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

NCT01404845 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 200

Last updated 2015-06-24

No results posted yet for this study

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

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.

Sponsors & Collaborators

  • Drescode

    collaborator UNKNOWN

  • Affordance

    lead NETWORK

Principal Investigators

  • Martine Mauget-faysse · Affordance

Study Design

Allocation
RANDOMIZED
Purpose
BASIC_SCIENCE
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
55 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2011-09-30
Primary Completion
2014-12-31
Completion
2015-01-31

Countries

  • France

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01404845 on ClinicalTrials.gov