MyopiaNCT05119543
Refractive Error in Chinese Students
An observational study of Myopia, run by Tianjin Eye Hospital at 1 site in China.
Trial summary
This cohort study aimed to assess the change of refractive status in Chinese school children. Read more about this study
- Who is it for?
- Ages 6 to 18 yearsHealthy volunteers can take part
- Conditions the study is for
- Myopia
- What is being tested?
- outdoor time
- How many people
- 36,452 participants
- Where
- 1 siteChina
- Study dates
- 1 Jan 2018to 31 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 18 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
Study population: This large-scale cohort study was conducted in 36452 schoolchildren on myopia development among schoolchildren in 96 elementary and high schools in 16 districts of Tianjin in China.
Who may be able to join
- no concurrent eye disease
- age from 6 to 18 years old
Who cannot join
- significant systemic illnesses
- ocular conditions
- congenital corneal diseases
- pterygium, keratoconus
- corneal degeneration or dystrophy
- media opacity, uveitis, glaucoma
Show all 9Show fewer
- history of ocular surgery
- neurologic diseases
- retinal disease.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Tianjin Eye Hospital
Tianjin, 300020
Yan Wang, director, +862227313336, wangyan7143@vip.sina.com
About this study
Official title: Refractive Error in Chinese Primary and High School Students Before and Amidst COVID-19 in Tianjin
This cohort study aimed to assess the change of refractive status in Chinese school children.
Read the detailed description
A cohort study was conducted in 96 primary and secondary schools in 16 districts of Tianjin from 2018 to 2020, including about 36452 people totally. The changes in myopia rate in 3 years were compared by a generalized estimation equation. The distribution of average equivalent spherical mirror and different regions and grades was evaluated by linear regression analysis, and the correlation between the equivalent spherical mirror and different gender, nationality, and age was evaluated.
- Conditions
- Myopia
- Being tested
- outdoor time
- Keywords
- COVID-19, Refractive error, China, Myopia
- Medical subject headings
- Myopia, COVID-19, Refractive Errors
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
outdoor timeOther
This cohort study aimed to assess the change of refractive status in Chinese school children under different outdoor time
| Study group | Role | What they receive |
|---|---|---|
| Grade | The changes in myopia rate in 3 years were compared by generalized estimation equation in different grades Receives: Other: outdoor time |
What is being measured
The primary outcome is the main question the study is designed to answer.
refractive error
The changes in refractive error were compared by generalized estimation equation.
Measured: change from baseline at 36 months
sex disparity
The changes in refractive error were compared between different sex
Measured: change from baseline at 36 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Nov 2021
- Study start1 Jan 2018
- Primary completion31 Dec 2021 (estimated)
- Study completion31 Dec 2021 (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
- Retrospective
- Enrolment
- 36,452 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Tianjin Eye Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Yan Wang, director, Study chair, Tianjin Eye Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05119543
- Sponsor's protocol ID
- 2021022
- Status last verified
- Nov 2021
- First submitted
- 1 Nov 2021
- Last updated
- 15 Nov 2021
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Saw SM, Matsumura S, Hoang QV. Prevention and Management of Myopia and Myopic Pathology. Invest Ophthalmol Vis Sci. 2019 Feb 1;60(2):488-499. doi: 10.1167/iovs.18-25221.
PubMed 30707221Wang J, Li Y, Musch DC, Wei N, Qi X, Ding G, Li X, Li J, Song L, Zhang Y, Ning Y, Zeng X, Hua N, Li S, Qian X. Progression of Myopia in School-Aged Children After COVID-19 Home Confinement. JAMA Ophthalmol. 2021 Mar 1;139(3):293-300. doi: 10.1001/jamaophthalmol.2020.6239.
PubMed 33443542Wang W, Zhu L, Zheng S, Ji Y, Xiang Y, Lv B, Xiong L, Li Z, Yi S, Huang H, Zhang L, Liu F, Wan W, Hu K. Survey on the Progression of Myopia in Children and Adolescents in Chongqing During COVID-19 Pandemic. Front Public Health. 2021 Apr 28;9:646770. doi: 10.3389/fpubh.2021.646770. eCollection 2021.
