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NCT Number: NCT07257536

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.

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Key information

Conditions

Refractive Errors Cataract Eye Diseases Lens Diseases

Age range

0 year–100 year

Sex eligibility

All sexes

Study type

Observational

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. Visual acuity

    Time frame: through study completion, an average of 1 year

    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.

Secondary outcomes

  1. Strabismus

    Time frame: through study completion, an average of 1 year

    Assess strabismus status and angle at both near and distance fixation.

  2. Autorefraction

    Time frame: through study completion, an average of 1 year

    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.

  3. Questionnaire

    Time frame: through study completion, an average of 1 year

    Questionnaires on demographics, disease histories and etc.

  4. Fundus examination

    Time frame: through study completion, an average of 1 year

    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.

  5. Anterior segment examination

    Time frame: through study completion, an average of 1 year

    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.

Study contacts

Contact information is provided by the study sponsor or research team.

Lingyi Liang

CONTACT

[email protected]

+8602087330487

Sponsors and collaborators

Lead sponsor

Zhongshan Ophthalmic Center, Sun Yat-sen University

Other

Registry information

Important dates

Study start
2025
Primary completion
2028
Study completion
2028
First posted
Dec 2, 2025
Registry last updated
Dec 2, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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