Assessment of Device for Treatment of Amblyopia | NCT02003235

Studies
Assessment of Device for Treatment of Amblyopia

NCT02003235

Sponsor

Visior Technologies Ltd.

Status

Completed

Last Update Posted

Jul 21, 2017Actual

Enrollment

35Actual

Phase

Not Applicable

Conditions

Amblyopia

Interventions

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

Countries

Israel

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jul 2017

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Oct 2013Actual

Primary Completion Date

Jul 15, 2017Actual

Completion Date

Jul 15, 2017Actual

First Submitted Date

Dec 1, 2013

First Submission Date that Met QC Criteria

Dec 1, 2013

First Posted Date

Dec 6, 2013Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jul 18, 2017

Last Update Posted Date

Jul 21, 2017Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

35Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Single Arm	Experimental	Daily watching videos using Reviview™, a dichoptic video display device	Device: Daily watching videos using Reviview™, a dichoptic video display device, for 60 min

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Daily watching videos using Reviview™, a dichoptic video display device, for 60 min	Device		Single Arm

Measure	Description	Time Frame
Improvement in VA in amblyopic eye		3 months

Eligibility Module

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

4 Years

Maximum Age

8 Years

Standard Ages

Child

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Haim Stolovitch, MD	Tel-Aviv Sourasky Medical Center	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Tel-Aviv Sourasky Medical Center		Tel Aviv			Israel

Condition Browse Module

MeSH Terms

ID	Term
D000550	Amblyopia

Ancestor Terms

ID	Term
D001927	Brain Diseases
D002493	Central Nervous System Diseases
D009422	Nervous System Diseases
D014786	Vision Disorders

Browse Leaves

Not provided

Browse Branches

Not provided