NCT07694505

Brief Summary

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.

Trial Health

63
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
2,854

participants targeted

Target at P75+ for all trials

Timeline
5mo left

Started Jul 2026

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress15%
Jul 2026Dec 2026

First Submitted

Initial submission to the registry

July 2, 2026

Completed
4 days until next milestone

Study Start

First participant enrolled

July 6, 2026

Completed
4 days until next milestone

First Posted

Study publicly available on registry

July 10, 2026

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 31, 2026

Expected
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2026

Last Updated

July 10, 2026

Status Verified

July 1, 2026

Enrollment Period

2 months

First QC Date

July 2, 2026

Last Update Submit

July 2, 2026

Conditions

Keywords

Effective refractive error coverageEffective cataract surgical coverageEffective hearing technology coverageOlder adultsPopulation-based surveyCross-sectional studySENSIISWHOearsXinxing County

Outcome Measures

Primary Outcomes (3)

  • Effective Refractive Error Coverage

    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.

    At the cross-sectional survey visit during the 2026-06 to 2026-12 data collection period.

  • Effective Cataract Surgical Coverage

    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.

    At the cross-sectional survey visit during the 2026-06 to 2026-12 data collection period.

  • Effective Hearing Technology Coverage

    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.

    At the cross-sectional survey visit during the 2026-06 to 2026-12 data collection period.

Secondary Outcomes (3)

  • Prevalence and Correction Status of Common Eye Diseases

    At the cross-sectional survey visit during the 2026-06 to 2026-12 data collection period.

  • Prevalence of Dual Sensory Impairment

    At the cross-sectional survey visit during the 2026-06 to 2026-12 data collection period.

  • Feasibility and Satisfaction of the SENSIIS System for Primary-Level Vision and Hearing Screening

    At or after the cross-sectional survey visit during the 2026-06 to 2026-12 data collection period.

Study Arms (1)

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.

Eligibility Criteria

Age65 Years+
Sexall
Healthy VolunteersYes
Age GroupsOlder Adult (65+)
Sampling MethodProbability 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.

You may qualify if:

  • Aged 65 years or older.
  • Voluntarily participates in the study and provides signed informed consent.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Xinxing County

Yunfu, Guangdong, China

Location

MeSH Terms

Conditions

Vision DisordersHearing LossCataractRefractive Errors

Condition Hierarchy (Ancestors)

Sensation DisordersNeurologic ManifestationsNervous System DiseasesEye DiseasesSigns and SymptomsPathological Conditions, Signs and SymptomsHearing DisordersEar DiseasesOtorhinolaryngologic DiseasesLens Diseases

Study Officials

  • Lingyi Liang, MD

    Zhongshan Ophthalmic Center, Sun Yat-sen University

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Study Design

Study Type
observational
Observational Model
ECOLOGIC OR COMMUNITY
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 2, 2026

First Posted

July 10, 2026

Study Start

July 6, 2026

Primary Completion (Estimated)

August 31, 2026

Study Completion (Estimated)

December 31, 2026

Last Updated

July 10, 2026

Record last verified: 2026-07

Data Sharing

IPD Sharing
Will not share

Locations