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

June 23, 2015 updated by: Affordance

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).

•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 Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

200

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Grenoble, France, 38000
        • Docteur Jean-Jacques Masella
      • Lyon, France, 69003
        • Centre Ophtalmologique Rabelais

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

51 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion criteria:

  • Both genders (male or female), ≥ 55 years of age.
  • Patients without any retinal pathology who underwent cataract surgery 1 month previously Or
  • Patients with neovascular AMD (Age-related macular Degeneration) in one eye.
  • Patients who gave their written consent

Exclusion Criteria:

Exclusion criteria related to the study:

  • Intolerance to the tested product
  • Change in fundus image
  • Patients already taking Nutrof Total or similar supplements containing Lutein and Zeaxanthin
  • Allergy to mydriatics

Exclusion criteria for ophthalmologic reasons:

o Ocular diseases or conditions whose presence might interfere with the measurement of optical density of macular pigment (e.g. cataract, diabetic retinopathy, optic atrophy, myopia> -6.5 Diopters)

Exclusion criteria for systemic reasons:

o Medical or surgical history, disorder or disease (e.g. severe organic disease, acute or chronic: liver disease, endocrine, neoplastic, hematologic, infectious diseases, severe psychiatric disorder, significant cardiovascular abnormalities, etc...) and / or aggravating factors or structural defect, considered as being inconsistent with the study by the investigator.

Exclusion criteria for general reasons:

  • Inability of the patient to understand the study procedures and to give informed consent.
  • Ward of court
  • Patient not covered by the social security scheme
  • Pregnancy

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Basic Science
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: B: patients with wet AMD in one eye.
group B: patients with wet AMD in one eye. In each group, A and B, half the patients will be randomized in a subgroup to Nutrof Total, and the other half in a subgroup to a food supplement not containing Lutein and Zeaxanthin.
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.
Active Comparator: A :patients without retinal pathology

group A :patients without retinal pathology who underwent cataract surgery 1 month previously.

In each group, A and B, half the patients will be randomized in a subgroup to Nutrof Total, and the other half in a subgroup to a food supplement not containing Lutein and Zeaxanthin.
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Comparative analysis of macular pigment density
Time Frame: 18 months

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
18 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Analysis of changes in macular pigment density
Time Frame: 18 months

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
18 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Affordance

Collaborators

Drescode

Investigators

  • Principal Investigator: Martine Mauget-faysse, Affordance

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

September 1, 2011

Primary Completion (Actual)

December 1, 2014

Study Completion (Actual)

January 1, 2015

Study Registration Dates

First Submitted

July 22, 2011

First Submitted That Met QC Criteria

July 27, 2011

First Posted (Estimate)

July 28, 2011

Study Record Updates

Last Update Posted (Estimate)

June 24, 2015

Last Update Submitted That Met QC Criteria

June 23, 2015

Last Verified

June 1, 2015

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2011-A00922-39

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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