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

Not Applicable

Completed

• Conditions: Exudative Age-related Macular Degeneration
• Interventions: Dietary Supplement: Nutrof Total; Dietary Supplement: food supplement without Lutein and Zeaxanthin

• Registration Number: NCT01404845
• Lead Sponsor: 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2011-07-22
• Study First Submitted QC: 2011-07-27
• Study First Posted: 2011-07-28
• Study Start: 2011-09
• Primary Completion: 2014-12
• Study Completion: 2015-01
• Status Verified: 2015-06
• Last Update Submitted: 2015-06-23
• Last Update Posted: 2015-06-24

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 200

Inclusion Criteria

Not provided

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
B: patients with wet AMD in one eye.	food supplement without Lutein and Zeaxanthin	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.
A :patients without retinal pathology	Nutrof Total	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.
A :patients without retinal pathology	food supplement without 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.
B: patients with wet AMD in one eye.	Nutrof Total	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.

Primary Outcome Measures

Name	Time	Method
Comparative analysis of macular pigment density	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

Secondary Outcome Measures

Name	Time	Method
Analysis of changes in macular pigment density	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

Trial Locations

Locations (2)

Docteur Jean-Jacques Masella; 🇫🇷 Grenoble, France

Centre ophtalmologique Rabelais; 🇫🇷 Lyon, France