NCT03279939已完成不适用
Evaluation of Heidelberg Engineering SPECTRALIS With OCT Angiography Module
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 88
- 试验地点
- 1
- 主要终点
- Clinically relevant findings on OCTA
研究概览
简要总结
Assessment of image quality and clinical relevance of OCT Angiography via comparison to FA/ICGA.
详细描述
The objectives of this study are:
- To compare the OCTA image quality between the SPECTRALIS and the predicate.
- To compare the agreement of clinical findings on SPECTRALIS OCTA to the predicate.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 22 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •All subjects:
- •Able and willing to undergo the test procedures, sign informed consent, and follow instructions.
- •Subjects with Normal Eyes:
- •Subjects presenting at the site without uncontrolled systemic conditions, or ocular disease, as determined by the Investigator
- •Corrected visual acuity ≥ 20/40 in each eye
- •No history of ocular surgical intervention (except for refractive or cataract surgery) in either eye
- •Subjects with Pathology:
- •Subjects with retinal conditions in at least one eye.
- •Subjects included can have a range of retinal vascular pathologies affecting different anatomic depths through the retina and choroid. Retinal conditions including but not limited to diabetic retinopathy, wet age-related macular degeneration (AMD), and branch or central retinal vein occlusion that give rise to features such as retinal ischemia, microaneurysms, choroidal neovascularization and retinal neovascularization will be included.
排除标准
- •Subjects unable to read or write
- •Subjects with ocular media not sufficiently clear to obtain acceptable study-related imaging
- •Subjects who cannot tolerate the imaging procedures
- •Subjects with known allergies to fluorescein dye, Indocyanine Green (ICG), shellfish, drugs for pupillary dilation
- •Subjects with contraindication to pupillary dilation in study eye
结局指标
主要结局
Clinically relevant findings on OCTA
时间窗: day 1
Clinically relevant grading results of study selected images
OCTA image quality
时间窗: day 1
Image quality grading results of study selected images
次要结局
未报告次要终点
研究者
研究点 (1)
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