MyopiaNCT04017234
Eye Exercise, Transcutaneous Electrical Nerve Stimulation on Prevention of Myopia Progression
A study testing frequency following response, eye exercise, and transcutaneous in people with Myopia, run by China Medical University Hospital at 1 site in Taiwan.
Trial summary
In Taiwan, the increasing prevalence of myopia shows a decline with age. Myopia has become a serious ocular problem in children because high myopia may lead to retinal damage, cataract and glaucoma. A prevention of myopia progression (PMP) will be developed and examined. Read more about this study
- Who is it for?
- Ages 6 to 13 years
- Conditions the study is for
- Myopia
- What is being tested?
- frequency following response, eye exercise, and transcutaneous
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 27 participants
- Where
- 1 siteTaiwan
- Study dates
- 10 Sep 2019to 30 Aug 2020
- 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 6 to 13 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- myopia is defined as the equivalent spherical surface degree of any one is less than or equal to -0.50D
- do not use cyclogel or atropine
- At least the eye ointment is deactivated for at least seven days
- no plastic tablets are currently used
- at least the plastic tablets are not allowed to be retired for more than seven days
Who cannot join
- Children with current traumatic and unrecoverable other eye disease
Trial locations and contacts
1 site in 1 country.
Taiwan1 site, 1 recruiting
- Recruiting
Chen Pin elementary school
Taichung, 406
Yu-Kuei Teng, PhD, 886-4-22053366 ext. 7132, tengyk@mail.cmu.edu.tw
Shin-Da Lee, PhD, 886-4-22053366 ext. 7300, shinda@mail.cmu.edu.tw
About this study
Official title: The Effects of Frequency Following Response, Eye Exercise, and Transcutaneous Electrical Nerve Stimulation on Prevention of Myopia Progression in Taiwan Schoolchildren
In Taiwan, the increasing prevalence of myopia shows a decline with age. Myopia has become a serious ocular problem in children because high myopia may lead to retinal damage, cataract and glaucoma. A prevention of myopia progression (PMP) will be developed and examined. This promotion program includes strategies such as a frequency following response, eye exercise, and transcutaneous electrical nerve stimulation on the prevention of myopia progression. Eye exercise defined as a computerized image led motion. The study aims to examine the effect of the implementation on the PMP.
Read the detailed description
This is an experimental study. A sample size of 25~40 participants from an elementary school will be recruited in the randomized controlled study.The sequential arrangement is arranged in a random manner for the participating children. A investigation of four groups will be designed for the PMP: Group 1 (frequency following response, Group 2(frequency following response,and eye exercise), Group 3 (frequency following response, eye exercise, transcutaneous electrical nerve stimulation and stimulating auricular acupoints), and Group 4, the control group. The PMP implement a 30 minute intervention two times per the investigators. Pre-test and post-test (eyeball diopter detection and Sellen's vision chart) will be carried out. The duration of each intervention is provided for two days. The washout period following next intervention is 7 days at least. After completing four intervention, the effect of the best intervention of eight the investigator will be conducted.The evaluation time of the interventions will be observed at first-time and one-month observations. A descriptive and inferential statistics by SpSS will be used for data analysis.
The investigators will apply the frequency following response, eye exercise, and transcutaneous electrical nerve stimulation on PMP among Taiwan schoolchildren. The findings of the study may provide information for promotion of visual health for schoolchildren and their parents.
- Conditions
- Myopia
- Being tested
- frequency following response, eye exercise, and transcutaneous
- Medical subject headings
- Myopia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
frequency following response, eye exercise, and transcutaneousOther
frequency following response, eye exercise, and TENS for 3 times per week during 4 weeks
| Study group | Role | What they receive |
|---|---|---|
| PMP group | Experimental | children received health education for eye and the intervention(which included frequency following response, eye exercise, and transcutaneous electrical nerve stimulation) a 30 minute three times per week for four weeks. Receives: Other: frequency following response, eye exercise, and transcutaneous |
| control group | No intervention | children just received health education for eye |
What is being measured
The primary outcome is the main question the study is designed to answer.
eyeball structure
eyeball diopter detection
Measured: one month detection after intervention
Secondary outcomes (1)
vision check
Sellen's vision chart
Measured: one month detection after intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Jul 2019
- Study start10 Sep 2019
- Primary completion30 May 2020 (estimated)
- Study completion30 Aug 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for MyopiaStudies of the same condition, open and under way.
