Macular Degeneration Clinical Trial
Official title:
Drusen Morphology Changes in Nonexudative Age-related Degeneration Using Spectral Domain Optical Coherence Tomography After Oral Antioxidants Supplementation: One-year Results.
Purpose: To determine drusen morphology (volume and area) changes in nonexudative age-related macular degeneration (AMD) after one year of oral supplementation with AREDS-like formulation.
Methods: Patients with AREDS category 2 and 3 AMD were prospectively enrolled in this study, and were randomized to receive daily oral supplementation with lutein (12mg) + zeaxanthin (2mg) + astaxanthin (8mg) + omega-3 fatty acids (docosahexaenoic acid [DHA] 540mg + eicosapentaenoic acid [EPA] 360mg) + vitamin C (40mg) + vitamin E (20mg) + zinc (16mg) + copper (2mg), or observation during one year. ETDRS vision, biomicroscopy, intraocular pressure (IOP), color fundus photography and automatic measurement of drusen with Topcon 3D-OCT 2000 (Topcon, Tokyo, Japan) using the 6 x 6 mm 3D cube scan protocol, were performed in all patients, at baseline and 12 months after. Automated delineation of macular drusen was modified by the investigators when evident segmentation errors occurred. ;
Allocation: Randomized, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Prevention
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