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
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
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.
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
NCT ID
NCT04213066
First Posted
December 22, 2019
Last Updated
December 24, 2019
Sponsor
National Cheng-Kung University Hospital
Collaborators
Chang Gung Memorial Hospital
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
Learn more about this trial
Stochastic Resonance Applied to Amblyopia Training and the Plasticity of Brain
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