Clinical trial NCT05135195: 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
Overall status: COMPLETED
Phase: NA
Conditions: Visual Impairment
Age-Related Macular Degeneration
Diabetic Retinopathy
Glaucoma
Lead sponsor: NYU Langone Health
Sponsor class: OTHER
First posted: 2021-11-26
Enrollment: 98
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SCREENING

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.


Eligibility criteria: 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)

Primary outcomes:
measure: Average time to complete the trial
timeFrame: 1 Day of Intervention
measure: Average number of obstacle collisions during the trial
timeFrame: 1 Day of Intervention
measure: Average travel time
timeFrame: 1 Day of Intervention
measure: Average distance traveled by the participant
timeFrame: 1 Day of Intervention
measure: Preferred walking speed
timeFrame: 1 Day of Intervention
measure: Orientation
timeFrame: 1 Day of Intervention
measure: Number of instances in which the participant stop for more than 2 seconds
timeFrame: 1 Day of Intervention
measure: Total time spent during stops of more than 2 seconds
timeFrame: 1 Day of Intervention
measure: Average time it takes to understand how to interact with the system and run the simulation of the bus ride
timeFrame: 1 Day of Intervention
Secondary outcomes:
Other outcomes:
Locations:
city: New York
country: United States
facility: NYU Langone Health
state: New York
Study officials:
affiliation: NYU Langone Health
name: John-Ross Rizzo, MD
role: PRINCIPAL_INVESTIGATOR
References: