- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05119543
Refractive Error in Chinese Students
November 11, 2021 updated by: Tianjin Eye Hospital
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.
Study Overview
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 Type
Observational
Enrollment (Anticipated)
36452
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Yan Wang, director
- Phone Number: +8615022756478
- Email: fanqian2002_yahoo@163.com
Study Locations
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-
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Tianjin, China, 300020
- Recruiting
- Tianjin Eye Hospital
-
Contact:
- yan wang, director
- Phone Number: +862227313336
- Email: wangyan7143@vip.sina.com
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-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
6 years to 18 years (Child, Adult)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
All
Sampling Method
Non-Probability Sample
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.
Description
Inclusion Criteria:
- no concurrent eye disease
- age from 6 to 18 years old
Exclusion Criteria:
- significant systemic illnesses
- ocular conditions
- congenital corneal diseases
- pterygium, keratoconus
- corneal degeneration or dystrophy
- media opacity, uveitis, glaucoma
- history of ocular surgery
- neurologic diseases
- retinal disease.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
|---|---|
|
Grade
The changes in myopia rate in 3 years were compared by generalized estimation equation in different grades
|
This cohort study aimed to assess the change of refractive status in Chinese school children under different outdoor time
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
refractive error
Time Frame: change from baseline at 36 months
|
The changes in refractive error were compared by generalized estimation equation.
|
change from baseline at 36 months
|
|
sex disparity
Time Frame: change from baseline at 36 months
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The changes in refractive error were compared between different sex
|
change from baseline at 36 months
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Study Chair: Yan Wang, director, Tianjin Eye Hospital
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General 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.
- Wang 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.
- Wang 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.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
January 1, 2018
Primary Completion (Anticipated)
December 31, 2021
Study Completion (Anticipated)
December 31, 2021
Study Registration Dates
First Submitted
November 1, 2021
First Submitted That Met QC Criteria
November 11, 2021
First Posted (Actual)
November 15, 2021
Study Record Updates
Last Update Posted (Actual)
November 15, 2021
Last Update Submitted That Met QC Criteria
November 11, 2021
Last Verified
November 1, 2021
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2021022
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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