Clinical trial NCT01404845: 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
Overall status: COMPLETED
Phase: NA
Conditions: Exudative Age-related Macular Degeneration
Keywords: exudative AMD
dietary supplements
macular pigment
lutein
zeaxanthin
Nutrof total
in one eye
Lead sponsor: Affordance
Sponsor class: NETWORK
Collaborators: name: Drescode
First posted: 2011-07-28
Enrollment: 200
Sex: ALL
Minimum age (years): 55
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: BASIC_SCIENCE

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.


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

Primary outcomes:
measure: Comparative analysis of macular pigment density
timeFrame: 18 months
Secondary outcomes:
measure: Analysis of changes in macular pigment density
timeFrame: 18 months
Other outcomes:
Locations:
city: Grenoble
country: France
facility: Docteur Jean-Jacques Masella
city: Lyon
country: France
facility: Centre ophtalmologique Rabelais
Study officials:
affiliation: Affordance
name: Martine Mauget-faysse
role: PRINCIPAL_INVESTIGATOR
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