Dry AMD
Conditions
Keywords
oral supplementation, mfERG, OCT
Brief summary
In patients with AMD a deterioration of the antioxidant mechanisms of the retina is observed and therefore an increase in the production of free radicals responsible for tissue damage. The Age-Related Eye Disease Study (AREDS) found that the intake of antioxidants reduces the risk of progression of the disease to an advanced stage (choroidal neovascularization or geographic atrophy ) and reduces the loss of visual acuity. In this study the investigators want to analyze the functional retinal changes (mfERG) of the macular region, in patients with dry age-related macular degeneration, after the use for 6 months of an oral supplementation based on Ganoderma lucidum (Reishi), Calendula Officinalis, Lutepure-Marigold ( 5% Lutein and 1% Zeaxanthin) Blueberry, Rutin, Alpha-lipoic acid, Bromelain, NAC, Vtiamine C, B9, B12, D3, Selenium, Zinc and Copper.
Interventions
OTHERMacuprev Group
oral supplementation (Macuprev) 2 capsules per day for 6 months
OTHERPlacebo Group
oral placebo 2 capsules per day for 6 months
Sponsors
Fondazione G.B. Bietti, IRCCS
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)
Intervention model description
monocentric, prospective, double blind randomized six months study
Eligibility
Sex/Gender
ALL
Age
50 Years to 80 Years
Healthy volunteers
No
Inclusion criteria
* age\> 50; * dry AMD not in therapy with oral supplements or antioxidants * visual acuity ≥ 20/40 * ability to provide written informed consent and to follow the procedures of the study;
Exclusion criteria
* spherical refractive error greater than ±6 diopters * cylindrical refractive error greater than ±3 dioptres * opacity of diopter means * any active or past retinal pathology other than AMD * history of ocular surgery (\<6 months) * Pregnancy
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change of Multifocal electroretinogram (mfERG) in patients with dry age-related macular degeneration after 6 months follow up | Functional retinal changes after 6 months follow up | To evaluate functional retinal changes of the macular region by multifocal electroretinogram in patients with dry age-related macular degeneration after the use for 6 months of an oral supplementation in tablets based on Ganoderma lucidum (Reishi), Calendula Officinalis, Lutepure-Marigold ( 5% Lutein and 1% Zeaxanthin) Blueberry, Rutin, Alpha-lipoic acid, Bromelain, NAC, Vtiamine C, B9, B12, D3, Selenium, Zinc and Copper. The researchers analyzed the average response amplitude densities (RAD: nanoV/ degree 2) between the first negative peak, N1 and the first positive peak, P1 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| To evaluate correlation between mfERG changes (functional activity) and morphological retinal changes (CRT: central retinal thickness and VD: vessel density at the superficial and deep capillary plexa) after 6 months follow up | Morpho-functional retinal relationships after 6 months follow up | The researchers evaluated the linear relationships between the mfERG (Response Amplitude Density (RAD nanoV/degree2) and OCT/OCTA values (CRT in micron and vessel density in mm3) by Pearson's Test after administration of a oral supplementation (Macuprev) |
Countries
Italy
Outcome results
None listed