AECS: The Aging Eye Cohort Study

• Sponsor: Zhongshan Ophthalmic Center, Sun Yat-sen University (Other)
• Overall Status: Recruiting
• CT.gov ID: NCT05851287
• Collaborator: (none)
• Enrollment: 2,500
• Location: 1
• Anticipated Duration (Months): 72
• Patients Per Site Per Month: 34.7

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Eye Diseases

Study Design

• Study Type: Observational [Patient Registry]
• Anticipated Enrollment: 2500 participants
• Observational Model: Cohort
• Time Perspective: Prospective
• Official Title: The Cohort Study of Eye Health of Aging People
• Actual Study Start Date: Feb 20, 2023
• Anticipated Primary Completion Date: Feb 19, 2028
• Anticipated Study Completion Date: Feb 19, 2029

Outcome Measures

Primary Outcome Measures

1. The incidence of visual impairment at Year 1 [1 Year]

   The best corrected visual acuity is worse than 15/25.

2. The incidence of visual impairment at Year 2 [2 Year]

   The best corrected visual acuity is worse than 15/25.

3. The incidence of visual impairment at Year 3 [3 Year]

   The best corrected visual acuity is worse than 15/25.

4. The incidence of visual impairment at Year 4 [4 Year]

   The best corrected visual acuity is worse than 15/25.

5. The incidence of visual impairment at Year 5 [5 Year]

   The best corrected visual acuity is worse than 15/25.

Secondary Outcome Measures

1. Change from Baseline Best Corrected Visual Acuity at 1 Year [1 Year]

2. Change from Baseline Best Corrected Visual Acuity at 2 Year [2 Year]

3. Change from Baseline Best Corrected Visual Acuity at 3 Year [3 Year]

4. Change from Baseline Best Corrected Visual Acuity at 4 Year [4 Year]

5. Change from Baseline Best Corrected Visual Acuity at 5 Year [5 Year]

6. 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).

7. 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).

8. 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).

9. 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).

10. 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).

11. 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.

12. 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.

13. 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.

14. 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.

15. 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.

16. The incidence of glaucoma at Year 1 [1 Year]

17. The incidence of glaucoma at Year 2 [2 Year]

18. The incidence of glaucoma at Year 3 [3 Year]

19. The incidence of glaucoma at Year 4 [4 Year]

20. The incidence of glaucoma at Year 5 [5 Year]

21. The incidence of diabetic retinopathy at Year 1 [1 Year]

22. The incidence of diabetic retinopathy at Year 2 [2 Year]

23. The incidence of diabetic retinopathy at Year 3 [3 Year]

24. The incidence of diabetic retinopathy at Year 4 [4 Year]

25. The incidence of diabetic retinopathy at Year 5 [5 Year]

26. The incidence of myopia-related fundus changes at Year 1 [1 Year]

27. The incidence of myopia-related fundus changes at Year 2 [2 Year]

28. The incidence of myopia-related fundus changes at Year 3 [3 Year]

29. The incidence of myopia-related fundus changes at Year 4 [4 Year]

30. The incidence of myopia-related fundus changes at Year 5 [5 Year]

31. 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.

32. 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.

33. 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.

34. 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.

35. 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.

36. 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.

37. 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.

38. 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.

39. 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.

40. 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.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 60 Years to 95 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Zhongshan Ophthalmic Center, Sun Yat-sen University	Guangzhou	Guangdong	China	510060

Sponsors and Collaborators

• Zhongshan Ophthalmic Center, Sun Yat-sen University

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Haotian Lin, The Vice President of Zhongshan Ophthalmic Center, Zhongshan Ophthalmic Center, Sun Yat-sen University
• ClinicalTrials.gov Identifier: NCT05851287
• Other Study ID Numbers: 2023KYPJ003
• First Posted: May 9, 2023
• Last Update Posted: May 9, 2023
• Last Verified: Apr 1, 2023

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Keywords provided by Haotian Lin, The Vice President of Zhongshan Ophthalmic Center, Zhongshan Ophthalmic Center, Sun Yat-sen University: Elderly population; Common eye disease; Risk factor; Genetics
• Additional relevant MeSH terms: Eye Diseases

Study Results

No Results Posted as of May 9, 2023