Age-related macular degeneration (AMD) is a degenerative disease of the centre of the retina (named macula) and is the leading cause of blindness in industrialized countries. There is growing interest in the potential preventive role of two carotenoids (lutein and zeaxanthin) of dietary origin, which specifically accumulate in the macula, where they form the macular pigment. A first step towards the demonstration of a preventive effect of macular pigment for AMD consists in the evaluation of the effect of lutein and zeaxanthin supplementation on their plasma and retinal concentrations.
The objective of this study is to estimate the efficiency of a nutritonal supplementation with lutein and zeaxanthin to increase their plasma concentration and the density of macular pigment, in subjects at high genetic risk for AMD (1st generation stemming from parent affected by DMLA). This study is a multicentric, double blind, randomized clinical trial of supplementation versus placebo
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
DOUBLE
Enrollment
120
2 capsules 2 times per day during 6 month
2 capsules 2 times per day during 6 month
Unité Médicale Rétine Neuro-Ophtalmologie - Service d'Ophtalmologie - Hopital Pellegrin
Bordeaux, France
Service Ophtalmologie - Hôpital général CHU de Dijon
Dijon, France
The main assessment criterion is the measure of the evolution of the density of the macular pigment after 6 months of supplementation
Difference in measures of the density of the macular pigment at baseline and 6 months after stop of the supplementation
Time frame: 6 months after stop of the supplementation
Measure of the modification of the visual acuteness with correction
Time frame: 12 months
Measure of the cognitive capacities
Time frame: 12 months
Measure rates plasmatiques of fatty acids
Time frame: 12 months
Measure of the evolution of the density of the macular pigment during supplementation and after stop of the supplementation
Measure of the density of the macular pigment before supplementation, in 3 and 6 months during the supplementation and in 3 and 6 months after stop of the supplementation
Time frame: 1 year
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