Ocular Blood Flow Clinical Trial
Official title:
The Effects of LycoRed Phytonutrient and Vitamin Supplement (a.k.a. LYC-001e) on Ocular Blood Flow
Objectives:To determine LYC-001e's influences on ocular blood flow Ocular blood flow has been
implicated as a parameter relevant to eye health and involved in the disease process of
several ophthalmic pathologies including AMD, glaucoma, and diabetes We hypothesis that
LYC-001e will increase measures of ocular blood flow in healthy individuals
Methods: This is a single-phase, randomized, parallel, double blind , comparative study of
LYC-001e versus placebo on ocular blood vessels in healthy individuals.
Age-Related Eye Disease (ARED) is a group of conditions that are associated with an increased
risk of manifesting later in life, and include: Age-related Macular Degeneration (AMD),
cataract, diabetic retinopathy, glaucoma, dry eye, and low vision. AMD and cataract are the
leading causes of visual impairment in the United States. According to the National Eye
Institute, approximately 1.7 million Americans suffer from some form of AMD, and over 1.5
million cataract surgeries are performed annually.
Although there are established risk factors, such as smoking and diabetes, cataracts are
generally considered a consequence of ageing. The National Eye Institute estimates more than
half of Americans will have cataracts or have had cataract surgery by the time they reach 80
years old. Additionally, AMD is the leading cause of central vision loss in developed
countries and affects 13.4% of all adults aged 60 years and older.
It is estimated that the number of patients with AMD in the U.S. will double in 2050, based
on 2010 demographics.
The severity and irreversibility of ocular pathology have created interest in researching
ways to either prevent or slow their progression. Nutritional methods have been demonstrated
to improve microvascular function in hypertensive patients, however diet modifications are
infrequently well established and maintained in the American population.
Over the last 15 years, researchers focused on the role of the AREDS vitamin formulation on
age related eye disease, specifically as it pertains to the development and progression of
AMD and cataracts. While the benefit of AREDS supplementation has proven beneficial for AMD,
its role in the prevention of cataract and/or glaucoma development has not been confirmed.
However, with evidence suggesting that some combination supplements do provide potential risk
reduction, it is our belief that further studies are needed to elucidate the role of
combination nutriceuticals for the prevention of cataracts.
Lycored Nutrient Complex for eyes (LNC for eyes) a.k.a. (LYC-001e) is a commercially
available multivitamin formula nutraceutical product that also contains a standardized tomato
extract. Research by Armoza, et al. has shown multiple benefits of tomato extract as it
pertains to limiting inflammatory processes of the vascular endothelium. Along with the
previously mentioned benefits of nutraceuticals, diminished endothelial damage may result in
increased ocular blood flow and alter the progression of Age Related Eye Diseases.
This is an important research consideration as ocular blood flow has been implicated in the
disease process of several ophthalmic pathologies including AMD, glaucoma, and diabetes.
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