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')
Verified date | January 2021 |
Source | Massachusetts Eye and Ear Infirmary |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
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 |
Country | Name | City | State |
---|---|---|---|
United States | Schepens Eye Research Institute | Boston | Massachusetts |
Lead Sponsor | Collaborator |
---|---|
Massachusetts Eye and Ear Infirmary |
United States,
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
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 |
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