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

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.

Study Overview

• Status: Unknown
• Conditions: Focus of Study: Finding Ways to Evaluate Visual Prosthesis Systems

• Study Type: Observational
• Enrollment (Anticipated): 50

Contacts and Locations

• Study Contact: Name: Carlos R Gordon, MD; Phone Number: 972-9-7471581; Email: cgordon@post.tau.ac.il

Study Locations

• Israel
  • Kfar Saba, Israel, 44281
    • Recruiting
    • Dept Neurology, Meir Medical Center
    • Contact: Carlos R Gordon, MD; Phone Number: 972-9-7471581; Email: cgordon@post.tau.ac.il
    • Principal Investigator: Carlos R Gordon, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 45 years (Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Volunteers with normal or corrected to normal sight

Description

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

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
quantitative comparison with standard visual acuity test (ETDRS)	December 1, 2012

Collaborators and Investigators

• Sponsor: Meir Medical Center
• Collaborators: Shamoon College of Engineering

Study record dates

Study Major Dates

• Study Start: August 1, 2012
• Primary Completion (Anticipated): December 1, 2015
• Study Completion (Anticipated): December 1, 2016

Study Registration Dates

• First Submitted: January 24, 2011
• First Submitted That Met QC Criteria: January 24, 2011
• First Posted (Estimate): January 25, 2011

Study Record Updates

• Last Update Posted (Estimate): May 20, 2015
• Last Update Submitted That Met QC Criteria: May 19, 2015
• Last Verified: June 1, 2014

More Information

Terms related to this study

• Other Study ID Numbers: MMC11142-2010CTIL