Glaucoma Clinical Trial
Official title:
A Virtual Reality Platform Simulating Visual Impairment for Testing of Electronic Travel Aids and Performing Orientation and Mobility Training
Verified date | June 2023 |
Source | NYU Langone Health |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
In this study, the study team utilize virtual reality (VR) to simulate visual impairments of different types and severity in healthy subjects. The platform implements three of the most widespread forms of visual impairment in the United States (US): age-related macular degeneration (AMD), diabetic retinopathy (DR), and glaucoma, each with three levels of severity, (mild, moderate, and severe). At present, glaucoma is further developed toward a multidimensional visual impairment simulation. The platform is utilized: i) to provide a safe, controllable, and repeatable set of environments for development and preliminary testing of electronic travel aids (ETAs) in a variety of conditions (i.e., using the ETA to navigate in the immersed environment); and ii) to equip blind and low vision (BVI) professionals, inclusive of orientation and mobility (O&M) instructors, with a controlled, tunable training platform for skill/capacity building, assessment, and refinement of O&M techniques, as well as visually impaired trainees with a safe and immersive environment to improve their O&M skills and learn novel techniques. Two sets of hypothesis-driven experiments are proposed to assess the feasibility of the platform with respect to these two objectives.
Status | Completed |
Enrollment | 98 |
Est. completion date | October 20, 2022 |
Est. primary completion date | October 20, 2022 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 18 Years to 80 Years |
Eligibility | Inclusion Criteria (patients with visual impairment) 1. Aged 18-80; 2. People with glaucoma of all different levels and etiologies. Inclusion Criteria (healthy controls) 1. Aged 18-80; 2. Gender neutral: male or female. Exclusion Criteria (patients with visual impairment & healthy controls) 1. Significant cognitive dysfunction (score <24 on Folsteins' Mini Mental Status Examination) 2. Previous neurological illness or psychiatric disorders, or suffer from a heart condition or other serious medical conditions 3. Significant mobility restrictions; people using walkers and wheelchairs 4. Pregnancy 5. Elderly 6. Seizures (people who previously have had a seizure, loss of awareness, or other symptom linked to an epileptic condition) 7. Interference with medical devices (the headset and controller(s) may contain magnets or components that emit radio waves, which could affect the operation of nearby electronics, including cardiac pacemakers, hearing aids, and defibrillators) |
Country | Name | City | State |
---|---|---|---|
United States | NYU Langone Health | New York | New York |
Lead Sponsor | Collaborator |
---|---|
NYU Langone Health |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Average time to complete the trial | 1 Day of Intervention | ||
Primary | Average number of obstacle collisions during the trial | 1 Day of Intervention | ||
Primary | Average travel time | 1 Day of Intervention | ||
Primary | Average distance traveled by the participant | 1 Day of Intervention | ||
Primary | Preferred walking speed | 1 Day of Intervention | ||
Primary | Orientation | Orientation is measured through the time average of a polarization index, measured as the cosin of the angle between the direction of the instantaneous velocity vector and the straight line linking the instantaneous position of the participant and the following waypoint. | 1 Day of Intervention | |
Primary | Number of instances in which the participant stop for more than 2 seconds | 1 Day of Intervention | ||
Primary | Total time spent during stops of more than 2 seconds | 1 Day of Intervention | ||
Primary | Average time it takes to understand how to interact with the system and run the simulation of the bus ride | 1 Day of Intervention |
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