- ICH GCP
- Amerikanska kliniska prövningsregistret
- Klinisk prövning NCT07694505
Survey of Sensory Impairment Indicators Among Adults Aged 65 Years and Older in Xinxing County
2 juli 2026 uppdaterad av: 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.
Studieöversikt
Status
Har inte rekryterat ännu
Detaljerad beskrivning
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.
Studietyp
Observationell
Inskrivning (Beräknad)
2854
Kontakter och platser
Det här avsnittet innehåller kontaktuppgifter för dem som genomför studien och information om var denna studie genomförs.
Studiekontakt
- Namn: Xiaotong Han
- Telefonnummer: 086-15999975559
- E-post: hanxiaotong@gzzoc.com
Studieorter
-
-
Guangdong
-
Yunfu, Guangdong, Kina
- Xinxing County
-
-
Deltagandekriterier
Forskare letar efter personer som passar en viss beskrivning, så kallade behörighetskriterier. Några exempel på dessa kriterier är en persons allmänna hälsotillstånd eller tidigare behandlingar.
Urvalskriterier
Åldrar som är berättigade till studier
- Äldre vuxen
Tar emot friska volontärer
Ja
Testmetod
Sannolikhetsprov
Studera befolkning
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.
Beskrivning
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
Det här avsnittet ger detaljer om studieplanen, inklusive hur studien är utformad och vad studien mäter.
Hur är studien utformad?
Designdetaljer
Kohorter och interventioner
Grupp / Kohort |
|---|
|
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.
|
Vad mäter studien?
Primära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
|
Effective Refractive Error Coverage
Tidsram: At the cross-sectional survey visit during the 2026-06 to 2026-12 data collection period.
|
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
Tidsram: At the cross-sectional survey visit during the 2026-06 to 2026-12 data collection period.
|
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
Tidsram: At the cross-sectional survey visit during the 2026-06 to 2026-12 data collection period.
|
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.
|
Sekundära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
|
Prevalence and Correction Status of Common Eye Diseases
Tidsram: At the cross-sectional survey visit during the 2026-06 to 2026-12 data collection period.
|
Prevalence and correction or treatment status of common eye diseases, including refractive error and cataract, based on standardized eye examinations and questionnaire data.
|
At the cross-sectional survey visit during the 2026-06 to 2026-12 data collection period.
|
|
Prevalence of Dual Sensory Impairment
Tidsram: At the cross-sectional survey visit during the 2026-06 to 2026-12 data collection period.
|
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.
|
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
Tidsram: At or after 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, assessed through questionnaires and interviews.
|
At or after the cross-sectional survey visit during the 2026-06 to 2026-12 data collection period.
|
Samarbetspartners och utredare
Det är här du hittar personer och organisationer som är involverade i denna studie.
Utredare
- Huvudutredare: Lingyi Liang, MD, Zhongshan Ophthalmic Center, Sun Yat-sen University
Studieavstämningsdatum
Dessa datum spårar framstegen för inlämningar av studieposter och sammanfattande resultat till ClinicalTrials.gov. Studieposter och rapporterade resultat granskas av National Library of Medicine (NLM) för att säkerställa att de uppfyller specifika kvalitetskontrollstandarder innan de publiceras på den offentliga webbplatsen.
Studera stora datum
Studiestart (Beräknad)
6 juli 2026
Primärt slutförande (Beräknad)
31 augusti 2026
Avslutad studie (Beräknad)
31 december 2026
Studieregistreringsdatum
Först inskickad
2 juli 2026
Först inskickad som uppfyllde QC-kriterierna
2 juli 2026
Första postat (Faktisk)
10 juli 2026
Uppdateringar av studier
Senaste uppdatering publicerad (Faktisk)
10 juli 2026
Senaste inskickade uppdateringen som uppfyllde QC-kriterierna
2 juli 2026
Senast verifierad
1 juli 2026
Mer information
Termer relaterade till denna studie
Nyckelord
Ytterligare relevanta MeSH-villkor
Andra studie-ID-nummer
- 2026KYPJ069
Plan för individuella deltagardata (IPD)
Planerar du att dela individuella deltagardata (IPD)?
NEJ
Läkemedels- och apparatinformation, studiedokument
Studerar en amerikansk FDA-reglerad läkemedelsprodukt
Nej
Studerar en amerikansk FDA-reglerad produktprodukt
Nej
Denna information hämtades direkt från webbplatsen clinicaltrials.gov utan några ändringar. Om du har några önskemål om att ändra, ta bort eller uppdatera dina studieuppgifter, vänligen kontakta register@clinicaltrials.gov. Så snart en ändring har implementerats på clinicaltrials.gov, kommer denna att uppdateras automatiskt även på vår webbplats .