Scanning Laser Ophthalmoscopy Registered Optical Coherence Tomography for Real-Time Eye Tracking
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- Successful performance of the real-time eye tracking function by post-image processing
研究概览
简要总结
Diabetic retinopathy (DR) is a leading cause of vision loss in working age Canadians. Current treatment consists of early detection and laser photocoagulation therapy for preventing progressive or severe vision loss. Microaneurysms (MA) are the earliest, clinically visible changes of DR, which are visualized using specialized imaging technologies. PulseMedica is developing a three-dimensional (3D) retinal imaging system with real-time eye tracking capabilities. The purpose of this study is to assess the feasibility of PulseMedica's prototype device, the OSNAT800 Imaging Only (IO), in providing real-time tracking of eye movements in patients with DR. It is hypothesized that the OSNAT 800 IO will be able to perform real-time eye tracking while imaging patients with DR.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Other
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Between 18 and 70 years of age
- •Male or female
- •Diagnosed diabetic retinopathy
- •Two eyes with clear ocular media
排除标准
- •Patients younger than 18 years and over 70 years of age
- •Patients without diabetic retinopathy
- •Opacification of cornea, lens, or vitreous
结局指标
主要结局
Successful performance of the real-time eye tracking function by post-image processing
时间窗: Through study completion, an average of 6 months
Successful acquisition of retinal images
次要结局
- Image Quality as assessed by user assessment of image quality parameters(Through study completion, an average of 6 months)
- Device usability as assessed by a survey(Through study completion, an average of 6 months)