Comment Period Extended to 3/23/2015 for Notice of Proposed Rulemaking (NPRM) for FDAAA 801 and NIH Draft Reporting Policy for NIH-Funded Trials

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

This study is currently recruiting participants. (see Contacts and Locations)
Verified June 2014 by Meir Medical Center
Shamoon College of Engineering
Information provided by (Responsible Party):
Meir Medical Center Identifier:
First received: January 24, 2011
Last updated: June 23, 2014
Last verified: June 2014

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.

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: June 2016
Estimated Primary Completion Date: June 2015 (Final data collection date for primary outcome measure)

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


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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT01282489

Contact: Carlos R Gordon, MD 972-9-7471581

Dept Neurology, Meir Medical Center Recruiting
Kfar Saba, Israel, 44281
Contact: Carlos R Gordon, MD    972-9-7471581   
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 Identifier: NCT01282489     History of Changes
Other Study ID Numbers: MMC11142-2010CTIL
Study First Received: January 24, 2011
Last Updated: June 23, 2014
Health Authority: Israel: Clalit Health Services processed this record on March 01, 2015