PubMed 33996724
Study at a glance
From the registry record, last updated by the sponsor on 15 Nov 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Refractive Error in Chinese Primary and High School Students Before and Amidst COVID-19 in Tianjin
- ClinicalTrials.gov ID
- NCT05119543
- Acronym / sponsor ID
- 2021022
- Conditions
- Myopia
- Keywords
- COVID-19, Refractive error, China, Myopia
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 36,452 participants (estimated)
- Lead sponsor
- Tianjin Eye HospitalUniversity, hospital or other
- Study start
- 1 Jan 2018 (actual)
- Primary completion
- 31 Dec 2021 (estimated)
- Study completion
- 31 Dec 2021 (estimated)
- First posted
- 15 Nov 2021 (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 cohort study aimed to assess the change of refractive status in Chinese school children.
Detailed description
A cohort study was conducted in 96 primary and secondary schools in 16 districts of Tianjin from 2018 to 2020, including about 36452 people totally. The changes in myopia rate in 3 years were compared by a generalized estimation equation. The distribution of average equivalent spherical mirror and different regions and grades was evaluated by linear regression analysis, and the correlation between the equivalent spherical mirror and different gender, nationality, and age was evaluated.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Grade | – | Other: outdoor timeThe changes in myopia rate in 3 years were compared by generalized estimation equation in different grades |
Who may qualify
- Ages
- 6 to 18 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
- Study population
- This large-scale cohort study was conducted in 36452 schoolchildren on myopia development among schoolchildren in 96 elementary and high schools in 16 districts of Tianjin in China.
Key inclusion criteria (2 listed)
- no concurrent eye disease
- age from 6 to 18 years old
Key exclusion criteria (9 listed)
- significant systemic illnesses
- ocular conditions
- congenital corneal diseases
- pterygium, keratoconus
- corneal degeneration or dystrophy
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 |
|---|---|---|
| outdoor timeThis cohort study aimed to assess the change of refractive status in Chinese school children under different outdoor time | Other | Grade |
Primary outcome
refractive error
Time frame: change from baseline at 36 months
The changes in refractive error were compared by generalized estimation equation.
sex disparity
Time frame: change from baseline at 36 months
The changes in refractive error were compared between different sex
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Nov 2021.
- Background: PubMed 30707221Saw SM, Matsumura S, Hoang QV. Prevention and Management of Myopia and Myopic Pathology. Invest Ophthalmol Vis Sci. 2019 Feb 1;60(2):488-499. doi: 10.1167/iovs.18-25221.
- Background: PubMed 33443542Wang J, Li Y, Musch DC, Wei N, Qi X, Ding G, Li X, Li J, Song L, Zhang Y, Ning Y, Zeng X, Hua N, Li S, Qian X. Progression of Myopia in School-Aged Children After COVID-19 Home Confinement. JAMA Ophthalmol. 2021 Mar 1;139(3):293-300. doi: 10.1001/jamaophthalmol.2020.6239.
- Background: PubMed 33996724Wang W, Zhu L, Zheng S, Ji Y, Xiang Y, Lv B, Xiong L, Li Z, Yi S, Huang H, Zhang L, Liu F, Wan W, Hu K. Survey on the Progression of Myopia in Children and Adolescents in Chongqing During COVID-19 Pandemic. Front Public Health. 2021 Apr 28;9:646770. doi: 10.3389/fpubh.2021.646770. eCollection 2021.
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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, director 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, 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 2 inclusion and 9 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 15 Nov 2021. 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 Yan Wang, director (+8615022756478, fanqian2002_yahoo@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
refractive error (time frame: change from baseline at 36 months). 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?
On the ClinicalTrials.gov record for NCT05119543, 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 15 Nov 2021.