A Phase 2 Study of the Value of Pre-symptomatic Genetic Risk Assessment for Age-Related Macular Degeneration
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 80
- 试验地点
- 2
- 主要终点
- Change in Skin Carotenoid Status in Response to Genetic Risk Disclosure as Measured by Reflectance Spectroscopy
研究概览
简要总结
The goals of this study are:
To assess the impact of genetic testing for Age-related Macular Degeneration (AMD) on lifestyle behaviors as measured by systemic and ocular carotenoid status.
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
Participants will be masked to their AMD risk until their disclosure. Outcomes assessor and investigator will be masked to treatment assignment until completion of study.
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
- •Participants must be between 18 and 64 years of age.
- •They must also be Caucasian as this genetic test is only validated in Caucasians.
- •They can have a positive family history of AMD but this is not necessary.
排除标准
- •Personal history of AMD
- •Non Caucasian
- •Employee of the Moran or other eye care practice (likely to have more knowledge about AMD than a layperson)
- •Personal history of prior genetic testing for AMD risk
- •Anticipated cataract surgery in the upcoming year (can affect Macular Pigment measurement)
- •Major psychiatric disorder
结局指标
主要结局
Change in Skin Carotenoid Status in Response to Genetic Risk Disclosure as Measured by Reflectance Spectroscopy
时间窗: Baseline and Month 12
Reflectance Spectroscopy (RS) is measured by Reflection Units. Possible scores range from 0 (no carotenoids detected) to greater than 500. Change = (Month 12 Score - Baseline Score).
Change in Skin Carotenoid Status in Response to Genetic Risk Disclosure as Measured by Resonance Raman Spectroscopy
时间窗: Baseline and Month 12
Resonance Raman Spectroscopy (RSS) is measured in Resonance Raman Units (RRU). Possible scores range from 0 (no carotenoids detected) to greater than 100,000. Change = (Month 12 Score - Baseline Score).
次要结局
- Change in Ocular Carotenoid Status in Response to Genetic Risk Disclosure as Measured by Macular Pigment Optical Volume(Baseline and Month 12)
- Change in Serum Carotenoid Status in Response to Genetic Risk Disclosure(Baseline and Month 12)
研究者
Paul S. Bernstein
Professor, Ophthalmology/Visual Sciences
University of Utah