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Recruiting NCT05851287

The Proactive Ophthalmic Examination Cohort

Observational Vision Impairment Eye Diseases

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
This is an observational study: the protocol does not assign a study treatment.
Who it may be relevant to
Registry conditions: Vision Impairment, Eye Diseases. Basic parameters: from 65 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
China
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Official title

The Proactive Ophthalmic Examination Cohort of Older Adults

Overview

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.

Primary outcome measures

  • Incidence of Visual Impairment [Time frame: Year 1, Year 2, Year 3, Year 4, Year 5, Year 6, Year 7, Year 8, Year 9, and Year 10]
Secondary outcome measures (7)
  • Change from Baseline in Best-Corrected Visual Acuity (BCVA) [Time frame: 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 [Time frame: 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) [Time frame: 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) [Time frame: 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 [Time frame: 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 [Time frame: 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 [Time frame: Baseline, Year 1, Year 2, Year 3, Year 4, Year 5, Year 6, Year 7, Year 8, Year 9, and Year 10]

Eligibility criteria

Inclusion criteria

\- Aged 65 years or older

Exclusion criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: Yes

Study design

Observational model
Cohort

Study locations

China · 1 center
  • Zhongshan Ophthalmic Center, Sun Yat-sen University — Guangzhou

Identifiers

NCT: NCT05851287 · 2023KYPJ003

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