跳至主要内容
临床试验/NCT05851287
NCT05851287招募中不适用

The Proactive Ophthalmic Examination Cohort of Older Adults

Zhongshan Ophthalmic Center, Sun Yat-sen University1 个研究点 分布在 1 个国家目标入组 5,000 人开始时间: 2023年2月20日最近更新:
适应症

试验速览

阶段
不适用
状态
招募中
入组人数
5,000
试验地点
1
主要终点
Incidence of Visual Impairment

研究概览

简要总结

The Proactive Ophthalmic Examination Cohort of Older Adults is a prospective cohort study recruiting community-dwelling older adults aged 65 years or older. Through comprehensive assessment of demographic profiles, medical histories, and ocular structural and functional parameters, alongside systematic collection of ophthalmic and systemic clinical data and biological specimens, we will establish a multidimensional, high-quality ocular health database encompassing demographic characteristics, socioeconomic factors, lifestyle variables, ocular disease risk factors, subjective ocular symptoms, objective examination findings, and biospecimens. The study will investigate the onset and progression patterns of ocular diseases, associated risk factors, and mechanisms of ocular aging in older populations, while simultaneously providing normal-controlled clinical and genomic data for other clinical studies on eye diseases. Furthermore, leveraging algorithmic innovation and artificial intelligence technologies, we will develop a personalized risk prediction and monitoring platform for age-related eye diseases, enhancing early screening and diagnostic capabilities and advancing precision medicine for ocular health in older adults.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

入排标准

年龄范围
65 Years 至 95 Years(Older Adult)
性别
All
接受健康志愿者
是

入选标准

  • •- Aged 65 years or older

排除标准

  • •Unable to complete required systemic or ophthalmic examinations due to frailty, poor general health, or other physical limitations
  • •Refusal to participate in the study

结局指标

主要结局

Incidence of Visual Impairment

时间窗: Year 1, Year 2, Year 3, Year 4, Year 5, Year 6, Year 7, Year 8, Year 9, and Year 10

Visual impairment is defined as best-corrected visual acuity (BCVA) worse than 20/40 in either eye, assessed using a standardized Early Treatment Diabetic Retinopathy Study (ETDRS) chart at each annual visit. Incidence is calculated as the number of new cases per 100 person-years among participants free of visual impairment at baseline. chart at each visit.

次要结局

  • Change from Baseline in Best-Corrected Visual Acuity (BCVA)(Year 1, Year 2, Year 3, Year 4, Year 5, Year 6, Year 7, Year 8, Year 9, and Year 10)
  • Incidence of Age-Related Cataract(Year 1, Year 2, Year 3, Year 4, Year 5, Year 6, Year 7, Year 8, Year 9, and Year 10)
  • Incidence of Age-Related Macular Degeneration (AMD)(Year 1, Year 2, Year 3, Year 4, Year 5, Year 6, Year 7, Year 8, Year 9, and Year 10)
  • Incidence of Diabetic Retinopathy (DR)(Year 1, Year 2, Year 3, Year 4, Year 5, Year 6, Year 7, Year 8, Year 9, and Year 10)
  • Incidence of Myopia-Related Fundus Changes(Year 1, Year 2, Year 3, Year 4, Year 5, Year 6, Year 7, Year 8, Year 9, and Year 10)
  • Change from Baseline in Montreal Cognitive Assessment (MoCA) Score(Year 1, Year 2, Year 3, Year 4, Year 5, Year 6, Year 7, Year 8, Year 9, and Year 10)
  • Proportion of Participants Reporting Visual Disturbances(Baseline, Year 1, Year 2, Year 3, Year 4, Year 5, Year 6, Year 7, Year 8, Year 9, and Year 10)

研究者

申办方类型
Other
责任方
Sponsor
主要研究者

Haotian Lin

The Vice President of Zhongshan Ophthalmic Center

Zhongshan Ophthalmic Center, Sun Yat-sen University

研究点 (1)

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