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Efficacy and Safety of Eyetronix Flicker Glasses to the Treatment of Anisometropic Amblyopia

Primary Purpose

Amblyopia, Anisometropic

Status
Unknown status
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
EFG group
Patching group
Sponsored by
Shanghai Eye Disease Prevention and Treatment Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Amblyopia, Anisometropic

Eligibility Criteria

4 Years - 13 Years (Child)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  1. aged from 4 to 13 years old
  2. the best corrected visual acuity in the amblyopic eye is no more than 0.1logMAR, with two lines or more of difference between the two eyes
  3. anisometropia is defined as an inter-ocular spherical refractive error difference of 1.00 D or more or a cylindrical difference of 1.50 D or more.
  4. no amblyopia treatment one month prior to the study except refractive correction.
  5. myopia is less than -6.00D or hyperopia is less than +9.00D, strabismus was less than 20 prism diopters
  6. willing to participate in this study and be able to follow up on time

Exclusion Criteria:

  1. ocular disease and other disease that have an influence on the visual acuity
  2. history of ocular surgery that have an influence on the visual acuity
  3. the patient is receiving other amblyopia treatment except refractive correction
  4. a family or personal history of seizures
  5. the patient is using some medicine that may have an influence on visual acuity

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    Active Comparator

    Arm Label

    EFG group

    Patching group

    Arm Description

    amblyopia in EFG group will receive Eyetronix Flicker Glassess treatment.

    amblyopia in patching group will receive patching treatment.

    Outcomes

    Primary Outcome Measures

    best corrected visual acuity
    have an improvement of best corrected visual acuity in the amblyopic eyes

    Secondary Outcome Measures

    stereocuity
    have an improvement of stereocuity in the amblyopic eyes
    contrast sensitivity function
    have an improvement of contrast sensitivity in the amblyopic eyes
    visual evoked potential
    P100 latency decrease and N75-P100 amplitude increase in the amblyopic eye.
    functional MRI
    the visual cortex activity have an improvement
    best corrected visual acuity
    have an improvement of best corrected visual acuity in the amblyopic eyes

    Full Information

    First Posted
    November 17, 2016
    Last Updated
    November 17, 2016
    Sponsor
    Shanghai Eye Disease Prevention and Treatment Center
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    1. Study Identification

    Unique Protocol Identification Number
    NCT02970708
    Brief Title
    Efficacy and Safety of Eyetronix Flicker Glasses to the Treatment of Anisometropic Amblyopia
    Official Title
    Efficacy and Safety of Eyetronix Flicker Glasses to the Treatment of Anisometropic Amblyopia in Chinese Children
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    November 2016
    Overall Recruitment Status
    Unknown status
    Study Start Date
    January 2017 (undefined)
    Primary Completion Date
    June 2017 (Anticipated)
    Study Completion Date
    January 2020 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    Shanghai Eye Disease Prevention and Treatment Center

    4. Oversight

    Data Monitoring Committee
    No

    5. Study Description

    Brief Summary
    To evaluate the efficacy and safety of Eyetronix Flicker Glassess therapy in treating anisometropic amblyopia.
    Detailed Description
    A total of 176 children with anisometropic amblyopia, aged 4 to 13 years, will randomize to receive patching or Eyetronix Flicker Glasses treatment in a 1:1 ratio.Eyetronix Flicker Glasses, a lightweight spectacle frame with liquid crystal lenses that provide direct square-wave alternating occlusion, will be used at a pre-programmed temporal frequency. Patching is a traditional treatment of amblyopia. The best corrected visual acuity, contrast sensitivity, binocular function,visual evoked potential and functional MRI will be measured at baseline and follow-up visits to assess the improvement of amblyopia.Feedback information from the questionnaires will be used to evaluate the compliance and adverse effects.

    6. Conditions and Keywords

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

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Masking
    Outcomes Assessor
    Allocation
    Randomized
    Enrollment
    176 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    EFG group
    Arm Type
    Experimental
    Arm Description
    amblyopia in EFG group will receive Eyetronix Flicker Glassess treatment.
    Arm Title
    Patching group
    Arm Type
    Active Comparator
    Arm Description
    amblyopia in patching group will receive patching treatment.
    Intervention Type
    Device
    Intervention Name(s)
    EFG group
    Intervention Description
    88 anisometropic amblyopia will be recruited to receive Eyetronix Flicker Glasses treatment.
    Intervention Type
    Device
    Intervention Name(s)
    Patching group
    Intervention Description
    88 anisometropic amblyopia will be recruited to receive patching treatment.
    Primary Outcome Measure Information:
    Title
    best corrected visual acuity
    Description
    have an improvement of best corrected visual acuity in the amblyopic eyes
    Time Frame
    6 months
    Secondary Outcome Measure Information:
    Title
    stereocuity
    Description
    have an improvement of stereocuity in the amblyopic eyes
    Time Frame
    6 months
    Title
    contrast sensitivity function
    Description
    have an improvement of contrast sensitivity in the amblyopic eyes
    Time Frame
    6 months
    Title
    visual evoked potential
    Description
    P100 latency decrease and N75-P100 amplitude increase in the amblyopic eye.
    Time Frame
    6 months
    Title
    functional MRI
    Description
    the visual cortex activity have an improvement
    Time Frame
    6 months
    Title
    best corrected visual acuity
    Description
    have an improvement of best corrected visual acuity in the amblyopic eyes
    Time Frame
    a year and a half

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    4 Years
    Maximum Age & Unit of Time
    13 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: aged from 4 to 13 years old the best corrected visual acuity in the amblyopic eye is no more than 0.1logMAR, with two lines or more of difference between the two eyes anisometropia is defined as an inter-ocular spherical refractive error difference of 1.00 D or more or a cylindrical difference of 1.50 D or more. no amblyopia treatment one month prior to the study except refractive correction. myopia is less than -6.00D or hyperopia is less than +9.00D, strabismus was less than 20 prism diopters willing to participate in this study and be able to follow up on time Exclusion Criteria: ocular disease and other disease that have an influence on the visual acuity history of ocular surgery that have an influence on the visual acuity the patient is receiving other amblyopia treatment except refractive correction a family or personal history of seizures the patient is using some medicine that may have an influence on visual acuity

    12. IPD Sharing Statement

    Plan to Share IPD
    Undecided

    Learn more about this trial

    Efficacy and Safety of Eyetronix Flicker Glasses to the Treatment of Anisometropic Amblyopia

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