RecruitingNCT07547748

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

Evaluation of a County-Based Eye Health Service Model for Preventing and Controlling Avoidable Visual Impairment in Rural Chinese Children

Sponsor

Zhongshan Ophthalmic Center, Sun Yat-sen University

Enrollment

20,000 participants

Start Date

Jan 1, 2025

Study Type

OBSERVATIONAL

Conditions

Strabismus Myopia

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

Min Age: 3 YearsMax Age: 18 Years

Inclusion Criteria3

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 Criteria2

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.

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Interventions

OTHERSchool-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