MyopiaNCT07851532
Screening for Hyperopic Reserve in Kindergarten
An observational study of Myopia, run by Beijing Tongren Hospital at 1 site in China.
Trial summary
Screening for hyperopic reserve among senior kindergarten children is an important population-based eye health measure. Hyperopic reserve refers to physiological hyperopia in young children, which acts as a natural buffer against myopia development. Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Myopia
- How many people
- 134,000 participants
- Where
- 1 siteChina
- Study dates
- 1 Sep 2026to 31 Oct 2026
- 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 Any age
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Study population: This is a population-based census (not a sampling survey) of senior kindergarten children within Beijing's education system. The candidate roster of 134,000 children was verified and provided by educational authorities before project initiation. Eligible participants are senior kindergarten children whose parents or guardians signed informed consent and who can cooperate with eye examinations. All children meeting inclusion criteria from over 2,200 kindergartens across Beijing are invited to join the study.
Who may be able to join
- Senior kindergarten children within the education system of Beijing.
- Informed consent signed by parents or guardians.
- Children are able to cooperate to complete examinations, with physical and cognitive status permitting.
Who cannot join
- Children whose parents or guardians refuse to sign informed consent.
- Children who cannot cooperate with screening examinations due to poor physical or cognitive status.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
Beijing Tongren Hospital, Capital Medical University
Beijing
Kai Cao, 01058265910, caozhi@ccmu.edu.cn
About this study
Official title: Screening for Hyperopic Reserve in Kindergarten Senior Class Children in Beijing
Screening for hyperopic reserve among senior kindergarten children is an important population-based eye health measure. Hyperopic reserve refers to physiological hyperopia in young children, which acts as a natural buffer against myopia development. This screening aims to identify children with insufficient hyperopic reserve at an early stage, providing information for implement targeted myopia prevention interventions, and reduce the risk of subsequent myopia onset and progression.
Read the detailed description
This population-based hyperopic reserve screening targeted all senior kindergarten children across Beijing (This is a population-based census, rather than a sample survey, covering all senior kindergarten children in Beijing.). The project covered all kindergartens in Beijing (more than 2,200 kindergartens in totals in year 2026), with anticipated 134,000 children enrolled (The roster of 134,000 children was verified kindergarten by kindergarten and provided by educational authorities before project initiation. Only children who signed informed consent underwent screening; therefore, the actual screened sample size would be smaller than 134,000.). Initiated by the Beijing Municipal Education Commission (provide the funding), the screening was implemented by Capital Medical University and supported by Beijing Tongren Hospital.
The ophthalmic assessments included visual acuity measurement and comprehensive ocular biometry. Ocular biometric parameters collected were not limited to axial length; corneal curvature and other biometric indicators were also measured. Non-cycloplegic autorefraction was performed to calculate spherical equivalent refraction for evaluating hyperopic reserve status. No anterior segment examination was included in this screening protocol. A standardized parental questionnaire, with 88 questions, was administered to collect information including demographic characteristics, family history of myopia, outdoor activity time, near-work behaviors, screen exposure and sleep duration, to explore factors associated with hyperopic reserve.
Prior to the launch of screening, documents were issued by educational authorities and distributed to all kindergartens. The screening team developed a detailed screening schedule according to the geographic distribution of kindergartens across Beijing, specifying the exact date for completing screening at each kindergarten. All initial screening procedures were conducted on-site at kindergartens. The screening sessions took place between 8:30 a.m. to 11:30 a.m. and between 2:00 p.m. to 4:30 p.m., with kindergartens providing the venue.
Screening was organized by class. Children were brought to designated areas within the kindergarten, usually large activity rooms with a 5-meter space reserved for visual acuity testing. Kindergarten life teachers assisted in maintaining order among children. The testing duration for each class was approximately 20-35 minutes, depending on children's cooperation level.
Unified equipment was used for screening. There were 22 screening teams equipped with 44 sets of self-developed electronic visual acuity charts from Capital Medical University (identical models), 22 NIDEK auto-refractors (identical models), and 22 NIDEK biometers (identical models). Each set of equipment was fitted with a custom crash-resistant transport case, and calibration was performed before measurements.
