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Choroidal Changes Post Short Term Exposure To Virtual Reality Devices (MIRABILE)

Primary Purpose

Myopia

Status
Withdrawn
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Visu
Sponsored by
Visu, Inc.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Myopia focused on measuring Choroidal thickness, Virtual reality

Eligibility Criteria

13 Years - undefined (Child, Adult, Older Adult)All SexesAccepts Healthy Volunteers

Key Inclusion Criteria:

  • Is at least 13 years of age and has full legal capacity to volunteer;
  • Has read and signed an information consent letter;
  • Visual Acuity of +0.20 logMAR or better in each eye;
  • Is willing and able to follow instructions and maintain the appointment schedule.

Key Exclusion Criteria:

  • Is participating in any concurrent clinical or research study;
  • Has any known active ocular disease and/or infection;
  • Has a systemic condition that in the opinion of the investigator may affect a study outcome variable;
  • Is amblyopic in either eye;
  • Has a colour vision abnormality;
  • Commonly experiences motion sickness.

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Other

    Other

    Arm Label

    Visu OD, Control OS

    Control OD, Visu OS

    Arm Description

    Contralateral eye study

    Contralateral eye study

    Outcomes

    Primary Outcome Measures

    Choroidal thickness

    Secondary Outcome Measures

    Choroidal thickness
    Axial length

    Full Information

    First Posted
    October 21, 2019
    Last Updated
    June 2, 2020
    Sponsor
    Visu, Inc.
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    1. Study Identification

    Unique Protocol Identification Number
    NCT04140877
    Brief Title
    Choroidal Changes Post Short Term Exposure To Virtual Reality Devices
    Acronym
    MIRABILE
    Official Title
    Choroidal Changes Post Short Term Exposure To Virtual Reality Devices
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    June 2020
    Overall Recruitment Status
    Withdrawn
    Why Stopped
    Strategy change
    Study Start Date
    July 2020 (Anticipated)
    Primary Completion Date
    December 2020 (Anticipated)
    Study Completion Date
    January 2021 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    Visu, Inc.

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No
    Product Manufactured in and Exported from the U.S.
    Yes
    Data Monitoring Committee
    No

    5. Study Description

    Brief Summary
    This is a prospective, randomized, controlled, contralateral eye, clinical study. The objective of the study is to determine the impact of Virtual Reality (VR) usage on choroidal thickness when viewed through a test display compared to a control (standard) VR display. The hypothesis is that there will be less choroidal thinning in the eye viewing the test VR screen compared to the eye viewing the control VR screen.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Myopia
    Keywords
    Choroidal thickness, Virtual reality

    7. Study Design

    Primary Purpose
    Prevention
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Model Description
    Randomized, contralateral eye study
    Masking
    ParticipantInvestigatorOutcomes Assessor
    Allocation
    Randomized
    Enrollment
    0 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    Visu OD, Control OS
    Arm Type
    Other
    Arm Description
    Contralateral eye study
    Arm Title
    Control OD, Visu OS
    Arm Type
    Other
    Arm Description
    Contralateral eye study
    Intervention Type
    Device
    Intervention Name(s)
    Visu
    Intervention Description
    An experimental (test) virtual reality display
    Primary Outcome Measure Information:
    Title
    Choroidal thickness
    Time Frame
    2 hours
    Secondary Outcome Measure Information:
    Title
    Choroidal thickness
    Time Frame
    3 months
    Title
    Axial length
    Time Frame
    3 months

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    13 Years
    Accepts Healthy Volunteers
    Accepts Healthy Volunteers
    Eligibility Criteria
    Key Inclusion Criteria: Is at least 13 years of age and has full legal capacity to volunteer; Has read and signed an information consent letter; Visual Acuity of +0.20 logMAR or better in each eye; Is willing and able to follow instructions and maintain the appointment schedule. Key Exclusion Criteria: Is participating in any concurrent clinical or research study; Has any known active ocular disease and/or infection; Has a systemic condition that in the opinion of the investigator may affect a study outcome variable; Is amblyopic in either eye; Has a colour vision abnormality; Commonly experiences motion sickness.
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Lyndon Jones, PhD, FCOptom
    Organizational Affiliation
    Centre for Ocular Research and Education
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Plan to Share IPD
    No

    Learn more about this trial

    Choroidal Changes Post Short Term Exposure To Virtual Reality Devices

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