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Survey of Sensory Impairment Indicators Among Adults Aged 65 Years and Older in Xinxing County

2 de julio de 2026 actualizado por: 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.

Descripción general del estudio

Estado

Aún no reclutando

Condiciones

Descripción detallada

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.

Tipo de estudio

De observación

Inscripción (Estimado)

2854

Contactos y Ubicaciones

Esta sección proporciona los datos de contacto de quienes realizan el estudio e información sobre dónde se lleva a cabo este estudio.

Estudio Contacto

Ubicaciones de estudio

  • Porcelana
    • Guangdong
      • Yunfu, Guangdong, Porcelana
        • Xinxing County

Criterios de participación

Los investigadores buscan personas que se ajusten a una determinada descripción, denominada criterio de elegibilidad. Algunos ejemplos de estos criterios son el estado de salud general de una persona o tratamientos previos.

Criterio de elegibilidad

Edades elegibles para estudiar

  • Adulto Mayor

Acepta Voluntarios Saludables

Sí

Método de muestreo

Muestra de probabilidad

Población de estudio

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.

Descripción

Inclusion Criteria:

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

Exclusion Criteria:

  1. Unable to cooperate with study-related examinations, including because of disability, communication barriers, or other reasons.
  2. Has severe systemic disease that may affect study examinations or make participation potentially hazardous to health.
  3. Considered by the investigator to be unsuitable for participation in the study.

Plan de estudios

Esta sección proporciona detalles del plan de estudio, incluido cómo está diseñado el estudio y qué mide el estudio.

¿Cómo está diseñado el estudio?

Detalles de diseño

Cohortes e Intervenciones

Grupo / Cohorte
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.

¿Qué mide el estudio?

Medidas de resultado primarias

Medida de resultado
Medida Descripción
Periodo de tiempo
Effective Refractive Error Coverage
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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.

Medidas de resultado secundarias

Medida de resultado
Medida Descripción
Periodo de tiempo
Prevalence and Correction Status of Common Eye Diseases
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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.

Colaboradores e Investigadores

Aquí es donde encontrará personas y organizaciones involucradas en este estudio.

Patrocinador

Zhongshan Ophthalmic Center, Sun Yat-sen University

Investigadores

  • Investigador principal: Lingyi Liang, MD, Zhongshan Ophthalmic Center, Sun Yat-sen University

Fechas de registro del estudio

Estas fechas rastrean el progreso del registro del estudio y los envíos de resultados resumidos a ClinicalTrials.gov. Los registros del estudio y los resultados informados son revisados ​​por la Biblioteca Nacional de Medicina (NLM) para asegurarse de que cumplan con los estándares de control de calidad específicos antes de publicarlos en el sitio web público.

Fechas importantes del estudio

Inicio del estudio (Estimado)

6 de julio de 2026

Finalización primaria (Estimado)

31 de agosto de 2026

Finalización del estudio (Estimado)

31 de diciembre de 2026

Fechas de registro del estudio

Enviado por primera vez

2 de julio de 2026

Primero enviado que cumplió con los criterios de control de calidad

2 de julio de 2026

Publicado por primera vez (Actual)

10 de julio de 2026

Actualizaciones de registros de estudio

Última actualización publicada (Actual)

10 de julio de 2026

Última actualización enviada que cumplió con los criterios de control de calidad

2 de julio de 2026

Última verificación

1 de julio de 2026

Más información

Términos relacionados con este estudio

Palabras clave

Términos MeSH relevantes adicionales

Otros números de identificación del estudio

  • 2026KYPJ069

Plan de datos de participantes individuales (IPD)

¿Planea compartir datos de participantes individuales (IPD)?

NO

Información sobre medicamentos y dispositivos, documentos del estudio

Estudia un producto farmacéutico regulado por la FDA de EE. UU.

No

Estudia un producto de dispositivo regulado por la FDA de EE. UU.

No

Esta información se obtuvo directamente del sitio web clinicaltrials.gov sin cambios. Si tiene alguna solicitud para cambiar, eliminar o actualizar los detalles de su estudio, comuníquese con register@clinicaltrials.gov. Tan pronto como se implemente un cambio en clinicaltrials.gov, también se actualizará automáticamente en nuestro sitio web. .

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