Enhancement of Macular Pigment Density by Oral Lutein Supplementation

Overview

The primary objective of EMPOLS is an increase in macular pigment density (MPD) and contrast sensitivity (CS) after six months supplementation of oral non-compound ester Lutein 10 mg daily, contained in VitaluxPlus®.

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Prevention
    • Masking: None (Open Label)
  • Study Primary Completion Date: December 2009

Detailed Description

The primary objective of EMPOLS is an increase in macular pigment density (MPD) and contrast sensitivity (CS) after six months supplementation of oral non-compound ester Lutein 10 mg daily, contained in VitaluxPlus®. Primary variable for a significant change will be 10% increase compared to baseline MPD.

The measurement will be carried out by means of a modified confocal scanning laser ophthalmoscope (HRA) recording autofluorescence images at 488 nm and 514 nm 6. MPD is determined on MPD maps within 0.5 degrees around the center of the fovea. All MPD measurements and photographs will by performed by the Bern Photographic Reading Center (BPRC). Complete examination of study patients comprises testing of standardized visual acuity (ETDRS-VA), visual contrast sensitivity (CS), biomicroscopy, fundus photography, and a blood sample. Participating patients also have to fill out a food frequency questionnaire (FFQ-Bern) allowing for correction of additional lutein intake by regular diet. Moreover possible confounding factors e.g. as sunlight exposure or smoking habits will be assessed. Secondary objective of EMPOLS is the effect of oral non-compound ester lutein supplementation on CS and ETDRS-VA during one year. The variable for a significant change in ETDRS-VA is loss or gain of 7 letters on the ETDRS chart, for a change in CS: loss or gain of at least four letters on the Pelli-Robson CS Chart. Additionally, serum carotenoid levels of lutein will be determined by high performance liquid chromatography (HPLC) for each visit 1.

Interventions

  • Dietary Supplement: VitaluxPlus®
    • 1 tablet daily
  • Dietary Supplement: Omega 3
    • 1 tablet daily

Arms, Groups and Cohorts

  • Active Comparator: 1
    • VitaluxPlus®
  • Active Comparator: 2
    • Omega 3

Clinical Trial Outcome Measures

Primary Measures

  • Macular pigment density
    • Time Frame: 6 months

Secondary Measures

  • contrast sensitivity
    • Time Frame: 6 months

Participating in This Clinical Trial

Inclusion Criteria

  • age related maculopathy

Exclusion Criteria

  • exudative age related degeneration

Gender Eligibility: All

Minimum Age: 50 Years

Maximum Age: N/A

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • University Hospital Inselspital, Berne
  • Provider of Information About this Clinical Study
    • Principal Investigator: Sebastian Wolf, Director – University Hospital Inselspital, Berne
  • Overall Official(s)
    • Sebastian Wolf, MD, Study Director, University of Bern
    • Ute Wolf-Schnurrbusch, MD, Principal Investigator, University of Bern

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