跳至主要内容
临床试验/NCT03024424
NCT03024424已完成不适用

Value of Genetic Counseling and Testing for Patients Who Would Like to Know More About Their Personal Risk of AMD

University of Utah2 个研究点 分布在 1 个国家目标入组 16 人开始时间: 2016年3月最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
16
试验地点
2
主要终点
Change in carotenoid levels in the skin

研究概览

简要总结

The goals of this study are:

To assess the impact of genetic testing based on how it alters behaviors, to assess the utility of serum biomarker measurement in combination with genetic testing, to assess the utility of genetic counseling in personal analysis of risk for age-related macular degeneration (AMD), and to assess the impact of presymptomatic genetic testing for choroidal neovascularization (CNV).

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
Triple (Participant, Investigator, Outcomes Assessor)

盲法说明

Masking is applicable to risk of age-related macular degeneration, not to intervention assignment.

入排标准

年龄范围
18 Years 至 64 Years(Adult)
性别
All
接受健康志愿者

入选标准

  • Caucasian (this particular genetic test is only validated in Caucasians) Participants can have a positive family history of AMD but this is not necessary.

排除标准

  • Individuals with a personal history of AMD are not eligible. Non-caucasian individuals are not eligible. Employees of the Moran Eye Center are not eligible.
  • Individuals with a personal history of previous AMD genetic risk testing are not eligible.
  • Individuals with a major psychiatric disorder

结局指标

主要结局

Change in carotenoid levels in the skin

时间窗: Twelve months

Carotenoid levels in the skin are measured non-invasively at baseline and again at 12 months. Carotenoid levels are a biomarker of fruit and vegetable intake.

Change in carotenoid levels in the eyes

时间窗: Twelve months

Carotenoid levels in the eyes are measured non-invasively at baseline and again at 12 months.

次要结局

未报告次要终点

研究者

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

Paul S. Bernstein

Professor, Ophthalmology/Visual Sciences

University of Utah

研究点 (2)

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