NCT01272063已完成不适用
Measurement and Analysis of Macular Retinal Pigment Epithelium (RPE) Elevations With Cirrus HD-OCT vs. Color Fundus Photography
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 91
- 试验地点
- 4
- 主要终点
- To compare area measurements of elevated RPE as observed in the Cirrus HD-OCT versus those designated as drusen on color fundus photographs.
研究概览
简要总结
The objective of this study is to compare the areas designated as elevated retinal pigment epithelium (RPE) by the Cirrus HD-OCT versus those designated as drusen on color fundus photographs (CFPs).
详细描述
This is a prospective, multiple site study. Ocular history and examination will be conducted on consented subjects to determine further participation in the study. Subjects qualified to continue will undergo color fundus photography and imaging of their study eye using the Cirrus HD-OCT.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
- 时间视角
- Prospective
入排标准
- 年龄范围
- 50 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Males or females 50 years of age or older diagnosed to have dry AMD with macular drusen.
- •Drusen should not be combined with other lesions such as geographic atrophy (GA) or choroidal neovascularization.
- •Able and willing to make the required study visits.
- •Able and willing to give consent and follow study instructions.
排除标准
- •History of retinal surgery, laser photocoagulation, and/or radiation therapy to the eye.
- •Evidence of other retinal diseases of the eye, including wet AMD, diabetic retinopathy, diabetic macular edema, or significant vitreomacular traction upon dilated examination, or upon evaluation of retinal photos.
- •Thick media opacity or inability to fixate that precludes obtaining acceptable scans.
- •Concomitant use of hydrochloroquine and chloroquine.
- •Unable to make the required study visits.
- •Unable to give consent or follow study instructions.
结局指标
主要结局
To compare area measurements of elevated RPE as observed in the Cirrus HD-OCT versus those designated as drusen on color fundus photographs.
时间窗: Study was released before December 1, 2012
次要结局
- To describe the clinical factors that affected the automated segmentation of elevated RPE by the Cirrus HD-OCT.(Study was released before December 1, 2012)
研究者
研究点 (4)
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