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| Sponsor: | Wicab |
|---|---|
| Information provided by (Responsible Party): | Wicab |
| ClinicalTrials.gov Identifier: | NCT01488786 |
Purpose
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.
| Condition | Intervention |
|---|---|
|
Blindness |
Device: BrainPort Vision Device |
| Study Type: | Interventional |
| Study Design: | Endpoint Classification: Safety/Efficacy Study Intervention Model: Single Group Assignment Masking: 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 |
| Estimated Enrollment: | 75 |
| Study Start Date: | October 2011 |
| Estimated Study Completion Date: | March 2013 |
| Estimated Primary Completion Date: | March 2013 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: BrainPort Vision Device
Single Arm
|
Device: BrainPort Vision Device
2-3 days of training (10 hours) followed by minimum in-home use 300 minutes per month for 12 months.
|
Eligibility| Ages Eligible for Study: | 18 Years to 79 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | Yes |
Inclusion Criteria:
Exclusion Criteria:
Contacts and Locations| United States, Florida | |
| Independence for the Blind of West Florida Inc. | Recruiting |
| Pensacola, Florida, United States, 32503 | |
| Contact: Walter Watson 850-477-2663 bruce.watson@ibwest.org | |
| Principal Investigator: Walter Watson | |
| United States, Illinois | |
| The Chicago Lighthouse for People Who Are Blind and Visually Impaired | Recruiting |
| Chicago, Illinois, United States, 60608 | |
| Contact: Janet Szlyk, PhD 312-997-3644 janet.szlyk@chicagolighthouse.org | |
| Principal Investigator: Janet Szlyk, PhD | |
| United States, Kansas | |
| Envision | Recruiting |
| Wichita, Kansas, United States, 67203 | |
| Contact: Donald Fletcher, MD 316-440-1681 shannon.riley@envisionus.com | |
| Principal Investigator: Donald Fletcher, MD | |
| United States, Louisiana | |
| Ochsner Clinic Foundation and Lighthouse for the Blind New Orleans Inc. | Not yet recruiting |
| New Orleans, Louisiana, United States, 70121 | |
| Contact: Jonathan Nussdorf, MD 504-842-3917 jnussdorf@ochsner.org | |
| Principal Investigator: Jonathan Nussdorf, MD | |
| Principal Investigator: Deborah Bennett, LOTR | |
| United States, New York | |
| Lighthouse International | Recruiting |
| New York, New York, United States, 10022 | |
| Contact: William Seiple, PhD 212-821-9499 wseiple@lighthouse.org | |
| Principal Investigator: William Seiple, PhD | |
| United States, Pennsylvania | |
| University of Pittsburgh Medical Center | Recruiting |
| Pittsburgh, Pennsylvania, United States, 15213 | |
| Contact: Amy Nau, OD 412-647-2200 ext 3235 nauxac@UPMC.EDU | |
| Principal Investigator: Amy Nau, OD | |
| Canada | |
| Canadian National Institute for the Blind | Recruiting |
| Toronto, Canada, M4G 3E8 | |
| Contact: Keith Gordon, PhD 416-486-2500 ext 7689 keith.gordon@cnib.ca | |
| Principal Investigator: Keith Gordon, PhD | |
| Study Director: | Aimee Arnoldussen | Wicab, Inc. |
| Principal Investigator: | William Seiple | Lighthouse International |
More Information
| Responsible Party: | Wicab |
| ClinicalTrials.gov Identifier: | NCT01488786 History of Changes |
| Other Study ID Numbers: | WCB1-010 |
| Study First Received: | December 6, 2011 |
| Last Updated: | December 7, 2011 |
| Health Authority: | United States: Institutional Review Board |
|
Assistive Technology Non-Surgical Visual Prosthetic Sensory Substitution |
|
Blindness Vision Disorders Sensation Disorders Neurologic Manifestations |
Nervous System Diseases Eye Diseases Signs and Symptoms |