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).

Sponsors

Lead Sponsor: Affordance

Collaborator: Drescode

Source Affordance
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.

Overall Status Completed
Start Date 2011-09-01
Completion Date 2015-01-01
Primary Completion Date 2014-12-01
Phase N/A
Study Type Interventional
Primary Outcome
Measure Time Frame
Comparative analysis of macular pigment density 18 months
Secondary Outcome
Measure Time Frame
Analysis of changes in macular pigment density 18 months
Enrollment 200
Condition
Intervention

Intervention Type: Dietary Supplement

Intervention Name: Nutrof Total

Description: Nutrof Total : 2 capsules per day,during 8 months (5 mg Lutéine + 1 mg Zéaxanthine / capsule).

Intervention Type: Dietary Supplement

Intervention Name: food supplement without Lutein and Zeaxanthin

Description: food supplement without Lutein and Zeaxanthin : 2 capsules per day, during 8 months.

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

Gender:

All

Minimum Age:

55 Years

Maximum Age:

N/A

Healthy Volunteers:

No

Overall Official
Last Name Role Affiliation
Martine Mauget-faysse Principal Investigator Affordance
Location
Facility:
Docteur Jean-Jacques Masella | Grenoble, 38000, France
Centre ophtalmologique Rabelais | Lyon, 69003, France
Location Countries

France

Verification Date

2015-06-01

Responsible Party

Type: Sponsor

Keywords
Has Expanded Access No
Condition Browse
Number Of Arms 2
Arm Group

Label: B: patients with wet AMD in one eye.

Type: Active Comparator

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.

Label: A :patients without retinal pathology

Type: Active Comparator

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.

Study Design Info

Allocation: Randomized

Intervention Model: Parallel Assignment

Primary Purpose: Basic Science

Masking: Triple (Participant, Care Provider, Investigator)

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