- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00563979
Enhancement of Macular Pigment Density by Oral Lutein Supplementation (EMPOLS)
Study Overview
Status
Conditions
Intervention / Treatment
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 Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
-
Bern, Switzerland
- Klinik und Poliklinik für Augenheilkunde, University Bern
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- age related maculopathy
Exclusion Criteria:
- exudative age related degeneration
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Active Comparator: 1
VitaluxPlus®
|
1 tablet daily
|
Active Comparator: 2
Omega 3
|
1 tablet daily
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Macular pigment density
Time Frame: 6 months
|
6 months
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
contrast sensitivity
Time Frame: 6 months
|
6 months
|
Collaborators and Investigators
Investigators
- Study Director: Sebastian Wolf, MD, University of Bern
- Principal Investigator: Ute Wolf-Schnurrbusch, MD, University of Bern
Publications and helpful links
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- KEK 152/07
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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