MyopiaNCT07547748
Evaluation of a County-Based Eye Health Service Model in Rural Chinese Children
An observational study of Myopia and Strabismus, run by Zhongshan Ophthalmic Center, Sun Yat-sen University at 1 site in China.
Trial summary
This project proposes to conduct a prospective, multicenter registry study in rural China to evaluate, under real-world conditions, the implementation effectiveness of an integrated child eye health service model centered at the county level and coordinated across county, township, village, and school tiers. Read more about this study
- Who is it for?
- Ages 3 to 18 yearsHealthy volunteers can take part
- Conditions the study is for
- Myopia, Strabismus, Eye Health
- What is being tested?
- School-based Eye Health Screening
- How many people
- 20,000 participants
- Where
- 1 siteChina
- Study dates
- 1 Jan 2025to 31 Dec 2028
- 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 3 to 18 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
Study population: Students enrolled in schools within the study areas-including kindergartens, primary schools, junior high schools, and senior high schools-in Yangxi County, Jiexi County, Huidong County, and Yingde City of Guangdong Province, as well as Fengqing County of Yunnan Province, or children and adolescents who are permanent residents in these jurisdictions.
Who may be able to join
- Aged 3 to 18 years; Enrolled in schools within the study areas, including kindergartens, primary schools, junior high schools, and senior high schools, in Yangxi County, Jiexi County, Huidong County, and Yingde City of Guangdong Province, as well as Fengqing County of Yunnan Province, or are children and adolescents who are permanent residents within these jurisdictions.
- Written informed consent has been provided by their legal guardians.
- For children aged 8 years and older, assent from the child is also required.
Who cannot join
- Presence of severe systemic diseases (such as severe congenital heart disease or intellectual developmental disorders) that preclude cooperation with ophthalmic examinations.
- Refusal by the legal guardian to participate, or inability of the legal guardian to cooperate with scheduled follow-up visits.
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
Fengqing County People's Hospital
Lincang, Yunnan
Chunguang Li, +86 13988359618, 1805391617@qq.com
About this study
Official title: Evaluation of a County-Based Eye Health Service Model for Preventing and Controlling Avoidable Visual Impairment in Rural Chinese Children
This project proposes to conduct a prospective, multicenter registry study in rural China to evaluate, under real-world conditions, the implementation effectiveness of an integrated child eye health service model centered at the county level and coordinated across county, township, village, and school tiers. The target population will include all children and adolescents within participating counties, and the primary exposure will be the annual coverage and implementation intensity of this service model. The study will focus on its impact on clinical outcomes such as refractive error correction rates and referral rates following eye disease screening, while also examining annual trends in disparities in access to different eye care services. Through long-term and systematic observation, the project aims to clarify the sustained effects of this eye health service model on improving the management of pediatric eye diseases, enhancing visual function, and promoting health equity, thereby providing evidence-based support for optimizing the rural child eye care system in China.
Read the detailed description
This project aims to address gaps in child eye health services in rural areas of China by developing an accessible, affordable, high-quality, and sustainable model of pediatric eye care. Childhood represents a critical stage of development, and if visual problems are not identified and treated in a timely manner, they may substantially impair motor, language, emotional, social, and cognitive development, with long-term adverse consequences for lifelong health and socioeconomic participation.
At present, the leading cause of visual impairment among children in China is uncorrected refractive error, accounting for more than 90% of cases. China has one of the highest prevalences of refractive error in the world. In 2020, the overall prevalence of myopia among Chinese children and adolescents was 52.7%; the prevalence was 14.3% at age 6, 35.6% in primary school, 71.1% in junior high school, and 80.5% in senior high school. Myopia has become a major public health issue affecting population health. Although wearing spectacles is a safe and cost-effective intervention for myopia correction, inadequate parental awareness, misconceptions about spectacle use, and the lack of high-quality refraction services at the primary-care level together constitute major barriers to effective correction of refractive errors.
In addition to refractive error, amblyopia is also relatively common in children, with a prevalence ranging from 1.0% to 5.0%. Among the approximately 300 million children in China, it is estimated that at least 3 million are affected by amblyopia. Risk factors for amblyopia include refractive error, anisometropia, strabismus, and congenital cataract, and the condition is most commonly seen during the preschool years, which are critical for visual development. If not detected and treated early, amblyopia may progress to persistent visual impairment. Although vision can often be improved through standardized treatment and training, treatment effectiveness declines with age; therefore, early screening and intervention are central principles of amblyopia prevention and control.
