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临床试验/NCT05141604
NCT05141604进行中(未招募)不适用

Monocular Visual Confusion for Field Expansion

Massachusetts Eye and Ear Infirmary1 个研究点 分布在 1 个国家目标入组 15 人开始时间: 2022年5月17日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
进行中(未招募)
入组人数
15
试验地点
1
主要终点
Response time

研究概览

简要总结

The investigators are developing a new test of pedestrian hazard detection in virtual reality (VR) head-mounted display (HMD) headset, which shows virtual oncoming pedestrians in 3D while subjects are walking in real-world environment, for evaluation of visual field expansion to improve mobility in people with visual field loss.

详细描述

The investigators will develop a new pedestrian hazard detection test and conduct a single arm interventional clinical trial to evaluate simulated low vision assistive devices in a sample of field loss subjects. Pedestrian detection performance with and without field expansion information will be tested and compared. The study will include 1 to 4 visits (each 2 to 4 hours) depending on the number of trials and experimental conditions (e.g., with and without simulated assistive devices) the subject is comfortable completing. The time between visits may vary depending on scheduling constraints and availability. During each visit, the subject will complete a series of simulated collision avoidance trials in VR requiring the detection and natural avoidance of a colliding pedestrian (alongside non-colliding pedestrians) while physically walking through an empty corridor. The study will be considered minimal-risk since there will be no physical obstacles that present actual collision risks.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Basic Science
盲法
None

入排标准

年龄范围
14 Years 至 —(Child, Adult, Older Adult)
性别
All
接受健康志愿者
否

入选标准

  • •At least 14 years of age (no upper age limit)
  • •In sufficiently good health to be able to complete sessions lasting 2-3 hours
  • •Able to understand English
  • •Able to give voluntary, informed consent
  • •Able to independently move short distances
  • •Binocular vision parameters within normal limits (Stereopsis ≤ 100 arc sec on any stereo test)
  • •Visual field loss, either peripheral field loss (<30 degrees diameter) or hemianopic field loss (blind in half of visual field)
  • •Better than 20/100 visual acuity in the worse eye

排除标准

  • •Patients with any self-reported physical or mental disabilities, including cognitive dysfunction, balance problems, or other deficits that could impair their ability to respond to the stimuli presented in this study
  • •Any person with a self-reported medical history (such as pacemaker use or photosensitive epilepsy) or physical condition listed on the device manual of the Oculus / HMD system used for the experiment as a contraindication
  • •Any self-reported history of seizures (any type) in the last 6 months

研究组 & 干预措施

Field expansion view

Experimental

Various configurations of field expansion views will be additionally displayed on HMD

干预措施: Field expansion view (Other)

结局指标

主要结局

Response time

时间窗: Through study completion, an average of four months

During the pedestrian detection task, average response time to the colliding pedestrian with and without prisms

次要结局

  • Head movement range(Through study completion, an average of four months)
  • Walking speed(Through study completion, an average of four months)
  • Error rate(Through study completion, an average of four months)
  • Pedestrian detection rate(Through study completion, an average of four months)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Eli Peli

Senior Scientist

Massachusetts Eye and Ear Infirmary

研究点 (1)

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