Stochastic Resonance Applied to Amblyopia Training and the Plasticity of Brain

NCT ID: NCT04213066

Last Updated: 2019-12-30

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 51 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2013-07-15
• Study Completion Date: 2016-01-31

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.

Conditions

Amblyopia; Amblyopia, Anisometropic

Keywords

Amblyopia; Amblyopic training; Contrast sensitivity; Grating acuity; Stochastic resonance; Visual acuity; Visual evoked potential

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: TRIPLE

Study Groups

Control group

This group received eye-hand practice for drawing pictures.

Group Type: ACTIVE_COMPARATOR

Portable tablet

Intervention Type: DEVICE

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

Grating group

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

Group Type: EXPERIMENTAL

Portable tablet

Intervention Type: DEVICE

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

Random dot group

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

Group Type: EXPERIMENTAL

Portable tablet

Intervention Type: DEVICE

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

Interventions

Portable tablet

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

Intervention Type: DEVICE

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.

• Minimum Eligible Age: 4 Years
• Maximum Eligible Age: 8 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Chang Gung Memorial Hospital

OTHER

Sponsor Role: collaborator

National Cheng-Kung University Hospital

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Fu-Zen Shaw, Professor

Role: PRINCIPAL_INVESTIGATOR

Department of Pyschology, National Cheng Kung University

References

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.

Reference Type: DERIVED

PMID: 34075118 (View on PubMed)

Other Identifiers

A-BR-102-050-t

Identifier Type: -

Identifier Source: org_study_id