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Not yet recruitingNCT07257536Updated Dec 2, 2025

Xinxing Eye Cohort Study

An observational study in Refractive Errors and Cataract, sponsored by Zhongshan Ophthalmic Center, Sun Yat-sen University. Not yet recruiting. Open to participants aged 0 Years to 100 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2025-12-02.

Sponsored by Zhongshan Ophthalmic Center, Sun Yat-sen University · Observational

Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
3,000
Ages
0 Years to 100 Years
Sex
All
01

Study summary

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.

02

Conditions studied

  • Refractive Errors
  • Cataract
03

Who can participate

Ages eligible
0 Years to 100 Years
Sexes eligible
All
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.

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

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
04

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
3,000 participants (estimated)
Patient registry
No
05

What researchers measure

Primary outcomes

  1. 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.

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

Secondary outcomes

  1. Strabismus

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

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

  2. 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.

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

  3. Questionnaire

    Questionnaires on demographics, disease histories and etc.

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

  4. 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.

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

  5. 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.

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

06

Study locations

No study locations are listed for this record.

07

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

08

Registry details

Key details

Study ID
NCT07257536
Lead sponsor
Zhongshan Ophthalmic Center, Sun Yat-sen University
Responsible party
Sponsor
First posted
Dec 2, 2025
Start date
Dec 15, 2025 (estimated)
Primary completion
Nov 30, 2028 (estimated)
Completion
Nov 30, 2028 (estimated)
Last update
Dec 2, 2025

Study contacts

Lingyi Liang
Contact
lianglingyi@gzzoc.com
+8602087330487

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is not yet recruiting, as verified in Sep 2025. You cannot join it, but the record below documents what was studied.

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