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Assessment of Device for Treatment of Amblyopia

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT02003235
First Posted: December 6, 2013
Last Update Posted: July 21, 2017
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.
Information provided by (Responsible Party):
Visior Technologies Ltd.
  Purpose

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.


Condition Intervention
Amblyopia Device: Daily watching videos using Reviview™, a dichoptic video display device, for 60 min

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment

Resource links provided by NLM:


Further study details as provided by Visior Technologies Ltd.:

Primary Outcome Measures:
  • Improvement in VA in amblyopic eye [ Time Frame: 3 months ]

Enrollment: 35
Actual Study Start Date: October 2013
Study Completion Date: July 15, 2017
Primary Completion Date: July 15, 2017 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Single Arm
Daily watching videos using Reviview™, a dichoptic video display device
Device: Daily watching videos using Reviview™, a dichoptic video display device, for 60 min

  Eligibility

Information from the National Library of Medicine

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, Learn About Clinical Studies.


Ages Eligible for Study:   4 Years to 8 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

  Contacts and Locations
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): NCT02003235


Locations
Israel
Tel-Aviv Sourasky Medical Center
Tel-Aviv, Israel
Sponsors and Collaborators
Visior Technologies Ltd.
Investigators
Principal Investigator: Haim Stolovitch, MD Tel-Aviv Sourasky Medical Center
  More Information

Responsible Party: Visior Technologies Ltd.
ClinicalTrials.gov Identifier: NCT02003235     History of Changes
Other Study ID Numbers: RV-TMSC-1
First Submitted: December 1, 2013
First Posted: December 6, 2013
Last Update Posted: July 21, 2017
Last Verified: July 2017

Keywords provided by Visior Technologies Ltd.:
Amblyopia

Additional relevant MeSH terms:
Amblyopia
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Vision Disorders
Sensation Disorders
Neurologic Manifestations
Eye Diseases
Signs and Symptoms