Clinical trial NCT04213066: 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
Overall status: COMPLETED
Phase: NA
Conditions: Amblyopia
Amblyopia, Anisometropic
Keywords: Amblyopia
Amblyopic training
Contrast sensitivity
Grating acuity
Stochastic resonance
Visual acuity
Visual evoked potential
Lead sponsor: National Cheng-Kung University Hospital
Sponsor class: OTHER
Collaborators: name: Chang Gung Memorial Hospital
First posted: 2019-12-30
Enrollment: 51
Sex: ALL
Minimum age (years): 4
Maximum age (years): 8
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: 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.

Primary outcomes:
measure: Visual acuity (VA)
timeFrame: Change from Baseline VA at 1, 2, 3 and 6 months
measure: Grating acuity (GA)
timeFrame: Change from Baseline GA at 1, 2, 3 and 6 months
measure: Contrast sensitivity (CS)
timeFrame: Change from Baseline CS at 1, 2, 3 and 6 months
measure: Visual evoked potential (VEP)
timeFrame: Change from Baseline VEP at 1, 2, 3 and 6 months
Secondary outcomes:
measure: Total practice duration
timeFrame: Throughout 6 months
Other outcomes:
Locations:
Study officials:
affiliation: Department of Pyschology, National Cheng Kung University
name: Fu-Zen Shaw, Professor
role: PRINCIPAL_INVESTIGATOR
References:
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.