An Open-label, Single-blinded, Randomized, 2-way Crossover, Performance Study of the EyeMirage (Test Device) Relative to Standard of Care (Reference Device) in Patients Undergoing Standard Eye Examinations for Various Conditions
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 160
- 试验地点
- 4
- 主要终点
- Accuracy and Reliability of EyeMirage Test Results from Four Elements of Visual Testing in Comparison to Current Standard of Care
研究概览
简要总结
This study will assess the effectiveness and accuracy of results of a new device for eye function testing. This will be done by comparing results of four eye tests that are done through the current standard used in eye clinics and that of this new device. Participants of this study will undergo the four eye tests using both the new device and the standard of care devices.
The study will be done in one visit to the eye clinic. Thirty days after the eye tests were done, participants will be called by the clinic for a general follow-up and to discuss any problems, if needed.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Screening
- 盲法
- Single (Investigator)
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Evidence of a signed and dated informed consent document confirming that the participant has been informed of all aspects of the clinical study.
- •Male or female participants, 18 to 65 years of age at time of screening.
- •Visual acuity of 20/200 or better.
- •Willingness to comply with required screening procedures, eye assessments, and follow-up visits, if needed.
排除标准
- •Visual acuity worse than 20/200 in either eye
- •Complete blindness or diffuse vision loss in either eye
- •Clinical diagnosis of cognitive and motor diseases including but not limited to the following:
- •Neurodegenerative diseases such as dementia-like Alzheimer's disease, posterior cortical atrophy
- •Movement disorders such as Parkinson's disease and Parkinsonism tremors
- •Multiple sclerosis, stroke or any other neurological or physical conditions with paresis or plegia (i.e. weakness or paralysis of the limbs)
- •Eyes with a spherical equivalent of greater than +9 or -9 diopters where the corrective lens is too large to fit in the headset.
研究组 & 干预措施
Standard of Care
This Cohort will undergo assessments for visual acuity, visual field, color vision, and self-paced saccade first via the current standard of care tests and then using the EyeMirage device and app.
干预措施: EyeMirage device (Device)
EyeMirage
This Cohort will undergo assessments for visual acuity, visual field, color vision, and self-paced saccade first via the EyeMirage device and app, then via the standard of care tests.
干预措施: EyeMirage device (Device)
结局指标
主要结局
Accuracy and Reliability of EyeMirage Test Results from Four Elements of Visual Testing in Comparison to Current Standard of Care
时间窗: From enrollment to the end of follow-up visit at Day 30 + 7 days
Results of the eye assessments for visual acuity, visual field, color vision, and self-paced saccade using the EyeMirage device and app, and standard of care will be analyzed using the paired t-test. Insignificant p values (\>0.5) will indicate that there is no statistical difference between eye assessment results from the use of EyeMirage compared to those obtained from current standard of care clinical testing.
次要结局
未报告次要终点