Clinical trial NCT05851287: The Aging Eye Cohort Study
Official title: The Cohort Study of Eye Health of Aging People
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Eye Diseases
Keywords: Elderly population
Common eye disease
Risk factor
Genetics
Lead sponsor: Zhongshan Ophthalmic Center, Sun Yat-sen University
Sponsor class: OTHER
First posted: 2023-05-09
Enrollment: 2500
Sex: ALL
Minimum age (years): 60
Maximum age (years): 95
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: The elderly population with normal visual acuity lives in Guangzhou, China.

Brief summary: Aging is a major risk factor for many blind-causing eye diseases, e.g., glaucoma, age-related cataracts, and age-related macular degeneration. With the population aging, the impact of lifestyle changes (less time spent outdoors, increasingly sedentary lifestyles, and unhealthy eating habits) on the eye health of the elderly needs further research. This study focuses on establishing a cohort of elderly subjects with normal vision and ocular structure at baseline. The main goal is to study the risk factors for common eye diseases in Chinese elderly population while providing normal-controlled clinical and genomic data for other clinical studies on eye diseases.


Eligibility criteria: Inclusion criteria:

1. Be able and willing to consent to the qualification and the follow-up phases of the study;
2. Be able to undergo yearly examinations for ≥5 years;
3. Age is older than 60 years;
4. Best-corrected visual acuity of both eyes is better than 20/32;
5. Intraocular pressure (non-contact tonometer) is between 10-21 mmHg;
6. Except for mild cataracts, no other structural abnormalities of the eye are found.
7. have fundus photographs of adequate quality as assessed with a standardized protocol by the University of Wisconsin Fundus Photograph Reading Center.

Exclusion Criteria:

1. the presence of ocular disease in either eye, except for mild cataracts and ametropia;
2. previous retinal or other ocular surgical procedures (other than cataract extraction and capsulotomy);
3. a chronic requirement for any systemic or ocular medication administered for other diseases and known to be toxic to the retina or optic nerve;
4. cataract surgery within three months or capsulotomy within six weeks before the qualification visit;
5. any systemic disease with a poor 5-year survival prognosis.

Primary outcomes:
measure: The incidence of visual impairment at Year 1
timeFrame: 1 Year
measure: The incidence of visual impairment at Year 2
timeFrame: 2 Year
measure: The incidence of visual impairment at Year 3
timeFrame: 3 Year
measure: The incidence of visual impairment at Year 4
timeFrame: 4 Year
measure: The incidence of visual impairment at Year 5
timeFrame: 5 Year
Secondary outcomes:
measure: Change from Baseline Best Corrected Visual Acuity at 1 Year
timeFrame: 1 Year
measure: Change from Baseline Best Corrected Visual Acuity at 2 Year
timeFrame: 2 Year
measure: Change from Baseline Best Corrected Visual Acuity at 3 Year
timeFrame: 3 Year
measure: Change from Baseline Best Corrected Visual Acuity at 4 Year
timeFrame: 4 Year
measure: Change from Baseline Best Corrected Visual Acuity at 5 Year
timeFrame: 5 Year
measure: The incidence of age-related cataract at Year 1
timeFrame: 1 Year
measure: The incidence of age-related cataract at Year 2
timeFrame: 1 Year
measure: The incidence of age-related cataract at Year 3
timeFrame: 3 Year
measure: The incidence of age-related cataract at Year 4
timeFrame: 4 Year
measure: The incidence of age-related cataract at Year 5
timeFrame: 5 Year
measure: The incidence of age-related macular degeneration at Year 1
timeFrame: 1 Year
measure: The incidence of age-related macular degeneration at Year 2
timeFrame: 2 Year
measure: The incidence of age-related macular degeneration at Year 3
timeFrame: 3 Year
measure: The incidence of age-related macular degeneration at Year 4
timeFrame: 4 Year
measure: The incidence of age-related macular degeneration at Year 5
timeFrame: 5 Year
measure: The incidence of glaucoma at Year 1
timeFrame: 1 Year
measure: The incidence of glaucoma at Year 2
timeFrame: 2 Year
measure: The incidence of glaucoma at Year 3
timeFrame: 3 Year
measure: The incidence of glaucoma at Year 4
timeFrame: 4 Year
measure: The incidence of glaucoma at Year 5
timeFrame: 5 Year
measure: The incidence of diabetic retinopathy at Year 1
timeFrame: 1 Year
measure: The incidence of diabetic retinopathy at Year 2
timeFrame: 2 Year
measure: The incidence of diabetic retinopathy at Year 3
timeFrame: 3 Year
measure: The incidence of diabetic retinopathy at Year 4
timeFrame: 4 Year
measure: The incidence of diabetic retinopathy at Year 5
timeFrame: 5 Year
measure: The incidence of myopia-related fundus changes at Year 1
timeFrame: 1 Year
measure: The incidence of myopia-related fundus changes at Year 2
timeFrame: 2 Year
measure: The incidence of myopia-related fundus changes at Year 3
timeFrame: 3 Year
measure: The incidence of myopia-related fundus changes at Year 4
timeFrame: 4 Year
measure: The incidence of myopia-related fundus changes at Year 5
timeFrame: 5 Year
measure: Change from Baseline Self-scoring of the Visual Quality assessment scale at Year 1
timeFrame: 1 Year
measure: Change from Baseline Self-scoring of the Visual Quality assessment scale at Year 2
timeFrame: 2 Year
measure: Change from Baseline Self-scoring of the Visual Quality assessment scale at Year 3
timeFrame: 3 Year
measure: Change from Baseline Self-scoring of the Visual Quality assessment scale at Year 4
timeFrame: 4 Year
measure: Change from Baseline Self-scoring of the Visual Quality assessment scale at Year 5
timeFrame: 5 Year
measure: Change from Baseline Self-scoring of the Quality of Life at Year 1
timeFrame: 1 Year
measure: Change from Baseline Self-scoring of the Quality of Life at Year 2
timeFrame: 2 Year
measure: Change from Baseline Self-scoring of the Quality of Life at Year 3
timeFrame: 3 Year
measure: Change from Baseline Self-scoring of the Quality of Life at Year 4
timeFrame: 4 Year
measure: Change from Baseline Self-scoring of the Quality of Life at Year 5
timeFrame: 5 Year
Other outcomes:
Locations:
city: Guangzhou
country: China
facility: Zhongshan Ophthalmic Center, Sun Yat-sen University
state: Guangdong
Study officials:
References: