MyopiaNCT01756287
Efficacy of Chinese Ocular Exercise on Visual Acuity and Ocular Accommodation in Myopic Teenager
A study testing Chinese ocular exercise in people with Myopia, run by Beijing Tongren Hospital at 1 site in China.
Trial summary
To assess whether Chinese ocular exercise is effective in altering distant and near visual acuity, ocular accommodation and visual symptoms in myopic teenager, and thus might have the possibility of slowing myopia progression in teenager through a weak but long-term effect. Read more about this study
- Who is it for?
- Ages 10 to 16 yearsHealthy volunteers can take part
- Conditions the study is for
- Myopia
- What is being tested?
- Chinese ocular exercise
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 190 participants
- Where
- 1 siteChina
- Study dates
- Aug 2012to Nov 2013
- 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 10 to 16 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- Visual acuity: 20/20 or better in each eye;
- Spherical error ranging from +0.5 D to -6.0 D and astigmatism less than 1.5 D in each eye, anisometropia less than 1.0 D between the two eyes Contact lens
- No strabismus, amblyopia and any other ocular or systematic diseases that may affect refractive development
Who cannot join
- Currently using other interventions to control myopia progression (acupuncture, massage, drugs, ear needles and so on)
- Unable to cooperate with the ocular examination and questionnaire survey
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Randomized Controlled Trial to Alter Ocular Accommodation in Myopic Teenager With Chinese Ocular Exercise
To assess whether Chinese ocular exercise is effective in altering distant and near visual acuity, ocular accommodation and visual symptoms in myopic teenager, and thus might have the possibility of slowing myopia progression in teenager through a weak but long-term effect.
Read the detailed description
Myopia is a public health problem worldwide, especially in some Asian countries like China, Singapore, and Japan. Chinese ocular exercise, originating in 1963 with the theory of Traditional Chinese Medicine, is a kind of massage on acupuncture points around the eye to prevent myopia and alleviate visual fatigue. The exercise has been spread as a community ritual and living habit of primary and high school students for nearly half a century. However, the prevalence of myopia in Chinese children increased remarkably in recent years. Therefore, the efficacy of Chinese ocular exercise on preventing myopia or alleviating visual fatigue is widely questioned. Evidence from clinical trials of high level is needed to clarify that whether Chinese ocular exercise is effective in slowing and preventing myopia progression, or at least in part in easing the symptoms related to myopia and visual fatigue.
- Conditions
- Myopia
- Being tested
- Chinese ocular exercise
- Medical subject headings
- Myopia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Chinese ocular exerciseOther
A kind of massage around the acupuncture points around the eye.
| Study group | Role | What they receive |
|---|---|---|
| Standardized Chinese ocular exercise | Experimental | The participants are trained with standardized Chinese ocular exercise which contains accurate positions of acupuncture points and appropriate pressure on the points. Receives: Other: Chinese ocular exercise |
| Nonstandardized ocular exercise | Sham comparator | The participants are trained with nonstandardized ocular exercise performed on wrong positions where no acupuncture points at all. Receives: Other: Chinese ocular exercise |
| Eye closure | No intervention | The participants are told to close eyes and don't do ocular exercise at all. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Distant and near visual acuity
Measured: Before and after the intervention immediately, about 5 minutes
Secondary outcomes (1)
Ocular accommodation
Measured: Before and after the intervention immediately, about 5 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Dec 2012 (estimated)
- Study startAug 2012
- Primary completionNov 2013
- Study completionNov 2013
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 MyopiaStudies of the same condition, open and under way.
- More trials run by Beijing Tongren 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, Investigator, Outcomes assessor
- Enrolment
- 190 participants (actual)
Sponsor and investigators
- Lead sponsor
- Beijing Tongren Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Shi-Ming Li, Beijing Tongren Hospital
- Investigators
- Ningli Wang, MD, PhD, Principal investigator, Beijing Tongren Eye Center, Beijing Tongren Hospital, Capital Medical University, Beijing, China
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01756287
- Sponsor's protocol ID
- 2011CB504601
- Status last verified
- Jun 2014
- First submitted
- 20 Dec 2012
- Last updated
- 18 Jun 2014
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Li SM, Kang MT, Peng XX, Li SY, Wang Y, Li L, Yu J, Qiu LX, Sun YY, Liu LR, Li H, Sun X, Millodot M, Wang N. Efficacy of Chinese eye exercises on reducing accommodative lag in school-aged children: a randomized controlled trial. PLoS One. 2015 Mar 5;10(3):e0117552. doi: 10.1371/journal.pone.0117552. eCollection 2015.
