Risk Factors for Drusen Progression
Keywords
Abstract
Dates
Last Verified: | 03/31/2015 |
First Submitted: | 04/09/2013 |
Estimated Enrollment Submitted: | 04/09/2013 |
First Posted: | 04/11/2013 |
Last Update Submitted: | 04/06/2015 |
Last Update Posted: | 04/07/2015 |
Actual Study Start Date: | 12/31/2014 |
Estimated Primary Completion Date: | 02/28/2015 |
Estimated Study Completion Date: | 02/28/2015 |
Condition or disease
Phase
Arm Groups
Arm | Intervention/treatment |
---|---|
300 patients with AMD |
Eligibility Criteria
Ages Eligible for Study | 50 Years To 50 Years |
Sexes Eligible for Study | All |
Sampling method | Non-Probability Sample |
Accepts Healthy Volunteers | Yes |
Criteria | Inclusion Criteria: - Men and postmenopausal women aged ≥ 50 years - AREDS categories 2 or 3 in at least one of the eyes - No ocular surgery within last 6 months Exclusion Criteria: - Late form of AMD in one or two eyes (AREDS category 4) - Moderate or severe non-proliferative diabetic retinopathy, proliferative diabetic retinopathy - Clinically significant macular edema - Macular or peripheral retinal dystrophies - Ocular surgery other than uncomplicated cataract surgery - Opacity of the ocular media by cornea or lens or diseases, which could potentially influence scan quality |
Outcome
Primary Outcome Measures
1. Drusen area and volume as measured using polarization sensitive-OCT [3 years]
Secondary Outcome Measures
1. Visual acuity and refraction [3 years]
2. Choroidal blood flow [3 years]
3. Macular pigment optical density [3 years]