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

Primary Purpose

Exudative Age-related Macular Degeneration

Status
Completed
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
Nutrof Total
food supplement without Lutein and Zeaxanthin
Sponsored by
Affordance
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional basic science trial for Exudative Age-related Macular Degeneration focused on measuring exudative AMD, dietary supplements, macular pigment, lutein, zeaxanthin, Nutrof total, in one eye

Eligibility Criteria

55 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Docteur Jean-Jacques Masella
  • Centre ophtalmologique Rabelais

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

B: patients with wet AMD in one eye.

A :patients without retinal pathology

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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

Full Information

First Posted
July 22, 2011
Last Updated
June 23, 2015
Sponsor
Affordance
Collaborators
Drescode
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1. Study Identification

Unique Protocol Identification Number
NCT01404845
Brief Title
Macular Pigment Density Evolution in Unilateral Wet AMD Versus Non AMD Patients With or Without Lutein and Zeaxanthine Supplementation
Official Title
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).
Study Type
Interventional

2. Study Status

Record Verification Date
June 2015
Overall Recruitment Status
Completed
Study Start Date
September 2011 (undefined)
Primary Completion Date
December 2014 (Actual)
Study Completion Date
January 2015 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Affordance
Collaborators
Drescode

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Exudative Age-related Macular Degeneration
Keywords
exudative AMD, dietary supplements, macular pigment, lutein, zeaxanthin, Nutrof total, in one eye

7. Study Design

Primary Purpose
Basic Science
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigator
Allocation
Randomized
Enrollment
200 (Actual)

8. Arms, Groups, and Interventions

Arm Title
B: patients with wet AMD in one eye.
Arm Type
Active Comparator
Arm Description
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.
Arm Title
A :patients without retinal pathology
Arm Type
Active Comparator
Arm Description
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.
Intervention Type
Dietary Supplement
Intervention Name(s)
Nutrof Total
Intervention Description
Nutrof Total : 2 capsules per day,during 8 months (5 mg Lutéine + 1 mg Zéaxanthine / capsule).
Intervention Type
Dietary Supplement
Intervention Name(s)
food supplement without Lutein and Zeaxanthin
Intervention Description
food supplement without Lutein and Zeaxanthin : 2 capsules per day, during 8 months.
Primary Outcome Measure Information:
Title
Comparative analysis of macular pigment density
Description
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
Secondary Outcome Measure Information:
Title
Analysis of changes in macular pigment density
Description
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

10. Eligibility

Sex
All
Minimum Age & Unit of Time
55 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Martine Mauget-faysse
Organizational Affiliation
Affordance
Official's Role
Principal Investigator
Facility Information:
Facility Name
Docteur Jean-Jacques Masella
City
Grenoble
ZIP/Postal Code
38000
Country
France
Facility Name
Centre ophtalmologique Rabelais
City
Lyon
ZIP/Postal Code
69003
Country
France

12. IPD Sharing Statement

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

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