Image Evaluation of Intalight Dream OCTA Scans With Optos FA & ICGA Images
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- Image assessment of retinal images
研究概览
简要总结
The goal of this study is to evaluate the image quality and clinical utility of the OCTA images from the VG200D OCT device (investigational device) compared against the FA and ICGA images from the UWF Optos California (CA) device. Image assessment will be conducted by three expert image graders and involve the assessment of the images based on both image quality and clinical utility. Evidence for substantial equivalence will be obtained through establishing similar image evaluation results across the devices based on image quality and clinical utility.
详细描述
1. Protocol Summary
The goal of this study is to evaluate the image quality and clinical utility of the OCTA images from the VG200D OCT device (investigational device) compared against the FA and ICGA images from the UWF Optos California (CA) device. Image assessment will be conducted by three expert image graders and involve the assessment of the images based on both image quality and clinical utility. Evidence for substantial equivalence will be obtained through establishing similar image evaluation results across the devices based on image quality and clinical utility.
Objectives and Endpoints
The primary objective is to evaluate image quality and clinical utility for visualization of the retinal vasculature from en-face OCTA scans between the VG200D and FA and ICGA images from the CA SLO device in eyes with retinal pathology.
The endpoint is the image grading results of the scans of the vascular structure of the retina in eyes with retinal associated pathology.
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
- 否
入选标准
- •Subjects 22 years of age or older on the date of informed consent
- •Subjects able to understand the written informed consent and willing to participate as evidenced by signing the informed consent
- •BCVA 20/400 or better in the study eye
- •Diagnosis of retinal associated pathology by investigator with the need to have an FA and/or ICGA performed in at least one eye
排除标准
- •Subjects unable to tolerate ophthalmic imaging
- •Subjects not able to obtain acceptable OCT images due to ocular media opacity or other reasons
- •Subject has a condition or is in a situation which the investigator feels may put the subject at significant risk, may confound the study results, or may interfere significantly with the subject's participation in the study
研究组 & 干预措施
Eyes with retina pathology
These are eyes with some type of retina pathology such as age-related macular degeneration, diabetic retinopathy, diabetic macula edema, and other retina pathologies
干预措施: Dream OCT (Device)
结局指标
主要结局
Image assessment of retinal images
时间窗: All images and clinical study data will be collected in one clinical visit, which typically should take approximately 1 hour.
The outcome measure is the image grading of retinal images including OCTA and FA and or ICGA images as graded by experts
次要结局
未报告次要终点