The purpose of this study is to assess the safety of the BrainPort vision device and to demonstrate improved object recognition and word identification and ambulation with use of the BrainPort vision device in subjects who are medically documented as blind, with acuity of 20/ 5000 or worse.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
SUPPORTIVE_CARE
Masking
NONE
Enrollment
75
2-3 days of training (10 hours) followed by minimum in-home use 300 minutes per month for 12 months.
Independence for the Blind of West Florida Inc.
Pensacola, Florida, United States
The Chicago Lighthouse for People Who Are Blind and Visually Impaired
Chicago, Illinois, United States
Envision
Wichita, Kansas, United States
Ochsner Clinic Foundation
New Orleans, Louisiana, United States
Safety
The primary safety objective is to demonstrate that the rate of clinically significant device-related adverse events is less than 10%. This will require an observed event-free rate of approximately 97%.
Time frame: 1 year
Object Recognition
The primary efficacy objective is to demonstrate that at least 50% of subjects achieve a success rate in object recognition exceeding that expected by chance alone.
Time frame: 1 year
Word Identification
A secondary efficacy objective is to demonstrate that at least 50% of subjects correctly identify at least 50% of a series of three- to five-letter words.
Time frame: 1 year
Ambulation/Mobility
Another secondary efficacy objective is to demonstrate at least 35% of subjects demonstrate sign recognition in a mobility task.
Time frame: 1 year
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Lighthouse International
New York, New York, United States
University of Pittsburgh Medical Center
Pittsburgh, Pennsylvania, United States
Canadian National Institute for the Blind
Toronto, Canada