Assessment of Device for Treatment of Amblyopia

July 18, 2017 updated by: Visior Technologies Ltd.

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

35

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Israel
      • Tel-Aviv, Israel
        • Tel-Aviv Sourasky Medical Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

4 years to 8 years (CHILD)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: NA
  • Interventional Model: SINGLE_GROUP
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Improvement in VA in amblyopic eye
Time Frame: 3 months
3 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Visior Technologies Ltd.

Investigators

  • Principal Investigator: Haim Stolovitch, MD, Tel-Aviv Sourasky Medical Center

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

October 1, 2013

Primary Completion (ACTUAL)

July 15, 2017

Study Completion (ACTUAL)

July 15, 2017

Study Registration Dates

First Submitted

December 1, 2013

First Submitted That Met QC Criteria

December 1, 2013

First Posted (ESTIMATE)

December 6, 2013

Study Record Updates

Last Update Posted (ACTUAL)

July 21, 2017

Last Update Submitted That Met QC Criteria

July 18, 2017

Last Verified

July 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • RV-TMSC-1

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Amblyopia

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Hungary

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe