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Clinical Trials in China / NCT07547748
Recruiting Observational

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

NCT07547748 · tracked via the Priya Life Science China tracker
Sponsor
Zhongshan Ophthalmic Center, Sun Yat-sen University
Phase
Observational
Started
2025-01-01
Last updated
2026-04-23

Condition(s) studied

MyopiaStrabismusEye Health

Investigational drug(s) / intervention(s)

School-based Eye Health Screening

School-based Eye Health Screening: 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 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.

Eligibility

Sex
ALL
Min age
3 Years
Max age
18 Years
Healthy volunteers
Accepted
Inclusion Criteria: * 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. Exclusion Criteria: * 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.

Primary outcome measure(s)

Trial sites (1)

FacilityCityRegionStatus
Fengqing County People's Hospital Lincang Yunnan Recruiting

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Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07547748 on ClinicalTrials.gov ↗ ← All trials in China