Virtual Reality Aniseikonia and Metamorphopsia Testing
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- Aegenta M-Test Score
研究概览
简要总结
The purpose of this study is to assess whether the use of small, lightweight, portable virtual reality headset devices can provide a more accessible, reliable, contained, and convenient testing environment compared to previous platforms.
Many tests only assess distortions in one plane or meridian and may have confounding effects from factors such as external stimuli or the use of colored filters to selectively display images to each eye. The investigators hypothesize that this device will help minimize, if not get rid of, a lot of these confounding factors that exist currently.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Device Feasibility
- 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
- •Over 18 years of age
- •Have no reported visual distortions with a negative Amsler test; or
- •Have visual distortions with a positive Amsler grid test and an ocular history of one of the following: epiretinal membrane (ERM), age-related Macular degeneration (AMD), central serous retinopathy (CSR), diabetic macular edema (DME), cystoid macular edema (CME)
- •Ophthalmology residents, staff, and physicians
排除标准
- •Eye pathology limiting view to the posterior pole to obtain adequate quality fundus photograph or OCT imaging in either eye
- •Impaired visual acuity with best-corrected visual acuity equal to or worse than 20/70
- •Motor deficits of the upper extremities
研究组 & 干预措施
Amsler-negative participants
Individuals without retinal pathology and without reported visual distortion on the Amsler grid will undergo testing with the Aegenta VR device in addition to established clinical assessments used to evaluate metamorphopsia and aniseikonia.
干预措施: Aegenta VR (Device)
Amsler-positive participants
Individuals with retinal pathology associated with visual distortion, including epiretinal membrane (ERM), age-related macular degeneration (AMD), diabetic macular edema (DME), central serous retinopathy (CSR), or cystoid macular edema (CME), who report distortion on the Amsler grid, will undergo testing with the Aegenta VR device in addition to established clinical assessments used to evaluate metamorphopsia and aniseikonia.
干预措施: Aegenta VR (Device)
结局指标
主要结局
Aegenta M-Test Score
时间窗: Day 0
Aegenta device output - a quantitative measure intended to capture the degree of metamorphopsia.
次要结局
未报告次要终点