All collected data were uploaded to the cloud in real time via the project platform without manual entry. In rare cases where data transmission failed due to signal delay, screening records were photographed for archiving and entered manually at a later stage.
A small number of children who had signed informed consent but were absent on the screening day due to illness or other reasons received centralized make-up screening on weekends.
Key principal investigators of this project: Vice President Chen Rui (Chen is the family name) from Capital Medical University, Professor Zhu Huiping (Zhu is the family name) from the School of Public Health, Director Jie Ying (Jie is the family name) of the Department of Ophthalmology at Beijing Tongren Hospital. Other researchers include ophthalmologist Tian Lei (Tian is the family name), ophthalmic researcher Cao Kai (Cao is the family name) from Beijing Institute of Ophthalmology, Beijing Tongren Hospital and Dr. Jiang Jiaxin(Jiang is the family name) from the School of Public Health, Capital Medical University.
The primary aim of this screening was to identify children with insufficient hyperopic reserve at an early stage. Combining ocular biometric data and questionnaire information, the study identified children at high risk of myopia onset, delivered myopia prevention health education to parents and kindergartens, and provided follow-up recommendations for high-risk individuals.
This project represents a milestone in myopia prevention and control in China. Nearly half of the participating children will be referred to Beijing Tongren Hospital and other affiliated hospitals of Capital Medical University that are members of the Hyperopic Reserve Protection Alliance for cycloplegic refraction re-examination. Consequently, the investigators can generate a highly precise profile of visual acuity, refractive status, axial length and other ocular biometric parameters among senior kindergarten children. Using the gold-standard data obtained from cycloplegic refraction, the investigators can refine the measurements acquired under non-cycloplegic conditions. These data will be used to develop predictive models to guide future large-scale screening programmes.
- Conditions
- Myopia
- Keywords
- Myopia, Hyperopic Reserve, Kindergarten
- Medical subject headings
- Myopia
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 |
|---|---|---|
| Senior kindergarten children, Beijing hyperopic reserve census | This is a population-based census of senior kindergarten children across Beijing, covering more than 2,200 kindergartens and approximately 134,000 participants. Initiated by the Beijing Municipal Commission of Education, the study was implemented by Capital Medical University with support from Beijing Tongren Hospital. All children underwent visual acuity tests and comprehensive ocular biometry, including axial length and corneal curvature measurements, as well as non-cycloplegic autorefraction. A standardized parental questionnaire was used to collect information on demographics, family myopia history, outdoor activity, and visual behaviors. Nearly half of the screened children were referred to Beijing Tongren Hospital and other member hospitals of the Hyperopic Reserve Protection Alliance affiliated with Capital Medical University for cycloplegic refraction re-examination (gold standard refractive measurement). After referral, children may receive additional examinations and clinic |
What is being measured
The primary outcome is the main question the study is designed to answer.
Spherical Equivalent Error
Spherical equivalent is calculated from refractive readings acquired via non-cycloplegic autorefraction during on-site kindergarten screening or cycloplegic re-examination (for half children, anticapated).
Measured: Baseline, 1-month, 6-month, 12-month
Axial length
Ocular axial length is measured using a NIDEK biometer during on-site kindergarten screening
Measured: Baseline, 1-month, 6-month, 12-month
Secondary outcomes (1)
Uncorrected Distance Visual acuity
Uncorrected distance visual acuity is tested on-site at kindergartens using the self-developed electronic visual acuity chart from Capital Medical University. The chart complies with the Chinese national standard GB Standard Logarithmic Visual Acuity Chart, adopting the 5-mark recording system (e.g., 5.0, 4.8) with a 5-meter testing distance.
Measured: Baseline, 6-month, 12-month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Oct 2026
- Study start1 Sep 2026
- Primary completion31 Oct 2026 (estimated)
- Study completion31 Oct 2026 (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
- 134,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Beijing Tongren Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Capital Medical University
- Responsible party
- Principal investigator, Ying Jie, Beijing Tongren Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07851532
- Sponsor's protocol ID
- yuanshichubeishaicha
- Status last verified
- Sep 2026
- First submitted
- 18 Sep 2026
- Last updated
- 1 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Individual participant data (IPD) will not be shared publicly at this stage. The dataset contains sensitive personal health information of young children. Data access is restricted by Chinese personal information protection regulations and institutional data management policies. Data may be available for authorized research upon formal project application and ethical review approval.
