MyopiaPhase 1NCT00457717
Myopia Control by Combining Auricular Acupoint and Atropine Eyedrops
A Phase 1 study testing 0.25 % atropine, 0.5 % atropine and 0.25 % atropine+auricular acupoints in people with Myopia, run by China Medical University, China at 1 site in Taiwan.
Trial summary
This study was designed to compare the difference of using atropine eyedrops alone from atropine combined with the stimulation of auricular acupoints therapy in reducing myopia progression. Read more about this study
- Who is it for?
- Ages 6 to 15 years
- Conditions the study is for
- Myopia
- What is being tested?
- 0.25 % atropine, 0.5 % atropine and 0.25 % atropine+auricular acupoints
- Type of treatment
- Surgery or procedure
- How many people
- 60 participants
- Where
- 1 siteTaiwan
- Study dates
- Jul 2005to Jul 2006
- 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 6 to 15 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- all included patients, age from 6 to 15 years, had myopia (spherical equivalent > -0.5 D) after cycloplegic refraction,
- The astigmatism and anisometropia were less than 2.0 D,
- IOP was less than 21 mmHg.
Who cannot join
- the presence of related disease such as infection, ulceration, eyelid disease, ocular and auricular disorders,
- individuals with amblyopia or strabismus,
- individuals received any other therapies in the period of study,
- individuals suffering some sort of haemostasis disorder,
- individuals did not follow the treatment (eyedrops and/or stimulation of auricular acupoints) over seven days
Trial locations and contacts
1 site in 1 country.
About this study
This study was designed to compare the difference of using atropine eyedrops alone from atropine combined with the stimulation of auricular acupoints therapy in reducing myopia progression.
Read the detailed description
A total of 64 school-aged children with myopia, fulfilling eligibility criteria, were recruited. They were randomly assigned to three arms:
- 21 treated with the 0.25 % atropine each night (0.25A).
- 20 treated with the 0.5 % atropine each night (0.5A).
- 23 treated with 0.25 % atropine each night together with stimulation of auricular acupoints(0.25A+E).
This protocol was proceeded for at least 6 months.The differences in post-treatment effects of these three groups were statistically accessed.
- Conditions
- Myopia
- Being tested
- 0.25 % atropine, 0.5 % atropine, 0.25 % atropine+auricular acupoints
- Keywords
- myopia, auricular acupoint, atropine, RCT
- Medical subject headings
- Myopia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
0.25 % atropineDrug
0.5 % atropineDrug
0.25 % atropine+auricular acupointsProcedure or surgery
What is being measured
The primary outcome is the main question the study is designed to answer.
the progression of myopia degree, axial length elongation of eye
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Apr 2007 (estimated)
- Study startJul 2005
- Study completionJul 2006
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)Papers the sponsor has linked to this study.
- 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Enrolment
- 60 participants
Sponsor and investigators
- Lead sponsor
- China Medical University, China
- Sponsor type
- University, hospital or other
- Investigators
- Shih-Liang Chang, PhD, Principal investigator, China Medical University, Taiwan
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00457717
- Sponsor's protocol ID
- DMR94-IRB-49
- Status last verified
- Apr 2007
- First submitted
- 5 Apr 2007
- Last updated
- 6 Apr 2007
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Goss DA. Attempts to reduce the rate of increase of myopia in young people--a critical literature review. Am J Optom Physiol Opt. 1982 Oct;59(10):828-41. doi: 10.1097/00006324-198210000-00010.
PubMed 7148977Lin LL, Shih YF, Hsiao CK, Chen CJ. Prevalence of myopia in Taiwanese schoolchildren: 1983 to 2000. Ann Acad Med Singap. 2004 Jan;33(1):27-33.
PubMed 15008558Saw SM, Shih-Yen EC, Koh A, Tan D. Interventions to retard myopia progression in children: an evidence-based update. Ophthalmology. 2002 Mar;109(3):415-21; discussion 422-4; quiz 425-6, 443. doi: 10.1016/s0161-6420(01)00972-1.
PubMed 11874738Shih YF, Chen CH, Chou AC, Ho TC, Lin LL, Hung PT. Effects of different concentrations of atropine on controlling myopia in myopic children. J Ocul Pharmacol Ther. 1999 Feb;15(1):85-90. doi: 10.1089/jop.1999.15.85.
PubMed 10048351Chen MC. 112 cases of juvenile myopia treated by auricular acupressure. J Tradit Chin Med. 1989 Sep;9(3):173. No abstract available.
PubMed 2615447Liang CK, Ho TY, Li TC, Hsu WM, Li TM, Lee YC, Ho WJ, Cheng JT, Tzeng CY, Liu IT, Chang SL. A combined therapy using stimulating auricular acupoints enhances lower-level atropine eyedrops when used for myopia control in school-aged children evaluated by a pilot randomized controlled clinical trial. Complement Ther Med. 2008 Dec;16(6):305-10. doi: 10.1016/j.ctim.2008.04.007. Epub 2008 May 29.
