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Assessment of Device for Treatment of Amblyopia

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02003235
Recruitment Status : Completed
First Posted : December 6, 2013
Last Update Posted : July 21, 2017
Sponsor:
Information provided by (Responsible Party):
Visior Technologies Ltd.

Tracking Information
First Submitted Date  ICMJE December 1, 2013
First Posted Date  ICMJE December 6, 2013
Last Update Posted Date July 21, 2017
Actual Study Start Date  ICMJE October 2013
Actual Primary Completion Date July 15, 2017   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: December 1, 2013)
Improvement in VA in amblyopic eye [ Time Frame: 3 months ]
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Assessment of Device for Treatment of Amblyopia
Official Title  ICMJE Not Provided
Brief Summary

The study will evaluate the effect of Reviview™, a dichoptic video display device for administrating a novel treatment protocol for Amblyopia (lazy eye) in kids.

The effect of the treatment will be measured by the change from baseline in Visual acuity and in Stereoscopic Vision; and to assess the ease of use of and compliance by the patients.

Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Amblyopia
Intervention  ICMJE Device: Daily watching videos using Reviview™, a dichoptic video display device, for 60 min
Study Arms  ICMJE Experimental: Single Arm
Daily watching videos using Reviview™, a dichoptic video display device
Intervention: Device: Daily watching videos using Reviview™, a dichoptic video display device, for 60 min
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: July 18, 2017)
35
Original Estimated Enrollment  ICMJE
 (submitted: December 1, 2013)
12
Actual Study Completion Date  ICMJE July 15, 2017
Actual Primary Completion Date July 15, 2017   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

Refractive or Strabismic Amblyopia, with best corrected visual acuity.

(1) Refractive Amblyopia, visual acuity score <6:15 (worse then)

  • or (2) Strabismic Amblyopia, visual acuity score between 6:15 and 6:30

Exclusion Criteria:

Diagnosed with epilepsy, recently treated with occlusion or penalization therapy

Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 4 Years to 8 Years   (Child)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Israel
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02003235
Other Study ID Numbers  ICMJE RV-TMSC-1
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Visior Technologies Ltd.
Study Sponsor  ICMJE Visior Technologies Ltd.
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Haim Stolovitch, MD Tel-Aviv Sourasky Medical Center
PRS Account Visior Technologies Ltd.
Verification Date July 2017

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP