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Virtual Reality Game Playing in Amblyopia Therapy

Primary Purpose

Amblyopia

Status
Unknown status
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Virtual Reality
Patching
Sponsored by
Hamideh Sabbaghi
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Amblyopia

Eligibility Criteria

4 Years - 10 Years (Child)All SexesAccepts Healthy Volunteers

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

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    Active Comparator

    Arm Label

    Virtual Reality

    Patching

    Arm Description

    Dichoptic playing games with fine stimulation will present to the amblyopic eye.

    Non- amblyopic eye will be recommended to patch.

    Outcomes

    Primary Outcome Measures

    Best Corrected Visual Acuity (BCVA)
    Change from baseline BCVA at 6 months

    Secondary Outcome Measures

    Full Information

    First Posted
    January 30, 2020
    Last Updated
    February 7, 2020
    Sponsor
    Hamideh Sabbaghi
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    1. Study Identification

    Unique Protocol Identification Number
    NCT04261868
    Brief Title
    Virtual Reality Game Playing in Amblyopia Therapy
    Official Title
    Virtual Reality Game Playing in Amblyopia Therapy
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    February 2020
    Overall Recruitment Status
    Unknown status
    Study Start Date
    March 11, 2020 (Anticipated)
    Primary Completion Date
    May 11, 2021 (Anticipated)
    Study Completion Date
    June 11, 2021 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor-Investigator
    Name of the Sponsor
    Hamideh Sabbaghi

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No

    5. Study Description

    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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Amblyopia

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Masking
    ParticipantCare ProviderInvestigator
    Allocation
    Randomized
    Enrollment
    50 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    Virtual Reality
    Arm Type
    Experimental
    Arm Description
    Dichoptic playing games with fine stimulation will present to the amblyopic eye.
    Arm Title
    Patching
    Arm Type
    Active Comparator
    Arm Description
    Non- amblyopic eye will be recommended to patch.
    Intervention Type
    Device
    Intervention Name(s)
    Virtual Reality
    Other Intervention Name(s)
    No additional intervention
    Intervention Description
    New treatment for amblyopia therapy using playing games
    Intervention Type
    Other
    Intervention Name(s)
    Patching
    Intervention Description
    Patching
    Primary Outcome Measure Information:
    Title
    Best Corrected Visual Acuity (BCVA)
    Description
    Change from baseline BCVA at 6 months
    Time Frame
    baseline and 6 months after training

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    4 Years
    Maximum Age & Unit of Time
    10 Years
    Accepts Healthy Volunteers
    Accepts Healthy Volunteers
    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
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    Hamideh Sabbaghi, PhD
    Phone
    989120285930
    Email
    sabbaghi.opt@gmail.com

    12. IPD Sharing Statement

    Plan to Share IPD
    Undecided

    Learn more about this trial

    Virtual Reality Game Playing in Amblyopia Therapy

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