Status:
COMPLETED
Macular Pigment Density Evolution in Unilateral Wet AMD Versus Non AMD Patients With or Without Lutein and Zeaxanthine Supplementation
Lead Sponsor:
Affordance
Collaborating Sponsors:
Drescode
Conditions:
Exudative Age-related Macular Degeneration
Eligibility:
All Genders
55+ years
Phase:
NA
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 a...
Eligibility Criteria
Inclusion
- 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
Exclusion
Key Trial Info
Start Date :
September 1 2011
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 1 2015
Estimated Enrollment :
200 Patients enrolled
Trial Details
Trial ID
NCT01404845
Start Date
September 1 2011
End Date
January 1 2015
Last Update
June 24 2015
Active Locations (2)
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1
Docteur Jean-Jacques Masella
Grenoble, France, 38000
2
Centre ophtalmologique Rabelais
Lyon, France, 69003