A Study to Evaluate the BrainPort® Vision Device in Subjects Who Are Blind
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT01488786|
Recruitment Status : Completed
First Posted : December 8, 2011
Last Update Posted : August 9, 2013
|Condition or disease||Intervention/treatment||Phase|
|Blindness||Device: BrainPort Vision Device||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||75 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Primary Purpose:||Supportive Care|
|Official Title:||A Study to Evaluate the Safety and Efficacy of the BrainPort® Vision Device in Subjects Who Are Blind|
|Study Start Date :||October 2011|
|Actual Primary Completion Date :||April 2013|
|Actual Study Completion Date :||April 2013|
Experimental: BrainPort Vision Device
Device: BrainPort Vision Device
2-3 days of training (10 hours) followed by minimum in-home use 300 minutes per month for 12 months.
- Safety [ Time Frame: 1 year ]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%.
- Object Recognition [ Time Frame: 1 year ]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.
- Word Identification [ Time Frame: 1 year ]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.
- Ambulation/Mobility [ Time Frame: 1 year ]Another secondary efficacy objective is to demonstrate at least 35% of subjects demonstrate sign recognition in a mobility task.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01488786
|United States, Florida|
|Independence for the Blind of West Florida Inc.|
|Pensacola, Florida, United States, 32503|
|United States, Illinois|
|The Chicago Lighthouse for People Who Are Blind and Visually Impaired|
|Chicago, Illinois, United States, 60608|
|United States, Kansas|
|Wichita, Kansas, United States, 67203|
|United States, Louisiana|
|Ochsner Clinic Foundation|
|New Orleans, Louisiana, United States, 70121|
|United States, New York|
|New York, New York, United States, 10022|
|United States, Pennsylvania|
|University of Pittsburgh Medical Center|
|Pittsburgh, Pennsylvania, United States, 15213|
|Canadian National Institute for the Blind|
|Toronto, Canada, M4G 3E8|
|Study Director:||Aimee Arnoldussen||Wicab, Inc.|
|Principal Investigator:||William Seiple||Lighthouse International|