MyopiaPhase 1NCT02064660
The Efficacy and Safety of Periocular Acupoint Stimulation on Myopia Progression in Children
A Phase 1 study testing massager in people with Myopia, run by Korean Medicine Hospital of Pusan National University at 1 site in South Korea.
Trial summary
Myopia is widely one of the three commonly detected refractive errors. Myopia is usually managed by correction through glasses or contact lenses. Other alternative available include surgery, drugs and acupuncture. Read more about this study
- Who is it for?
- Ages 7 to 12 years
- Conditions the study is for
- Myopia
- What is being tested?
- massager
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteSouth Korea
- Study dates
- Dec 2013to Dec 2014
- Phase
- Phase 1
- 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 7 to 12 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Aged 7-12 years
- Spherical equivalent greater than -5D
- Individuals without strabismus, anistopia
- Willingness to participate in the study
Who cannot join
- The presence of a related disease such as cataract, glaucoma, or other eye disease.
- Individuals who were received ocular or scalp trauma.
- Individuals who were received ocular surgery and had ocular wound.
- Individuals who were adapted bifocal lense.
- Individuals suffering fever or bad conditions.
- Individuals suffering systemic or neurologic disease.
- Indibiduals who were receiving other therapy during the period of study
- Individuals who did not comply with the treatment which affected myopia progression.
Trial locations and contacts
1 site in 1 country.
South Korea1 site
Pusan National University Korean Medicine Hospital
Yangsan, Gyeongsangnam-do, 626-770
About this study
Official title: An Integrative Medical Approach of Acupoint Stimulation for Children With Myopia : A Pilot Study
Myopia is widely one of the three commonly detected refractive errors. Myopia is usually managed by correction through glasses or contact lenses. Other alternative available include surgery, drugs and acupuncture. There are various therapeutic approaches and different points can be used in acupuncture treatment for myopia, such as auricular acupuncture, acupressure body acupuncture. However, the mechanism of acupuncture therapy for myopia is largely unknown. Furthermore, little information exists regarding the effects and safety of acupuncture for degenerative myopia in children.
The investigators aimed to assess the overall effectiveness, safety of periocular acupressure for children with myopia
Read more
The hypotheses of this study are as follows:
Periocular acupressure is effective for myopia progression delay.
The study aims to include 56 participants.
- Conditions
- Myopia
- Being tested
- massager
- Keywords
- Myopia, Children, Acupressure, Refractive error, Axial length, Korean medicine
- Medical subject headings
- Myopia, Refractive Errors
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
massagerDevice
Also called proprietary name : Nurieye-1
The patients will be doing self-stimulation using acupressure device, The acupuncture treatment will be applied two times per day for six months. Acupressure divice will stimulate for 14 minutes. Examples of acupuncture points to be used might include GB1, GB14, TE23, ST1, ST2, BL01, BL02, the Extra-point Tae-yang, In-dang.
| Study group | Role | What they receive |
|---|---|---|
| single arm | Experimental | A series of acupressure sessions within six months from the baseline Receives: Device: massager |
What is being measured
The primary outcome is the main question the study is designed to answer.
Refractive error
Change from baseline in the refractive erros will be used.
Measured: 6 months
Secondary outcomes (1)
Axial length
Change from baseline in the axial length will be used.
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Feb 2014 (estimated)
- Study startDec 2013
- Primary completionDec 2014
- Study completionDec 2014
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.
- 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 1
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Korean Medicine Hospital of Pusan National University
- Sponsor type
- University, hospital or other
- Collaborators
- Korea Institute of Oriental Medicine
- Responsible party
- Principal investigator, Ki-Bong, Kim, Korean Medicine Hospital of Pusan National University
- Investigators
- Ki-bong Kim, Principal investigator, Pusan National University Korean Medicine Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02064660
- Sponsor's protocol ID
- blueicek
- Status last verified
- Sep 2015
- First submitted
- 13 Feb 2014
- Last updated
- 3 Sep 2015
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 3 Sep 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Integrative Medical Approach of Acupoint Stimulation for Children With Myopia : A Pilot Study
- ClinicalTrials.gov ID
- NCT02064660
- Acronym / sponsor ID
- blueicek
- Conditions
- Myopia
- Keywords
- Myopia, Children, Acupressure, Refractive error, Axial length, Korean medicine
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Korean Medicine Hospital of Pusan National UniversityUniversity, hospital or other
- Collaborators
- Korea Institute of Oriental Medicine
- Study start
- Dec 2013
- Primary completion
- Dec 2014 (actual)
- Study completion
- Dec 2014 (actual)
- First posted
- 17 Feb 2014 (estimated)
- 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.
Myopia is widely one of the three commonly detected refractive errors. Myopia is usually managed by correction through glasses or contact lenses. Other alternative available include surgery, drugs and acupuncture. There are various therapeutic approaches and different points can be used in acupuncture treatment for myopia, such as auricular acupuncture, acupressure body acupuncture. However, the mechanism of acupuncture therapy for myopia is largely unknown. Furthermore, little information exists regarding the effects and safety of acupuncture for degenerative myopia in children.
The investigators aimed to assess the overall effectiveness, safety of periocular acupressure for children with myopia
The hypotheses of this study are as follows:
Periocular acupressure is effective for myopia progression delay.
The study aims to include 56 participants.
Study design
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| single arm | Experimental | Device: massagerA series of acupressure sessions within six months from the baseline |
Who may qualify
- Ages
- 7 to 12 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (4 listed)
- Aged 7-12 years
- Spherical equivalent greater than -5D
- Individuals without strabismus, anistopia
- Willingness to participate in the study
Key exclusion criteria (8 listed)
- The presence of a related disease such as cataract, glaucoma, or other eye disease.
- Individuals who were received ocular or scalp trauma.
- Individuals who were received ocular surgery and had ocular wound.
- Individuals who were adapted bifocal lense.
- Individuals suffering fever or bad conditions.
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 |
|---|---|---|
| massagerAlso: proprietary name : Nurieye-1The patients will be doing self-stimulation using acupressure device, The acupuncture treatment will be applied two times per day for six months. Acupressure divice will stimulate for 14 minutes. Examples of acupuncture points to be used might include GB1, GB14, TE23, ST1, ST2, BL01, BL02, the Extra-point Tae-yang, In-dang. | Device | single arm |
Primary outcome
Refractive error
Time frame: 6 months
Change from baseline in the refractive erros will be used.
1 secondary outcome
Axial length
Time frame: 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 3 Sep 2015.
Related trials for Myopia
Recruiting
Managing Premyopia in Chinese Children Using Artificial Intelligence Assisted Defocus Incorporated Multiple Segments Based Spectacle Lens: a Randomized Controlled Clinical Trial
Pre-myopia, Myopia
Not yet recruiting
BRIGHT-LIGHT: Studying Red Light Therapy for Severe Short-Sightedness or Short-Sightedness That Worsens Despite Standard Treatment
Myopia, Myopia Progressing
Not yet recruiting
Clinical Performance and Outcomes After Toric Lens Transition
Astigmatism
Active, not recruiting
Effect of IOP Lowering on Progressive HM
High Myopia, Intraocular Pressure
Recruiting
Evaluation of a New Laser Refractive Vision Correction Using the TENEO™ 317 Model 2
Hyperopia and Myopia
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.
Ki-bong Kim principal investigator
Pusan National University Korean Medicine Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing massager in people with Myopia, run by Korean Medicine Hospital of Pusan National University at 1 site in South Korea.
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 4 inclusion and 8 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 3 Sep 2015. 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 South Korea. 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.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
Refractive error (time frame: 6 months). 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 3 Sep 2015.