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

Study Overview
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Brief Summary
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•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.

Official Title
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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).

Conditions
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Exudative Age-related Macular Degeneration

Intervention / Treatment
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* Dietary Supplement: Nutrof Total
* Dietary Supplement: food supplement without Lutein and Zeaxanthin


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 55 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Basic Science
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: B: patients with wet AMD in one eye.<br>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. | Dietary Supplement: Nutrof Total<br>* Nutrof Total : 2 capsules per day,during 8 months (5 mg Lutéine + 1 mg Zéaxanthine / capsule).<br>Dietary Supplement: food supplement without Lutein and Zeaxanthin<br>* food supplement without Lutein and Zeaxanthin : 2 capsules per day, during 8 months.<br>|
| Active Comparator: A :patients without retinal pathology<br>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. | Dietary Supplement: Nutrof Total<br>* Nutrof Total : 2 capsules per day,during 8 months (5 mg Lutéine + 1 mg Zéaxanthine / capsule).<br>Dietary Supplement: food supplement without Lutein and Zeaxanthin<br>* food supplement without Lutein and Zeaxanthin : 2 capsules per day, during 8 months.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 18 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 18 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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lutein, exudative AMD, dietary supplements, macular pigment, zeaxanthin, Nutrof total, in one eye