Evaluation of a County-Based Eye Health Service Model in Rural Chinese Children
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: School-based Eye Health Screening.
- Who it may be relevant to
- Registry conditions: Myopia, Strabismus, Eye Health. Basic parameters: 3 years — 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- China
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Evaluation of a County-Based Eye Health Service Model for Preventing and Controlling Avoidable Visual Impairment in Rural Chinese Children
Overview
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.
Interventions
- Other 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
Primary outcome measures
- Annual Eye Health Screening Coverage Rate [Time frame: Through study completion, assessed once per year, with completion expected within 3 years.]
Secondary outcome measures (8)
- 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.]
Eligibility criteria
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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: Yes
Study design
- Observational model
- Cohort
Study locations
China · 1 center
- Fengqing County People's Hospital — Lincang
Identifiers
NCT: NCT07547748 · 2023KYPJ358