Ignite Creation Date:
2024-05-06 @ 3:20 AM
Last Modification Date:
2024-10-26 @ 11:32 AM
Study NCT ID:
NCT02264938
Status:
COMPLETED
Last Update Posted:
2014-10-15
First Post:
2014-10-09
Brief Title:
Drusen Morphology Changes in Nonexudative Age-related Degeneration After Oral Antioxidants Supplementation
Sponsor:
Germans Trias i Pujol Hospital
Organization:
Germans Trias i Pujol Hospital
Study Overview
Official Title:
Drusen Morphology Changes in Nonexudative Age-related Degeneration Using Spectral Domain Optical Coherence Tomography After Oral Antioxidants Supplementation One-year Results
Status:
COMPLETED
Status Verified Date:
2014-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None