At present, the distribution of ophthalmic resources in China is mismatched with the geographic distribution of patients: approximately 70% of ophthalmic patients are located in primary-level settings, whereas high-quality resources are concentrated in urban areas. In rural regions, eye care services are markedly inadequate in terms of availability, accessibility, affordability, and acceptability, which seriously constrains efforts to prevent and manage childhood eye diseases. Therefore, a key scientific and practical challenge is how to establish and sustainably operate an integrated child eye care system in resource-limited settings.
Against this background, the project proposes to explore a pediatric eye care model tailored to rural China by conducting eye health screening among children and adolescents, establishing a county-level referral system for pediatric eye diseases, and strengthening pediatric ophthalmic service capacity in county hospitals. The project will also develop related service guidelines and implementation plans, with the ultimate goal of improving children's visual health and quality of life.
- Conditions
- Myopia, Strabismus, Eye Health
- Being tested
- School-based Eye Health Screening
- Medical subject headings
- Myopia, Strabismus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
School-based Eye Health ScreeningOther
This intervention consists of standardized annual school-based eye health examinations conducted under routine field conditions. Basic demographic information, including sex and age, is first recorded. Visual acuity testing is performed before intraocular pressure measurement or any other examination that may affect vision. Uncorrected visual acuity and, where applicable, presenting visual acuity are measured using a standard logarithmic visual acuity chart or ETDRS chart. For participants whose visual acuity is worse than 0.8, pinhole visual acuity is additionally assessed. Intraocular pressure is measured using non-contact tonometry (NCT). For children suspected of strabismus or amblyopia, further assessments may include ocular position examination, alternate cover testing, corneal light reflex testing, angle measurement, and an automatic smartphone-based Digital Ruler of Strabismus (DRS). Refraction is measured using a computerized autorefractor. This screening workflow enables syst
| Study group | Role | What they receive |
|---|---|---|
| Routine School-Based Eye Health Screening Group | Not described Receives: Other: School-based Eye Health Screening |
What is being measured
The primary outcome is the main question the study is designed to answer.
Annual Eye Health Screening Coverage Rate
The proportion of children who actually received eye health screening among the total number of target children in the study area during a given year, calculated as: number of children screened / total number of target children in the catchment area × 100%. This indicator reflects the reach and implementation coverage of the annual screening program.
Measured: Through study completion, assessed once per year, with completion expected within 3 years.
Secondary outcomes (8)
DRS Sensitivity
Sensitivity is defined as the proportion of true strabismus cases that are correctly identified as positive by the DRS.
Measured: Through study completion, assessed once per year, with completion expected within 3 years.
Refractive Error Correction Rate
At annual reassessment, children previously diagnosed with refractive error but not yet corrected will undergo repeat refraction to determine whether they are now wearing appropriately prescribed spectacles.
This indicator reflects the extent to which identified refractive errors have been corrected in the target population.
Measured: Through study completion, assessed once per year, with completion expected within 3 years.
Effective Refractive Error Correction Coverage (eREC)
The proportion of individuals in need of refractive error correction who have received correction, such as spectacles, contact lenses, or refractive surgery, and have achieved an effective or adequate visual outcome. This indicator measures not only access to refractive correction, but also the quality and effectiveness of that correction.
Measured: Through study completion, assessed once per year, with completion expected within 3 years.
Strabismus/Amblyopia Screening Detection Rate
The proportion of children screened who are identified as having strabismus or amblyopia, calculated as: number of children screened positive for strabismus or amblyopia / total number of children participating in eye health screening × 100%. This indicator reflects the program's yield in detecting major pediatric ocular alignment and visual development disorders.
Measured: Through study completion, assessed once per year, with completion expected within 3 years.
Referral Rate After Eye Disease Screening
The proportion of children with positive screening results who are successfully referred to county-level hospitals, calculated as: number of screen-positive children who actually attended referral at county-level hospitals / total number of screen-positive children × 100%. This indicator reflects the effectiveness of the referral pathway and the linkage between screening and follow-up care.
Measured: Through study completion, assessed once per year, with completion expected within 3 years.
DRS Specificity
Specificity is defined as the proportion of non-strabismus cases that are correctly identified as negative by the DRS.
