluster A. The intervention was administered at month 6 and monitored for two years. Receives: Other: Six interventions for children and adolescents |
| Cluster B | Experimental | The study population (school-based) was divided into four clusters. Each cluster will receive the same intervention.and one cluster was randomly selected as Cluster B. The intervention was administered at month 12 and monitored for one and a half years. Receives: Other: Six interventions for children and adolescents |
| Cluster C | Experimental | The study population (school-based) was divided into four clusters.Each cluster will receive the same intervention. and one cluster was randomly selected as Cluster C. The intervention was administered at month 18 and monitored for a continuous period of one year. Receives: Other: Six interventions for children and adolescents |
| Cluster D | Experimental | The study population (school-based) was divided into four clusters.Each cluster will receive the same intervention.and one cluster was randomly selected as Cluster D. The intervention was implemented at month 18 and an evaluation of the effect of the intervention was performed. Receives: Other: Six interventions for children and adolescents |
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes in questionnaire survey
Questionnaires based on myopia prevention and control for children and adolescents, including a questionnaire on myopia in children and adolescents.
Measured: Baseline, 6 months, 1 year, 1.5 years, 2 years
Changes in uncorrected vision within two years
Uncorrected visual acuity (UCVA) was measured for the right eye, then the left eye, with a E Standard Logarithm Vision Acuity Chart (GB11533-2011) in 5-grade notation (5- LogMAR), with illumination of the chart around 500lx. If one of the eyes UCVA was less than 5.0, then tests with combined lenses were conducted among the poor eye-sighted for confirming the types of ametropia (normal, myopia, hyperopia or other eye diseases)．All the measurements were recorded.
Measured: Baseline, 6 months, 1 year, 1.5 years, 2 years
Changes in visual acuity in computer optometry
Optometry Automated computerized optometry is performed by an optometrist. Automatic optometry instrument using desktop computer automatic optometry, equipment requirements should conform to the "ISO10342-2010 Ophthalmic instruments: Optometry" provisions.
Measured: Baseline, 6 months, 1 year, 1.5 years, 2 years
Changes in visual acuity during dilated pupil optometry
Between 5% and 10% of the participants were selected for Dilated pupil optometry.
Measured: Baseline, 6 months, 1 year, 1.5 years, 2 years
Secondary outcomes (2)
Eye protection diary
Daily questionnaire based on the development of myopia prevention and control in children and adolescents.
Measured: Three months.
Qualitative interview
Based on the interview outline on myopia prevention and control, some randomly selected students, parents, teachers and related departments were investigated.
Measured: Baseline, 1 year, 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Feb 2023
- Study start1 Dec 2022
- Primary completionDec 2024 (estimated)
- Study completionDec 2024 (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
- Factorial
- Masking
- None (open label)
- Enrolment
- 1,000,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Anhui Medical University
- Sponsor type
- University, hospital or other
- Collaborators
- Shanghai Eye Disease Prevention and Treatment Center, Beijing Center for Disease Control and Prevention
- Responsible party
- Principal investigator, Fangbiao Tao, Anhui Medical University
- Investigators
- FangBiao Tao, Professor, Study director, Anhui Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05715424
- Sponsor's protocol ID
- 20210735
- Status last verified
- Apr 2024
- First submitted
- 10 Nov 2022
- Last updated
- 9 Apr 2024
- 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 9 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Research on Precise Myopia Prevention and Control Technology and Demonstration Application for Children and Adolescent
- ClinicalTrials.gov ID
- NCT05715424
- Acronym / sponsor ID
- 20210735
- Conditions
- Myopia, Refractive Errors
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 1,000,000 participants (estimated)
- Lead sponsor
- Anhui Medical UniversityUniversity, hospital or other
- Collaborators
- Shanghai Eye Disease Prevention and Treatment Center, Beijing Center for Disease Control and Prevention
- Study start
- 1 Dec 2022 (actual)
- Primary completion
- Dec 2024 (estimated)
- Study completion
- Dec 2024 (estimated)
- First posted
- 8 Feb 2023 (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.
The objective of this intervention study was to understand the visual health status of nearly one million children and adolescents in ten provinces in China, and then to conduct intervention and evaluate the effect of intervention measures with the development of myopia as the outcome indicator. The study will be conducted in the form of a stepped intervention and will answer the following questions.
