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临床试验/NCT02147171
NCT02147171已完成2 期

The Bioavailability of Retinal Carotenoids in the Older Human Eye and Their Effects on Photoreceptor Performance

University of Manchester2 个研究点 分布在 1 个国家目标入组 88 人开始时间: 2011年11月最近更新:
适应症

试验速览

阶段
2 期
状态
已完成
入组人数
88
试验地点
2
主要终点
Changes in macular pigment optical density

研究概览

简要总结

Normal ageing affects vision as a result of preretinal and retinal changes. Photoreceptors, the light sensitive cells in the retina, degenerate and the rods (responsible for night vision) are most susceptible to damage with increasing age. Rod loss leads to poor vision in the dark which increases the risk of accidents amongst the elderly. Macular pigment (located in the photoreceptors)is thought to protect the retina and reduce the risk of age related changes. Dark adaptation, mediated by the rods, slows down with age, and is also reduced in AMD (age-related macular degeneration). Recent evidence suggests that lutein (the main component of macular pigment) supplementation improves the dark adaptation deficit in AMD subjects. Research into the effects of lutein in a normal human has not been previously conducted. Since the older population is increasing, our aim is to firstly establish the extent of night vision loss (using dark adaptometry) and secondly to examine the possibility of slowing down or reversing this loss through lutein supplementation.

详细描述

It is believed that the macular pigment protects the retina against photooxidative damage which can lead to agerelated macular degeneration (AMD). It is also hypothesized to enhance visual performance in normal human eyes. Much of the research into lutein supplementation has been centered around AMD subjects. AMD can result from agerelated retinal photoreceptor dysfunction which could hypothetically be prevented or slowed down through early supplementation. To our knowledge, the effects of lutein in normal ageing, have not been studied previously.

Macular pigment is composed of lutein and zeaxanthin. These compounds absorb blue light and therefore protect the retinal photoreceptors. They also possess powerful antioxidant properties and therefore help maintain the integrity of the macular region. With increasing age, the visual performance worsens as a result of preretinal and retinal changes such as photoreceptor degeneration. Rods (responsible for night vision) are highly susceptible to degeneration in a normal aging eye and in AMD. Older subjects often complain of reduced vision in the dark which can contribute to increased risk of road traffic accidents and falls. Since the older population is rapidly growing, it is vital to study the mechanics of photoreceptor degeneration and the possible beneficial effects of supplementation with retinal carotenoids, particularly lutein.

The supplement that will be used in this study will be the commercially available Visionace Plus (details attached). The manufacturer of Visionace Plus is Vitabiotics. The placebo will be soya-based, also manufactured by Vitabiotics.

研究设计

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

入排标准

年龄范围
50 Years 至 90 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Not on food supplements containing lutein or zeaxanthin
  • Visual acuity at least 0.4 logMAR units (6/15 Snellen)
  • Body mass index of less than 35
  • No diagnosed ocular disease (e.g. established AMD, cataract, glaucoma)
  • Age between 50 and 90

排除标准

  • Any diagnosed ocular disease (e.g. AMD, cataract, glaucoma)
  • Under 50 and over 90 years old

结局指标

主要结局

Changes in macular pigment optical density

时间窗: 12 months

Changes in serum lutein

时间窗: 12 months

次要结局

  • Changes in visual performance(12 months)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Laura Patryas

Miss

University of Manchester

研究点 (2)

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