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- Klinische proef NCT07694505
Survey of Sensory Impairment Indicators Among Adults Aged 65 Years and Older in Xinxing County
2 juli 2026 bijgewerkt door: 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.
Studie Overzicht
Toestand
Nog niet aan het werven
Gedetailleerde beschrijving
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.
Studietype
Observationeel
Inschrijving (Geschat)
2854
Contacten en locaties
In dit gedeelte vindt u de contactgegevens van degenen die het onderzoek uitvoeren en informatie over waar dit onderzoek wordt uitgevoerd.
Studiecontact
- Naam: Xiaotong Han
- Telefoonnummer: 086-15999975559
- E-mail: hanxiaotong@gzzoc.com
Studie Locaties
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Guangdong
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Yunfu, Guangdong, China
- Xinxing County
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Deelname Criteria
Onderzoekers zoeken naar mensen die aan een bepaalde beschrijving voldoen, de zogenaamde geschiktheidscriteria. Enkele voorbeelden van deze criteria zijn iemands algemene gezondheidstoestand of eerdere behandelingen.
Geschiktheidscriteria
Leeftijden die in aanmerking komen voor studie
- Oudere volwassene
Accepteert gezonde vrijwilligers
Ja
Bemonsteringsmethode
Kanssteekproef
Studie Bevolking
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.
Beschrijving
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.
Studie plan
Dit gedeelte bevat details van het studieplan, inclusief hoe de studie is opgezet en wat de studie meet.
Hoe is de studie opgezet?
Ontwerpdetails
Cohorten en interventies
Groep / 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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Wat meet het onderzoek?
Primaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
|---|---|---|
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Effective Refractive Error Coverage
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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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Secundaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
|---|---|---|
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Prevalence and Correction Status of Common Eye Diseases
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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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Medewerkers en onderzoekers
Hier vindt u mensen en organisaties die betrokken zijn bij dit onderzoek.
Onderzoekers
- Hoofdonderzoeker: Lingyi Liang, MD, Zhongshan Ophthalmic Center, Sun Yat-sen University
Studie record data
Deze datums volgen de voortgang van het onderzoeksdossier en de samenvatting van de ingediende resultaten bij ClinicalTrials.gov. Studieverslagen en gerapporteerde resultaten worden beoordeeld door de National Library of Medicine (NLM) om er zeker van te zijn dat ze voldoen aan specifieke kwaliteitscontrolenormen voordat ze op de openbare website worden geplaatst.
Bestudeer belangrijke data
Studie start (Geschat)
6 juli 2026
Primaire voltooiing (Geschat)
31 augustus 2026
Studie voltooiing (Geschat)
31 december 2026
Studieregistratiedata
Eerst ingediend
2 juli 2026
Eerst ingediend dat voldeed aan de QC-criteria
2 juli 2026
Eerst geplaatst (Werkelijk)
10 juli 2026
Updates van studierecords
Laatste update geplaatst (Werkelijk)
10 juli 2026
Laatste update ingediend die voldeed aan QC-criteria
2 juli 2026
Laatst geverifieerd
1 juli 2026
Meer informatie
Termen gerelateerd aan deze studie
Trefwoorden
Aanvullende relevante MeSH-voorwaarden
Andere studie-ID-nummers
- 2026KYPJ069
Plan Individuele Deelnemersgegevens (IPD)
Bent u van plan om gegevens van individuele deelnemers (IPD) te delen?
NEE
Informatie over medicijnen en apparaten, studiedocumenten
Bestudeert een door de Amerikaanse FDA gereguleerd geneesmiddel
Nee
Bestudeert een door de Amerikaanse FDA gereguleerd apparaatproduct
Nee
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