Enhancement of Macular Pigment Density by Oral Lutein Supplementation

Not Applicable

Completed

• Conditions: Age-Related Maculopathies
• Interventions: Dietary Supplement: Omega 3; Dietary Supplement: VitaluxPlus®

• Registration Number: NCT00563979
• Lead Sponsor: Insel Gruppe AG, University Hospital Bern

Brief Summary

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®.

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.

Study Timeline

• Study Start: 2007-07
• Study First Submitted: 2007-11-26
• Study First Submitted QC: 2007-11-26
• Study First Posted: 2007-11-27
• Primary Completion: 2009-12
• Study Completion: 2009-12
• Status Verified: 2015-06
• Last Update Submitted: 2015-06-10
• Last Update Posted: 2015-06-12

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 80

Inclusion Criteria

• age related maculopathy

Exclusion Criteria

• exudative age related degeneration

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
2	Omega 3	Omega 3
1	VitaluxPlus®	VitaluxPlus®

Primary Outcome Measures

Name	Time	Method
Macular pigment density	6 months

Secondary Outcome Measures

Name	Time	Method
contrast sensitivity	6 months

Trial Locations

Locations (1)

Klinik und Poliklinik für Augenheilkunde, University Bern; 🇨🇭 Bern, Switzerland