Clinical trial NCT00563979: Enhancement of Macular Pigment Density by Oral Lutein Supplementation
Official title: Enhancement of Macular Pigment Density by Oral Lutein Supplementation
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Age-Related Maculopathies
Keywords: age related macular degeneration
supplementation
macular pigment
Lead sponsor: Insel Gruppe AG, University Hospital Bern
Sponsor class: OTHER
First posted: 2007-11-27
Enrollment: 80
Sex: ALL
Minimum age (years): 50
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.

Eligibility criteria: Inclusion Criteria:

* age related maculopathy

Exclusion Criteria:

* exudative age related degeneration

Primary outcomes:
measure: Macular pigment density
timeFrame: 6 months
Secondary outcomes:
measure: contrast sensitivity
timeFrame: 6 months
Other outcomes:
Locations:
city: Bern
country: Switzerland
facility: Klinik und Poliklinik für Augenheilkunde, University Bern
Study officials:
affiliation: University of Bern
name: Sebastian Wolf, MD
role: STUDY_DIRECTOR
affiliation: University of Bern
name: Ute Wolf-Schnurrbusch, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Wolf-Schnurrbusch UE, Zinkernagel MS, Munk MR, Ebneter A, Wolf S. Oral Lutein Supplementation Enhances Macular Pigment Density and Contrast Sensitivity but Not in Combination With Polyunsaturated Fatty Acids. Invest Ophthalmol Vis Sci. 2015 Dec;56(13):8069-74. doi: 10.1167/iovs.15-17586.