Exudative Age-related Macular Degeneration
Conditions
Keywords
exudative AMD, dietary supplements, macular pigment, lutein, zeaxanthin, Nutrof total, in one eye
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.
Interventions
DIETARY_SUPPLEMENTNutrof Total
Nutrof Total : 2 capsules per day,during 8 months (5 mg Lutéine + 1 mg Zéaxanthine / capsule).
DIETARY_SUPPLEMENTfood supplement without Lutein and Zeaxanthin
food supplement without Lutein and Zeaxanthin : 2 capsules per day, during 8 months.
Sponsors
Drescode
Affordance
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
BASIC_SCIENCE
Masking
TRIPLE (Subject, Caregiver, Investigator)
Eligibility
Sex/Gender
ALL
Age
55 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Comparative analysis of macular pigment density | 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
| Measure | Time frame | Description |
|---|---|---|
| Analysis of changes in macular pigment density | 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 |
Countries
France
Outcome results
None listed