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RecruitingNCT07851532Updated Oct 1, 2026

Screening for Hyperopic Reserve in Kindergarten

An observational study in Myopia, sponsored by Beijing Tongren Hospital. Recruiting at 1 site in China. Per ClinicalTrials.gov, last updated 2026-10-01.

Sponsored by Beijing Tongren Hospital · Observational

From the registry’s dates

  • Started Sep 2026; still recruiting 1 month later.
Updated Oct 1, 2026Newly registeredGo to Updates ↓
Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
134,000
Sex
All
01

Study 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. 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.

02

Conditions studied

  • Myopia

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Keywords

  • Myopia
  • Hyperopic Reserve
  • Kindergarten
03

In context

Myopia

984 studies on the registry are indexed under Myopia; 210 are open to participants now.

This study's planned enrollment of 134,000 is above the median of 150 across 173 observational studies indexed under Myopia.

Browse Myopia studies →

Lead sponsor

Beijing Tongren Hospital is the lead sponsor of 154 studies on the registry; 49 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
Child (0–17), Adult (18–64), Older adult (65+)
Sexes eligible
All
Accepts healthy volunteers
Yes
Sampling method
Non-probability sample

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.

Inclusion criteria

  1. Senior kindergarten children within the education system of Beijing.
  2. Informed consent signed by parents or guardians.
  3. Children are able to cooperate to complete examinations, with physical and cognitive status permitting.

Exclusion criteria

Exclusion Criteria:

  1. Children whose parents or guardians refuse to sign informed consent.
  2. Children who cannot cooperate with screening examinations due to poor physical or cognitive status.
05

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
134,000 participants (estimated)
Patient registry
No

Groups and cohorts

  • 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

06

What researchers measure

Primary outcomes

  1. 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).

    Time frame: Baseline, 1-month, 6-month, 12-month

  2. Axial length

    Ocular axial length is measured using a NIDEK biometer during on-site kindergarten screening

    Time frame: 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.

    Time frame: Baseline, 6-month, 12-month

07

Study locations

1 of 1 sites recruiting
  • Beijing Tongren Hospital, Capital Medical University
    Beijing, China
    Recruiting
08

References and documents

Individual participant data

Plan to share: 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.

No publications or documents are linked to this record.

09

Updates

1 registry update since Sep 25, 2026
Registered
First appeared on the registry. No changes since
Oct 1, 2026
Show all 1 update
  1. Oct 1, 2026
    First appeared on the registry

From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗

10

Registry details

Key details

Study ID
NCT07851532
Lead sponsor
Beijing Tongren Hospital
Collaborators
Capital Medical University
Responsible party
Ying Jie (Head of the Ophthalmology Department, Beijing Tongren Hospital) — Principal investigator
First posted
Oct 1, 2026
Start date
Sep 1, 2026
Primary completion
Oct 31, 2026 (estimated)
Completion
Oct 31, 2026 (estimated)
Last update
Oct 1, 2026

Study contacts

Kai Cao
Contact
caozhi@ccmu.edu.cn
01058265900

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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