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

Drusen Morphology Changes in Nonexudative Age-related Degeneration Using Spectral Domain Optical Coherence Tomography After Oral Antioxidants Supplementation: One-year Results.

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT02264938

Enrollment

Registered

2014-10-15

Start date

2013-01-31

Completion date

2014-10-31

Last updated

2014-10-15

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Macular Degeneration

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.

Interventions

DIETARY_SUPPLEMENTAntioxidant

Oral supplemmentation with antioxidants

Study design

Allocation

RANDOMIZED

Intervention model

SINGLE_GROUP

Primary purpose

PREVENTION

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

50 Years to No maximum

Healthy volunteers

Inclusion criteria

* AREDS category 2 and 3 AMD

Exclusion criteria

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

Design outcomes

Primary

Measure	Time frame
Drusen volume change	12 months

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026