The Proactive Ophthalmic Examination Cohort
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age65+
SponsorZhongshan Ophthalmic Center, Sun Yat-sen University
About this trial
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.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
None
Disqualifiers
Unable to complete required systemic or ophthalmic examinations due to frailty, poor general health, or other physical limitations
Refusal to participate in the study
Trial population
The study population comprises community-dwelling older adults aged 65 years or older. Participants are recruited on a voluntary basis and are willing to undergo comprehensive annual ophthalmic examinations throughout the follow-up period. Individuals who are unable to complete required systemic or ophthalmic assessments due to frailty or poor general health are excluded.
Trial design
Design model
Cohort
Time perspective
Prospective
Treatments tested in this trial
Not listed
Trial groups
No trial groups listed
Trial outcomes
Primary outcomes
1
Incidence of Visual Impairment
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.
Time frame
Year 1, Year 2, Year 3, Year 4, Year 5, Year 6, Year 7, Year 8, Year 9, and Year 10Secondary outcomes
1
Change from Baseline in Best-Corrected Visual Acuity (BCVA)
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.
Time frame
Year 1, Year 2, Year 3, Year 4, Year 5, Year 6, Year 7, Year 8, Year 9, and Year 102
Incidence of Age-Related Cataract
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.
Time frame
Year 1, Year 2, Year 3, Year 4, Year 5, Year 6, Year 7, Year 8, Year 9, and Year 103
Incidence of Age-Related Macular Degeneration (AMD)
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.
Time frame
Year 1, Year 2, Year 3, Year 4, Year 5, Year 6, Year 7, Year 8, Year 9, and Year 104
Incidence of Diabetic Retinopathy (DR)
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.
Time frame
Year 1, Year 2, Year 3, Year 4, Year 5, Year 6, Year 7, Year 8, Year 9, and Year 10Sponsors and contacts
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Source ClinicalTrials.gov