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

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ClinicalTrials.gov Identifier: NCT01756287
Recruitment Status : Completed
First Posted : December 25, 2012
Last Update Posted : June 18, 2014
Sponsor:
Information provided by (Responsible Party):

Study Description
Brief 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.

Condition or disease Intervention/treatment
Myopia Other: Chinese ocular exercise

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

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 190 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Randomized Controlled Trial to Alter Ocular Accommodation in Myopic Teenager With Chinese Ocular Exercise
Study Start Date : August 2012
Primary Completion Date : November 2013
Study Completion Date : November 2013

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U.S. FDA Resources

Arms and Interventions

Arm Intervention/treatment
Experimental: 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.
Other: Chinese ocular exercise
A kind of massage around the acupuncture points around the eye.
Sham Comparator: Nonstandardized ocular exercise
The participants are trained with nonstandardized ocular exercise performed on wrong positions where no acupuncture points at all.
Other: Chinese ocular exercise
A kind of massage around the acupuncture points around the eye.
No Intervention: Eye closure
The participants are told to close eyes and don't do ocular exercise at all.


Outcome Measures

Primary Outcome Measures :
  1. Distant and near visual acuity [ Time Frame: Before and after the intervention immediately, about 5 minutes ]

Secondary Outcome Measures :
  1. Ocular accommodation [ Time Frame: Before and after the intervention immediately, about 5 minutes ]

Other Outcome Measures:
  1. Self evaluation of the improvement after the intervention [ Time Frame: Before and after the intervention immediately, about 5 minutes ]

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   10 Years to 16 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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
Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01756287


Locations
China, Henan
Shi-Ming Li
Anyang, Henan, China, 455000
Sponsors and Collaborators
Beijing Tongren Hospital
Investigators
Principal Investigator: Ningli Wang, MD, PhD Beijing Tongren Eye Center, Beijing Tongren Hospital, Capital Medical University, Beijing, China
More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Shi-Ming Li, Dr., Beijing Tongren Hospital
ClinicalTrials.gov Identifier: NCT01756287     History of Changes
Other Study ID Numbers: 2011CB504601
First Posted: December 25, 2012    Key Record Dates
Last Update Posted: June 18, 2014
Last Verified: June 2014