Long Term Effects of Lutein/Zeaxanthin and Omega-3- Supplementation on Optical Density of AMD Patients (LUTEGA)

Not Applicable

Completed

• Conditions: Age Related Maculopathy
• Interventions: Dietary Supplement: Lutein/ Zeaxanthin + Omega-3-FA; Dietary Supplement: Placebo

• Registration Number: NCT00763659
• Lead Sponsor: University of Jena

Brief Summary

The primary objective of LUTEGA is it to determine the long term effect (about 1 year) of the supplementation with a fixed combination of lutein/zeaxanthin and omega-3- fatty acids on the optical density (OD) of macular pigment in patients with non- exudative age related maculopathy.

Furthermore, it is to be examined whether changes of the optical density are different dosages dependent. Possible changes of lipofuscin content and effect on drusen in AMD patients are studied. The measurement of optical density of macular pigment uses the 1- wavelength reflection method recording reflection images at 460 nm by a fundus camera. The patients are investigated at baseline and are followed up over one year in four more visits. In addition to the OD- measurement each examination includes standardized visual acuity test (ETDRS), amsler- grid, slit lamp biomicroscopy, fundus photography (color and autofluorescence) and a blood sample.

Detailed Description

Not available

Study Timeline

• Study Start: 2008-05
• Study First Submitted: 2008-09-30
• Study First Submitted QC: 2008-09-30
• Study First Posted: 2008-10-01
• Primary Completion: 2011-09
• Study Completion: 2011-09
• Status Verified: 2012-07
• Last Update Submitted: 2012-07-19
• Last Update Posted: 2012-07-20

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 172

Inclusion Criteria

• All non- exudative forms of age related maculopathy

Exclusion Criteria

• Exudative age related maculopathy

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
1	Lutein/ Zeaxanthin + Omega-3-FA	20mg Lutein, 2mg Zeaxanthin, 510 mg Omega-3-FA; daily supplementation about one year
2	Lutein/ Zeaxanthin + Omega-3-FA	10mg Lutein, 1mg Zeaxanthin, 255 mg Omega-3-FA; daily supplementation about one year
3	Placebo	Placebo

Primary Outcome Measures

Name	Time	Method
Optical density of macular pigment	12 months

Trial Locations

Locations (1)

Department of Ophthalmology, University Hospital; 🇩🇪 Jena, Germany