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Enrolling by Invitation

NCT Number: NCT06931444

The Beijing Childhood Eye Study

Axial myopia has emerged as the leading cause of irreversible vision loss in East Asia, driven by its progression to sight-threatening complications including myopic macular degeneration, retinal detachment, open-angle glaucoma, and other complications. In the current study, we aim to observe the natural course of the development , progression, and its associated factors in children

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Key information

Age range

6 year–12 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Beijing Tongren hospital

Beijing, Beijing Municipality, 100083, China

About this study

This is a prospective epidemiological cohort study, recruiting students in grades 1-3 in primary school for myopia. Through stratified cluster random sampling, among aii the primary schools in Dongcheng District, Beijing, schools were stratified into key and ordinary schools, with 2 schools randomly selected from each stratum.

A prospective study cohort comprising 3,667 subjects was established. All study subjects completed a standard questionnaire and underwent routine ophthalmic examinations. Follow-up assessments will be conducted regularly to monitor changes in refractive errors and fundus indicators. Informed consent, approved by the Ethics Committee of Beijing Tongren Hospital, was obtained from all participants.

Who can participate

Healthy volunteers accepted: Yes

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

Inclusion criteria

1) Currently enrolled students in grades 1-3 of the selected primary schools, in good health, with normal ocular appearance. 2) No ocular diseases, no strabismus, ocular trauma, or history of intraocular surgery, with unaided visual acuity of 20/20 or better. 3) Parental and student consent to participate in the survey and signed informed consent form.

Exclusion criteria

1) Not currently enrolled in grades 1-3 of a primary school. 2) Students with pre-existing strabismus, other ocular diseases, or a history of ocular surgery at baseline, or those allergic to cycloplegic eyedrops. 3) Students unable to continue studying at their current school for more than three years from the baseline, including those who transfer to another school or withdraw from the study; 4) parental or student disagreement with participation in the survey.

Treatment and study plan

Primary outcomes

  1. Myopia development

    Time frame: 3 years

    Myopia was classified as a Spherical equivalent (SE) of -0.5 D or lower, and was further categorized into mild (-3 D < SE ≤ -0.5 D), moderate (-6 D < SE ≤ -3 D), and severe (SE ≤ -6 D). Hyperopia was classified as a SE of +1.0 D or greater. Intermediate refractive states (-0.5 D < SE < +1 D) were considered emmetropic. Astigmatism was defined as an absolute cylinder power of 0.75 diopters (D). Anisometropia were defined by an interocular SE difference of at least 1.0 D.

Sponsors and collaborators

Lead sponsor

Beijing Tongren Hospital

Other

Registry information

Official study title

School Based Cohort Study for Myopia-The Beijing Childhood Eye Study

Acronym: BCES

Important dates

Study start
2020
Primary completion
2025
Study completion
2025
First posted
Apr 17, 2025
Registry last updated
Apr 17, 2025

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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