Collision Warning Device for Blind and Visually Impaired

NCT03057496 | Completed Results FDA Device

• 1 other identifier: 1007377
• Study Type: interventional
• Target: 49
• Locations: 1 country
• Sites: 1

Brief Summary

This study evaluates a novel collision warning device to help people with severe vision impairment or blindness avoid collisions with obstacles. The main hypothesis to be tested is that the device reduces the number of collisions with obstacles in everyday activities.

Conditions

Hemianopia; Hemianopsia; Peripheral Visual Field Defect; Blindness; Retinitis Pigmentosa; Glaucoma

Outcome Measures

Primary Outcomes (1)

• Number of Collision Incidents (All Contacts)

  Collision incidents recorded by the device in everyday use, including long cane contacts and body contacts with surrounding objects in the environment.

  During the one-month period of device use

Secondary Outcomes (2)

• Number of Body Contacts

  During the one-month period of device use

• Device Questionnaire

  During the one-month period of device use

Study Arms (1)

Intervention

EXPERIMENTAL

Participants will use the collision warning device as much as possible for about one month during everyday activities, when walking indoors and outdoors.

Device: Collision warning device

Interventions

Collision warning device DEVICE

The collision warning device is a pocket-sized, electronic system that includes a micro-computer, a clip-on miniature camera, a gyro-sensor, an accelerometer, and a rechargeable battery, all contained within a shoulder bag. It is about the size of a smart phone. When a potential collision is detected by the device it emits a warning to the user, either in the form of an audible beep or a tactile warning through bracelets worn on the wrist. The time to collision will be coded in both the auditory and tactile domains. The device is designed to only give warnings about high risk collisions, so the users will not be continually bombarded by warnings for every potential collision object in the environment.

Intervention

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Blindness (or very limited vision with visual acuity no better than "counting fingers"),
• Or severe peripheral field loss / tunnel vision (≤ 40° remaining visual field) with visual acuity of at least 20/200,
• Or homonymous hemianopia with visual acuity of at least 20/200;
• Able to walk independently either with or without mobility aids such as a long cane or guide dog (but without the aid of a sighted guide);
• Reports at least minor bumps or collisions within the last 3 months;

You may not qualify if:

• Currently participating in a mobility training program
• Diagnosed dementia
• Significant cognitive decline
• Participants with hemianopia will be excluded if they have hemianopia for less than 3 months and/or have spatial neglect

Sponsors & Collaborators

• Massachusetts Eye and Ear Infirmary: lead

Study Sites (1)

Schepens Eye Research Institute

Boston, Massachusetts, 02114, United States

Location

Related Publications (2)

• Pundlik S, Baliutaviciute V, Moharrer M, Bowers AR, Luo G. Data Acquisition, Processing, and Reduction for Home-Use Trial of a Wearable Video Camera-Based Mobility Aid. Transl Vis Sci Technol. 2020 Jun 11;9(7):14. doi: 10.1167/tvst.9.7.14. eCollection 2020 Jun.

  PMID: 32832221 BACKGROUND

• Pundlik S, Baliutaviciute V, Moharrer M, Bowers AR, Luo G. Home-Use Evaluation of a Wearable Collision Warning Device for Individuals With Severe Vision Impairments: A Randomized Clinical Trial. JAMA Ophthalmol. 2021 Sep 1;139(9):998-1005. doi: 10.1001/jamaophthalmol.2021.2624.

  PMID: 34292298 DERIVED

MeSH Terms

Conditions

Hemianopsia; Blindness; Retinitis Pigmentosa; Glaucoma

Condition Hierarchy (Ancestors)

Vision Disorders; Sensation Disorders; Neurologic Manifestations; Nervous System Diseases; Eye Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Eye Diseases, Hereditary; Retinal Dystrophies; Retinal Degeneration; Retinal Diseases; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Ocular Hypertension

Results Point of Contact

• Title: Alex Bowers
• Organization: Schepens Eye Research Institute of Massachusetts Eye and Ear

alex_bowers@meei.harvard.edu

617 912 2512

Study Officials

• Alex Bowers, PhD

  Schepens Eye Research Institute, Mass Eye and Ear

  PRINCIPAL INVESTIGATOR

• Gang Luo, PhD

  Schepens Eye Research Institute, Mass Eye and Ear

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Masking Details: Although this is a single-arm study, participants will be masked in the sense that they will not know whether the device is operating in the active mode (intervention condition), when it gives warnings, or the silent mode (control condition), when it does not give warnings. The device will be programmed to generate a different randomized active/silent schedule for each subject. The investigator conducting the statistical analyses will also be masked as to whether the device was in the active or silent mode
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor of Ophthalmology

Model Details: The device will operate in two modes: active mode (intervention condition), when it gives warnings and, silent mode (control condition), when it does not give warnings. The device will be programmed to generate a different randomized active/silent schedule for each subject. Participants will not know whether it is in the active or silent mode.

Study Record Dates

• First Submitted: February 14, 2017
• First Posted: February 20, 2017
• Study Start: January 22, 2018
• Primary Completion: November 8, 2019
• Study Completion: December 5, 2019
• Last Updated: February 10, 2021
• Results First Posted: December 21, 2020

Record last verified: 2021-01

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)