Study at a glance
From the registry record, last updated by the sponsor on 1 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Screening for Hyperopic Reserve in Kindergarten Senior Class Children in Beijing
- ClinicalTrials.gov ID
- NCT07851532
- Acronym / sponsor ID
- yuanshichubeishaicha
- Conditions
- Myopia
- Keywords
- Myopia, Hyperopic Reserve, Kindergarten
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 134,000 participants (estimated)
- Lead sponsor
- Beijing Tongren HospitalUniversity, hospital or other
- Collaborators
- Capital Medical University
- Study start
- 1 Sep 2026 (actual)
- Primary completion
- 31 Oct 2026 (estimated)
- Study completion
- 31 Oct 2026 (estimated)
- First posted
- 1 Oct 2026 (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.
Screening for hyperopic reserve among senior kindergarten children is an important population-based eye health measure. Hyperopic reserve refers to physiological hyperopia in young children, which acts as a natural buffer against myopia development. This screening aims to identify children with insufficient hyperopic reserve at an early stage, providing information for implement targeted myopia prevention interventions, and reduce the risk of subsequent myopia onset and progression.
Detailed description
This population-based hyperopic reserve screening targeted all senior kindergarten children across Beijing (This is a population-based census, rather than a sample survey, covering all senior kindergarten children in Beijing.). The project covered all kindergartens in Beijing (more than 2,200 kindergartens in totals in year 2026), with anticipated 134,000 children enrolled (The roster of 134,000 children was verified kindergarten by kindergarten and provided by educational authorities before project initiation. Only children who signed informed consent underwent screening; therefore, the actual screened sample size would be smaller than 134,000.). Initiated by the Beijing Municipal Education Commission (provide the funding), the screening was implemented by Capital Medical University and supported by Beijing Tongren Hospital.
The ophthalmic assessments included visual acuity measurement and comprehensive ocular biometry. Ocular biometric parameters collected were not limited to axial length; corneal curvature and other biometric indicators were also measured. Non-cycloplegic autorefraction was performed to calculate spherical equivalent refraction for evaluating hyperopic reserve status. No anterior segment examination was included in this screening protocol. A standardized parental questionnaire, with 88 questions, was administered to collect information including demographic characteristics, family history of myopia, outdoor activity time, near-work behaviors, screen exposure and sleep duration, to explore factors associated with hyperopic reserve.
Prior to the launch of screening, documents were issued by educational authorities and distributed to all kindergartens. The screening team developed a detailed screening schedule according to the geographic distribution of kindergartens across Beijing, specifying the exact date for completing screening at each kindergarten. All initial screening procedures were conducted on-site at kindergartens. The screening sessions took place between 8:30 a.m. to 11:30 a.m. and between 2:00 p.m. to 4:30 p.m., with kindergartens providing the venue.
Screening was organized by class. Children were brought to designated areas within the kindergarten, usually large activity rooms with a 5-meter space reserved for visual acuity testing. Kindergarten life teachers assisted in maintaining order among children. The testing duration for each class was approximately 20-35 minutes, depending on children's cooperation level.
Unified equipment was used for screening. There were 22 screening teams equipped with 44 sets of self-developed electronic visual acuity charts from Capital Medical University (identical models), 22 NIDEK auto-refractors (identical models), and 22 NIDEK biometers (identical models). Each set of equipment was fitted with a custom crash-resistant transport case, and calibration was performed before measurements.
All collected data were uploaded to the cloud in real time via the project platform without manual entry. In rare cases where data transmission failed due to signal delay, screening records were photographed for archiving and entered manually at a later stage.
A small number of children who had signed informed consent but were absent on the screening day due to illness or other reasons received centralized make-up screening on weekends.
