- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07694505
Survey of Sensory Impairment Indicators Among Adults Aged 65 Years and Older in Xinxing County
July 2, 2026 updated by: Zhongshan Ophthalmic Center, Sun Yat-sen University
A Cross-Sectional Survey of Global Priority Sensory Impairment Indicators Among People Aged 65 Years and Older in Xinxing County
This cross-sectional population-based survey will be conducted among residents aged 65 years and older in Xinxing County, Yunfu, Guangdong Province, China.
The study will use standardized eye examinations, visual acuity and refractive assessment, anterior segment examination, hearing screening and questionnaires to estimate effective refractive error coverage, effective cataract surgical coverage, effective hearing technology coverage, common eye disease status, and dual sensory impairment among older adults.
The findings are intended to provide evidence for primary-level eye and hearing health services.
Study Overview
Status
Not yet recruiting
Detailed Description
The study addresses visual impairment, hearing impairment, and dual sensory impairment among older adults in a county-level population.
Participants will be recruited from older adults aged 65 years and above covered by the national basic public health service system in Xinxing County.
A probability proportional to size cluster sampling method will be used, with village or residential committees as the sampling frame.
Study procedures include distance and near visual acuity testing, assessment with habitual correction where applicable, pinhole testing when visual acuity is worse than 6/12, corresponding to decimal visual acuity less than 0.5, slit-lamp examination of the anterior segment, bilateral ear examination, hearing screening using the WHOears app, and relevant questionnaires.
Data will be entered and managed electronically and analyzed using descriptive and inferential statistical methods.
Study Type
Observational
Enrollment (Estimated)
2854
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Xiaotong Han
- Phone Number: 086-15999975559
- Email: hanxiaotong@gzzoc.com
Study Locations
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Guangdong
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Yunfu, Guangdong, China
- Xinxing County
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Older Adult
Accepts Healthy Volunteers
Yes
Sampling Method
Probability Sample
Study Population
Community-dwelling residents aged 65 years and older in Xincheng Town, Xinxing County, Yunfu, Guangdong Province, China, covered by the national basic public health service system.
Description
Inclusion Criteria:
- Aged 65 years or older.
- Voluntarily participates in the study and provides signed informed consent.
Exclusion Criteria:
- Unable to cooperate with study-related examinations, including because of disability, communication barriers, or other reasons.
- Has severe systemic disease that may affect study examinations or make participation potentially hazardous to health.
- Considered by the investigator to be unsuitable for participation in the study.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
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Adults aged 65 years and older in Xinxing County
Residents aged 65 years and older who meet eligibility criteria and provide written informed consent will undergo standardized visual, ocular, hearing, and questionnaire assessments during the cross-sectional survey.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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Effective Refractive Error Coverage
Time Frame: At the cross-sectional survey visit during the 2026-06 to 2026-12 data collection period.
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Effective refractive error coverage among the surveyed population, calculated at the person level as the proportion of participants with met refractive correction need among all participants with met, under-met, or unmet refractive correction need.
The primary threshold will be worse than 6/12 in the better eye, corresponding to decimal visual acuity less than 0.5, with improvement to 6/12 or better through habitual correction, pinhole, or refraction used to classify met, under-met, and unmet need.
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At the cross-sectional survey visit during the 2026-06 to 2026-12 data collection period.
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Effective Cataract Surgical Coverage
Time Frame: At the cross-sectional survey visit during the 2026-06 to 2026-12 data collection period.
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Effective cataract surgical coverage among the surveyed population, calculated at the person level as the proportion of participants with operated cataract and a good visual outcome among all participants with operated or operable cataract.
Good visual outcome is defined as presenting visual acuity of 6/12 or better; the final operable cataract threshold should be confirmed before release.
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At the cross-sectional survey visit during the 2026-06 to 2026-12 data collection period.
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Effective Hearing Technology Coverage
Time Frame: At the cross-sectional survey visit during the 2026-06 to 2026-12 data collection period.
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Effective hearing technology coverage among the surveyed population, calculated as the proportion of participants with moderate or greater hearing loss who regularly use hearing technology and report perceived benefit from its use.
Hearing loss classification will be based on WHOears app screening and study questionnaire data.
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At the cross-sectional survey visit during the 2026-06 to 2026-12 data collection period.
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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Prevalence and Correction Status of Common Eye Diseases
Time Frame: At the cross-sectional survey visit during the 2026-06 to 2026-12 data collection period.
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Prevalence and correction or treatment status of common eye diseases, including refractive error and cataract, based on standardized eye examinations and questionnaire data.
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At the cross-sectional survey visit during the 2026-06 to 2026-12 data collection period.
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Prevalence of Dual Sensory Impairment
Time Frame: At the cross-sectional survey visit during the 2026-06 to 2026-12 data collection period.
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Prevalence of dual sensory impairment, defined as the proportion of participants who meet both the study visual impairment criterion and the study hearing impairment criterion.
The visual impairment criterion will use worse than 6/12 in the better eye, corresponding to decimal visual acuity less than 0.5; the hearing impairment criterion will be based on WHOears app screening and study questionnaire data.
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At the cross-sectional survey visit during the 2026-06 to 2026-12 data collection period.
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Feasibility and Satisfaction of the SENSIIS System for Primary-Level Vision and Hearing Screening
Time Frame: At or after the cross-sectional survey visit during the 2026-06 to 2026-12 data collection period.
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Feasibility and satisfaction of the SENSIIS system for primary-level vision and hearing screening, assessed through questionnaires and interviews.
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At or after the cross-sectional survey visit during the 2026-06 to 2026-12 data collection period.
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Investigators
- Principal Investigator: Lingyi Liang, MD, Zhongshan Ophthalmic Center, Sun Yat-sen University
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Estimated)
July 6, 2026
Primary Completion (Estimated)
August 31, 2026
Study Completion (Estimated)
December 31, 2026
Study Registration Dates
First Submitted
July 2, 2026
First Submitted That Met QC Criteria
July 2, 2026
First Posted (Actual)
July 10, 2026
Study Record Updates
Last Update Posted (Actual)
July 10, 2026
Last Update Submitted That Met QC Criteria
July 2, 2026
Last Verified
July 1, 2026
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2026KYPJ069
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
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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