An interventional study of VIS4ION Platform in Visual Impairment, sponsored by NYU Langone Health. Not yet recruiting at 1 site in United States. Open to participants aged 18 Years to 80 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-03-02.
Sponsored by NYU Langone Health · Not applicable, Interventional, and Supportive care
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.
Participants with low vision and matched controls will complete walking, navigation, information gathering, and object identification / reaching tasks in both controlled laboratory and real-world environments. Throughout these tasks, physiological measures (e.g., electrodermal activity, heart rate, brain activity, eye movements), biomechanical data (e.g., gait, posture, limb movements), and cognitive metrics will be collected. VIS4ION will be specifically evaluated for its potential to improve the low vision users' scene understanding, navigation efficiency, increase physical activity (e.g., step count, moderate-equivalent minutes), and contribute to improved outcomes in terms of health, awareness, cognitive load, and safety.
Study tasks include obstacle negotiation, dual-task walking, and object identification / reaching under varying conditions (indoor vs. outdoor; with vs. without VIS4ION). A subset of participants will use VIS4ION over extended periods to assess its impact on activities in daily life in real-world settings.
360 studies on the registry are indexed under Vision Disorders; 84 are open to participants now.
This study's planned enrollment of 150 is above the median of 78 across 244 interventional studies indexed under Vision Disorders.
Browse Vision Disorders studies →NYU Langone Health is the lead sponsor of 1,430 studies on the registry; 258 are open to participants now.
Of its 235 completed or terminated interventional studies of FDA-regulated products, 197 (84%) have results posted.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
People with Visual Impairment:
Healthy Controls:
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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.
Device: VIS4ION Platform
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.
Device: VIS4ION Platform
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.
Device: VIS4ION Platform
The VIS4ION platform, a non-invasive wearable and smartphone-based system providing auditory (bone-conduction headphones) and haptic (wristband/belt) feedback to enhance mobility and daily living for people with blindness or low vision.
Localization Accuracy Percentage
Phase I only. Successful location accuracy defined as percentage of attempts with localization accuracy within 1 meter.
Time frame: Baseline
Orientation Precision Percentage
Phase I only. Successful location accuracy defined as percentage of attempts with orientation precision within 5 degrees.
Time frame: Baseline
Percentage of Tasks Successfully Completed
Phase I only.
Time frame: Baseline
Object/Hazard Detection Error Rate
Phase I only. Object/hazard detection error rate measured during navigation tasks.
Time frame: Baseline
Average Time to Complete Activities of Daily Living (ADLs)
Phase I only.
Time frame: Baseline
Change from Baseline in Moderate-Equivalent Minutes of Physical Activity Per Week
Phase II only. Data captured via wearable sensors and the International Physical Activity Questionnaire (IPAQ).
Time frame: Baseline, End of Intervention Period (Month 6 for Group A; Month 12 for Group B)
Change from Baseline in Average Daily Step Count
Phase II only.
Time frame: Baseline, End of Intervention Period (Month 6 for Group A; Month 12 for Group B)
Change from Baseline in Blood Pressure
Phase II only.
Time frame: Baseline, Month 3; Baseline, Month 6; Baseline, Month 9; Baseline, Month 12
Change from Baseline in Resting Heart Rate
Phase II only.
Time frame: Baseline, Month 3; Baseline, Month 6; Baseline, Month 9; Baseline, Month 12
Change from Baseline in Body Weight
Phase II only.
Time frame: Baseline, Month 3; Baseline, Month 6; Baseline, Month 9; Baseline, Month 12
System Usability Scale (SUS) Score
Phase II only. 10-item assessment evaluating usability of a system. Each item is rated on a Likert scale from 1-5. The raw score is the sum of responses and is transformed to a standardized score from 0-100; higher scores indicate greater satisfaction.
Time frame: End of Intervention Period (Month 6 for Group A; Month 12 for Group B)
Change in WHO Quality of Life Brief Instrument (WHO-QoL-BREF) Score
Phase II only. WHO-QoL-BREF is a 26-item questionnaire assessing quality of life. Each item is rated on a 5-point Likert scale to determine a raw item score. The mean score for each six domains of the questionnaire is calculated, resulting in a mean score per domain that is between 4 and 20. This mean domain score is then multiplied by 4 in order to transform the domain score into a scaled score ranging from 16-80, with a higher score indicating a higher QOL.
Time frame: Baseline, End of Intervention Period (Month 6 for Group A; Month 12 for Group B)
Change in National Eye Institute Visual Function Questionnaire (VFQ-25) Score
Phase II only. The VFQ-25 is a 25-item assessment of visual function. Each item is rated on a scale from 0-4; the total score is the sum of responses and ranges from 0-100; higher scores indicate greater vision function and vision quality of life.
Time frame: Baseline, End of Intervention Period (Month 6 for Group A; Month 12 for Group B)
Plan to share: Yes — The de-identified participant data from the final research dataset will be shared upon reasonable request beginning 9 to 36 months after publication or as required by a condition of awards or supporting agreements, provided the requesting investigator executes a data use agreement with NYU Langone Health. This instance of data sharing will also require separate IRB review as well as review from NYU Langone's Data Sharing Strategy Board (DSSB). Requests should be directed to: Mahya.beheshti@nyulangone.org. The protocol and statistical analysis plan will be posted on Clinicaltrials.gov only as required by federal regulation or supporting awards and agreements.
Supporting information: Study protocol, Statistical analysis plan
Time frame: Beginning 9 months and ending 36 months following article publication or as required by a condition of awards and agreements supporting the research.
Access criteria: The investigator who proposed to use the data will be granted access upon reasonable request. Requests should be directed to Mahya.beheshti@nyulangone.org. To gain access, data requestors will need to sign a data access agreement. This instance of data sharing will also require separate IRB review as well as review from NYU Langone's DSSB.
No publications or documents are linked to this record.
Start is estimated for Mar 2026; primary completion for Dec 2028, 33 months later.
Of 84 non-industry interventional studies with no phase under Vision Disorders, half reached primary completion within 31 months of starting (the median), counting those still running; a quarter within 7 and three quarters within 51. This study's planned 33 months is close to that.
Counting every sponsor, half of 94 studies reached it within 24 months; a quarter within 6 and three quarters within 51.
How these figures are worked out, and which studies are left out of them.
This study is not yet recruiting, as verified in Feb 2026. You cannot join it, but the record below documents what was studied.
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