Measured: Through study completion, assessed once per year, with completion expected within 3 years.
DRS Positive predictive value (PPV)
PPV is defined as the proportion of DRS-positive cases that are confirmed as true strabismus by the reference standard.
Measured: Through study completion, assessed once per year, with completion expected within 3 years.
DRS Accuracy
Accuracy is defined as the proportion of all screened subjects who are correctly classified by the DRS.
Measured: Through study completion, assessed once per year, with completion expected within 3 years.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Apr 2026
- Study start1 Jan 2025
- Primary completion31 Dec 2028 (estimated)
- Study completion31 Dec 2028 (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.
- More trials run by Zhongshan Ophthalmic Center, Sun Yat-sen UniversityThe sponsor's other registered studies.
- 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
- 20,000 participants (estimated)
- Target duration
- 3 Years
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07547748
- Sponsor's protocol ID
- 2023KYPJ358
- Status last verified
- Mar 2026
- First submitted
- 3 Apr 2026
- Last updated
- 23 Apr 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of a County-Based Eye Health Service Model for Preventing and Controlling Avoidable Visual Impairment in Rural Chinese Children
- ClinicalTrials.gov ID
- NCT07547748
- Acronym / sponsor ID
- 2023KYPJ358
- Conditions
- Myopia, Strabismus, Eye Health
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 20,000 participants (estimated)
- Lead sponsor
- Zhongshan Ophthalmic Center, Sun Yat-sen UniversityUniversity, hospital or other
- Study start
- 1 Jan 2025 (actual)
- Primary completion
- 31 Dec 2028 (estimated)
- Study completion
- 31 Dec 2028 (estimated)
- First posted
- 23 Apr 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.
This project proposes to conduct a prospective, multicenter registry study in rural China to evaluate, under real-world conditions, the implementation effectiveness of an integrated child eye health service model centered at the county level and coordinated across county, township, village, and school tiers. The target population will include all children and adolescents within participating counties, and the primary exposure will be the annual coverage and implementation intensity of this service model. The study will focus on its impact on clinical outcomes such as refractive error correction rates and referral rates following eye disease screening, while also examining annual trends in disparities in access to different eye care services. Through long-term and systematic observation, the project aims to clarify the sustained effects of this eye health service model on improving the management of pediatric eye diseases, enhancing visual function, and promoting health equity, thereby providing evidence-based support for optimizing the rural child eye care system in China.
Detailed description
This project aims to address gaps in child eye health services in rural areas of China by developing an accessible, affordable, high-quality, and sustainable model of pediatric eye care. Childhood represents a critical stage of development, and if visual problems are not identified and treated in a timely manner, they may substantially impair motor, language, emotional, social, and cognitive development, with long-term adverse consequences for lifelong health and socioeconomic participation.
At present, the leading cause of visual impairment among children in China is uncorrected refractive error, accounting for more than 90% of cases. China has one of the highest prevalences of refractive error in the world. In 2020, the overall prevalence of myopia among Chinese children and adolescents was 52.7%; the prevalence was 14.3% at age 6, 35.6% in primary school, 71.1% in junior high school, and 80.5% in senior high school. Myopia has become a major public health issue affecting population health. Although wearing spectacles is a safe and cost-effective intervention for myopia correction, inadequate parental awareness, misconceptions about spectacle use, and the lack of high-quality refraction services at the primary-care level together constitute major barriers to effective correction of refractive errors.
In addition to refractive error, amblyopia is also relatively common in children, with a prevalence ranging from 1.0% to 5.0%. Among the approximately 300 million children in China, it is estimated that at least 3 million are affected by amblyopia. Risk factors for amblyopia include refractive error, anisometropia, strabismus, and congenital cataract, and the condition is most commonly seen during the preschool years, which are critical for visual development. If not detected and treated early, amblyopia may progress to persistent visual impairment. Although vision can often be improved through standardized treatment and training, treatment effectiveness declines with age; therefore, early screening and intervention are central principles of amblyopia prevention and control.
At present, the distribution of ophthalmic resources in China is mismatched with the geographic distribution of patients: approximately 70% of ophthalmic patients are located in primary-level settings, whereas high-quality resources are concentrated in urban areas. In rural regions, eye care services are markedly inadequate in terms of availability, accessibility, affordability, and acceptability, which seriously constrains efforts to prevent and manage childhood eye diseases. Therefore, a key scientific and practical challenge is how to establish and sustainably operate an integrated child eye care system in resource-limited settings.
