VIS4ION Platform for Visual Impairment

GH
Overseen ByGiles Hamilton-Fletcher
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial examines how visual impairment affects navigation and daily tasks, focusing on the potential benefits of assistive technologies. The main tool tested is the VIS4ION platform, a wearable device that enhances awareness of surroundings through tactile and auditory feedback. Researchers will divide participants into groups to test the device under different conditions, both with and without its use over time. The study seeks individuals with visual impairments who use a mobility aid like a white cane or guide dog and can travel independently. As an unphased trial, it offers participants the chance to contribute to innovative research that could improve daily life for those with visual impairments.

Do I need to stop my current medications for the trial?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

What prior data suggests that the VIS4ION Platform is safe for individuals with visual impairment?

Previous studies have shown that the VIS4ION platform is safe for people with visual impairments. Research indicates that this wearable technology does not cause significant side effects. The platform provides touch-based and sound-based feedback to help users navigate more easily.

Importantly, no major side effects have been reported, suggesting it is well-tolerated by users. The device aims to ease daily activities by enhancing awareness of surroundings and reducing the mental effort required for navigation.

While researchers continue to study the VIS4ION platform, available data supports its safety. Participants in earlier trials used it without serious issues, making it a promising option for those seeking assistive technology for visual impairment.12345

Why are researchers excited about this trial?

Researchers are excited about the VIS4ION Platform because it offers a new approach to assisting individuals with blindness or low vision. Unlike traditional options like guide dogs, canes, or visual aids, the VIS4ION Platform aims to enhance navigation and object identification through a digital interface. This innovative method allows participants to interact with their surroundings in a way that's more intuitive and potentially less cumbersome. By providing a digital tool that can be used both in the short term and over extended periods, researchers hope to determine how this platform can improve daily living and independence for those with visual impairments.

What evidence suggests that the VIS4ION Platform is effective for visual impairment?

Research has shown that the VIS4ION platform can significantly assist people with visual impairments. The system uses touch and sound to help users understand their surroundings, making navigation easier. Studies have found that it reduces the mental effort required for movement by providing real-time assistance with environmental understanding and navigation. As a result, users can move more safely and with greater confidence. In this trial, participants in the Technical Evaluation Group will complete tasks both with and without VIS4ION's services to assess its effectiveness. Meanwhile, participants in the Extended Use Trial will experience the platform's impact over time, with Group A using the device initially and Group B starting without it. Another study highlighted how VIS4ION improved mobility and independence for those with vision challenges. Overall, the platform is designed to enhance daily life for people with low vision.12346

Who Is on the Research Team?

JR

John-Ross Rizzo, MD

Principal Investigator

NYU Langone Health

Are You a Good Fit for This Trial?

This trial is for adults aged 18–80, both with and without visual impairment. Participants must be able to give consent, travel independently (if visually impaired), use a mobility aid like a cane or guide dog, and complete study tasks. People with major cognitive issues, severe hearing loss, significant depression, pregnancy, or serious medical conditions cannot join.

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
See 7 more

Exclusion Criteria

Pregnancy
Significant cognitive dysfunction (score <24 on Folsteins' Mini Mental Status Examination)
I cannot understand human speech due to severe hearing loss.
See 4 more

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

Trial Overview

The study tests the VIS4ION platform—a wearable device that gives touch and sound feedback—to see if it helps people with vision loss navigate daily life more easily. The research compares responses in real-world settings between users of this technology and those who do not use it.

How Is the Trial Designed?

3

Treatment groups

Experimental Treatment

Group I: Technical Evaluation GroupExperimental Treatment1 Intervention
Group II: Extended Use Trial: Group BExperimental Treatment1 Intervention
Group III: Extended Use Trial: Group AExperimental Treatment1 Intervention

Find a Clinic Near You

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+

Citations

VIS4ION Platform for Visual Impairment · Info for Participants

This study aims to investigate how visual impairment affects neurophysiological and biomechanical responses during real-world navigation and ...

(PDF) A Smart Service System for Spatial Intelligence and ...

A Smart Service System for Spatial Intelligence and Onboard Navigation for Individuals with Visual Impairment (VIS4ION Thailand): study protocol of a randomized ...

A Low-Vision Navigation Platform for Economies in Transition ...

A novel wearable device and computing platform called VIS 4 ION is reducing the disadvantage gaps and raising living standards for the visually challenged.

Feasibility and Efficacy of the VIS4ION platform and ...

The aim of this study is to examine if and how well a new system that has touch and sound capabilities can assist people with vision impairment.

A Smart Service System for Spatial Intelligence and Onboard ...

VIS4ION, a mobile computing platform capable of real-time scene understanding with human-in-the-loop navigation assistance, has four components: ...

VIS4ION (Visually Impaired Smart Service System for Spatial ...

The VIS4ION-Thailand project develops a real-time navigation assistance system for visually impaired individuals using AI and assistive technology.