Back to resultsAssessment of Device for Treatment of Amblyopia
Primary Purpose
Amblyopia
Status
Completed
Phase
Not Applicable
Locations
Israel
Study Type
Interventional
Intervention
Daily watching videos using Reviview™, a dichoptic video display device, for 60 min
Sponsored by
About this trial
This is an interventional treatment trial for Amblyopia focused on measuring Amblyopia
Eligibility 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
Sites / Locations
- Tel-Aviv Sourasky Medical Center
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Single Arm
Arm Description
Daily watching videos using Reviview™, a dichoptic video display device
Outcomes
Primary Outcome Measures
Improvement in VA in amblyopic eye
Secondary Outcome Measures
Full Information
NCT ID
NCT02003235
First Posted
December 1, 2013
Last Updated
July 18, 2017
Sponsor
Visior Technologies Ltd.
1. Study Identification
Unique Protocol Identification Number
NCT02003235
Brief Title
Assessment of Device for Treatment of Amblyopia
Study Type
Interventional
2. Study Status
Record Verification Date
July 2017
Overall Recruitment Status
Completed
Study Start Date
October 2013 (Actual)
Primary Completion Date
July 15, 2017 (Actual)
Study Completion Date
July 15, 2017 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Visior Technologies Ltd.
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Amblyopia
Keywords
Amblyopia
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
35 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Single Arm
Arm Type
Experimental
Arm Description
Daily watching videos using Reviview™, a dichoptic video display device
Intervention Type
Device
Intervention Name(s)
Daily watching videos using Reviview™, a dichoptic video display device, for 60 min
Primary Outcome Measure Information:
Title
Improvement in VA in amblyopic eye
Time Frame
3 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
4 Years
Maximum Age & Unit of Time
8 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Haim Stolovitch, MD
Organizational Affiliation
Tel-Aviv Sourasky Medical Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Tel-Aviv Sourasky Medical Center
City
Tel-Aviv
Country
Israel
12. IPD Sharing Statement
Learn more about this trial
Assessment of Device for Treatment of Amblyopia
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