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

Germans Trias i Pujol Hospital

Status: Completed

Conditions: Macular Degeneration

Treatments: Dietary Supplement: Antioxidant

Study type: Interventional

Funder types: Other

Identifiers

NCT02264938

AC-11-112

Details and patient eligibility

About

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.

Full 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.

Enrollment: 35 patients

Sex: All

Ages: 50+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• AREDS category 2 and 3 AMD

Exclusion criteria

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)

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35 participants in 2 patient groups

Observation

No Intervention group

Description:

Patients with AREDS category 2 and 3 AMD are observed during 1 year

Antioxidant

Active Comparator group

Description:

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.

Treatment:

Dietary Supplement: Antioxidant