Efficacy of Chinese Ocular Exercise on Visual Acuity and Ocular Accommodation in Myopic Teenager

NCT ID: NCT01756287

Last Updated: 2014-06-18

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

190 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-08-31

Study Completion Date

2013-11-30

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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

See the medical conditions and disease areas that this research is targeting or investigating.

Myopia

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Investigators Outcome Assessors

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Standardized Chinese ocular exercise

The participants are trained with standardized Chinese ocular exercise which contains accurate positions of acupuncture points and appropriate pressure on the points.

Group Type EXPERIMENTAL

Chinese ocular exercise

Intervention Type OTHER

A kind of massage around the acupuncture points around the eye.

Nonstandardized ocular exercise

The participants are trained with nonstandardized ocular exercise performed on wrong positions where no acupuncture points at all.

Group Type SHAM_COMPARATOR

Chinese ocular exercise

Intervention Type OTHER

A kind of massage around the acupuncture points around the eye.

Eye closure

The participants are told to close eyes and don't do ocular exercise at all.

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Chinese ocular exercise

A kind of massage around the acupuncture points around the eye.

Intervention Type OTHER

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

1. Visual acuity: 20/20 or better in each eye;
2. 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
3. No strabismus, amblyopia and any other ocular or systematic diseases that may affect refractive development

Exclusion Criteria

1. Currently using other interventions to control myopia progression (acupuncture, massage, drugs, ear needles and so on)
2. Unable to cooperate with the ocular examination and questionnaire survey
Minimum Eligible Age

10 Years

Maximum Eligible Age

16 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Beijing Tongren Hospital

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Shi-Ming Li

Dr.

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Ningli Wang, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Beijing Tongren Eye Center, Beijing Tongren Hospital, Capital Medical University, Beijing, China

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Shi-Ming Li

Anyang, Henan, China

Site Status

Countries

Review the countries where the study has at least one active or historical site.

China

References

Explore related publications, articles, or registry entries linked to this study.

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.

Reference Type DERIVED
PMID: 25742161 (View on PubMed)

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

2011CB504601

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.

Myopia Prevention With Reading Glasses
NCT05030103 NOT_YET_RECRUITING NA