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临床试验/NCT01354093
NCT01354093已完成不适用

Utah Center for the Collaborative Study of the Role of the Macular Pigment Carotenoids in the Pathogenesis and Treatment of MacTel

Paul S. Bernstein1 个研究点 分布在 1 个国家目标入组 8 人开始时间: 2011年11月最近更新:
适应症
干预措施
相关药物

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
8
试验地点
1
主要终点
Change from baseline in macular pigment distribution and concentration

研究概览

简要总结

Macular telangiectasia type 2 ("MacTel Type 2") is an uncommon eye disorder that results in slow vision loss beginning in middle age. The macula is the central part of the retina, which lines the back of the eye like the film of a camera. The macula is responsible for central or reading vision. Telangiectasis refers to dilated, leaky vessels, for example varicose veins in the legs. One of the earliest manifestations of macular telangiectasia type 2 is an acquired reduction and/or redistribution of the macular pigment carotenoids at the foveal center. Currently, the biochemical mechanisms and clinical significance underlying these changes are not known, but it seems likely that better understanding of this phenomenon could lead to new interventions against MacTel.

The objectives of this study are to image the maculas of MacTel subjects using two-wavelength autofluorescence imaging and resonance Raman imaging to target the 7-degree radius pigment ring characteristic of macular telangiectasia type 2 in order to gain further insight into the significance of this early clinical sign, and to evaluate whether supplementation with oral zeaxanthin can normalize macular pigment distribution in MacTel subjects

详细描述

One of the earliest manifestations of macular telangiectasia type 2 ("MacTel") is an acquired reduction and/or redistribution of the macular pigment carotenoids at the foveal center. Currently, the biochemical mechanisms and clinical significance underlying these changes are not known, but it seems likely that better understanding of this phenomenon could lead to new interventions against MacTel.

Dr. Bernstein's laboratory at the Moran Eye Center of the University of Utah has focused for the past fifteen years on the role of the macular pigment carotenoids, lutein and zeaxanthin, in maintaining macular health. These xanthophyll carotenoids are derived exclusively from the diet, especially from green leafy vegetables and orange-yellow fruits and vegetables. They are thought to protect the macula from light-induced oxidative damage by virtue of their light-screening and antioxidant properties. Dietary supplement products, from infant formula to those aimed at seniors, primarily contain lutein; however the central macula (the fovea) actually has been shown to have higher concentrations of zeaxanthin.

Dr. Bernstein's lab has identified and characterized the binding proteins responsible for the uptake and stabilization of lutein and zeaxanthin in the macula, developed new, noninvasive methods to quantify and image carotenoids in the retina and many other non-ocular tissues, and has participated in intervention trials of lutein and zeaxanthin against age-related macular degeneration. As a leading site for identification of MacTel families in North America as part of the "MacTel Project", Dr. Bernstein and other researchers at the University of Utah have unique expertise in the biochemistry and biophysics of the macular pigment carotenoids that may help to hasten progress toward effective diagnosis and intervention against MacTel in a highly collaborative manner.

Macular Pigment Imaging:

Dr. Bernstein has extensive experience with various methods to image and quantify macular pigment in the living human eye, especially using autofluorescence imaging (AFI) and resonance Raman imaging (RRI). Dr. Bernstein is also currently utilizing these methods to evaluate age-related macular degeneration (AMD) patients participating in the "AREDS2" study.

研究设计

研究类型
Observational
观察模型
Other
时间视角
Prospective

入排标准

年龄范围
50 Years 至 85 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Male or female subjects who have MacTel and can conveniently travel to the University of Utah for study evaluations

排除标准

  • 未提供

研究组 & 干预措施

MacTel Type 2 20 mg/day dose group

Participants will have macular telangiectasis type 2 as confirmed by the reading center. Participants will take 20 mg of zeaxanthin per day.

干预措施: zeaxanthin (Drug)

MacTel Type 2 10 mg/day dose group

Participants will have macular telangiectasia type 2 as confirmed by the reading center. Participants will take 10 mg of zeaxanthin per day.

干预措施: zeaxanthin (Drug)

结局指标

主要结局

Change from baseline in macular pigment distribution and concentration

时间窗: 1 year

The primary outcome measure will be will be change from baseline in macular pigment distribution and concentration.

次要结局

  • Change in visual acuity(1 year)

研究者

发起方
Paul S. Bernstein
申办方类型
Other
责任方
Sponsor Investigator
主要研究者

Paul S. Bernstein

Professor of Ophthalmology

University of Utah

研究点 (1)

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