Refractive ErrorsNCT04338880
Academic Performance and Refractive Error
An observational study of Refractive Errors, run by Sun Yat-sen University at 1 site in China.
Trial summary
Refractive errors constitute the leading cause of visual disability worldwide and that myopia progresses dramatically when students reach school age. Studies from different countries have reported inconsistent associations between educational outcomes and refractive errors. Read more about this study
- Who is it for?
- Ages 6 to 15 years
- Conditions the study is for
- Refractive Errors
- How many people
- 10,000 participants
- Where
- 1 siteChina
- Study dates
- 1 Sep 2016to 1 Dec 2020
- 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 15 years
- All sexes
- Child
Study population: A prospective multicohort observational study of schoolchildren who studied in the 1st to 9th grades was performed.
Who may be able to join
- schoolchildren in the 1st to 9th grades
Who cannot join
- schoolchildren unwilling to participate
- had a history of wearing rigid contact lenses, medical treatment or diseases that could cause poor vision or negatively affect the academic outcomes
- with unreliable auto-refraction values
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Zhognshan Ophthalmic Center, Sun Yat-sen University
Guangzhou, Guangdong, 510080
Yahan Yang, M.D., 15521013933, yah.yang39@qq.com
About this study
Official title: The Associations of High Academic Performance With Childhood Ametropia Prevalence and Myopia Progression
Refractive errors constitute the leading cause of visual disability worldwide and that myopia progresses dramatically when students reach school age. Studies from different countries have reported inconsistent associations between educational outcomes and refractive errors. Therefore, our study aimed to assess the associations of high academic performance with ametropia prevalence and myopia progression in Chinese schoolchildren base on a multicohort observational design.
- Conditions
- Refractive Errors
- Medical subject headings
- Refractive Errors
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 posted8 Apr 2020
- Study start1 Sep 2016
- Primary completion30 Jun 2019
- Study completion1 Dec 2020 (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
- 10,000 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
- NCT04338880
- Sponsor's protocol ID
- CCPMOH2016-China-0901
- Status last verified
- Apr 2020
- First submitted
- 7 Apr 2020
- Last updated
- 8 Apr 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 8 Apr 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Associations of High Academic Performance With Childhood Ametropia Prevalence and Myopia Progression
- ClinicalTrials.gov ID
- NCT04338880
- Acronym / sponsor ID
- CCPMOH2016-China-0901
- Conditions
- Refractive Errors
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 10,000 participants (estimated)
- Lead sponsor
- Sun Yat-sen UniversityUniversity, hospital or other
- Study start
- 1 Sep 2016 (actual)
- Primary completion
- 30 Jun 2019 (actual)
- Study completion
- 1 Dec 2020 (estimated)
- First posted
- 8 Apr 2020 (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.
Refractive errors constitute the leading cause of visual disability worldwide and that myopia progresses dramatically when students reach school age. Studies from different countries have reported inconsistent associations between educational outcomes and refractive errors. Therefore, our study aimed to assess the associations of high academic performance with ametropia prevalence and myopia progression in Chinese schoolchildren base on a multicohort observational design.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 6 to 15 years
- Sex
- All
- Age groups
- Child
- Study population
- A prospective multicohort observational study of schoolchildren who studied in the 1st to 9th grades was performed.
Key inclusion criteria (1 listed)
- schoolchildren in the 1st to 9th grades
Key exclusion criteria (3 listed)
- schoolchildren unwilling to participate
- had a history of wearing rigid contact lenses, medical treatment or diseases that could cause poor vision or negatively affect the academic outcomes
- with unreliable auto-refraction values
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 8 Apr 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, 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 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 8 Apr 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 8 Apr 2020.