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

NYU Langone Health

Status: Completed

Conditions: Age-Related Macular Degeneration; Glaucoma; Visual Impairment; Diabetic Retinopathy

Treatments: Other: In-House Developed VR Platform - AMD, DR, Glaucoma; Other: In-House Developed VR Platform - Glaucoma

Study type: Interventional

Funder types: Other

Identifiers

NCT05135195

21-00925

Details and patient eligibility

About

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.

Enrollment: 98 patients

Sex: All

Ages: 18 to 80 years old

Volunteers: Accepts Healthy Volunteers

Inclusion and exclusion 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)

Trial design

Primary purpose: Screening

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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98 participants in 2 patient groups

First Set of Experiments

Experimental group

Description:

The anticipated number of participants is 336. All participants have healthy vision.

Treatment:

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

Second Set of Experiments

Experimental group

Description:

The anticipated number of participants is 100. Of these, 80 participants have healthy vision, and 20 have glaucoma.

Treatment:

Other: In-House Developed VR Platform - Glaucoma