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Completed

NCT Number: NCT05967702

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

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.

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Key information

Age range

6 year–18 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Tianjin Eye Hospital

Tianjin, Tianjin Municipality, China

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • All 6-18 years students

Exclusion criteria

  • No eye diseases such as cataracts, glaucoma, keratoconus, etc.
  • No psychiatric disorders
  • Astigmatism ≤ -6.00D

Treatment and study plan

Primary outcomes

  1. Prevalence of myopia

    Time frame: One day measurement

    Myopia was defined as an equivalent spherical refraction ≤ -0.50D in either eye

  2. Prevalence of high myopia

    Time frame: One day measurement

    High myopia was defined as an equivalent spherical refraction ≤ -6.00D in either eye

Sponsors and collaborators

Lead sponsor

Tianjin Eye Hospital

Other

Registry information

Important dates

Study start
2019
Primary completion
2021
Study completion
2021
First posted
Aug 1, 2023
Registry last updated
Aug 1, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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