Repeatability and Reproducibility of Cirrus HD-OCT Macular Retinal Pigment Epithelium Elevation
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 54
- 试验地点
- 1
- 主要终点
- Coefficient of variation for area (mm^2) of RPE elevation measurements in the central 3 mm circle.
研究概览
简要总结
The objective of this study is to determine the repeatability and reproducibility of the Cirrus HD-OCT measurements of drusen area and volume.
详细描述
This is a prospective, single site study. Ocular history and examination will be conducted on consented subjects to determine further participation in the study. The study will be divided into two phases. In Phase 1, the inter-device variability of Cirrus HD-OCT measurements of drusen area and volume will be determined. In Phase 2, the inter-operator variability of Cirrus HD-OCT measurements of drusen area and volume will be determined. In each of these phases, the Macular Cube 200 x 200 scan and the Macular Cube 512 x 128 scan will be evaluated.
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.
- •Thick media opacity or inability to fixate that precludes obtaining acceptable scans.
- •Concomitant use of hydrochloroquine or chloroquine.
- •Unable to make the required study visits.
- •Unable to give consent or follow study instructions.
结局指标
主要结局
Coefficient of variation for area (mm^2) of RPE elevation measurements in the central 3 mm circle.
时间窗: Single visit observation
次要结局
- Coefficient of variation for volume (mm^3) of RPE elevation measurements in the central 3 mm circle.(Single visit observation)