- ICH GCP
- US Clinical Trials Registry
- Klinisk forsøg NCT07694505
Survey of Sensory Impairment Indicators Among Adults Aged 65 Years and Older in Xinxing County
2. juli 2026 opdateret af: 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.
Studieoversigt
Status
Ikke rekrutterer endnu
Betingelser
Detaljeret beskrivelse
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.
Undersøgelsestype
Observationel
Tilmelding (Anslået)
2854
Kontakter og lokationer
Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.
Studiekontakt
- Navn: Xiaotong Han
- Telefonnummer: 086-15999975559
- E-mail: hanxiaotong@gzzoc.com
Studiesteder
-
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Guangdong
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Yunfu, Guangdong, Kina
- Xinxing County
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-
Deltagelseskriterier
Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.
Berettigelseskriterier
Aldre berettiget til at studere
- Ældre voksen
Tager imod sunde frivillige
Ja
Prøveudtagningsmetode
Sandsynlighedsprøve
Studiebefolkning
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.
Beskrivelse
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.
Studieplan
Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
Kohorter og interventioner
Gruppe / kohorte |
|---|
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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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Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
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Effective Refractive Error Coverage
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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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Sekundære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
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Prevalence and Correction Status of Common Eye Diseases
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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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Samarbejdspartnere og efterforskere
Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.
Efterforskere
- Ledende efterforsker: Lingyi Liang, MD, Zhongshan Ophthalmic Center, Sun Yat-sen University
Datoer for undersøgelser
Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.
Studer store datoer
Studiestart (Anslået)
6. juli 2026
Primær færdiggørelse (Anslået)
31. august 2026
Studieafslutning (Anslået)
31. december 2026
Datoer for studieregistrering
Først indsendt
2. juli 2026
Først indsendt, der opfyldte QC-kriterier
2. juli 2026
Først opslået (Faktiske)
10. juli 2026
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
10. juli 2026
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
2. juli 2026
Sidst verificeret
1. juli 2026
Mere information
Begreber relateret til denne undersøgelse
Nøgleord
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
- 2026KYPJ069
Plan for individuelle deltagerdata (IPD)
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