Collision Warning Device for Blind and Visually Impaired

Glaucoma Clinical Trial

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')

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03057496
• Other study ID #: 1007377
• Status: Completed
• Phase: N/A
• Start date: January 22, 2018
• Est. completion date: December 5, 2019

Study information

• Verified date: January 2021
• Source: Massachusetts Eye and Ear Infirmary
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 49
• Est. completion date: December 5, 2019
• Est. primary completion date: November 8, 2019
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

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

Intervention

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.

Locations

Country	Name	City	State
United States	Schepens Eye Research Institute	Boston	Massachusetts

Sponsors (1)

Lead Sponsor	Collaborator
Massachusetts Eye and Ear Infirmary

Country where clinical trial is conducted

United States, 

References & Publications (1)

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Number of Body Contacts	Collision incidents with body contacts recorded by the device	During the one-month period of device use
Secondary	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