Assessment of Device for Treatment of Amblyopia

NCT ID: NCT02003235

Last Updated: 2017-07-21

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

35 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-10-31

Study Completion Date

2017-07-15

Brief Summary

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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.

Detailed Description

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Conditions

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Amblyopia

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Single Arm

Daily watching videos using Reviview™, a dichoptic video display device

Group Type EXPERIMENTAL

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

Intervention Type DEVICE

Interventions

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

Intervention Type DEVICE

Eligibility Criteria

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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
Minimum Eligible Age

4 Years

Maximum Eligible Age

8 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Visior Technologies Ltd.

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Haim Stolovitch, MD

Role: PRINCIPAL_INVESTIGATOR

Tel-Aviv Sourasky Medical Center

Locations

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Tel-Aviv Sourasky Medical Center

Tel Aviv, , Israel

Site Status

Countries

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Israel

Other Identifiers

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RV-TMSC-1

Identifier Type: -

Identifier Source: org_study_id

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