Current China children and adolescent's vision health, including the different degrees of myopia prevalence, and farsightedness reserve status. To evaluate the implementation and effect of eight appropriate technologies and six interventions developed in this study, to reduce the incidence of myopia among children and adolescents in China, to achieve the purpose of nationwide application.
In the early stage of this study, a baseline survey will be conducted on participants. In the middle stage, participants will be required to adjust the seat height regularly and increase the time for outdoor activities, etc. In the later stage, intervention measures will be evaluated based on the overall research situation to consider national promotion.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Cluster A | Experimental | Other: Six interventions for children and adolescentsThe study population (school-based) was divided into four clusters.Each cluster will receive the same intervention.and one cluster was randomly selected as Cluster A. The intervention was administered at month 6 and monitored for two years. |
| Cluster B | Experimental | Other: Six interventions for children and adolescentsThe study population (school-based) was divided into four clusters. Each cluster will receive the same intervention.and one cluster was randomly selected as Cluster B. The intervention was administered at month 12 and monitored for one and a half years. |
| Cluster C | Experimental | Other: Six interventions for children and adolescentsThe study population (school-based) was divided into four clusters.Each cluster will receive the same intervention. and one cluster was randomly selected as Cluster C. The intervention was administered at month 18 and monitored for a continuous period of one year. |
| Cluster D | Experimental | Other: Six interventions for children and adolescentsThe study population (school-based) was divided into four clusters.Each cluster will receive the same intervention.and one cluster was randomly selected as Cluster D. The intervention was implemented at month 18 and an evaluation of the effect of the intervention was performed. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (5 listed)
- ● Kindergarten kids.
Key exclusion criteria (3 listed)
- ●Visual defect or other eye diseases.
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 |
|---|---|---|
| Six interventions for children and adolescents* Vision Health Record Establishment and Myopia Risk Assessment. * Evaluation of vision care behavior and development of reasonable eye use behavior. * Health education for teachers and parents. * Action to improve the reading and writing environment at home and school. * One hour of outdoor activities in and out of school during the day. * Myopia grading management and medical correction action. | Other | Cluster A, Cluster B, Cluster C, Cluster D |
Primary outcome
Changes in questionnaire survey
Time frame: Baseline, 6 months, 1 year, 1.5 years, 2 years
Questionnaires based on myopia prevention and control for children and adolescents, including a questionnaire on myopia in children and adolescents.
Changes in uncorrected vision within two years
Time frame: Baseline, 6 months, 1 year, 1.5 years, 2 years
Uncorrected visual acuity (UCVA) was measured for the right eye, then the left eye, with a E Standard Logarithm Vision Acuity Chart (GB11533-2011) in 5-grade notation (5- LogMAR), with illumination of the chart around 500lx. If one of the eyes UCVA was less than 5.0, then tests with combined lenses were conducted among the poor eye-sighted for confirming the types of ametropia (normal, myopia, hyperopia or other eye diseases)．All the measurements were recorded.
Changes in visual acuity in computer optometry
Time frame: Baseline, 6 months, 1 year, 1.5 years, 2 years
Optometry Automated computerized optometry is performed by an optometrist. Automatic optometry instrument using desktop computer automatic optometry, equipment requirements should conform to the "ISO10342-2010 Ophthalmic instruments: Optometry" provisions.
Changes in visual acuity during dilated pupil optometry
Time frame: Baseline, 6 months, 1 year, 1.5 years, 2 years
Between 5% and 10% of the participants were selected for Dilated pupil optometry.
2 secondary outcomes
Eye protection diary
Time frame: Three months.
Qualitative interview
Time frame: Baseline, 1 year, 2 years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Apr 2024.
- Individual participant dataSharing planned: No
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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. This study is not recruiting at the moment.
FangBiao Tao, Professor study director
Anhui Medical University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Six interventions for children and adolescents in people with Myopia and Refractive Errors, run by Anhui Medical University 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 5 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: status not confirmed, as of the sponsor's last update on 9 Apr 2024. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact FangBiao Tao, Professor (+86 19966513010, vipur8@outlook.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Changes in questionnaire survey (time frame: Baseline, 6 months, 1 year, 1.5 years, 2 years). The study lists 4 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 9 Apr 2024.