Xinxing Eye Cohort Study

To establish the baseline levels and monitor the progress of two newly introduced global eye health indicators in Xinxing County, including effective refractive error coverage (eREC) and effective cataract surgery coverage (eCSC). And to assess the prevalence and treatment status of common eye disease in Xinxing County.

Study Overview

• Status: Not yet recruiting
• Conditions: Refractive Errors; Cataract

• Study Type: Observational
• Enrollment (Estimated): 3000

Contacts and Locations

• Study Contact: Name: Lingyi Liang; Phone Number: +8602087330487; Email: lianglingyi@gzzoc.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: Yes

• Sampling Method: Probability Sample

Study Population

Primary and secondary school students in Xinxing County and people covered by the national basic public health service, including children aged 0-6, seniors over 65 years old and diabetic patients, etc.

Description

Inclusion Criteria:

• Primary and secondary school students in Xinxing County and people covered by the national basic public health service, including children aged 0-6, seniors over 65 years old and diabetic patients, etc.
• Voluntarily participate in this study and provide signed informed consent

Exclusion Criteria:

• Unable to cooperate with research-related examinations, such as those with disabilities, communication barriers, or other reasons that prevent examinations
• With serious systemic disease that may affect the examination, or participating in the research examination may endanger one's health
• Other people who the researchers consider unsuitable to participate in this study

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Visual acuity	Test and record uncorrected visual acuity; if the participant wears glasses, measure the best corrected visual acuity with glasses. For participants with poor unaided or corrected visual acuity (<4.7), perform additional pinhole visual acuity testing.	through study completion, an average of 1 year

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Strabismus	Assess strabismus status and angle at both near and distance fixation.	through study completion, an average of 1 year
Autorefraction	Measure spherical power, cylindrical power, and axis in both eyes. Cycloplegia may be required in children, preferably using 1% tropicamide, one drop each time, three times. Before cycloplegia, check allergy history, medical history, and anterior chamber depth; inform guardians of potential risks and precautions related to cycloplegia, and ensure that guardians accompany the child throughout the procedure.	through study completion, an average of 1 year
Questionnaire	Questionnaires on demographics, disease histories and etc.	through study completion, an average of 1 year
Fundus examination	Examine the retina of both eyes and document any retinal pathology. If pupils are too small, mydriasis may be required, following the same drugs and procedures as above.	through study completion, an average of 1 year
Anterior segment examination	Use a slit lamp to examine eyelids, conjunctiva, cornea, anterior chamber, and lens in both eyes. Record any abnormalities. Grade lens opacities according to the LOCS III classification system.	through study completion, an average of 1 year

Collaborators and Investigators

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

Study record dates

Study Major Dates

• Study Start (Estimated): December 15, 2025
• Primary Completion (Estimated): November 30, 2028
• Study Completion (Estimated): November 30, 2028

Study Registration Dates

• First Submitted: November 18, 2025
• First Submitted That Met QC Criteria: November 30, 2025
• First Posted (Actual): December 2, 2025

Study Record Updates

• Last Update Posted (Actual): December 2, 2025
• Last Update Submitted That Met QC Criteria: November 30, 2025
• Last Verified: September 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Eye Diseases; Lens Diseases; Cataract; Refractive Errors
• Other Study ID Numbers: 2025KYPJ117

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No