Key principal investigators of this project: Vice President Chen Rui (Chen is the family name) from Capital Medical University, Professor Zhu Huiping (Zhu is the family name) from the School of Public Health, Director Jie Ying (Jie is the family name) of the Department of Ophthalmology at Beijing Tongren Hospital. Other researchers include ophthalmologist Tian Lei (Tian is the family name), ophthalmic researcher Cao Kai (Cao is the family name) from Beijing Institute of Ophthalmology, Beijing Tongren Hospital and Dr. Jiang Jiaxin(Jiang is the family name) from the School of Public Health, Capital Medical University.
The primary aim of this screening was to identify children with insufficient hyperopic reserve at an early stage. Combining ocular biometric data and questionnaire information, the study identified children at high risk of myopia onset, delivered myopia prevention health education to parents and kindergartens, and provided follow-up recommendations for high-risk individuals.
This project represents a milestone in myopia prevention and control in China. Nearly half of the participating children will be referred to Beijing Tongren Hospital and other affiliated hospitals of Capital Medical University that are members of the Hyperopic Reserve Protection Alliance for cycloplegic refraction re-examination. Consequently, the investigators can generate a highly precise profile of visual acuity, refractive status, axial length and other ocular biometric parameters among senior kindergarten children. Using the gold-standard data obtained from cycloplegic refraction, the investigators can refine the measurements acquired under non-cycloplegic conditions. These data will be used to develop predictive models to guide future large-scale screening programmes.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Senior kindergarten children, Beijing hyperopic reserve census | – | –This is a population-based census of senior kindergarten children across Beijing, covering more than 2,200 kindergartens and approximately 134,000 participants. Initiated by the Beijing Municipal Commission of Education, the study was implemented by Capital Medical University with support from Beijing Tongren Hospital. All children underwent visual acuity tests and comprehensive ocular biometry, including axial length and corneal curvature measurements, as well as non-cycloplegic autorefraction. A standardized parental questionnaire was used to collect information on demographics, family myopia history, outdoor activity, and visual behaviors. Nearly half of the screened children were referred to Beijing Tongren Hospital and other member hospitals of the Hyperopic Reserve Protection Alliance affiliated with Capital Medical University for cycloplegic refraction re-examination (gold standard refractive measurement). After referral, children may receive additional examinations and clinic |
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
- Study population
- This is a population-based census (not a sampling survey) of senior kindergarten children within Beijing's education system. The candidate roster of 134,000 children was verified and provided by educational authorities before project initiation. Eligible participants are senior kindergarten children whose parents or guardians signed informed consent and who can cooperate with eye examinations. All children meeting inclusion criteria from over 2,200 kindergartens across Beijing are invited to join the study.
Key inclusion criteria (3 listed)
- Senior kindergarten children within the education system of Beijing.
- Informed consent signed by parents or guardians.
- Children are able to cooperate to complete examinations, with physical and cognitive status permitting.
Key exclusion criteria (2 listed)
- Children whose parents or guardians refuse to sign informed consent.
- Children who cannot cooperate with screening examinations due to poor physical or cognitive status.
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
Spherical Equivalent Error
Time frame: Baseline, 1-month, 6-month, 12-month
Spherical equivalent is calculated from refractive readings acquired via non-cycloplegic autorefraction during on-site kindergarten screening or cycloplegic re-examination (for half children, anticapated).
Axial length
Time frame: Baseline, 1-month, 6-month, 12-month
Ocular axial length is measured using a NIDEK biometer during on-site kindergarten screening
1 secondary outcome
Uncorrected Distance Visual acuity
Time frame: Baseline, 6-month, 12-month
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 1 Oct 2026.
- Individual participant dataSharing planned: No. Individual participant data (IPD) will not be shared publicly at this stage. The dataset contains sensitive personal health information of young children. Data access is restricted by Chinese personal information protection regulations and institutional data management policies. Data may be available for authorized research upon formal project application and ethical review approval.
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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.
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?
The sponsor lists 3 inclusion and 2 exclusion criteria. 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: looking for participants now, as of the sponsor's last update on 1 Oct 2026. 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?
Contact Kai Cao (01058265900, caozhi@ccmu.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Spherical Equivalent Error (time frame: Baseline, 1-month, 6-month, 12-month). The study lists 2 primary outcomes in all. 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 1 Oct 2026.