The Aging Eye Cohort Study

Recruiting

• Conditions: Eye Diseases

• Registration Number: NCT05851287
• Lead Sponsor: Zhongshan Ophthalmic Center, Sun Yat-sen University

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2023-02-20
• Status Verified: 2023-04
• Study First Submitted: 2023-04-09
• Study First Submitted QC: 2023-04-29
• Last Update Submitted: 2023-04-29
• Study First Posted: 2023-05-09
• Last Update Posted: 2023-05-09
• Primary Completion: 2028-02-19
• Study Completion: 2029-02-19

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 2500

Inclusion Criteria

Not provided

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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
The incidence of visual impairment at Year 1	1 Year	The best corrected visual acuity is worse than 15/25.
The incidence of visual impairment at Year 2	2 Year	The best corrected visual acuity is worse than 15/25.
The incidence of visual impairment at Year 3	3 Year	The best corrected visual acuity is worse than 15/25.
The incidence of visual impairment at Year 4	4 Year	The best corrected visual acuity is worse than 15/25.
The incidence of visual impairment at Year 5	5 Year	The best corrected visual acuity is worse than 15/25.

Secondary Outcome Measures

Name	Time	Method
The incidence of glaucoma at Year 1	1 Year
Change from Baseline Best Corrected Visual Acuity at 4 Year	4 Year
The incidence of age-related cataract at Year 2	1 Year	Presence of moderate to severe cataract in one or both eyes, graded by Lens Opacities Classification System III (LOCSIII).
The incidence of diabetic retinopathy at Year 2	2 Year
The incidence of diabetic retinopathy at Year 3	3 Year
The incidence of myopia-related fundus changes at Year 1	1 Year
The incidence of myopia-related fundus changes at Year 2	2 Year
The incidence of myopia-related fundus changes at Year 3	3 Year
The incidence of myopia-related fundus changes at Year 4	4 Year
Change from Baseline Best Corrected Visual Acuity at 2 Year	2 Year
Change from Baseline Best Corrected Visual Acuity at 3 Year	3 Year
Change from Baseline Best Corrected Visual Acuity at 1 Year	1 Year
Change from Baseline Best Corrected Visual Acuity at 5 Year	5 Year
The incidence of age-related cataract at Year 3	3 Year	Presence of moderate to severe cataract in one or both eyes, graded by Lens Opacities Classification System III (LOCSIII).
The incidence of age-related cataract at Year 5	5 Year	Presence of moderate to severe cataract in one or both eyes, graded by Lens Opacities Classification System III (LOCSIII).
The incidence of age-related macular degeneration at Year 3	3 Year	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.
The incidence of age-related cataract at Year 1	1 Year	Presence of moderate to severe cataract in one or both eyes, graded by Lens Opacities Classification System III (LOCSIII).
The incidence of age-related macular degeneration at Year 4	4 Year	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.
The incidence of age-related macular degeneration at Year 5	5 Year	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.
The incidence of glaucoma at Year 3	3 Year
The incidence of glaucoma at Year 5	5 Year
The incidence of diabetic retinopathy at Year 1	1 Year
Change from Baseline Self-scoring of the Visual Quality assessment scale at Year 1	1 Year	Self-assessment of the visual quality will be evaluated by Visual Function index-14 (Chinese version) Questionnaire, higher scores mean a worse outcome.
Change from Baseline Self-scoring of the Visual Quality assessment scale at Year 4	4 Year	Self-assessment of the visual quality will be evaluated by Visual Function index-14 (Chinese version) Questionnaire, higher scores mean a worse outcome.
Change from Baseline Self-scoring of the Visual Quality assessment scale at Year 5	5 Year	Self-assessment of the visual quality will be evaluated by Visual Function index-14 (Chinese version) Questionnaire, higher scores mean a worse outcome.
The incidence of age-related cataract at Year 4	4 Year	Presence of moderate to severe cataract in one or both eyes, graded by Lens Opacities Classification System III (LOCSIII).
The incidence of age-related macular degeneration at Year 1	1 Year	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.
The incidence of diabetic retinopathy at Year 5	5 Year
The incidence of myopia-related fundus changes at Year 5	5 Year
Change from Baseline Self-scoring of the Visual Quality assessment scale at Year 2	2 Year	Self-assessment of the visual quality will be evaluated by Visual Function index-14 (Chinese version) Questionnaire, higher scores mean a worse outcome.
Change from Baseline Self-scoring of the Quality of Life at Year 3	3 Year	Self-assessment of the life quality will be evaluated by EQ-5D questionnaires, lowerer scores mean a worse outcome.
Change from Baseline Self-scoring of the Quality of Life at Year 4	4 Year	Self-assessment of the life quality will be evaluated by EQ-5D questionnaires, lowerer scores mean a worse outcome.
The incidence of age-related macular degeneration at Year 2	2 Year	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.
The incidence of glaucoma at Year 2	2 Year
The incidence of glaucoma at Year 4	4 Year
The incidence of diabetic retinopathy at Year 4	4 Year
Change from Baseline Self-scoring of the Visual Quality assessment scale at Year 3	3 Year	Self-assessment of the visual quality will be evaluated by Visual Function index-14 (Chinese version) Questionnaire, higher scores mean a worse outcome.
Change from Baseline Self-scoring of the Quality of Life at Year 2	2 Year	Self-assessment of the life quality will be evaluated by EQ-5D questionnaires, lowerer scores mean a worse outcome.
Change from Baseline Self-scoring of the Quality of Life at Year 1	1 Year	Self-assessment of the life quality will be evaluated by EQ-5D questionnaires, lowerer scores mean a worse outcome.
Change from Baseline Self-scoring of the Quality of Life at Year 5	5 Year	Self-assessment of the life quality will be evaluated by EQ-5D questionnaires, lowerer scores mean a worse outcome.

Trial Locations

Locations (1)

Zhongshan Ophthalmic Center, Sun Yat-sen University; 🇨🇳 Guangzhou, Guangdong, China