Evaluation of a County-Based Eye Health Service Model in Rural Chinese Children
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age3-18
SponsorZhongshan Ophthalmic Center, Sun Yat-sen University
About this trial
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 criteria
This trial accepts healthy volunteersQualifiers
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.
Disqualifiers
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 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.
Trial design
Design model
Cohort
Time perspective
Prospective
Treatments tested in this trial
School-based Eye Health Screening
Other interventionThis 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
Treatment groups
20,000 Participants
are divided into 1 treatment groupGroup A: Routine School-Based Eye Health Screening Group1 intervention
Trial outcomes
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.
Time frame
Through study completion, assessed once per year, with completion expected within 3 years.Secondary outcomes
1
DRS Sensitivity
Sensitivity is defined as the proportion of true strabismus cases that are correctly identified as positive by the DRS.
Time frame
Through study completion, assessed once per year, with completion expected within 3 years.2
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.
Time frame
Through study completion, assessed once per year, with completion expected within 3 years.3
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.
Time frame
Through study completion, assessed once per year, with completion expected within 3 years.4
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.
Time frame
Through study completion, assessed once per year, with completion expected within 3 years.Sponsors and contacts
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Source ClinicalTrials.gov