Collision Warning Device for Blind and Visually Impaired

Wearable Collision Warning Device for Blind and Visually Impaired: Clinical Trial (As Part of: 'Development of a Vision Assistive Device for Veterans With Traumatic Brain Injury-Associated Visual Dysfunctions')

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.

Study Overview

• Status: Completed
• Conditions: Glaucoma; Retinitis Pigmentosa; Blindness; Hemianopsia; Hemianopia; Peripheral Visual Field Defect
• Intervention / Treatment: Device: Collision warning device

Detailed Description

Participants with blindness or severe visual field loss (hemianopia or tunnel vision) will be trained to use a collision warning device that alerts them to impending collisions. Participants will use the device at home during everyday mobility for about 1 month. The device is designed to supplement existing mobility devices, such as a long cane or dog guide. The device will provide warnings about potential collisions with mid- or high-level obstacles (which are typically not detected by a long cane).

• Study Type: Interventional
• Enrollment (Actual): 49
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Massachusetts
    • Boston, Massachusetts, United States, 02114
      • Schepens Eye Research Institute

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• 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;

Exclusion Criteria:

• 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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: OTHER
• Allocation: NA
• Interventional Model: SINGLE_GROUP
• Masking: NONE

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

EXPERIMENTAL: Intervention; 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; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of Body Contacts	Collision incidents with body contacts recorded by the device	During the one-month period of device use
Device Questionnaire	Questionnaire addressing participants' experiences of using the device. Scores were on a 5-point rating scale (1 to 5) with higher scores representing a better score. Questions were grouped into four main categories: i) overall satisfaction, ii) comfort, iii) mobility benefit, and iv) ease of operation. An average score was computed for questions within each category.	During the one-month period of device use

Collaborators and Investigators

• Sponsor: Massachusetts Eye and Ear Infirmary
• Investigators: Principal Investigator: Alex Bowers, PhD, Schepens Eye Research Institute, Mass Eye and Ear; Principal Investigator: Gang Luo, PhD, Schepens Eye Research Institute, Mass Eye and Ear

Publications and helpful links

General Publications

• 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.
• 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.

Study record dates

Study Major Dates

• Study Start (ACTUAL): January 22, 2018
• Primary Completion (ACTUAL): November 8, 2019
• Study Completion (ACTUAL): December 5, 2019

Study Registration Dates

• First Submitted: February 14, 2017
• First Submitted That Met QC Criteria: February 15, 2017
• First Posted (ACTUAL): February 20, 2017

Study Record Updates

• Last Update Posted (ACTUAL): February 10, 2021
• Last Update Submitted That Met QC Criteria: January 25, 2021
• Last Verified: January 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Nervous System Diseases; Eye Diseases; Neurologic Manifestations; Retinal Degeneration; Retinal Diseases; Genetic Diseases, Inborn; Eye Diseases, Hereditary; Retinal Dystrophies; Sensation Disorders; Vision Disorders; Retinitis; Retinitis Pigmentosa; Blindness; Hemianopsia
• Other Study ID Numbers: 1007377

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: No