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The Proactive Ophthalmic Examination Cohort

The Proactive Ophthalmic Examination Cohort of Older Adults

Status
Recruiting
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT05851287
Acronym
POEC
Enrollment
5000
Registered
2023-05-09
Start date
2023-02-20
Completion date
2034-02-19
Last updated
2026-06-09

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Eye Diseases, Vision Impairment

Keywords

older adults, eye health, cohort, risk factor, eye diseases

Brief summary

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.

Interventions

None listed

Sponsors

Zhongshan Ophthalmic Center, Sun Yat-sen University
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
65 Years to No maximum
Healthy volunteers
Yes

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

Design outcomes

Primary

MeasureTime frameDescription
Incidence of Visual ImpairmentYear 1, Year 2, Year 3, Year 4, Year 5, Year 6, Year 7, Year 8, Year 9, and Year 10Visual 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

MeasureTime frameDescription
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 10Best-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.
Incidence of Age-Related CataractYear 1, Year 2, Year 3, Year 4, Year 5, Year 6, Year 7, Year 8, Year 9, and Year 10Incidence 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.
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 10Incidence 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.
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 10Incident 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.
Incidence of Myopia-Related Fundus ChangesYear 1, Year 2, Year 3, Year 4, Year 5, Year 6, Year 7, Year 8, Year 9, and Year 10Incident 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.
Change from Baseline in Montreal Cognitive Assessment (MoCA) ScoreYear 1, Year 2, Year 3, Year 4, Year 5, Year 6, Year 7, Year 8, Year 9, and Year 10Global 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.
Proportion of Participants Reporting Visual DisturbancesBaseline, Year 1, Year 2, Year 3, Year 4, Year 5, Year 6, Year 7, Year 8, Year 9, and Year 10The 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.

Countries

China

Contacts

CONTACTHaotian Lin, M.D., Ph.D.
haot.lin@hotmail.com+86 13802793086
CONTACTXun Wang, M.D.
wangx48@mail2.sysu.edu.cn+86 15017541549

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Jun 10, 2026