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NCT02003235 Clinical Trial

Assessment of Device for Treatment of Amblyopia

Amblyopia Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT02003235
Other study ID # RV-TMSC-1
Secondary ID
Status Completed
Phase N/A
First received December 1, 2013
Last updated July 18, 2017
Start date October 2013
Est. completion date July 15, 2017

Study information
Verified date July 2017
Source Visior Technologies Ltd.
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.

Recruitment information / eligibility
Status Completed
Enrollment 35
Est. completion date July 15, 2017
Est. primary completion date July 15, 2017
Accepts healthy volunteers No
Gender All
Age group 4 Years to 8 Years
Eligibility 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

Study Design

Related Conditions & MeSH terms

Intervention

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

Locations
Country Name City State
Israel Tel-Aviv Sourasky Medical Center Tel-Aviv

Sponsors (1)
Lead Sponsor Collaborator
Visior Technologies Ltd.

Country where clinical trial is conducted

Israel, 

Outcome
Type Measure Description Time frame Safety issue
Primary Improvement in VA in amblyopic eye 3 months
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