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Design of a randomized trial of supplementation with lutein, zeaxanthin, omega 3 fatty acids and antioxidants for increasing macular pigment density in high-risk subjects: the LIMPIA study

Session Details

Session Title: AMD III

Session Date/Time: Sunday 29/09/2013 | 11:00-13:00

Paper Time: 12:44

Venue: Hall G1 (Level 2)

First Author: J.Korobelnik FRANCE

Co Author(s):    M. Delyfer   M. Rougier   H. Savel   G. Chene     

Abstract Details

Purpose:

The macular pigment may protect against age-related macular degeneration (AMD). It is formed of lutein and zeaxanthin, two dietary carotenoids. Some studies have suggested that omega 3 fatty acids may help increasing macular pigment density. We performed a randomized trial testing the efficacy of a dietary supplement containing lutein, zeaxanthin, omega 3 fatty acids and antioxidants for increasing macular pigment density in subjects at high genetic risk for AMD

Setting:

The Limpia Study is a double-blind, placebo controlled, prospective randomized clinical trial performed in 120 subjects with at least one parent affected by neovascular AMD

Methods:

To be included, subjects had to be aged 40-70 years, have best-corrected visual acuity (BCVA) greater than 20/25, be free of late AMD and other major eye conditions (severe glaucoma, high myopia, severe retinal disease, cataract surgery…). Subjects having used supplements containing lutein and/or zeaxanthin in the preceding year were not included. Included subjects were randomly assigned to receive Nutrof® Total (2 gels/day, representing lutein 10 mg/day, zeaxanthin 2 mg/day, long chain omega 3 fatty acids 540 mg/day, vitamin C 180 mg/day, vitamin E 30 mg/day, zinc 15 mg/day, copper 1 mg/day and resveratrol 1 mg/day ) or placebo for 6 months (Figure 1). The primary outcome was the variation of macular pigment optical density (MPOD). Secondary outcomes included visual function, nutritional biomarkers and cognitive function. MPOD was measured by two methods (modified Heidelberg Retinal Analyzer, Heidelberg, Germany and Visucam 200 MPD, Carl Zeiss Meditec, Germany) every 3 months during one year. This allows studying the variation of macular pigment density during the 6 month-supplementation phase, and during 6 months after the cessation of the supplementation.

Results:

120 subjects were included from December 2010 to January 2012. Mean age was 56.7 years and 71.7 % were women. The mother of 97 subjects (80.8 %) was affected by AMD, while in only 25 subjects (20.8 %) the father was affected.

Conclusions:

This prospective trial will give informations on the baseline macular pigment of our population, on the increase in subjects that were supplemented as compared to placebo, and on the possible decrease in the months following the end of supplementation.

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