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Trials / Completed

CompletedNCT05967702

A 3-year Cross-sectional Assessment of the Tianjin Child and Adolescent Large-scale Eye Study

Status
Completed
Phase
Study type
Observational
Enrollment
126,810 (actual)
Sponsor
Tianjin Eye Hospital · Academic / Other
Sex
All
Age
6 Years – 18 Years
Healthy volunteers
Accepted

Summary

This is a school-based, cross-sectional study to assess the incidence and prevalence, risk factors of myopia among schoolchildren in both eye-use environment, eye-use habits, lifestyle, and family and subjective factors before and during COVID-19. Large population and representative study subjects. Environmental exposure and daily within and out-of-school activities will be evaluated in a random subgroup.

Detailed description

Myopia is the most common refractive error and a major reason for reducing uncorrected visual acuity among schoolchildren. It was reported that during COVID-19, home confinement resulted in a significant increase in myopia due to the changed lifestyle of schoolchildren dramatically. However, it is unclear which kind of risk factors should be the first to bear the brunt before and during COVID-19. And which factors should be emphasized and confronted as the optimum strategy for myopia prevention and control? This cohort study aims to determine the risk factors, prevalence, and incidence of myopia, and SE changes among schoolchildren before and during COVID-19, hence identifying the factors that impact the onset and progression of myopia. This is a 3-year cross-sectional study. This study plans to enroll 126,810 participants (aged 6-18 years) from Tianjin, China. All grade students from 10 regions of Tianjin City, China will be analyzed. Over a 3-year follow-up period, students will receive detailed eye examinations annually and complete questionnaires about eye-use environment, eye-use habits, lifestyle, and family and subjective factors. In a 5% random sample size of this cohort study, outdoor activity, light intensity, eye use habits, and eye use environment data will be obtained using objective measuring devices. Myopia was defined as spherical equivalent refractive (SER) of ≤ -0.5D.

Conditions

Timeline

Start date
2019-07-01
Primary completion
2021-12-31
Completion
2021-12-31
First posted
2023-08-01
Last updated
2023-08-01

Locations

1 site across 1 country: China

Source: ClinicalTrials.gov record NCT05967702. Inclusion in this directory is not an endorsement.