A Study to Evaluate the BrainPort® Vision Device in Subjects Who Are Blind

Completed · Not applicable

Conditions studied: Blindness

In brief

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.

Key facts

Study ID

NCT01488786

Run by

Wicab

People needed

75

Starts

2011-10-01

Expected to finish

2013-04-01

Last updated by the study team

2013-08-09

Who can join

Age: 18 and older, up to 79. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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.

Where it is running

• 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
• 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

Full record on ClinicalTrials.gov

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