A Virtual Reality Platform Simulating Visual Impairment for Testing of Electronic Travel Aids and Performing Orientation and Mobility Training
Primary Purpose
Visual Impairment, Age-Related Macular Degeneration, Diabetic Retinopathy
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
In-House Developed VR Platform - AMD, DR, Glaucoma
In-House Developed VR Platform - Glaucoma
Sponsored by
About this trial
This is an interventional screening trial for Visual Impairment
Eligibility Criteria
Inclusion Criteria (patients with visual impairment)
- Aged 18-80;
- People with glaucoma of all different levels and etiologies.
Inclusion Criteria (healthy controls)
- Aged 18-80;
- Gender neutral: male or female.
Exclusion Criteria (patients with visual impairment & healthy controls)
- Significant cognitive dysfunction (score <24 on Folsteins' Mini Mental Status Examination)
- Previous neurological illness or psychiatric disorders, or suffer from a heart condition or other serious medical conditions
- Significant mobility restrictions; people using walkers and wheelchairs
- Pregnancy
- Elderly
- Seizures (people who previously have had a seizure, loss of awareness, or other symptom linked to an epileptic condition)
- 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)
Sites / Locations
- NYU Langone Health
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Experimental
Arm Label
First Set of Experiments
Second Set of Experiments
Arm Description
The anticipated number of participants is 336. All participants have healthy vision.
The anticipated number of participants is 100. Of these, 80 participants have healthy vision, and 20 have glaucoma.
Outcomes
Primary Outcome Measures
Average time to complete the trial
Average number of obstacle collisions during the trial
Average travel time
Average distance traveled by the participant
Preferred walking speed
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.
Number of instances in which the participant stop for more than 2 seconds
Total time spent during stops of more than 2 seconds
Average time it takes to understand how to interact with the system and run the simulation of the bus ride
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT05135195
Brief Title
A Virtual Reality Platform Simulating Visual Impairment for Testing of Electronic Travel Aids and Performing Orientation and Mobility Training
Official Title
A Virtual Reality Platform Simulating Visual Impairment for Testing of Electronic Travel Aids and Performing Orientation and Mobility Training
Study Type
Interventional
2. Study Status
Record Verification Date
June 2023
Overall Recruitment Status
Completed
Study Start Date
October 24, 2021 (Actual)
Primary Completion Date
October 20, 2022 (Actual)
Study Completion Date
October 20, 2022 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
NYU Langone Health
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Visual Impairment, Age-Related Macular Degeneration, Diabetic Retinopathy, Glaucoma
7. Study Design
Primary Purpose
Screening
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
98 (Actual)
8. Arms, Groups, and Interventions
Arm Title
First Set of Experiments
Arm Type
Experimental
Arm Description
The anticipated number of participants is 336. All participants have healthy vision.
Arm Title
Second Set of Experiments
Arm Type
Experimental
Arm Description
The anticipated number of participants is 100. Of these, 80 participants have healthy vision, and 20 have glaucoma.
Intervention Type
Other
Intervention Name(s)
In-House Developed VR Platform - AMD, DR, Glaucoma
Intervention Description
Participants will conduct experiments using commercial VR headsets and controllers. Visual impairments will be systematically simulated in VR. There are three visual impairment simulations (AMD, DR, and glaucoma) at three levels of severity (mild, moderate, or severe). Symptoms' simulation tools include a gaussian blur shader, distortion shader, and a culling mask with a gray spot in the middle.
Intervention Type
Other
Intervention Name(s)
In-House Developed VR Platform - Glaucoma
Intervention Description
In the second set of experiments, a multidimensional visual impairment simulation of a single pathology (glaucoma) will be used at three levels of severity (mild, moderate, or severe). The post-processing package to simulate includes glare, difficulty in light, change adaptation, ambient occlusion, visual clutter, and overall blurred effect. The shader graph package will be used to create a distortion localized on assets surfaces only.
Primary Outcome Measure Information:
Title
Average time to complete the trial
Time Frame
1 Day of Intervention
Title
Average number of obstacle collisions during the trial
Time Frame
1 Day of Intervention
Title
Average travel time
Time Frame
1 Day of Intervention
Title
Average distance traveled by the participant
Time Frame
1 Day of Intervention
Title
Preferred walking speed
Time Frame
1 Day of Intervention
Title
Orientation
Description
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.
Time Frame
1 Day of Intervention
Title
Number of instances in which the participant stop for more than 2 seconds
Time Frame
1 Day of Intervention
Title
Total time spent during stops of more than 2 seconds
Time Frame
1 Day of Intervention
Title
Average time it takes to understand how to interact with the system and run the simulation of the bus ride
Time Frame
1 Day of Intervention
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria (patients with visual impairment)
Aged 18-80;
People with glaucoma of all different levels and etiologies.
Inclusion Criteria (healthy controls)
Aged 18-80;
Gender neutral: male or female.
Exclusion Criteria (patients with visual impairment & healthy controls)
Significant cognitive dysfunction (score <24 on Folsteins' Mini Mental Status Examination)
Previous neurological illness or psychiatric disorders, or suffer from a heart condition or other serious medical conditions
Significant mobility restrictions; people using walkers and wheelchairs
Pregnancy
Elderly
Seizures (people who previously have had a seizure, loss of awareness, or other symptom linked to an epileptic condition)
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)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
John-Ross Rizzo, MD
Organizational Affiliation
NYU Langone Health
Official's Role
Principal Investigator
Facility Information:
Facility Name
NYU Langone Health
City
New York
State/Province
New York
ZIP/Postal Code
10016
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
Yes
IPD Sharing Plan Description
Individual participant data that underlie the results reported in this article, after deidentification (text, tables, figures, and appendices) will be available upon reasonable request.
IPD Sharing Time Frame
Beginning 9 months and ending 36 months following article publication or as required by a condition of awards and agreements supporting the research.
IPD Sharing Access Criteria
The investigator who proposed to use the data will have access to the data upon reasonable request. Requests should be directed to Johnross.rizzo@nyulangone.org. To gain access, data requestors will need to sign a data access agreement.
Learn more about this trial
A Virtual Reality Platform Simulating Visual Impairment for Testing of Electronic Travel Aids and Performing Orientation and Mobility Training
We'll reach out to this number within 24 hrs