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Completed

NCT Number: NCT04213066

Stochastic Resonance Applied to Amblyopia Training and the Plasticity of Brain

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.

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Key information

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Portable tablet

Device

Each training session was limited to 15 minutes a day, 5 days a week. The entire training period was 6 months.

Primary outcomes

  1. Visual acuity (VA)

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

    Landolt C chart was used.

  2. 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.

  3. 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.

  4. 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

  1. Total practice duration

    Time frame: Throughout 6 months

    Practice duration was recorded in the tablet.

Sponsors and collaborators

Lead sponsor

National Cheng-Kung University Hospital

Other

Collaborators

  • Chang Gung Memorial Hospital

Registry information

Important dates

Study start
2013
Primary completion
2016
Study completion
2016
First posted
Dec 30, 2019
Registry last updated
Dec 30, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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