NCT01404845

Macular Pigment Density Evolution in Unilateral Wet AMD Versus Non AMD Patients With or Without Lutein and Zeaxanthine Supplementation

Assessment of the Evolution of Macular Pigment Density in Two Distinct Populations, Before and After Supplementation With Nutrof Total Versus Dietary Supplement Without Lutein and Zeaxanthin, Using the Macular Pigment Module of Visucam 200 or Visucam 500 (Zeiss).

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 200 (actual)
• Sponsor: Affordance · Network
• Sex: All
• Age: 55 Years
• Healthy volunteers: Not accepted

Summary

•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.

Conditions

• Exudative Age-related Macular Degeneration

Interventions

Type	Name	Description
DIETARY_SUPPLEMENT	Nutrof Total	Nutrof Total : 2 capsules per day,during 8 months (5 mg Lutéine + 1 mg Zéaxanthine / capsule).
DIETARY_SUPPLEMENT	food supplement without Lutein and Zeaxanthin	food supplement without Lutein and Zeaxanthin : 2 capsules per day, during 8 months.

Timeline

• Start date: 2011-09-01
• Primary completion: 2014-12-01
• Completion: 2015-01-01
• First posted: 2011-07-28
• Last updated: 2015-06-24

Locations

2 sites across 1 country: France