Virtual Reality System for Cross-modal Rehabilitation of Hemianopia
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 6
- 试验地点
- 2
- 主要终点
- Humphrey Visual Field Perimetry
研究概览
简要总结
The purpose of this research study is to investigate the effectiveness of a new rehabilitation for visual hemianopia. The study team believes a cross-modal rehabilitation technique delivered by a virtual reality system can help restore the visual field for subjects with homonymous hemianopia.
详细描述
The study tests a novel rehabilitation system, translated from promising cross-modal rehabilitation animal research, that is the first treatment capable of restoring the visual field for hemianopia patients. This noninvasive technique uses a virtual reality device to deliver visual and auditory stimulus. The goals of this study are to obtain proof of concept and procure rehabilitation data to support the development of this novel rehabilitation treatment.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 99 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Adult volunteers diagnosed with homonymous visual hemianopia / hemianopsia (ages 18-99)
排除标准
- •Volunteers who are unable to complete the study tasks or understand instructions
- •Subjects that are not able to provide written consent or verbal assent
- •Subjects who are not available to complete all rehabilitation sessions
结局指标
主要结局
Humphrey Visual Field Perimetry
时间窗: up to 2 Months
The area of the subject's visual field measured by 30-2 Humphrey visual field (HVF) perimetry. Both left and right sides will be tested. The deficit side includes is the hemianopic side. The intact side is the non-hemianopic side. During the HVF test, light is projected into a white bowl with a standardized background light intensity to form a circular stimulus, around 30 cm away from the patient's eye. The overall field mapping technique used is a form of static perimetry, where a stimulus appears in various areas of the field of vision. The patient indicates when they can see the stimulus and the perimetrist then records the point where the stimulus was seen. These data points are used to determine the patient's visual field.
Virtual Reality Visual Field Test--Mean Percent Correct
时间窗: Day 29
Percent of correct trials in each location tested. Location at 15 degrees and 30 degrees on the horizontal meridian on both the left and right side were tested. Virtual Reality Visual Field test is a brief 5-minute test using the VR system to track rehabilitation progress. The test consists of 30 trials with visual stimulus presented either 15° or 30° in either the hemianopia field or the intact field at random time intervals.
Virtual Reality (VR) Visual Field Test--Mean Percent Correct
时间窗: Day 1
Percent of correct trials in each location tested. Location at 15 degrees and 30 degrees on the horizontal meridian on both the left and right side were tested. Virtual Reality Visual Field test is a brief 5-minute test using the VR system to track rehabilitation progress. The test consists of 30 trials with visual stimulus presented either 15° or 30° in either the hemianopia field or the intact field at random time intervals.
Peripheral Visual Field Frame Test
时间窗: 6 Months
The number of points subjects can detect in each location of the visual field along the horizontal meridian. Percent of correct trials in each location tested in the deficit and intact side. Locations at 15°, 30°, 45°, 60°, and 75° on the horizontal meridian on the left and right side were tested.
次要结局
- National Eye Institute Visual Function Questionnaire (NEI-VFQ-25)--Composite Score(Baseline, 2 months, 3 months)
- NEI-VFQ-25--General Vision Score Subscale(6 months)
- NEI-VFQ-25--General Health Score Subscale(6 months)
- NEI-VFQ-25--Near Activities Score Subscale(6 months)
- NEI-VFQ-25--Peripheral Vision Score Subscale(6 months)
- VA LV VFQ-48--Composite Score(6 months)
- NEI-VFQ-25--Role Difficulties Score Subscale(6 months)
- NEI-VFQ-25--Composite Score(6 month)
- NEI-VFQ-25--Ocular Pain Score Subscale(6 months)
- NEI-VFQ-25--Social Functioning Score Subscale(6 months)
- NEI-VFQ-25--Dependency Score Subscale(6 months)
- NEI-VFQ-25--Driving Score Subscale(6 months)
- Veterans Affairs Low Vision Visual Function Questionnaire-48 (VA LV VFQ-48)--Item Score(Baseline, 2 months)
- NEI-VFQ-25--Distance Activities Score Subscale(6 months)
- NEI-VFQ-25--Color Vision Score Subscale(6 months)
- VA LV VFQ-48--Item Score(6 months)
- VA LV VFQ-48--Reading Domain Score(6 months)
- NEI-VFQ-25--Mental Health Score Subscale(6 months)