Virtual Reality Game Playing in Amblyopia Therapy | NCT04261868

Studies
Virtual Reality Game Playing in Amblyopia Therapy

NCT04261868

Sponsor

Hamideh Sabbaghi

Status

Unknown status

Last Update Posted

Feb 10, 2020Actual

Enrollment

50Estimated

Phase

Not Applicable

Conditions

Amblyopia

Interventions

Virtual Reality
Patching

Countries

Not provided

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

Feb 2020

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Not yet recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Mar 11, 2020Estimated

Primary Completion Date

May 11, 2021Estimated

Completion Date

Jun 11, 2021Estimated

First Submitted Date

Jan 30, 2020

First Submission Date that Met QC Criteria

Feb 7, 2020

First Posted Date

Feb 10, 2020Actual

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

Feb 7, 2020

Last Update Posted Date

Feb 10, 2020Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Hamideh Sabbaghi, Principal Investigator, Shahid Beheshti University of Medical SciencesSponsor-Investigator

Lead Sponsor

Hamideh SabbaghiOTHER

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

Not provided

Is FDA Regulated Drug

Is FDA Regulated Device

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

Background: "Amblyopia is a neurodevelopmental disorder in both monocular and binocular functions and it extends even beyond the primary visual integration centers", therefore, amblyopia is not a "lazy eye" but it is a "lazy brain".

Purpose: The investigators aimed to compare the visual outcome of occlusion therapy with virtual reality game playing as a new therapy on amblyopic children.

Methods: This RCT was performed on 50 children with unilateral amblyopia ,4 to 10 years old. They were randomly divided to case and control (each= 25) groups. case group were trained binocularly using the virtual reality games through head set for one hour a day, 5 days in a week for 4 to 6 weeks. Controls occluded their non- amblyopic eyes, 2, 4 and 6 hours for mild (0.2 to 0.3 LogMAR), moderate (0.3 to 0.6 LogMAR) and severe (BCVA < 0.6 LogMAR) amblyopia, respectively.

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

50Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Virtual Reality	Experimental	Dichoptic playing games with fine stimulation will present to the amblyopic eye.	Device: Virtual Reality
Patching	Active Comparator	Non- amblyopic eye will be recommended to patch.	Other: Patching

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Virtual Reality	Device	New treatment for amblyopia therapy using playing games	Virtual Reality

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Best Corrected Visual Acuity (BCVA)	Change from baseline BCVA at 6 months	baseline and 6 months after training

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

- The best corrected visual acuity worse than 0.3 LogMAR

Exclusion Criteria:

Patients with abnormal fixation
Patients with neurological problems
Patients with any types of ocular pathologies

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

4 Years

Maximum Age

10 Years

Standard Ages

Child

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Hamideh Sabbaghi, PhD	Contact	989120285930		sabbaghi.opt@gmail.com

Overall Officials

Not provided

Locations

Not provided

IPD Sharing Statement Module

Plan to Share IPD

Undecided

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

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