Refractive ErrorsNCT07257536
Xinxing Eye Cohort Study
An observational study of Refractive Errors and Cataract, run by Zhongshan Ophthalmic Center, Sun Yat-sen University.
Trial 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). Read more about this study
- Who is it for?
- Ages 0 to 100 yearsHealthy volunteers can take part
- Conditions the study is for
- Refractive Errors, Cataract
- How many people
- 3,000 participants
- Where
- No sites listed yet
- Study dates
- 15 Dec 2025to 30 Nov 2028
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 0 to 100 years
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
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.
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this 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.
- Conditions
- Refractive Errors, Cataract
- Medical subject headings
- Refractive Errors, Cataract
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: through study completion, an average of 1 year
Secondary outcomes (5)
Strabismus
Assess strabismus status and angle at both near and distance fixation.
Measured: 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.
Measured: through study completion, an average of 1 year
Questionnaire
Questionnaires on demographics, disease histories and etc.
Measured: 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.
Measured: 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.
Measured: through study completion, an average of 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Dec 2025
- Study start15 Dec 2025 (estimated)
- Primary completion30 Nov 2028 (estimated)
- Study completion30 Nov 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Refractive ErrorsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 3,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Zhongshan Ophthalmic Center, Sun Yat-sen University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07257536
- Sponsor's protocol ID
- 2025KYPJ117
- Status last verified
- Sep 2025
- First submitted
- 18 Nov 2025
- Last updated
- 2 Dec 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Xinxing Eye Cohort Study
- ClinicalTrials.gov ID
- NCT07257536
- Acronym / sponsor ID
- 2025KYPJ117
- Conditions
- Refractive Errors, Cataract
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 3,000 participants (estimated)
- Lead sponsor
- Zhongshan Ophthalmic Center, Sun Yat-sen UniversityUniversity, hospital or other
- Study start
- 15 Dec 2025 (estimated)
- Primary completion
- 30 Nov 2028 (estimated)
- Study completion
- 30 Nov 2028 (estimated)
- First posted
- 2 Dec 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 0 to 100 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
- 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.
Key inclusion criteria (2 listed)
- 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
Key exclusion criteria (3 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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.
5 secondary outcomes
Strabismus
Time frame: through study completion, an average of 1 year
Autorefraction
Time frame: through study completion, an average of 1 year
Questionnaire
Time frame: through study completion, an average of 1 year
Fundus examination
Time frame: through study completion, an average of 1 year
Anterior segment examination
Time frame: through study completion, an average of 1 year
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Dec 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Questions about this trial
What is this clinical trial studying?
An observational study of Refractive Errors and Cataract, run by Zhongshan Ophthalmic Center, Sun Yat-sen University.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 2 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Lingyi Liang (+8602087330487, lianglingyi@gzzoc.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Visual acuity (time frame: through study completion, an average of 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Dec 2025.