The Aging Eye Cohort Study

Eye Diseases Clinical Trial

— AECS  

Official title:

The Cohort Study of Eye Health of Aging People

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05851287
• Other study ID #: 2023KYPJ003
• Status: Recruiting
• Start date: February 20, 2023
• Est. completion date: February 19, 2029

Study information

• Verified date: April 2023
• Source: Zhongshan Ophthalmic Center, Sun Yat-sen University
• Contact: Xun Wang, M.D.
• Phone: +8615017541549
• Email: wangx48[@]mail2.sysu.edu.cn
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 2500
• Est. completion date: February 19, 2029
• Est. primary completion date: February 19, 2028
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 60 Years to 95 Years

Eligibility

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.

Related Conditions & MeSH terms

• Eye Diseases

Locations

Country	Name	City	State
China	Zhongshan Ophthalmic Center, Sun Yat-sen University	Guangzhou	Guangdong

Sponsors (1)

Lead Sponsor	Collaborator
Zhongshan Ophthalmic Center, Sun Yat-sen University

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The incidence of visual impairment at Year 1	The best corrected visual acuity is worse than 15/25.	1 Year
Primary	The incidence of visual impairment at Year 2	The best corrected visual acuity is worse than 15/25.	2 Year
Primary	The incidence of visual impairment at Year 3	The best corrected visual acuity is worse than 15/25.	3 Year
Primary	The incidence of visual impairment at Year 4	The best corrected visual acuity is worse than 15/25.	4 Year
Primary	The incidence of visual impairment at Year 5	The best corrected visual acuity is worse than 15/25.	5 Year
Secondary	Change from Baseline Best Corrected Visual Acuity at 1 Year		1 Year
Secondary	Change from Baseline Best Corrected Visual Acuity at 2 Year		2 Year
Secondary	Change from Baseline Best Corrected Visual Acuity at 3 Year		3 Year
Secondary	Change from Baseline Best Corrected Visual Acuity at 4 Year		4 Year
Secondary	Change from Baseline Best Corrected Visual Acuity at 5 Year		5 Year
Secondary	The incidence of age-related cataract at Year 1	Presence of moderate to severe cataract in one or both eyes, graded by Lens Opacities Classification System III (LOCSIII).	1 Year
Secondary	The incidence of age-related cataract at Year 2	Presence of moderate to severe cataract in one or both eyes, graded by Lens Opacities Classification System III (LOCSIII).	1 Year
Secondary	The incidence of age-related cataract at Year 3	Presence of moderate to severe cataract in one or both eyes, graded by Lens Opacities Classification System III (LOCSIII).	3 Year
Secondary	The incidence of age-related cataract at Year 4	Presence of moderate to severe cataract in one or both eyes, graded by Lens Opacities Classification System III (LOCSIII).	4 Year
Secondary	The incidence of age-related cataract at Year 5	Presence of moderate to severe cataract in one or both eyes, graded by Lens Opacities Classification System III (LOCSIII).	5 Year
Secondary	The incidence of age-related macular degeneration at Year 1	The development of the neovascular form of AMD or the development of geographic atrophy that involves the center of the macula in one or both eyes.	1 Year
Secondary	The incidence of age-related macular degeneration at Year 2	The development of the neovascular form of AMD or the development of geographic atrophy that involves the center of the macula in one or both eyes.	2 Year
Secondary	The incidence of age-related macular degeneration at Year 3	The development of the neovascular form of AMD or the development of geographic atrophy that involves the center of the macula in one or both eyes.	3 Year
Secondary	The incidence of age-related macular degeneration at Year 4	The development of the neovascular form of AMD or the development of geographic atrophy that involves the center of the macula in one or both eyes.	4 Year
Secondary	The incidence of age-related macular degeneration at Year 5	The development of the neovascular form of AMD or the development of geographic atrophy that involves the center of the macula in one or both eyes.	5 Year
Secondary	The incidence of glaucoma at Year 1		1 Year
Secondary	The incidence of glaucoma at Year 2		2 Year
Secondary	The incidence of glaucoma at Year 3		3 Year
Secondary	The incidence of glaucoma at Year 4		4 Year
Secondary	The incidence of glaucoma at Year 5		5 Year
Secondary	The incidence of diabetic retinopathy at Year 1		1 Year
Secondary	The incidence of diabetic retinopathy at Year 2		2 Year
Secondary	The incidence of diabetic retinopathy at Year 3		3 Year
Secondary	The incidence of diabetic retinopathy at Year 4		4 Year
Secondary	The incidence of diabetic retinopathy at Year 5		5 Year
Secondary	The incidence of myopia-related fundus changes at Year 1		1 Year
Secondary	The incidence of myopia-related fundus changes at Year 2		2 Year
Secondary	The incidence of myopia-related fundus changes at Year 3		3 Year
Secondary	The incidence of myopia-related fundus changes at Year 4		4 Year
Secondary	The incidence of myopia-related fundus changes at Year 5		5 Year
Secondary	Change from Baseline Self-scoring of the Visual Quality assessment scale at Year 1	Self-assessment of the visual quality will be evaluated by Visual Function index-14 (Chinese version) Questionnaire, higher scores mean a worse outcome.	1 Year
Secondary	Change from Baseline Self-scoring of the Visual Quality assessment scale at Year 2	Self-assessment of the visual quality will be evaluated by Visual Function index-14 (Chinese version) Questionnaire, higher scores mean a worse outcome.	2 Year
Secondary	Change from Baseline Self-scoring of the Visual Quality assessment scale at Year 3	Self-assessment of the visual quality will be evaluated by Visual Function index-14 (Chinese version) Questionnaire, higher scores mean a worse outcome.	3 Year
Secondary	Change from Baseline Self-scoring of the Visual Quality assessment scale at Year 4	Self-assessment of the visual quality will be evaluated by Visual Function index-14 (Chinese version) Questionnaire, higher scores mean a worse outcome.	4 Year
Secondary	Change from Baseline Self-scoring of the Visual Quality assessment scale at Year 5	Self-assessment of the visual quality will be evaluated by Visual Function index-14 (Chinese version) Questionnaire, higher scores mean a worse outcome.	5 Year
Secondary	Change from Baseline Self-scoring of the Quality of Life at Year 1	Self-assessment of the life quality will be evaluated by EQ-5D questionnaires, lowerer scores mean a worse outcome.	1 Year
Secondary	Change from Baseline Self-scoring of the Quality of Life at Year 2	Self-assessment of the life quality will be evaluated by EQ-5D questionnaires, lowerer scores mean a worse outcome.	2 Year
Secondary	Change from Baseline Self-scoring of the Quality of Life at Year 3	Self-assessment of the life quality will be evaluated by EQ-5D questionnaires, lowerer scores mean a worse outcome.	3 Year
Secondary	Change from Baseline Self-scoring of the Quality of Life at Year 4	Self-assessment of the life quality will be evaluated by EQ-5D questionnaires, lowerer scores mean a worse outcome.	4 Year
Secondary	Change from Baseline Self-scoring of the Quality of Life at Year 5	Self-assessment of the life quality will be evaluated by EQ-5D questionnaires, lowerer scores mean a worse outcome.	5 Year