The Proactive Ophthalmic Examination Cohort

NCT05851287 | Recruiting DMC

• 1 other identifier: 2023KYPJ003
• Study Type: observational
• Target: 5,000
• Locations: 1 country
• Sites: 1

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.

Conditions

Eye Diseases; Vision Impairment

Keywords

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

Outcome Measures

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.

  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)

  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

  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)

  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)

  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

  Year 1, Year 2, Year 3, Year 4, Year 5, Year 6, Year 7, Year 8, Year 9, and Year 10

Eligibility Criteria

• Age: 65 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Older Adult (65+)
• Sampling Method: Non-Probability Sample

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.

You may qualify if:

• \- Aged 65 years or older

You may not qualify if:

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

Sponsors & Collaborators

• Zhongshan Ophthalmic Center, Sun Yat-sen University: lead

Study Sites (1)

Zhongshan Ophthalmic Center, Sun Yat-sen University

Guangzhou, Guangdong, 510060, China

RECRUITING

Biospecimen

Retention: SAMPLES WITH DNA

4 mL whole blood for each subject

MeSH Terms

Conditions

Vision Disorders; Eye Diseases

Condition Hierarchy (Ancestors)

Sensation Disorders; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Central Study Contacts

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

CONTACT

+86 13802793086; haot.lin@hotmail.com

Xun Wang, M.D.

CONTACT

+86 15017541549; wangx48@mail2.sysu.edu.cn

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 10 Years
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 9, 2023
• First Posted: May 9, 2023
• Study Start: February 20, 2023
• Primary Completion (Estimated): February 19, 2033
• Study Completion (Estimated): February 19, 2034
• Last Updated: June 9, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)