Drusen Morphology Changes in Nonexudative Age-related Degeneration After Oral Antioxidants Supplementation

Not Applicable

Completed

• Conditions: Macular Degeneration
• Interventions: Dietary Supplement: Antioxidant

• Registration Number: NCT02264938
• Lead Sponsor: Germans Trias i Pujol Hospital

Brief Summary

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.

Detailed Description

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.

Study Timeline

• Study Start: 2013-01
• Primary Completion: 2014-07
• Status Verified: 2014-10
• Study Completion: 2014-10
• Study First Submitted: 2014-10-09
• Study First Submitted QC: 2014-10-09
• Last Update Submitted: 2014-10-09
• Study First Posted: 2014-10-15
• Last Update Posted: 2014-10-15

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 35

Inclusion Criteria

• AREDS category 2 and 3 AMD

Exclusion Criteria

• AREDS category 4 AMD
• other ophthalmological diseases
• currently on antioxidant supplementation

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Antioxidant	Antioxidant	Patients with AREDS category 2 and 3 AMD are enrolled to take 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) during 1 year.

Primary Outcome Measures

Name	Time	Method
Drusen volume change	12 months