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

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ClinicalTrials.gov Identifier: NCT01282489
Recruitment Status : Unknown
Verified June 2014 by Meir Medical Center.
Recruitment status was:  Recruiting
First Posted : January 25, 2011
Last Update Posted : May 20, 2015
Sponsor:
Collaborator:
Shamoon College of Engineering
Information provided by (Responsible Party):
Meir Medical Center

Brief Summary:

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 or disease
Focus of Study: Finding Ways to Evaluate Visual Prosthesis Systems

Study Type : Observational
Estimated Enrollment : 50 participants
Official Title: Evaluation of Methods to Asses Visual Prosthesis Systems Using Sighted Volunteers and Visual Reality Simulator
Study Start Date : August 2012
Estimated Primary Completion Date : December 2015
Estimated Study Completion Date : December 2016



Primary Outcome Measures :
  1. quantitative comparison with standard visual acuity test (ETDRS) [ Time Frame: December 1, 2012 ]


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Ages Eligible for Study:   18 Years to 45 Years   (Adult)
Sexes Eligible for Study:   All
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


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

Responsible Party: Meir Medical Center
ClinicalTrials.gov Identifier: NCT01282489     History of Changes
Other Study ID Numbers: MMC11142-2010CTIL
First Posted: January 25, 2011    Key Record Dates
Last Update Posted: May 20, 2015
Last Verified: June 2014