PubMed 25742161
Study at a glance
From the registry record, last updated by the sponsor on 18 Jun 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized Controlled Trial to Alter Ocular Accommodation in Myopic Teenager With Chinese Ocular Exercise
- ClinicalTrials.gov ID
- NCT01756287
- Acronym / sponsor ID
- 2011CB504601
- Conditions
- Myopia
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 190 participants (actual)
- Lead sponsor
- Beijing Tongren HospitalUniversity, hospital or other
- Study start
- Aug 2012
- Primary completion
- Nov 2013 (actual)
- Study completion
- Nov 2013 (actual)
- First posted
- 25 Dec 2012 (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.
To assess whether Chinese ocular exercise is effective in altering distant and near visual acuity, ocular accommodation and visual symptoms in myopic teenager, and thus might have the possibility of slowing myopia progression in teenager through a weak but long-term effect.
Detailed description
Myopia is a public health problem worldwide, especially in some Asian countries like China, Singapore, and Japan. Chinese ocular exercise, originating in 1963 with the theory of Traditional Chinese Medicine, is a kind of massage on acupuncture points around the eye to prevent myopia and alleviate visual fatigue. The exercise has been spread as a community ritual and living habit of primary and high school students for nearly half a century. However, the prevalence of myopia in Chinese children increased remarkably in recent years. Therefore, the efficacy of Chinese ocular exercise on preventing myopia or alleviating visual fatigue is widely questioned. Evidence from clinical trials of high level is needed to clarify that whether Chinese ocular exercise is effective in slowing and preventing myopia progression, or at least in part in easing the symptoms related to myopia and visual fatigue.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Standardized Chinese ocular exercise | Experimental | Other: Chinese ocular exerciseThe participants are trained with standardized Chinese ocular exercise which contains accurate positions of acupuncture points and appropriate pressure on the points. |
| Nonstandardized ocular exercise | Sham comparator | Other: Chinese ocular exerciseThe participants are trained with nonstandardized ocular exercise performed on wrong positions where no acupuncture points at all. |
| Eye closure | No intervention | –The participants are told to close eyes and don't do ocular exercise at all. |
Who may qualify
- Ages
- 10 to 16 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (3 listed)
- Visual acuity: 20/20 or better in each eye;
- Spherical error ranging from +0.5 D to -6.0 D and astigmatism less than 1.5 D in each eye, anisometropia less than 1.0 D between the two eyes Contact lens
- No strabismus, amblyopia and any other ocular or systematic diseases that may affect refractive development
Key exclusion criteria (2 listed)
- Currently using other interventions to control myopia progression (acupuncture, massage, drugs, ear needles and so on)
- Unable to cooperate with the ocular examination and questionnaire survey
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 |
|---|---|---|
| Chinese ocular exerciseA kind of massage around the acupuncture points around the eye. | Other | Nonstandardized ocular exercise, Standardized Chinese ocular exercise |
Primary outcome
Distant and near visual acuity
Time frame: Before and after the intervention immediately, about 5 minutes
1 secondary outcome
Ocular accommodation
Time frame: Before and after the intervention immediately, about 5 minutes
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 18 Jun 2014.
- Derived from this study: PubMed 25742161Li SM, Kang MT, Peng XX, Li SY, Wang Y, Li L, Yu J, Qiu LX, Sun YY, Liu LR, Li H, Sun X, Millodot M, Wang N. Efficacy of Chinese eye exercises on reducing accommodative lag in school-aged children: a randomized controlled trial. PLoS One. 2015 Mar 5;10(3):e0117552. doi: 10.1371/journal.pone.0117552. eCollection 2015.
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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.
Ningli Wang, MD, PhD principal investigator
Beijing Tongren Eye Center, Beijing Tongren Hospital, Capital Medical University, Beijing, China
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Chinese ocular exercise in people with Myopia, run by Beijing Tongren Hospital at 1 site in China.
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 18 Jun 2014. 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 China. 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. Some participants in this study may receive a placebo. 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?
Distant and near visual acuity (time frame: Before and after the intervention immediately, about 5 minutes). 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 NCT01756287, 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 18 Jun 2014.