Age-Related Maculopathies Clinical Trial
Official title:
Enhancement of Macular Pigment Density by Oral Lutein Supplementation
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®.
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.
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Allocation: Randomized, Endpoint Classification: Bio-availability Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Prevention
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