The Beijing Childhood Eye Study (BCES)

April 15, 2025 updated by: Beijing Tongren Hospital

School Based Cohort Study for Myopia-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

Study Overview

Status

Enrolling by invitation

Conditions

Detailed Description

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.

Study Type

Observational

Enrollment (Estimated)

3760

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
    • Beijing
      • Beijing, Beijing, China, 100083
        • Beijing Tongren Hospital

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

  • Child

Accepts Healthy Volunteers

Yes

Sampling Method

Non-Probability Sample

Study Population

Grades 1-3 primary school students.

Description

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.

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
3 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Beijing Tongren Hospital

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, 2020

Primary Completion (Estimated)

August 1, 2025

Study Completion (Estimated)

September 1, 2025

Study Registration Dates

First Submitted

April 15, 2025

First Submitted That Met QC Criteria

April 15, 2025

First Posted (Actual)

April 17, 2025

Study Record Updates

Last Update Posted (Actual)

April 17, 2025

Last Update Submitted That Met QC Criteria

April 15, 2025

Last Verified

April 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Beijing Childhood Eye Study
  • Z201100005520045 (Other Grant/Funding Number: the Science & Technology Project of Beijing Municipal Science & Technology Commission)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

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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