A Study to Evaluate the BrainPort® Vision Device in Subjects Who Are Blind
This study has been completed.
Information provided by (Responsible Party):
First received: December 6, 2011
Last updated: August 6, 2013
Last verified: August 2013
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.
Device: BrainPort Vision Device
||Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Supportive Care
||A Study to Evaluate the Safety and Efficacy of the BrainPort® Vision Device in Subjects Who Are Blind
Primary Outcome Measures:
- Safety [ Time Frame: 1 year ] [ Designated as safety issue: Yes ]
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 ] [ Designated as safety issue: No ]
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.
Secondary Outcome Measures:
- Word Identification [ Time Frame: 1 year ] [ Designated as safety issue: No ]
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 ] [ Designated as safety issue: No ]
Another secondary efficacy objective is to demonstrate at least 35% of subjects demonstrate sign recognition in a mobility task.
| Study Start Date:
| Study Completion Date:
| Primary Completion Date:
||April 2013 (Final data collection date for primary outcome measure)
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.
|Ages Eligible for Study:
||18 Years to 79 Years
|Genders Eligible for Study:
|Accepts Healthy Volunteers:
- Confirmed written medical or low vision diagnosis of No Light Perception or Light Perception
- Performance on the FrACT acuity test of worse than 20/5000 or impossible to measure.
- Minimum post 6 months diagnosis blindness.
- Previously completed conventional rehabilitation such as orientation and mobility training with a cane or guide dog.
- Able to have read to him or her, understand, and sign the informed consent form.
- Daily access to an accessible computer with email for study communication, device- use logging and access to device user manual preferred.
- Willing and able to complete all testing, training, and follow- up evaluations required by the study protocol, after receiving a short orientation on the use of the device.
- Current oral health problems as determined from the oral health exam which preclude enrollment in the study in the judgment of the Principal Investigator.
- Any medical condition that would interfere with performance on the assessments.
- Prior use of the BrainPort vision device.
- Known neuropathies of tongue or skin tactile system.
- Smoke or chew tobacco products less than 12 months prior to study enrollment
- Any allergies to nickel or stainless steel
- History of seizures or epilepsy.
- If female, pregnant. Women of child bearing potential must agree to use appropriate birth control to prevent pregnancy for the duration of the study.
- People with implanted electrical medical devices (i.e. pacemaker, deep brain stimulator, cochlear implant).
- Psychiatric disease including anxiety disorders and forms of depression (using provided Beck Anxiety Inventory (BAI) and Beck Depression Inventory (BDI- II) as screening tools).
- Any disease or condition that prevents understanding or communication of informed consent, study demands and testing protocols including the following:
- Cognitive decline including forms of dementia and/or progressive neurological disease
- Deafness or selective frequency hearing loss that prevents hearing device alarms and alerts.
- Does not speak English
- Blindness occurring due to cortical injury (i.e. stroke, traumatic brain injury, etc)
- Principal Investigator, in his or her judgment, does not believe the subject is a good candidate for the trial.
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study.
To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below.
For general information, see Learn About Clinical Studies.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01488786
|Independence for the Blind of West Florida Inc.
|Pensacola, Florida, United States, 32503 |
|The Chicago Lighthouse for People Who Are Blind and Visually Impaired
|Chicago, Illinois, United States, 60608 |
|Wichita, Kansas, United States, 67203 |
|Ochsner Clinic Foundation
|New Orleans, Louisiana, United States, 70121 |
|New York, New York, United States, 10022 |
|University of Pittsburgh Medical Center
|Pittsburgh, Pennsylvania, United States, 15213 |
|Canadian National Institute for the Blind
|Toronto, Canada, M4G 3E8 |
No publications provided
History of Changes
|Other Study ID Numbers:
|Study First Received:
||December 6, 2011
||August 6, 2013
||United States: Institutional Review Board
Keywords provided by Wicab:
ClinicalTrials.gov processed this record on September 18, 2014
Non-Surgical Visual Prosthetic