Evaluation of a County-Based Eye Health Service Model in Rural Chinese Children

NCT07547748 | Recruiting

• 1 other identifier: 2023KYPJ358
• Study Type: observational
• Target: 20,000
• Locations: 1 country
• Sites: 1

Brief 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. 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.

Conditions

Myopia; Strabismus; Eye Health

Outcome Measures

Primary Outcomes (1)

• 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.

  Through study completion, assessed once per year, with completion expected within 3 years.

Secondary Outcomes (8)

• DRS Sensitivity

  Through study completion, assessed once per year, with completion expected within 3 years.

• Refractive Error Correction Rate

  Through study completion, assessed once per year, with completion expected within 3 years.

• Effective Refractive Error Correction Coverage (eREC)

  Through study completion, assessed once per year, with completion expected within 3 years.

• Strabismus/Amblyopia Screening Detection Rate

  Through study completion, assessed once per year, with completion expected within 3 years.

• Referral Rate After Eye Disease Screening

  Through study completion, assessed once per year, with completion expected within 3 years.

Study Arms (1)

Routine School-Based Eye Health Screening Group

Other: School-based Eye Health Screening

Interventions

School-based Eye Health Screening OTHER

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

Routine School-Based Eye Health Screening Group

Eligibility Criteria

• Age: 3 Years - 18 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64)
• Sampling Method: Non-Probability Sample

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.

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Zhongshan Ophthalmic Center, Sun Yat-sen University: lead

Study Sites (1)

Fengqing County People's Hospital

Lincang, Yunnan, China

RECRUITING

MeSH Terms

Conditions

Myopia; Strabismus

Condition Hierarchy (Ancestors)

Refractive Errors; Eye Diseases; Ocular Motility Disorders; Cranial Nerve Diseases; Nervous System Diseases

Central Study Contacts

Wenyong Huang, Professor

CONTACT

+86 18922103835; huangwenyong@gzzoc.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 3 Years
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 3, 2026
• First Posted: April 23, 2026
• Study Start: January 1, 2025
• Primary Completion (Estimated): December 31, 2028
• Study Completion (Estimated): December 31, 2028
• Last Updated: April 23, 2026

Record last verified: 2026-03

Locations

CN (1)