Assessment of Device for Treatment of Amblyopia

This study is enrolling participants by invitation only.
Sponsor:
Information provided by (Responsible Party):
Visior Technologies Ltd.
ClinicalTrials.gov Identifier:
NCT02003235
First received: December 1, 2013
Last updated: May 20, 2016
Last verified: April 2016
  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: Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: 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 ] [ Designated as safety issue: No ]

Enrollment: 25
Study Start Date: October 2013
Estimated Study Completion Date: March 2017
Estimated Primary Completion Date: December 2016 (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

Ages Eligible for Study:   4 Years to 8 Years   (Child)
Genders Eligible for Study:   Both
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
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 ClinicalTrials.gov identifier: 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 
Study First Received: December 1, 2013
Last Updated: May 20, 2016
Health Authority: Israel: Ethics Commission
Israel: Ministry of Health

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

ClinicalTrials.gov processed this record on August 25, 2016