Refractive ErrorsNCT04161326
Environmental Health and Myopia Prevention and Control
An observational study of Refractive Errors and Myopia (Disorder), run by Sun Yat-sen University at 1 site in China.
Trial summary
Myopia is one of the major causes of low visual acuity during childhood. It is generally more prevalent in urban areas than in rural areas. Current evidence does not address our understanding of the myopia incidence and development and associated risk geographic factors, such as green spaces. Read more about this study
- Who is it for?
- Ages 6 to 9 yearsHealthy volunteers can take part
- Conditions the study is for
- Refractive Errors, Myopia (Disorder)
- How many people
- 100,000 participants
- Where
- 1 siteChina
- Study dates
- 1 Jan 2016to 30 Dec 2021
- Phase
- Observational
- 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 6 to 9 years
- All sexes
- Healthy volunteers accepted
- Child
Study population: A prospective longitudinal cohort study of schoolchildren who studied in the 1st to 4th grades was performed.
Who may be able to join
- schoolchildren in the 1st to 4th grades
Who cannot join
- schoolchildren unwilling to participate
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Zhongshan Ophthalmic Center, Sun Yat-sen University
Guangzhou, Guangdong, 510000
Yahan Yang, MD., +86-15521013933, yah.yang@hotmail.com
About this study
Official title: Environmental Health and Myopia Prevention and Control: A Longitudinal Study in China
Myopia is one of the major causes of low visual acuity during childhood. It is generally more prevalent in urban areas than in rural areas. Current evidence does not address our understanding of the myopia incidence and development and associated risk geographic factors, such as green spaces. Therefore, our study aimed to evaluate the association between geographic factors and myopia base on a population-based large-scaled cohort design.
- Conditions
- Refractive Errors, Myopia (Disorder)
- Medical subject headings
- Refractive Errors, Myopia
What is being measured
The primary outcome is the main question the study is designed to answer.
the changes of spherical equivalent refractive (RSE)
A multi-linear regression was used.
Measured: up to 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Nov 2019
- Study start1 Jan 2016
- Primary completion30 Dec 2019
- Study completion30 Dec 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Refractive ErrorsStudies of the same condition, open and under way.
- More trials run by Sun Yat-sen UniversityThe sponsor's other registered studies.
- 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
- 100,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Sun Yat-sen University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Haotian Lin, Sun Yat-sen University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04161326
- Sponsor's protocol ID
- CCPMOH2016-China-0304
- Status last verified
- Feb 2020
- First submitted
- 11 Nov 2019
- Last updated
- 25 Feb 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Feb 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Environmental Health and Myopia Prevention and Control: A Longitudinal Study in China
- ClinicalTrials.gov ID
- NCT04161326
- Acronym / sponsor ID
- CCPMOH2016-China-0304
- Conditions
- Refractive Errors, Myopia (Disorder)
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 100,000 participants (estimated)
- Lead sponsor
- Sun Yat-sen UniversityUniversity, hospital or other
- Study start
- 1 Jan 2016 (actual)
- Primary completion
- 30 Dec 2019 (actual)
- Study completion
- 30 Dec 2021 (estimated)
- First posted
- 13 Nov 2019 (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 is one of the major causes of low visual acuity during childhood. It is generally more prevalent in urban areas than in rural areas. Current evidence does not address our understanding of the myopia incidence and development and associated risk geographic factors, such as green spaces. Therefore, our study aimed to evaluate the association between geographic factors and myopia base on a population-based large-scaled cohort design.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 6 to 9 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
- Study population
- A prospective longitudinal cohort study of schoolchildren who studied in the 1st to 4th grades was performed.
Key inclusion criteria (1 listed)
- schoolchildren in the 1st to 4th grades
Key exclusion criteria (1 listed)
- schoolchildren unwilling to participate
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
the changes of spherical equivalent refractive (RSE)
Time frame: up to 3 years
A multi-linear regression was used.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Feb 2020.
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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.
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 Refractive Errors and Myopia (Disorder), run by Sun Yat-sen 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 1 inclusion and 1 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 25 Feb 2020. 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 Yahan Yang, M.D (+8615521013933, yah.yang39@hotmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
the changes of spherical equivalent refractive (RSE) (time frame: up to 3 years). 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 25 Feb 2020.