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Treating Amblyopia in Adults With Interactive Video Games

Primary Purpose

Amblyopia

Status
Withdrawn
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Video game Mario Kart Wii
Sponsored by
Mayo Clinic
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Amblyopia

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Aged >17 years old
  • Refraction within past year and wearing updated glasses or contact lenses
  • Diagnosis of strabismic, anisometropic or combined amblyopia (> 2 lines inter-ocular difference)
  • Stable visual acuity as defined as <1 LogMAR change over 2 visits 8 weeks apart, or wearing glasses for at least 16 weeks

Exclusion Criteria:

  • Monovision and unwilling to wear corrective glasses
  • Allergy to adhesive bandages
  • Women who are currently pregnant

Sites / Locations

    Arms of the Study

    Arm 1

    Arm Type

    Experimental

    Arm Label

    Subjects with Amblyopia

    Arm Description

    Adult amblyopia subjects will play the video game Mario Kart Wii

    Outcomes

    Primary Outcome Measures

    Change in visual acuity
    measured using the LogMAR (Logarithm of the Minimum Angle of Resolution) chart comprised of rows of letters to estimate visual acuity

    Secondary Outcome Measures

    Full Information

    First Posted
    April 5, 2019
    Last Updated
    December 23, 2021
    Sponsor
    Mayo Clinic
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    1. Study Identification

    Unique Protocol Identification Number
    NCT03906994
    Brief Title
    Treating Amblyopia in Adults With Interactive Video Games
    Official Title
    Treating Amblyopia in Adults With Interactive Video Games
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    December 2021
    Overall Recruitment Status
    Withdrawn
    Why Stopped
    Original study PI left institution and the new PI elected not to proceed with the study.
    Study Start Date
    October 1, 2019 (Anticipated)
    Primary Completion Date
    December 2021 (Anticipated)
    Study Completion Date
    December 2021 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Mayo Clinic

    4. Oversight

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

    5. Study Description

    Brief Summary
    Researchers are trying to determine whether interactive video game play, while wearing a patch over better-seeing eye, will improve subject reduced vision (amblyopia).
    Detailed Description
    The purpose of this research is to determine whether amblyopia (reduced vision in one eye) in adults can be improved using interactive video game play. Study participation involves playing the video game Mario KartTM (provided by the study), while wearing a patch over their better-seeing eye. Participants are asked to play the game for a total of 40 hours over a one-month period. The primary outcome measure will be LogMAR visual acuity measured 1 month after initiating game play.

    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
    Single Group Assignment
    Masking
    None (Open Label)
    Allocation
    N/A
    Enrollment
    0 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    Subjects with Amblyopia
    Arm Type
    Experimental
    Arm Description
    Adult amblyopia subjects will play the video game Mario Kart Wii
    Intervention Type
    Other
    Intervention Name(s)
    Video game Mario Kart Wii
    Intervention Description
    Subjects will place a patch over the better-seeing eye and play the video game Mario Kart Wii for a total of 40 hours over a 1 month perior
    Primary Outcome Measure Information:
    Title
    Change in visual acuity
    Description
    measured using the LogMAR (Logarithm of the Minimum Angle of Resolution) chart comprised of rows of letters to estimate visual acuity
    Time Frame
    Baseline, one month

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: Aged >17 years old Refraction within past year and wearing updated glasses or contact lenses Diagnosis of strabismic, anisometropic or combined amblyopia (> 2 lines inter-ocular difference) Stable visual acuity as defined as <1 LogMAR change over 2 visits 8 weeks apart, or wearing glasses for at least 16 weeks Exclusion Criteria: Monovision and unwilling to wear corrective glasses Allergy to adhesive bandages Women who are currently pregnant
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Erick Bothun, MD
    Organizational Affiliation
    Mayo Clinic
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Plan to Share IPD
    No
    Links:
    URL
    https://www.mayo.edu/research/clinical-trials
    Description
    Mayo Clinic Clinical Trials

    Learn more about this trial

    Treating Amblyopia in Adults With Interactive Video Games

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