VIS4ION Platform for Visual Impairment

Overseen By Giles Hamilton-Fletcher

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: NYU Langone Health

Disqualifiers: Cognitive dysfunction, Neurological illness, Mobility restrictions, Pregnancy, Auditory impairments, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 3

What You Need to Know Before You Apply

What is the purpose of this trial?

This study aims to investigate how visual impairment affects neurophysiological and biomechanical responses during real-world navigation and daily activities, with a focus on the rehabilitative feasibility and impact of assistive technologies. These technologies include applications and wearable devices designed to support various aspects of daily living for individuals with visual impairment. The VIS4ION platform (Visually Impaired Smart Service System for Spatial Intelligence \& On-board Navigation), a wearable system providing tactile and auditory feedback, is one component of this broader study. VIS4ION is designed to enhance environmental awareness and reduce cognitive load during mobility tasks for the visually impaired.

Who Is on the Research Team?

John-Ross Rizzo, MD

Principal Investigator

NYU Langone Health

Are You a Good Fit for This Trial?

Inclusion Criteria

I am able to understand and agree to participate in the study.

I am between 18 and 80 years old and have a visual impairment.

Willingness to complete all study-related assessments and procedures

Exclusion Criteria

Pregnancy

Significant cognitive dysfunction (score <24 on Folsteins' Mini Mental Status Examination)

I cannot understand human speech due to severe hearing loss.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Phase I

Participants complete navigation, object-identification, and object-reaching tasks with and without VIS4ION's services

Baseline period

Multiple visits for task completion and data collection

Phase II

Extended use of VIS4ION to assess its impact on daily activities and physical activity over months

12 months

Regular monitoring and data collection at months 3, 6, 9, and 12

Follow-up

Participants are monitored for safety and effectiveness after the intervention period

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• VIS4ION Platform

How Is the Trial Designed?

Group I: Technical Evaluation Group Experimental Treatment 1 Intervention

Participants, both sighted-blindfolded and people with blindness or low vision, will complete simple navigation, object-identification, and object-reaching tasks, both with and without VIS4ION's services.

Group II: Extended Use Trial: Group B Experimental Treatment 1 Intervention

Participants with blindness or low vision will complete navigation and object-identification tasks without the device during months 1-6, then with the device during months 6-12.

Group III: Extended Use Trial: Group A Experimental Treatment 1 Intervention

Participants with blindness or low vision will complete navigation and object-identification tasks with the device during months 1-6, then without the device during months 6-12.

Who Is Running the Clinical Trial?

NYU Langone Health

Lead Sponsor

Trials

1,431

Recruited

838,000+

National Eye Institute (NEI)

Collaborator

Trials

572

Recruited

1,320,000+