MyopiaBCESNCT06931444
The Beijing Childhood Eye Study
An observational study of Myopia, run by Beijing Tongren Hospital at 1 site in China.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 6 to 12 yearsHealthy volunteers can take part
- Conditions the study is for
- Myopia
- How many people
- 3,760 participants
- Where
- 1 siteChina
- Study dates
- 1 Jan 2020to 1 Sep 2025
- How long will I take part?
- 3 Years
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 6 to 12 years
- All sexes
- Healthy volunteers accepted
- Child
Study population: Grades 1-3 primary school students.
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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
About this study
Official title: 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
Read the 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.
- Conditions
- Myopia
- Keywords
- myopia, child, axial length, refractive error
- Medical subject headings
- Myopia, Refractive Errors
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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 being measured
The primary outcome is the main question the study is designed to answer.
Myopia development
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.
Measured: 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Apr 2025
- Study start1 Jan 2020
- Primary completion1 Aug 2025 (estimated)
- Study completion1 Sep 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for MyopiaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 3,760 participants (estimated)
- Target duration
- 3 Years
Sponsor and investigators
- Lead sponsor
- Beijing Tongren Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06931444
- Sponsor's protocol ID
- Beijing Childhood Eye Study
- Other IDs
- Z201100005520045
- Acronym
- BCES
- Status last verified
- Apr 2025
- First submitted
- 15 Apr 2025
- Last updated
- 17 Apr 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 17 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- School Based Cohort Study for Myopia-The Beijing Childhood Eye Study
- ClinicalTrials.gov ID
- NCT06931444
- Acronym / sponsor ID
- BCES / Beijing Childhood Eye Study
- Conditions
- Myopia
- Keywords
- myopia, child, axial length, refractive error
- Study type
- Observational
- Recruitment status
- Enrolling by invitation
- Enrolment
- 3,760 participants (estimated)
- Lead sponsor
- Beijing Tongren HospitalUniversity, hospital or other
- Study start
- 1 Jan 2020 (actual)
- Primary completion
- 1 Aug 2025 (estimated)
- Study completion
- 1 Sep 2025 (estimated)
- First posted
- 17 Apr 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 3 Years
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 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. |
Who may qualify
- Ages
- 6 to 12 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
- Study population
- Grades 1-3 primary school students.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Apr 2025.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Myopia, run by Beijing Tongren Hospital at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: enrolling by invitation, as of the sponsor's last update on 17 Apr 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Myopia development (time frame: 3 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Apr 2025.