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临床试验/NCT07694505
NCT07694505尚未招募不适用

A Cross-Sectional Survey of Global Priority Sensory Impairment Indicators Among People Aged 65 Years and Older in Xinxing County

Zhongshan Ophthalmic Center, Sun Yat-sen University1 个研究点 分布在 1 个国家目标入组 2,854 人开始时间: 2026年7月6日最近更新:
适应症

试验速览

阶段
不适用
状态
尚未招募
入组人数
2,854
试验地点
1
主要终点
Effective Refractive Error Coverage

研究概览

简要总结

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.

详细描述

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.

研究设计

研究类型
Observational
观察模型
Ecologic Or Community
时间视角
Cross Sectional

入排标准

年龄范围
65 Years 至 —(Older Adult)
性别
All
接受健康志愿者

入选标准

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

排除标准

  • 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.

结局指标

主要结局

Effective Refractive Error Coverage

时间窗: 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.

Effective Cataract Surgical Coverage

时间窗: 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.

Effective Hearing Technology Coverage

时间窗: 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.

次要结局

  • 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.)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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