Against this background, the project proposes to explore a pediatric eye care model tailored to rural China by conducting eye health screening among children and adolescents, establishing a county-level referral system for pediatric eye diseases, and strengthening pediatric ophthalmic service capacity in county hospitals. The project will also develop related service guidelines and implementation plans, with the ultimate goal of improving children's visual health and quality of life.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 3 Years
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Routine School-Based Eye Health Screening Group | – | Other: School-based Eye Health Screening |
Who may qualify
- Ages
- 3 to 18 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
- Study population
- Students enrolled in schools within the study areas-including kindergartens, primary schools, junior high schools, and senior high schools-in Yangxi County, Jiexi County, Huidong County, and Yingde City of Guangdong Province, as well as Fengqing County of Yunnan Province, or children and adolescents who are permanent residents in these jurisdictions.
Key inclusion criteria (3 listed)
- Aged 3 to 18 years; Enrolled in schools within the study areas, including kindergartens, primary schools, junior high schools, and senior high schools, in Yangxi County, Jiexi County, Huidong County, and Yingde City of Guangdong Province, as well as Fengqing County of Yunnan Province, or are children and adolescents who are permanent residents within these jurisdictions.
- Written informed consent has been provided by their legal guardians.
- For children aged 8 years and older, assent from the child is also required.
Key exclusion criteria (2 listed)
- Presence of severe systemic diseases (such as severe congenital heart disease or intellectual developmental disorders) that preclude cooperation with ophthalmic examinations.
- Refusal by the legal guardian to participate, or inability of the legal guardian to cooperate with scheduled follow-up visits.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| School-based Eye Health ScreeningThis intervention consists of standardized annual school-based eye health examinations conducted under routine field conditions. Basic demographic information, including sex and age, is first recorded. Visual acuity testing is performed before intraocular pressure measurement or any other examination that may affect vision. Uncorrected visual acuity and, where applicable, presenting visual acuity are measured using a standard logarithmic visual acuity chart or ETDRS chart. For participants whose visual acuity is worse than 0.8, pinhole visual acuity is additionally assessed. Intraocular pressure is measured using non-contact tonometry (NCT). For children suspected of strabismus or amblyopia, further assessments may include ocular position examination, alternate cover testing, corneal light reflex testing, angle measurement, and an automatic smartphone-based Digital Ruler of Strabismus (DRS). Refraction is measured using a computerized autorefractor. This screening workflow enables syst | Other | Routine School-Based Eye Health Screening Group |
Primary outcome
Annual Eye Health Screening Coverage Rate
Time frame: Through study completion, assessed once per year, with completion expected within 3 years.
The proportion of children who actually received eye health screening among the total number of target children in the study area during a given year, calculated as: number of children screened / total number of target children in the catchment area × 100%. This indicator reflects the reach and implementation coverage of the annual screening program.
8 secondary outcomes
DRS Sensitivity
Time frame: Through study completion, assessed once per year, with completion expected within 3 years.
Refractive Error Correction Rate
Time frame: Through study completion, assessed once per year, with completion expected within 3 years.
Effective Refractive Error Correction Coverage (eREC)
Time frame: Through study completion, assessed once per year, with completion expected within 3 years.
Strabismus/Amblyopia Screening Detection Rate
Time frame: Through study completion, assessed once per year, with completion expected within 3 years.
Referral Rate After Eye Disease Screening
Time frame: Through study completion, assessed once per year, with completion expected within 3 years.
DRS Specificity
Time frame: Through study completion, assessed once per year, with completion expected within 3 years.
DRS Positive predictive value (PPV)
Time frame: Through study completion, assessed once per year, with completion expected within 3 years.
DRS Accuracy
Time frame: Through study completion, assessed once per year, with completion expected within 3 years.
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 23 Apr 2026.
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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 and Strabismus, run by Zhongshan Ophthalmic Center, Sun Yat-sen University 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 23 Apr 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 Wenyong Huang, Professor (+86 18922103835, huangwenyong@gzzoc.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Annual Eye Health Screening Coverage Rate (time frame: Through study completion, assessed once per year, with completion expected within 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 23 Apr 2026.