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

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

Official Title: A Study to Evaluate the Safety and Efficacy of the BrainPort® Vision Device in Subjects Who Are Blind

Brief Summary: 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.

Detailed Summary:
Sponsor: Wicab

Current Primary Outcome:

• Safety [ Time Frame: 1 year ]
  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 ]
  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.

Original Primary Outcome: Same as current

Current Secondary Outcome:

• Word Identification [ Time Frame: 1 year ]
  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 ]
  Another secondary efficacy objective is to demonstrate at least 35% of subjects demonstrate sign recognition in a mobility task.

Original Secondary Outcome: Same as current

Information By: Wicab

Dates:
Date Received: December 6, 2011
Date Started: October 2011
Date Completion:
Last Updated: August 6, 2013
Last Verified: August 2013