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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT04213066
Other study ID # A-BR-102-050-t
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date July 15, 2013
Est. completion date January 31, 2016

Study information

Verified date December 2019
Source National Cheng-Kung University Hospital
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


Recruitment information / eligibility

Status Completed
Enrollment 51
Est. completion date January 31, 2016
Est. primary completion date January 31, 2016
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 4 Years to 8 Years
Eligibility 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.

Study Design


Related Conditions & MeSH terms


Intervention

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

Locations

Country Name City State
n/a

Sponsors (2)

Lead Sponsor Collaborator
National Cheng-Kung University Hospital Chang Gung Memorial Hospital

Outcome

Type Measure Description Time frame Safety issue
Primary Visual acuity (VA) Landolt C chart was used. Change from Baseline VA at 1, 2, 3 and 6 months
Primary Grating acuity (GA) Horizontal or vertical square-wave grating stimuli were used. Change from Baseline GA at 1, 2, 3 and 6 months
Primary Contrast sensitivity (CS) Circular-shape horizontal square-wave grating stimuli were used. Change from Baseline CS at 1, 2, 3 and 6 months
Primary Visual evoked potential (VEP) Transient VEP and Steady state VEP of the Cortical EEG were recorded. Change from Baseline VEP at 1, 2, 3 and 6 months
Secondary Total practice duration Practice duration was recorded in the tablet. Throughout 6 months
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