Virtual Reality Visual Field Testing as an Alternative to Standard Automated Perimetry in Childhood Eye Disease
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 1,000
- 试验地点
- 2
- 主要终点
- Mean deviation results of visual field parameters
研究概览
简要总结
The purpose of this study is to test a new way of measuring the peripheral vision (called a visual field test) using a device which can be worn as goggles rather than being a large instrument the patient must sit at. This new visual field test (called VisuALL) is an FDA-approved virtual reality system which has been used in adults and children. This study will compare the performance of the VisuALL to the standard testing for peripheral vision, which is called the Humphrey Visual Field (HVF) test.
The study will recruit both healthy children, as well children and young adults who have eye conditions which require visual field testing as part of their standard care. The test will be performed on a day when the child or young adult already has a scheduled eye appointment as standard care. The test does not touch the eyes or require any eye drops to be given, and there is no known risk associated with the test itself. There may be a risk of loss of confidentiality. Participating in this study will require approximately 30 minutes, has no extra cost associated with it, and will be compensated by a parking pass for the day of the visit. There are no direct benefits for participants.
Selected participants will be also be given training and then loaned a home VisuALL system to allow home visual field testing. If your child is selected, additional information would be provided.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Diagnostic
- 盲法
- None
入排标准
- 年龄范围
- 4 Years 至 21 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Patients must be at least four (4) years old
- •Cognitively normal (no developmental delay or syndrome)
- •Be able to tolerate wearing the virtual reality goggles for at least 10 minutes
- •Be able to provide informed consent of a parent/guardian (and assent if 12 years or older)
- •Do not have any ocular diseases that could interfere with the visual field testing
排除标准
- •Developmental delay
- •Inability to obtain consent
- •Inability to understand English
研究组 & 干预措施
Patient (pathology) group
This group will perform both the standard of care Humphrey Visual Field (HVF) and the VisuALL Virtual Reality Visual Field.
干预措施: VisuALL (Device)
Patient (pathology) group
This group will perform both the standard of care Humphrey Visual Field (HVF) and the VisuALL Virtual Reality Visual Field.
干预措施: Humphrey Visual Field (Device)
Control group
This group will only perform the VisuALL Virtual Reality Visual Field.
干预措施: VisuALL (Device)
结局指标
主要结局
Mean deviation results of visual field parameters
时间窗: During office visit, approximately 30 minutes
Mean deviation of the visual field is one score measured in decibels calculated from device reading
Pattern standard deviation results of visual field parameters
时间窗: During office visit, approximately 30 minutes
Pattern standard deviation of the visual field is one score calculated from device reading
Sensitivity results of visual field parameters
时间窗: During office visit, approximately 30 minutes
Sensitivities are the results of each space in the visual field measured in decibels
次要结局
- Percent of patients able to use VisuALL in-office testing as measured by patient observation(During office visit, approximately 30 minutes)
- Percent of participants stating satisfaction as measured by questionnaire(During office visit, approximately 5 minutes)
- Percent of times that scotomas were visualized as measured by visual field tests(During office visit, approximately 30 minutes)
- Percent of patients able to use VisuALL home testing as measured by device reading(One month, 1-2 tests per week)