Diabetic Retinopathy Tethered Augmented Reality With Eye4 Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 20
- 试验地点
- 2
- 主要终点
- Visual acuity at distance
研究概览
简要总结
Diabetes has reached epidemic levels in North America and with it, diabetic retinopathy is increasingly affecting the vision of millions of people. Despite treatment many patients still have vision loss that cannot be improved medically or with prescription eyeglasses. Our study is going to look at an FDA Class 1 Exempted visual aid that uses augmented reality to help people see better.
详细描述
In this study subjects will have their best corrected visual acuity and contrast sensitivity compared to their best vision and contrast with the Eyedaptic device. The Eyedaptic device is an FDA 510(k) Class 1 Exempt device as it is a visual aid. This is a pilot study to determine whether subjects with diabetic retinopathy associated vision loss obtain a benefit with augmented reality vision.
Subjects will receive a manifest refraction. When subjects have their optimal corrective lenses, the subjects' vision will be tested with their corrective lenses alone and again using the Eyedaptic device. This will be a single visit study, with no follow up.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Crossover
- 主要目的
- Supportive Care
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Best correct visual acuity in the better seeing eye between 20/60 and 20/800
- •History of diabetic retinopathy
排除标准
- •Unable to complete the visit
- •Unable to give a reliable measurement of vision
- •Unable to comfortably wear the glasses for at least 60 minutes
结局指标
主要结局
Visual acuity at distance
时间窗: Day 1
Visual acuity at distance using Snellen Visual Acuity Chart
次要结局
- Contrast sensitivity(Day 1)
- Visual acuity at near(Day 1)