- More trials run by China Medical 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 27 participants (estimated)
Sponsor and investigators
- Lead sponsor
- China Medical University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Yu-Kuei Teng, Principal investigator, China Medical University, Taiwan
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04017234
- Sponsor's protocol ID
- CMUH107-REC1-124
- Status last verified
- May 2020
- First submitted
- 10 Jul 2019
- Last updated
- 13 May 2020
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 May 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effects of Frequency Following Response, Eye Exercise, and Transcutaneous Electrical Nerve Stimulation on Prevention of Myopia Progression in Taiwan Schoolchildren
- ClinicalTrials.gov ID
- NCT04017234
- Acronym / sponsor ID
- CMUH107-REC1-124
- Conditions
- Myopia
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 27 participants (estimated)
- Lead sponsor
- China Medical University HospitalUniversity, hospital or other
- Study start
- 10 Sep 2019 (actual)
- Primary completion
- 30 May 2020 (estimated)
- Study completion
- 30 Aug 2020 (estimated)
- First posted
- 12 Jul 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.
In Taiwan, the increasing prevalence of myopia shows a decline with age. Myopia has become a serious ocular problem in children because high myopia may lead to retinal damage, cataract and glaucoma. A prevention of myopia progression (PMP) will be developed and examined. This promotion program includes strategies such as a frequency following response, eye exercise, and transcutaneous electrical nerve stimulation on the prevention of myopia progression. Eye exercise defined as a computerized image led motion. The study aims to examine the effect of the implementation on the PMP.
Detailed description
This is an experimental study. A sample size of 25~40 participants from an elementary school will be recruited in the randomized controlled study.The sequential arrangement is arranged in a random manner for the participating children. A investigation of four groups will be designed for the PMP: Group 1 (frequency following response, Group 2(frequency following response,and eye exercise), Group 3 (frequency following response, eye exercise, transcutaneous electrical nerve stimulation and stimulating auricular acupoints), and Group 4, the control group. The PMP implement a 30 minute intervention two times per the investigators. Pre-test and post-test (eyeball diopter detection and Sellen's vision chart) will be carried out. The duration of each intervention is provided for two days. The washout period following next intervention is 7 days at least. After completing four intervention, the effect of the best intervention of eight the investigator will be conducted.The evaluation time of the interventions will be observed at first-time and one-month observations. A descriptive and inferential statistics by SpSS will be used for data analysis.
The investigators will apply the frequency following response, eye exercise, and transcutaneous electrical nerve stimulation on PMP among Taiwan schoolchildren. The findings of the study may provide information for promotion of visual health for schoolchildren and their parents.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| PMP group | Experimental | Other: frequency following response, eye exercise, and transcutaneouschildren received health education for eye and the intervention(which included frequency following response, eye exercise, and transcutaneous electrical nerve stimulation) a 30 minute three times per week for four weeks. |
| control group | No intervention | –children just received health education for eye |
Who may qualify
- Ages
- 6 to 13 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (5 listed)
- myopia is defined as the equivalent spherical surface degree of any one is less than or equal to -0.50D
- do not use cyclogel or atropine
- At least the eye ointment is deactivated for at least seven days
- no plastic tablets are currently used
- at least the plastic tablets are not allowed to be retired for more than seven days
Key exclusion criteria (1 listed)
- Children with current traumatic and unrecoverable other eye disease
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 |
|---|---|---|
| frequency following response, eye exercise, and transcutaneousfrequency following response, eye exercise, and TENS for 3 times per week during 4 weeks | Other | PMP group |
Primary outcome
eyeball structure
Time frame: one month detection after intervention
eyeball diopter detection
1 secondary outcome
vision check
Time frame: one month detection after intervention
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 May 2020.
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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.
Yu-Kuei Teng principal investigator
China Medical University, Taiwan
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing frequency following response, eye exercise, and transcutaneous in people with Myopia, run by China Medical University Hospital at 1 site in Taiwan.
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 5 inclusion and 1 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: status not confirmed, as of the sponsor's last update on 13 May 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Taiwan. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Yu-Kuei Teng (886-4-22053366 ext. 7132, tengyk@mail.cmu.edu.tw), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
eyeball structure (time frame: one month detection after intervention). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 13 May 2020.