AmblyopiaNCT04213066
Stochastic Resonance Applied to Amblyopia Training and the Plasticity of Brain
A study testing Portable tablet in people with Amblyopia and Amblyopia, Anisometropic, run by National Cheng-Kung University Hospital.
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. Read more about this study
- Who is it for?
- Ages 4 to 8 yearsHealthy volunteers can take part
- Conditions the study is for
- Amblyopia, Amblyopia, Anisometropic
- What is being tested?
- Portable tablet
- Type of treatment
- Pill or oral medicine, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 51 participants
- Where
- No sites listed yet
- Study dates
- 15 Jul 2013to 31 Jan 2016
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 4 to 8 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- 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.
Who cannot join
- Children with deprivation amblyopia were excluded.
- Children with ptosis were excluded.
About this study
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
- Being tested
- Portable tablet
- Keywords
- Amblyopia, Amblyopic training, Contrast sensitivity, Grating acuity, Stochastic resonance, Visual acuity, Visual evoked potential
- Medical subject headings
- Amblyopia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Portable tabletDevice
Each training session was limited to 15 minutes a day, 5 days a week. The entire training period was 6 months.
| Study group | Role | What they receive |
|---|---|---|
| Control group | Active comparator | This group received eye-hand practice for drawing pictures. Receives: Device: Portable tablet |
| Grating group | Experimental | This group received eye-hand practice for drawing pictures with rotating grating stimuli of various spatial frequencies. Receives: Device: Portable tablet |
| 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. Receives: Device: Portable tablet |
What is being measured
The primary outcome is the main question the study is designed to answer.
Visual acuity (VA)
Landolt C chart was used.
Measured: Change from Baseline VA at 1, 2, 3 and 6 months
Grating acuity (GA)
Horizontal or vertical square-wave grating stimuli were used.
Measured: Change from Baseline GA at 1, 2, 3 and 6 months
Contrast sensitivity (CS)
Circular-shape horizontal square-wave grating stimuli were used.
Measured: Change from Baseline CS at 1, 2, 3 and 6 months
Visual evoked potential (VEP)
Transient VEP and Steady state VEP of the Cortical EEG were recorded.
Measured: Change from Baseline VEP at 1, 2, 3 and 6 months
Secondary outcomes (1)
Total practice duration
Practice duration was recorded in the tablet.
Measured: Throughout 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Dec 2019
- Study start15 Jul 2013
- Primary completion31 Jan 2016
- Study completion31 Jan 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for AmblyopiaStudies of the same condition, open and under way.
- More trials run by National Cheng-Kung University HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 51 participants (actual)
Sponsor and investigators
- Lead sponsor
- National Cheng-Kung University Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Chang Gung Memorial Hospital
- Responsible party
- Sponsor
- Investigators
- Fu-Zen Shaw, Professor, Principal investigator, Department of Pyschology, National Cheng Kung University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04213066
- Sponsor's protocol ID
- A-BR-102-050-t
- Status last verified
- Dec 2019
- First submitted
- 22 Dec 2019
- Last updated
- 30 Dec 2019
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
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.
PubMed 34075118
Study at a glance
From the registry record, last updated by the sponsor on 30 Dec 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Stochastic Resonance Applied to Amblyopia Training and the Plasticity of Brain
- ClinicalTrials.gov ID
- NCT04213066
- Acronym / sponsor ID
- A-BR-102-050-t
- Conditions
- Amblyopia, Amblyopia, Anisometropic
- Keywords
- Amblyopia, Amblyopic training, Contrast sensitivity, Grating acuity, Stochastic resonance, Visual acuity, Visual evoked potential
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 51 participants (actual)
- Lead sponsor
- National Cheng-Kung University HospitalUniversity, hospital or other
- Collaborators
- Chang Gung Memorial Hospital
- Study start
- 15 Jul 2013 (actual)
- Primary completion
- 31 Jan 2016 (actual)
- Study completion
- 31 Jan 2016 (actual)
- First posted
- 30 Dec 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Control group | Active comparator | Device: Portable tabletThis group received eye-hand practice for drawing pictures. |
| Grating group | Experimental | Device: Portable tabletThis group received eye-hand practice for drawing pictures with rotating grating stimuli of various spatial frequencies. |
| Random dot group | Experimental | Device: Portable tabletThis group received eye-hand practice for drawing pictures with rotating grating stimuli of various spatial frequencies constructed by random dots of stochastic resonance. |
Who may qualify
- Ages
- 4 to 8 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (2 listed)
- Children with deprivation amblyopia were excluded.
- Children with ptosis were excluded.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Portable tabletEach training session was limited to 15 minutes a day, 5 days a week. The entire training period was 6 months. | Device | Control group, Grating group, Random dot group |
Primary outcome
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.
1 secondary outcome
Total practice duration
Time frame: Throughout 6 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Dec 2019.
- Derived from this study: PubMed 34075118Yeh 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Fu-Zen Shaw, Professor principal investigator
Department of Pyschology, National Cheng Kung University
Questions about this trial
What is this clinical trial studying?
A study testing Portable tablet in people with Amblyopia and Amblyopia, Anisometropic, run by National Cheng-Kung University Hospital.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 30 Dec 2019. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Visual acuity (VA) (time frame: Change from Baseline VA at 1, 2, 3 and 6 months). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04213066, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Dec 2019.