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

This is an interventional supportive care trial for Blindness focused on measuring Assistive Technology, Non-Surgical Visual Prosthetic, Sensory Substitution Read More

Inclusion Criteria:

• 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.

Exclusion Criteria:

• 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.