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

Affordance

Status: Completed

Conditions: Exudative Age-related Macular Degeneration

Treatments: Dietary Supplement: food supplement without Lutein and Zeaxanthin; Dietary Supplement: Nutrof Total

Study type: Interventional

Funder types: NETWORK; Other

Identifiers

NCT01404845

2011-A00922-39

Details and patient eligibility

About

•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.

Enrollment: 200 patients

Sex: All

Ages: 55+ years old

Volunteers: No 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

Trial design

Primary purpose: Basic Science

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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200 participants in 2 patient groups

B: patients with wet AMD in one eye.

Active Comparator group

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.

Treatment:

Dietary Supplement: Nutrof Total

Dietary Supplement: food supplement without Lutein and Zeaxanthin

A :patients without retinal pathology

Active Comparator group

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.

Treatment:

Dietary Supplement: Nutrof Total

Dietary Supplement: food supplement without Lutein and Zeaxanthin