Value of Genetic Counseling and Testing for Patients Who Would Like to Know More About Their Personal Risk of AMD
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 16
- 试验地点
- 1
- 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
- 是
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
研究组 & 干预措施
Early disclosure
Early disclosure group receives results of genetic testing at Week 4
干预措施: Early disclosure (Behavioral)
Late disclosure
Late disclosure group receives results of genetic testing at final study visit (Month 12)
干预措施: Late disclosure (Behavioral)
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
Paul S. Bernstein
Professor, Ophthalmology/Visual Sciences
University of Utah