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Collision Warning Device for Blind and Visually Impaired

Primary Purpose

Hemianopia, Hemianopsia, Peripheral Visual Field Defect

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Collision warning device
Sponsored by
Massachusetts Eye and Ear Infirmary
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Hemianopia

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • Schepens Eye Research Institute

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Intervention

Arm Description

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

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Number of Body Contacts
Collision incidents with body contacts recorded by the device
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.

Full Information

First Posted
February 14, 2017
Last Updated
January 25, 2021
Sponsor
Massachusetts Eye and Ear Infirmary
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1. Study Identification

Unique Protocol Identification Number
NCT03057496
Brief Title
Collision Warning Device for Blind and Visually Impaired
Official Title
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')
Study Type
Interventional

2. Study Status

Record Verification Date
January 2021
Overall Recruitment Status
Completed
Study Start Date
January 22, 2018 (Actual)
Primary Completion Date
November 8, 2019 (Actual)
Study Completion Date
December 5, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Massachusetts Eye and Ear Infirmary

4. Oversight

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
Data Monitoring Committee
No

5. Study Description

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.
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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hemianopia, Hemianopsia, Peripheral Visual Field Defect, Blindness, Retinitis Pigmentosa, Glaucoma

7. Study Design

Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Model Description
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.
Masking
None (Open Label)
Masking Description
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
Allocation
N/A
Enrollment
49 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Intervention
Arm Type
Experimental
Arm Description
Participants will use the collision warning device as much as possible for about one month during everyday activities, when walking indoors and outdoors.
Intervention Type
Device
Intervention Name(s)
Collision warning device
Intervention Description
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.
Primary Outcome Measure Information:
Title
Number of Collision Incidents (All Contacts)
Description
Collision incidents recorded by the device in everyday use, including long cane contacts and body contacts with surrounding objects in the environment.
Time Frame
During the one-month period of device use
Secondary Outcome Measure Information:
Title
Number of Body Contacts
Description
Collision incidents with body contacts recorded by the device
Time Frame
During the one-month period of device use
Title
Device Questionnaire
Description
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.
Time Frame
During the one-month period of device use

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Alex Bowers, PhD
Organizational Affiliation
Schepens Eye Research Institute, Mass Eye and Ear
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Gang Luo, PhD
Organizational Affiliation
Schepens Eye Research Institute, Mass Eye and Ear
Official's Role
Principal Investigator
Facility Information:
Facility Name
Schepens Eye Research Institute
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02114
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
32832221
Citation
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.
Results Reference
background
PubMed Identifier
34292298
Citation
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.
Results Reference
derived

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Collision Warning Device for Blind and Visually Impaired

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