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Stochastic Resonance Applied to Amblyopia Training and the Plasticity of Brain

Primary Purpose

Amblyopia, Amblyopia, Anisometropic

Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Portable tablet
Sponsored by
National Cheng-Kung University Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Amblyopia focused on measuring Amblyopia, Amblyopic training, Contrast sensitivity, Grating acuity, Stochastic resonance, Visual acuity, Visual evoked potential

Eligibility Criteria

4 Years - 8 Years (Child)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  1. Participants were 4-8 years old.
  2. Participant had binocular or monocular best-corrected visual acuity (BCVA) of ≤0.8, or they exhibited binocular BCVA difference of ≥0.2.
  3. Participant had the wearing of optimal spectacle correction.

Exclusion Criteria:

  1. Children with deprivation amblyopia were excluded.
  2. Children with ptosis were excluded.

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm 3

    Arm Type

    Active Comparator

    Experimental

    Experimental

    Arm Label

    Control group

    Grating group

    Random dot group

    Arm Description

    This group received eye-hand practice for drawing pictures.

    This group received eye-hand practice for drawing pictures with rotating grating stimuli of various spatial frequencies.

    This group received eye-hand practice for drawing pictures with rotating grating stimuli of various spatial frequencies constructed by random dots of stochastic resonance.

    Outcomes

    Primary Outcome Measures

    Visual acuity (VA)
    Landolt C chart was used.
    Grating acuity (GA)
    Horizontal or vertical square-wave grating stimuli were used.
    Contrast sensitivity (CS)
    Circular-shape horizontal square-wave grating stimuli were used.
    Visual evoked potential (VEP)
    Transient VEP and Steady state VEP of the Cortical EEG were recorded.

    Secondary Outcome Measures

    Total practice duration
    Practice duration was recorded in the tablet.

    Full Information

    First Posted
    December 22, 2019
    Last Updated
    December 24, 2019
    Sponsor
    National Cheng-Kung University Hospital
    Collaborators
    Chang Gung Memorial Hospital
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    1. Study Identification

    Unique Protocol Identification Number
    NCT04213066
    Brief Title
    Stochastic Resonance Applied to Amblyopia Training and the Plasticity of Brain
    Official Title
    Stochastic Resonance Applied to Amblyopia Training and the Plasticity of Brain
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    December 2019
    Overall Recruitment Status
    Completed
    Study Start Date
    July 15, 2013 (Actual)
    Primary Completion Date
    January 31, 2016 (Actual)
    Study Completion Date
    January 31, 2016 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    National Cheng-Kung University Hospital
    Collaborators
    Chang Gung Memorial Hospital

    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
    The prevalence of Taiwan's population with amblyopia is 2-5%. Amblyopia affects the daily life and learning ability. The human visual system can be developed normally with exposure of clear images on the retina, which often drive the development and projection of optic nerves progressively. In general, the visual acuity progresses gradually with age. A normal vision is relatively mature until 8 years old. Several types of amblyopia (strabismic amblyopia, refractive amblyopia, and deprivation amblyopia) are identified. The refractive amblyopia and deprivation amblyopia must be corrected by wearing glasses or surgeries. Otherwise, amblyopia is often corrected by occlusion of the dominant eye or amblyopia training. The Cambridge Stimulator (CAM) with rotating grating is commonly used in clinic in Taiwan. The principle of the CAM allows subjects to draw pictures on the plate in coincidence with occlusion of the dominant eye. The parents have to go with their children to a hospital weekly. The CAM training is a stereotyped visuomotor behavior, which usually causes fatigue and uninteresting results for children. Recently, some computer games have been incorporated with CAM training. However, their clinical impact on amblyopia is largely unknown. Moreover, most of studies don't have long-term tracking, and they only use limited assessments. In this project, a home-based training would be built for children with amblyopia. A CAM training with a hierarchical structure with story-based organization would be implemented in the tablet. It will save time for children and parents for traffic between the home and hospital. The CAM training with organized structure would increase acceptability and create subjects' motivation for long-term training. In addition, a stochastic resonance theory would be incorporated with the CAM training to potentiate the learning curve of a visuomotor skill in young children. Five systematic assessments, including visual acuity, grating acuity, contrast sensitivity, and 2 measurements of visual evoked potentials (VEPs), would be used. The investigators hypothesized that the rotating grating stimulation and stochastic resonance stimulation groups showed significant enhancement of the visual functions compared with the control group and performance of the VEPs toward better eye through the home-based training apparatus.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Amblyopia, Amblyopia, Anisometropic
    Keywords
    Amblyopia, Amblyopic training, Contrast sensitivity, Grating acuity, Stochastic resonance, Visual acuity, Visual evoked potential

    7. Study Design

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

    8. Arms, Groups, and Interventions

    Arm Title
    Control group
    Arm Type
    Active Comparator
    Arm Description
    This group received eye-hand practice for drawing pictures.
    Arm Title
    Grating group
    Arm Type
    Experimental
    Arm Description
    This group received eye-hand practice for drawing pictures with rotating grating stimuli of various spatial frequencies.
    Arm Title
    Random dot group
    Arm Type
    Experimental
    Arm Description
    This group received eye-hand practice for drawing pictures with rotating grating stimuli of various spatial frequencies constructed by random dots of stochastic resonance.
    Intervention Type
    Device
    Intervention Name(s)
    Portable tablet
    Intervention Description
    Each training session was limited to 15 minutes a day, 5 days a week. The entire training period was 6 months.
    Primary Outcome Measure Information:
    Title
    Visual acuity (VA)
    Description
    Landolt C chart was used.
    Time Frame
    Change from Baseline VA at 1, 2, 3 and 6 months
    Title
    Grating acuity (GA)
    Description
    Horizontal or vertical square-wave grating stimuli were used.
    Time Frame
    Change from Baseline GA at 1, 2, 3 and 6 months
    Title
    Contrast sensitivity (CS)
    Description
    Circular-shape horizontal square-wave grating stimuli were used.
    Time Frame
    Change from Baseline CS at 1, 2, 3 and 6 months
    Title
    Visual evoked potential (VEP)
    Description
    Transient VEP and Steady state VEP of the Cortical EEG were recorded.
    Time Frame
    Change from Baseline VEP at 1, 2, 3 and 6 months
    Secondary Outcome Measure Information:
    Title
    Total practice duration
    Description
    Practice duration was recorded in the tablet.
    Time Frame
    Throughout 6 months

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    4 Years
    Maximum Age & Unit of Time
    8 Years
    Accepts Healthy Volunteers
    Accepts Healthy Volunteers
    Eligibility Criteria
    Inclusion Criteria: Participants were 4-8 years old. Participant had binocular or monocular best-corrected visual acuity (BCVA) of ≤0.8, or they exhibited binocular BCVA difference of ≥0.2. Participant had the wearing of optimal spectacle correction. Exclusion Criteria: Children with deprivation amblyopia were excluded. Children with ptosis were excluded.
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Fu-Zen Shaw, Professor
    Organizational Affiliation
    Department of Pyschology, National Cheng Kung University
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Citations:
    PubMed Identifier
    34075118
    Citation
    Yeh WH, Lai LJ, Chang DW, Lin WS, Lin GM, Shaw FZ. Portable rotating grating stimulation for anisometropic amblyopia with 6 months training. Sci Rep. 2021 Jun 1;11(1):11430. doi: 10.1038/s41598-021-90936-7.
    Results Reference
    derived

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    Stochastic Resonance Applied to Amblyopia Training and the Plasticity of Brain

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