•Purpose: Age-related Macular Degeneration ( AMD) is the leading cause of blindness and visual impairment in industrialized countries. The macular pigment, composed of carotenoid derivatives (lutein and zeaxanthin), may play an important role in the occurrence of AMD. An increase in macular pigment following dietary supplementation with lutein and zeaxanthin could allow early treatment with such supplements in subjects with a high risk of AMD, and encourage them to change their eating habits. •Primary outcome: Comparative analysis of the density and evolution of the density of macular pigment: * In patients without any retinal pathology who underwent cataract surgery 1 month previously * In the non-exudative eye of patients with exudative AMD in one eye by analyzing the density and evolution of the density of macular pigment in the non-exudative eye * Secondary outcomes: Analysis of changes in macular pigment density after taking food supplements (Nutrof Total versus comparator): * Time taken to reach the maximum plateau of macular pigment density (no increase in density between 2 measurements) * Time taken to return to the baseline macular pigment density after cessation of supplementation * Study design : Pilot study -Prospective, randomised, double-masked, comparative, multicenter.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
BASIC_SCIENCE
Masking
TRIPLE
Enrollment
200
Nutrof Total : 2 capsules per day,during 8 months (5 mg Lutéine + 1 mg Zéaxanthine / capsule).
food supplement without Lutein and Zeaxanthin : 2 capsules per day, during 8 months.
Docteur Jean-Jacques Masella
Grenoble, France
Centre ophtalmologique Rabelais
Lyon, France
Comparative analysis of macular pigment density
Comparative analysis of macular pigment density in patients who underwent cataract operation 1 month ago, without retinal pathology and in patients with exudative AMD in one eye by analyzing the density and evolution of the density of macular pigment in the non-exudative eye. Optical density (OD)parameters of the macular pigments measured by an objective reflectometry method based on a 30° field image acquired by the Visucam 200 or 500 of Zeiss : Area : where macular pigments could be detected Max OD/Mean OD/ Volume : Maximum value/Mean Value/Sum of all OD in the area
Time frame: 18 months
Analysis of changes in macular pigment density
Analysis of changes in macular pigment density after taking food supplements (Nutrof Total versus comparator): * Time taken to reach the maximum plateau of macular pigment density (no increase in density between 2 measurements) * Time taken to return to the baseline macular pigment density after cessation of supplementation
Time frame: 18 months
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