MyopiaNCT05336799
Prevalence and Environmental Factors for Myopia Among Chinese School-aged Children and Adolescent in Tianjin
An observational study of Myopia and Refractive Errors, run by Tianjin Eye Hospital at 1 site in China.
Trial summary
The high prevalence of myopia has become a global public health problem. The study amied to investigate the prevalence and progression of myopia associated with social environmental factors in Tianjin, a Chinese megacity in north China. Read more about this study
- Who is it for?
- Ages 6 to 18 yearsHealthy volunteers can take part
- Conditions the study is for
- Myopia, Refractive Errors
- How many people
- 500,000 participants
- Where
- 1 siteChina
- Study dates
- 1 Mar 2021to 31 Dec 2025
- 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 18 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
Study population: All school-aged children and adolescents completed the vision screening in the included school.
Who may be able to join
- aged 6 to 18 years
- no ocular diseases and systemic diseases
- consent to undergo an eye examination
Who cannot join
- schoolchildren unwilling to participate
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Tianjin Eye Hospital
Tianjin, Tianjin Municipality
yan wang, director, +862227313336, wangyan7143@vip.sina.com
About this study
The high prevalence of myopia has become a global public health problem. The study amied to investigate the prevalence and progression of myopia associated with social environmental factors in Tianjin, a Chinese megacity in north China.
Read the detailed description
The high prevalence of myopia has become a global public health problem, especially in East and South Asian countries. It's still not clear for the prevalence and progression of myopia associated with social environmental factors. Thus, the investigators will conducted a long-term observational study to the effect of the socioeconomics, medical resources and school-related environmental parameters and others on the prevalence and progression of myopia among Chinese school-aged children and adolescent.
- Conditions
- Myopia, Refractive Errors
- Keywords
- Myopia, Socioeconomics
- Medical subject headings
- Myopia, Refractive Errors
What is being measured
The primary outcome is the main question the study is designed to answer.
Prevalence of myopia
Myopia is defined as any eye's SER (sphere + 1/2 cylinder) of at least -0.5 diopters (D).
Measured: up to 3years
Secondary outcomes (2)
Changes in prevalence of myopia
Myopia is defined as any eye's SER (sphere + 1/2 cylinder) of at least -0.5 diopters (D).
Measured: up to 3years
Changes of Spherical equivalent
Changes of Spherical equivalent
Measured: changes from baseline at 36months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Apr 2022
- Study start1 Mar 2021
- Primary completion1 Dec 2022 (estimated)
- Study completion31 Dec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- 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
- 500,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Tianjin Eye Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- yan wang, Study chair, Tianjin Eye Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05336799
- Sponsor's protocol ID
- Tianjin Myopia Study
- Status last verified
- Nov 2022
- First submitted
- 8 Apr 2022
- Last updated
- 29 Nov 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Morgan IG, French AN, Ashby RS, Guo X, Ding X, He M, Rose KA. The epidemics of myopia: Aetiology and prevention. Prog Retin Eye Res. 2018 Jan;62:134-149. doi: 10.1016/j.preteyeres.2017.09.004. Epub 2017 Sep 23.
PubMed 28951126Guo Y, Liu LJ, Xu L, Lv YY, Tang P, Feng Y, Meng M, Jonas JB. Outdoor activity and myopia among primary students in rural and urban regions of Beijing. Ophthalmology. 2013 Feb;120(2):277-83. doi: 10.1016/j.ophtha.2012.07.086. Epub 2012 Oct 23.
PubMed 23098368Tenovuo J, Mielityinen H, Paunio K. The effect of dental plaque grown in the presence of xylitol or sucrose on bone resorption in vitro. Pharmacol Ther Dent. 1981;6(1-2):35-43.
PubMed 6941318
Study at a glance
From the registry record, last updated by the sponsor on 29 Nov 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prevalence and Environmental Factors for Myopia Among Chinese School-aged Children and Adolescent in Tianjin
- ClinicalTrials.gov ID
- NCT05336799
- Acronym / sponsor ID
- Tianjin Myopia Study
- Conditions
- Myopia, Refractive Errors
- Keywords
- Myopia, Socioeconomics
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 500,000 participants (estimated)
- Lead sponsor
- Tianjin Eye HospitalUniversity, hospital or other
- Study start
- 1 Mar 2021 (actual)
- Primary completion
- 1 Dec 2022 (estimated)
- Study completion
- 31 Dec 2025 (estimated)
- First posted
- 20 Apr 2022 (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 high prevalence of myopia has become a global public health problem. The study amied to investigate the prevalence and progression of myopia associated with social environmental factors in Tianjin, a Chinese megacity in north China.
Detailed description
The high prevalence of myopia has become a global public health problem, especially in East and South Asian countries. It's still not clear for the prevalence and progression of myopia associated with social environmental factors. Thus, the investigators will conducted a long-term observational study to the effect of the socioeconomics, medical resources and school-related environmental parameters and others on the prevalence and progression of myopia among Chinese school-aged children and adolescent.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 6 to 18 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
- Study population
- All school-aged children and adolescents completed the vision screening in the included school.
Key inclusion criteria (3 listed)
- aged 6 to 18 years
- no ocular diseases and systemic diseases
- consent to undergo an eye examination
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
Prevalence of myopia
Time frame: up to 3years
Myopia is defined as any eye's SER (sphere + 1/2 cylinder) of at least -0.5 diopters (D).
2 secondary outcomes
Changes in prevalence of myopia
Time frame: up to 3years
Changes of Spherical equivalent
Time frame: changes from baseline at 36months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Nov 2022.
- Background: PubMed 28951126Morgan IG, French AN, Ashby RS, Guo X, Ding X, He M, Rose KA. The epidemics of myopia: Aetiology and prevention. Prog Retin Eye Res. 2018 Jan;62:134-149. doi: 10.1016/j.preteyeres.2017.09.004. Epub 2017 Sep 23.
- Background: PubMed 23098368Guo Y, Liu LJ, Xu L, Lv YY, Tang P, Feng Y, Meng M, Jonas JB. Outdoor activity and myopia among primary students in rural and urban regions of Beijing. Ophthalmology. 2013 Feb;120(2):277-83. doi: 10.1016/j.ophtha.2012.07.086. Epub 2012 Oct 23.
- Background: PubMed 6941318Tenovuo J, Mielityinen H, Paunio K. The effect of dental plaque grown in the presence of xylitol or sucrose on bone resorption in vitro. Pharmacol Ther Dent. 1981;6(1-2):35-43.
- 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.
yan wang study chair
Tianjin Eye Hospital
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 Tianjin Eye Hospital 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 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 29 Nov 2022. 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 xiaoyan yang, director (+8627306525, yanzitjsykyy@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Prevalence of myopia (time frame: up to 3years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05336799, which also lists 3 linked publications.
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 29 Nov 2022.