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Clinical Trials/NCT04213066
NCT04213066CompletedNot Applicable

Stochastic Resonance Applied to Amblyopia Training and the Plasticity of Brain

National Cheng-Kung University Hospital0 sites51 target enrollmentStarted: July 15, 2013Last updated:
Conditions
Interventions

Trial Snapshot

Phase
Not Applicable
Status
Completed
Enrollment
51
Primary Endpoint
Visual acuity (VA)

Study Overview

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.

Study Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel
Primary Purpose
Treatment
Masking
Triple (Participant, Care Provider, Investigator)

Eligibility Criteria

Ages
4 Years to 8 Years (Child)
Sex
All
Accepts Healthy Volunteers
Yes

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.
  • •Participant had the wearing of optimal spectacle correction.

Exclusion Criteria

  • •Children with deprivation amblyopia were excluded.
  • •Children with ptosis were excluded.

Arms & Interventions

Control group

Active Comparator

This group received eye-hand practice for drawing pictures.

Intervention: Portable tablet (Device)

Grating group

Experimental

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

Intervention: Portable tablet (Device)

Random dot group

Experimental

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: Portable tablet (Device)

Outcomes

Primary Outcomes

Visual acuity (VA)

Time Frame: Change from Baseline VA at 1, 2, 3 and 6 months

Landolt C chart was used.

Grating acuity (GA)

Time Frame: Change from Baseline GA at 1, 2, 3 and 6 months

Horizontal or vertical square-wave grating stimuli were used.

Contrast sensitivity (CS)

Time Frame: Change from Baseline CS at 1, 2, 3 and 6 months

Circular-shape horizontal square-wave grating stimuli were used.

Visual evoked potential (VEP)

Time Frame: Change from Baseline VEP at 1, 2, 3 and 6 months

Transient VEP and Steady state VEP of the Cortical EEG were recorded.

Secondary Outcomes

  • Total practice duration(Throughout 6 months)

Investigators

Sponsor Class
Other
Responsible Party
Sponsor

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