Vision ImpairmentPOECNCT05851287
The Proactive Ophthalmic Examination Cohort
An observational study of Vision Impairment and Eye Diseases, run by Zhongshan Ophthalmic Center, Sun Yat-sen University at 1 site in China.
Trial 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… Read more about this study
- Who is it for?
- Ages 65 years and olderHealthy volunteers can take part
- Conditions the study is for
- Vision Impairment, Eye Diseases
- How many people
- 5,000 participants
- Where
- 1 siteChina
- Study dates
- 20 Feb 2023to 19 Feb 2034
- How long will I take part?
- 10 Years
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 65 years and older
- All sexes
- Healthy volunteers accepted
- Older adult
Study 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.
Who may be able to join
- Aged 65 years or older
Who cannot join
- 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 locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
Zhongshan Ophthalmic Center, Sun Yat-sen University
Guangzhou, Guangdong, 510060
Haotian Lin, M.D., Ph.D, 8613802793086, haot.lin@hotmail.com
Xun Wang, M.D., Ph.D, 8615017541549, wangx48@mail2.sysu.edu.cn
About this study
Official title: The Proactive Ophthalmic Examination Cohort of Older Adults
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.
- Conditions
- Vision Impairment, Eye Diseases
- Keywords
- older adults, eye health, cohort, risk factor, eye diseases
- Medical subject headings
- Vision Disorders, Eye Diseases
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Year 1, Year 2, Year 3, Year 4, Year 5, Year 6, Year 7, Year 8, Year 9, and Year 10
Secondary outcomes (7)
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.
Measured: 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
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.
Measured: 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)
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.
Measured: 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)
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.
Measured: 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
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.
Measured: 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
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.
Measured: 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
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.
Measured: Baseline, Year 1, Year 2, Year 3, Year 4, Year 5, Year 6, Year 7, Year 8, Year 9, and Year 10
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 May 2023
- Study start20 Feb 2023
- Primary completion19 Feb 2033 (estimated)
- Study completion19 Feb 2034 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Vision ImpairmentStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 5,000 participants (estimated)
- Target duration
- 10 Years
Sponsor and investigators
- Lead sponsor
- Zhongshan Ophthalmic Center, Sun Yat-sen University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05851287
- Sponsor's protocol ID
- 2023KYPJ003
- Acronym
- POEC
- Status last verified
- Feb 2026
- First submitted
- 9 Apr 2023
- Last updated
- 9 Jun 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Proactive Ophthalmic Examination Cohort of Older Adults
- ClinicalTrials.gov ID
- NCT05851287
- Acronym / sponsor ID
- POEC / 2023KYPJ003
- Conditions
- Vision Impairment, Eye Diseases
- Keywords
- older adults, eye health, cohort, risk factor, eye diseases
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 5,000 participants (estimated)
- Lead sponsor
- Zhongshan Ophthalmic Center, Sun Yat-sen UniversityUniversity, hospital or other
- Study start
- 20 Feb 2023 (actual)
- Primary completion
- 19 Feb 2033 (estimated)
- Study completion
- 19 Feb 2034 (estimated)
- First posted
- 9 May 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 10 Years
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Older adult
- Study 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.
Key inclusion criteria (1 listed)
- Aged 65 years or older
Key exclusion criteria (2 listed)
- Unable to complete required systemic or ophthalmic examinations due to frailty, poor general health, or other physical limitations
- Refusal to participate in the study
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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.
7 secondary outcomes
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Jun 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Vision Impairment and Eye Diseases, run by Zhongshan Ophthalmic Center, Sun Yat-sen University at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 9 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Haotian Lin, M.D., Ph.D. (+86 13802793086, haot.lin@hotmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Jun 2026.