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临床试验/NCT03068377
NCT03068377已完成不适用

The Effects of LycoRed Phytonutrient and Vitamin Supplement (a.k.a. LYC-001e) on Ocular Blood Flow

LycoRed Ltd.2 个研究点 分布在 1 个国家目标入组 60 人开始时间: 2017年3月20日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
发起方
LycoRed Ltd.
入组人数
60
试验地点
2
主要终点
Retinal microcirculation via Heidelberg Retinal Flowmeter

研究概览

简要总结

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.

详细描述

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.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Supportive Care
盲法
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

盲法说明

randomized double blind

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Healthy males and females of 18 years of age or older and free of any eye disease (other than myopia)
  • Willing to sign an informed consent statement and able to comply with the requirements of the examination

排除标准

  • Women who are pregnant or lactating or who plan to become pregnant (self reporting) within the duration of the study or within one month after study completion.
  • Receiving medications or dietary supplements known to have any interaction with the study supplements.
  • Smoker during last ten years (self reporting)
  • Concurrent use of any of the components of the study supplement
  • Individuals with narrow anterior chamber angles

研究组 & 干预措施

Experimental

Experimental

Soft gel capsules containing a mixture of tomato extract, lutein, zeaxanthin as well as other phytonutrients and vitamins

干预措施: Experimental (Dietary Supplement)

Placebo

Placebo Comparator

Soft gel capsules without test material

干预措施: Placebo (Dietary Supplement)

结局指标

主要结局

Retinal microcirculation via Heidelberg Retinal Flowmeter

时间窗: 3 weeks

Measures retinal capillary blood flow

次要结局

  • Ocular perfusion pressure(3 weeks)
  • Retinal photographic oximetry(3 weeks)

研究者

发起方
LycoRed Ltd.
申办方类型
Industry
责任方
Sponsor

研究点 (2)

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