Skip to main content
OpenTrials
Recruiting

NCT Number: NCT05851287

The Proactive Ophthalmic Examination Cohort

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.

Recruiting

Interested in participating?

Request Info

Key information

Conditions

Vision Impairment Eye Diseases Nervous System Diseases Neurologic Manifestations Pathological Conditions, Signs and Symptoms Sensation Disorders Signs and Symptoms Vision Disorders

Age range

65 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. 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

    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.

Secondary outcomes

  1. 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

    Best-corrected visual acuity (BCVA) is measured using a standardized Early Treatment Diabetic Retinopathy Study (ETDRS) chart at each annual visit. Change is calculated as the difference between each follow-up measurement and the baseline value obtained at enrollment.

  2. 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 cataract, defined as the presence of lens opacity in one or both eyes, was graded using the Lens Opacities Classification System III (LOCS III). New cases are identified among participants who are free of cataract at baseline.

  3. 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 AMD, defined as the new development of AMD in one or both eyes, was assessed by fundus photography and optical coherence tomography (OCT) at each annual visit.

  4. 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

    Incident diabetic retinopathy is defined among participants with diabetes mellitus and no diabetic retinopathy at baseline as the first detection of any definite diabetic retinopathy, indicated by an Early Treatment Diabetic Retinopathy Study (ETDRS) Diabetic Retinopathy Severity Scale level ≥20 in either eye on standardized annual fundus photography.

  5. 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

    Incident myopia-related fundus changes are defined among highly myopic eyes without the specified fundus changes at baseline as the first detection during follow-up of lacquer cracks, myopic choroidal neovascularization, patchy chorioretinal atrophy, or macular atrophy, identified by standardized fundus photography and optical coherence tomography (OCT) at annual visits. High myopia was defined as an axial length ≥26.0 mm or spherical equivalent ≤-6.00 diopters at baseline.

  6. 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

    Global cognitive function is assessed using the Montreal Cognitive Assessment (MoCA), a validated screening tool covering visuospatial/executive function, naming, memory, attention, language, abstraction, and orientation. Change is calculated as the difference between each annual follow-up score and the baseline score obtained at enrollment.

  7. 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

    The proportion of participants reporting visual disturbances, including but not limited to photopsia, floaters, diplopia, and metamorphopsia, is collected via a standardized structured questionnaire at each annual visit.

Study contacts

Contact information is provided by the study sponsor or research team.

Haotian Lin, M.D., Ph.D.

CONTACT

[email protected]

+86 13802793086

Xun Wang, M.D.

CONTACT

[email protected]

+86 15017541549

Sponsors and collaborators

Lead sponsor

Zhongshan Ophthalmic Center, Sun Yat-sen University

Other

Registry information

Official study title

The Proactive Ophthalmic Examination Cohort of Older Adults

Acronym: POEC

Important dates

Study start
2023
Primary completion
2033
Study completion
2034
First posted
May 9, 2023
Registry last updated
Jun 9, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.