Evaluation of Methods to Asses Visual Prosthesis Systems Using Sighted Volunteers and Visual Reality Simulator

This study is currently recruiting participants.
Verified February 2013 by Meir Medical Center
Sponsor:
Collaborator:
Shamoon College of Engineering
Information provided by (Responsible Party):
Meir Medical Center
ClinicalTrials.gov Identifier:
NCT01282489
First received: January 24, 2011
Last updated: February 17, 2013
Last verified: February 2013
  Purpose

A basic requirement for every therapeutic procedure is that there be an objective and validated method to assess the benefit of the treatment for the patient. Currently, there is no acceptable procedure to quantify the benefit obtained from visual prostheses.

The goal of the proposed research is to evaluate visual tasks and tests that will be given to a very large number of volunteers with normal vision who will be using a novel virtual prosthesis simulator. This device will simulate the realistic visual information that a visual implant can provide and will be used to measure implants in current clinical trials.


Condition
Focus of Study: Finding Ways to Evaluate Visual Prosthesis Systems

Study Type: Observational
Official Title: Evaluation of Methods to Asses Visual Prosthesis Systems Using Sighted Volunteers and Visual Reality Simulator

Further study details as provided by Meir Medical Center:

Primary Outcome Measures:
  • quantitative comparison with standard visual acuity test (ETDRS) [ Time Frame: December 1, 2012 ] [ Designated as safety issue: No ]

Estimated Enrollment: 50
Study Start Date: August 2012
Estimated Study Completion Date: August 2014
Estimated Primary Completion Date: January 2014 (Final data collection date for primary outcome measure)
  Eligibility

Ages Eligible for Study:   18 Years to 45 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population

Volunteers with normal or corrected to normal sight

Criteria

Inclusion Criteria:

Normal or corrected to normal sight (up to +/- 3.5 D) - Healthy Age 18 to 45

Exclusion Criteria:

Had any incident of dizziness from video or computer game Minors or special population

  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01282489

Contacts
Contact: Carlos R Gordon, MD 972-9-7471581 cgordon@post.tau.ac.il

Locations
Israel
Dept Neurology, Meir Medical Center Recruiting
Kfar Saba, Israel, 44281
Contact: Carlos R Gordon, MD    972-9-7471581    cgordon@post.tau.ac.il   
Principal Investigator: Carlos R Gordon, MD         
Sponsors and Collaborators
Meir Medical Center
Shamoon College of Engineering
  More Information

No publications provided

Responsible Party: Meir Medical Center
ClinicalTrials.gov Identifier: NCT01282489     History of Changes
Other Study ID Numbers: MMC11142-2010CTIL
Study First Received: January 24, 2011
Last Updated: February 17, 2013
Health Authority: Israel: Clalit Health Services

ClinicalTrials.gov processed this record on April 17, 2014