Clinical trial NCT03057496: 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
Overall status: COMPLETED
Phase: NA
Conditions: Hemianopia
Hemianopsia
Peripheral Visual Field Defect
Blindness
Retinitis Pigmentosa
Glaucoma
Lead sponsor: Massachusetts Eye and Ear Infirmary
Sponsor class: OTHER
First posted: 2017-02-20
Enrollment: 49
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention 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.
Primary purpose: OTHER

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).

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

Primary outcomes:
measure: Number of Collision Incidents (All Contacts)
timeFrame: During the one-month period of device use
Secondary outcomes:
measure: Number of Body Contacts
timeFrame: During the one-month period of device use
measure: Device Questionnaire
timeFrame: During the one-month period of device use
Other outcomes:
Locations:
city: Boston
country: United States
facility: Schepens Eye Research Institute
state: Massachusetts
Study officials:
affiliation: Schepens Eye Research Institute, Mass Eye and Ear
name: Alex Bowers, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Schepens Eye Research Institute, Mass Eye and Ear
name: Gang Luo, PhD
role: PRINCIPAL_INVESTIGATOR
References:
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.
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.