Trial record 7 of 8 for:    Open Studies | "Amblyopia"

Assessment of Device for Treatment of Amblyopia

This study is currently recruiting participants.
Verified December 2013 by Visior Technologies Ltd.
Sponsor:
Information provided by (Responsible Party):
Visior Technologies Ltd.
ClinicalTrials.gov Identifier:
NCT02003235
First received: December 1, 2013
Last updated: March 26, 2014
Last verified: December 2013
  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

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 ]

Estimated Enrollment: 20
Study Start Date: October 2013
Estimated Primary Completion Date: October 2014 (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
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
Please refer to this study by its ClinicalTrials.gov identifier: NCT02003235

Contacts
Contact: Chaim Stolovitch, MD +972-3-6974361

Locations
Israel
Tel-Aviv Sourasky Medical Center Recruiting
Tel-Aviv, Israel
Contact: Gili Lavi, coordinator    +972-3-6974361      
Principal Investigator: Chaim Stolovitch, MD         
Sponsors and Collaborators
Visior Technologies Ltd.
Investigators
Principal Investigator: Haim Stolovitch, MD Tel-Aviv Sourasky Medical Center
  More Information

No publications provided

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: March 26, 2014
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 April 17, 2014