PubMed 19028329
Study at a glance
From the registry record, last updated by the sponsor on 6 Apr 2007. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Myopia Control by Combining Auricular Acupoint and Atropine Eyedrops
- ClinicalTrials.gov ID
- NCT00457717
- Acronym / sponsor ID
- DMR94-IRB-49
- Conditions
- Myopia
- Keywords
- myopia, auricular acupoint, atropine, RCT
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants
- Lead sponsor
- China Medical University, ChinaUniversity, hospital or other
- Study start
- Jul 2005
- Study completion
- Jul 2006 (actual)
- First posted
- 6 Apr 2007 (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.
This study was designed to compare the difference of using atropine eyedrops alone from atropine combined with the stimulation of auricular acupoints therapy in reducing myopia progression.
Detailed description
A total of 64 school-aged children with myopia, fulfilling eligibility criteria, were recruited. They were randomly assigned to three arms:
- 21 treated with the 0.25 % atropine each night (0.25A).
- 20 treated with the 0.5 % atropine each night (0.5A).
- 23 treated with 0.25 % atropine each night together with stimulation of auricular acupoints(0.25A+E).
This protocol was proceeded for at least 6 months.The differences in post-treatment effects of these three groups were statistically accessed.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
Who may qualify
- Ages
- 6 to 15 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (3 listed)
- all included patients, age from 6 to 15 years, had myopia (spherical equivalent > -0.5 D) after cycloplegic refraction,
- The astigmatism and anisometropia were less than 2.0 D,
- IOP was less than 21 mmHg.
Key exclusion criteria (5 listed)
- the presence of related disease such as infection, ulceration, eyelid disease, ocular and auricular disorders,
- individuals with amblyopia or strabismus,
- individuals received any other therapies in the period of study,
- individuals suffering some sort of haemostasis disorder,
- individuals did not follow the treatment (eyedrops and/or stimulation of auricular acupoints) over seven days
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 |
|---|---|---|
| 0.25 % atropine | Drug | – |
| 0.5 % atropine | Drug | – |
| 0.25 % atropine+auricular acupoints | Procedure or surgery | – |
Primary outcome
the progression of myopia degree, axial length elongation of eye
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 6 Apr 2007.
- Background: PubMed 7148977Goss DA. Attempts to reduce the rate of increase of myopia in young people--a critical literature review. Am J Optom Physiol Opt. 1982 Oct;59(10):828-41. doi: 10.1097/00006324-198210000-00010.
- Background: PubMed 15008558Lin LL, Shih YF, Hsiao CK, Chen CJ. Prevalence of myopia in Taiwanese schoolchildren: 1983 to 2000. Ann Acad Med Singap. 2004 Jan;33(1):27-33.
- Background: PubMed 11874738Saw SM, Shih-Yen EC, Koh A, Tan D. Interventions to retard myopia progression in children: an evidence-based update. Ophthalmology. 2002 Mar;109(3):415-21; discussion 422-4; quiz 425-6, 443. doi: 10.1016/s0161-6420(01)00972-1.
- Results publication: PubMed 10048351Shih YF, Chen CH, Chou AC, Ho TC, Lin LL, Hung PT. Effects of different concentrations of atropine on controlling myopia in myopic children. J Ocul Pharmacol Ther. 1999 Feb;15(1):85-90. doi: 10.1089/jop.1999.15.85.
- Results publication: PubMed 2615447Chen MC. 112 cases of juvenile myopia treated by auricular acupressure. J Tradit Chin Med. 1989 Sep;9(3):173. No abstract available.
- Derived from this study: PubMed 19028329Liang CK, Ho TY, Li TC, Hsu WM, Li TM, Lee YC, Ho WJ, Cheng JT, Tzeng CY, Liu IT, Chang SL. A combined therapy using stimulating auricular acupoints enhances lower-level atropine eyedrops when used for myopia control in school-aged children evaluated by a pilot randomized controlled clinical trial. Complement Ther Med. 2008 Dec;16(6):305-10. doi: 10.1016/j.ctim.2008.04.007. Epub 2008 May 29.
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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.
Shih-Liang Chang, PhD 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 Phase 1 study testing 0.25 % atropine, 0.5 % atropine and 0.25 % atropine+auricular acupoints in people with Myopia, run by China Medical University, China 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 3 inclusion and 5 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 6 Apr 2007. 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.
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?
the progression of myopia degree, axial length elongation of eye. 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 NCT00457717, which also lists 6 linked publications.
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 6 Apr 2007.