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OpenTrials
Completed

NCT Number: NCT01404845

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

•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.

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Key information

Conditions

Exudative Age-Related Macular Degeneration

Age range

55 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Docteur Jean-Jacques Masella, Grenoble, France

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Nutrof Total

Dietary Supplement

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

food supplement without Lutein and Zeaxanthin

Dietary Supplement

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

Primary outcomes

  1. Comparative analysis of macular pigment density

    Time frame: 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 outcomes

  1. Analysis of changes in macular pigment density

    Time frame: 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

Sponsors and collaborators

Lead sponsor

Affordance

Network

Collaborators

  • Drescode

Registry information

Official study 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).

Important dates

Study start
2011
Primary completion
2014
Study completion
2015
First posted
Jul 28, 2011
Registry last updated
Jun 24, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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