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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT05336799
Other study ID # Tianjin Myopia Study
Secondary ID
Status Recruiting
Phase
First received
Last updated
Start date March 1, 2021
Est. completion date December 31, 2025

Study information

Verified date November 2022
Source Tianjin Eye Hospital
Contact xiaoyan yang, director
Phone +8627306525
Email yanzitjsykyy@163.com
Is FDA regulated No
Health authority
Study type Observational

Clinical 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.


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.


Recruitment information / eligibility

Status Recruiting
Enrollment 500000
Est. completion date December 31, 2025
Est. primary completion date December 1, 2022
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 6 Years to 18 Years
Eligibility Inclusion Criteria: - aged 6 to 18 years - no ocular diseases and systemic diseases - consent to undergo an eye examination Exclusion Criteria: - schoolchildren unwilling to participate

Study Design


Related Conditions & MeSH terms


Locations

Country Name City State
China Tianjin Eye Hospital Tianjin Tianjin

Sponsors (1)

Lead Sponsor Collaborator
Tianjin Eye Hospital

Country where clinical trial is conducted

China, 

References & Publications (3)

Guo 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. — View Citation

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. Review. — View Citation

Tenovuo 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. — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary Prevalence of myopia Myopia is defined as any eye's SER (sphere + 1/2 cylinder) of at least -0.5 diopters (D). up to 3years
Secondary Changes in prevalence of myopia Myopia is defined as any eye's SER (sphere + 1/2 cylinder) of at least -0.5 diopters (D). up to 3years
Secondary Changes of Spherical equivalent Changes of Spherical equivalent changes from baseline at 36months
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