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OpenTrials
Completed

NCT Number: NCT05135195

A Virtual Reality Platform Simulating Visual Impairment for Testing of Electronic Travel Aids and Performing Orientation and Mobility Training

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.

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Key information

Conditions

Visual Impairment Age-Related Macular Degeneration Cardiovascular Diseases Diabetes Complications Diabetes Mellitus Diabetic Angiopathies Diabetic Retinopathy Endocrine System Diseases Eye Diseases Glaucoma Macular Degeneration Nervous System Diseases Neurologic Manifestations Ocular Hypertension Pathological Conditions, Signs and Symptoms Retinal Degeneration Retinal Diseases Sensation Disorders Signs and Symptoms Vascular Diseases Vision Disorders

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

NYU Langone Health

New York, 10016, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

In-House Developed VR Platform - AMD, DR, Glaucoma

Other

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.

In-House Developed VR Platform - Glaucoma

Other

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 outcomes

  1. Average time to complete the trial

    Time frame: 1 Day of Intervention

  2. Average number of obstacle collisions during the trial

    Time frame: 1 Day of Intervention

  3. Average travel time

    Time frame: 1 Day of Intervention

  4. Average distance traveled by the participant

    Time frame: 1 Day of Intervention

  5. Preferred walking speed

    Time frame: 1 Day of Intervention

  6. Orientation

    Time frame: 1 Day of Intervention

    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.

  7. Number of instances in which the participant stop for more than 2 seconds

    Time frame: 1 Day of Intervention

  8. Total time spent during stops of more than 2 seconds

    Time frame: 1 Day of Intervention

  9. 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

Sponsors and collaborators

Lead sponsor

NYU Langone Health

Other

Registry information

Important dates

Study start
2021
Primary completion
2022
Study completion
2022
First posted
Nov 26, 2021
Registry last updated
Jul 3, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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