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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| BrainPort Vision Device | Experimental | Single Arm |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| BrainPort Vision Device | Device | 2-3 days of training (10 hours) followed by minimum in-home use 300 minutes per month for 12 months. |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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%. | 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. | 1 year |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 1 year |
| Ambulation/Mobility |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Aimee Arnoldussen | Wicab, Inc. | Study Director |
| William Seiple | Lighthouse International | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Independence for the Blind of West Florida Inc. | Pensacola | Florida | 32503 | United States | ||
| The Chicago Lighthouse for People Who Are Blind and Visually Impaired |
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| ID | Term |
|---|---|
| D001766 | Blindness |
| ID | Term |
|---|---|
| D014786 | Vision Disorders |
| D012678 | Sensation Disorders |
| D009461 | Neurologic Manifestations |
| D009422 | Nervous System Diseases |
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Another secondary efficacy objective is to demonstrate at least 35% of subjects demonstrate sign recognition in a mobility task.
| 1 year |
| Chicago |
| Illinois |
| 60608 |
| United States |
| Envision | Wichita | Kansas | 67203 | United States |
| Ochsner Clinic Foundation | New Orleans | Louisiana | 70121 | United States |
| Lighthouse International | New York | New York | 10022 | United States |
| University of Pittsburgh Medical Center | Pittsburgh | Pennsylvania | 15213 | United States |
| Canadian National Institute for the Blind | Toronto | M4G 3E8 | Canada |
| D005128 |
| Eye Diseases |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |