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

Primary Purpose

Myopia

Status
Completed
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
Chinese ocular exercise
Sponsored by
Beijing Tongren Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Myopia

Eligibility Criteria

10 Years - 16 Years (Child)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • Shi-Ming Li

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Sham Comparator

No Intervention

Arm Label

Standardized Chinese ocular exercise

Nonstandardized ocular exercise

Eye closure

Arm Description

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

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

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

Outcomes

Primary Outcome Measures

Distant and near visual acuity

Secondary Outcome Measures

Ocular accommodation

Full Information

First Posted
December 20, 2012
Last Updated
June 17, 2014
Sponsor
Beijing Tongren Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT01756287
Brief Title
Efficacy of Chinese Ocular Exercise on Visual Acuity and Ocular Accommodation in Myopic Teenager
Official Title
A Randomized Controlled Trial to Alter Ocular Accommodation in Myopic Teenager With Chinese Ocular Exercise
Study Type
Interventional

2. Study Status

Record Verification Date
June 2014
Overall Recruitment Status
Completed
Study Start Date
August 2012 (undefined)
Primary Completion Date
November 2013 (Actual)
Study Completion Date
November 2013 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Beijing Tongren Hospital

4. Oversight

Data Monitoring Committee
Yes

5. 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Myopia

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
190 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Standardized Chinese ocular exercise
Arm Type
Experimental
Arm Description
The participants are trained with standardized Chinese ocular exercise which contains accurate positions of acupuncture points and appropriate pressure on the points.
Arm Title
Nonstandardized ocular exercise
Arm Type
Sham Comparator
Arm Description
The participants are trained with nonstandardized ocular exercise performed on wrong positions where no acupuncture points at all.
Arm Title
Eye closure
Arm Type
No Intervention
Arm Description
The participants are told to close eyes and don't do ocular exercise at all.
Intervention Type
Other
Intervention Name(s)
Chinese ocular exercise
Intervention Description
A kind of massage around the acupuncture points around the eye.
Primary Outcome Measure Information:
Title
Distant and near visual acuity
Time Frame
Before and after the intervention immediately, about 5 minutes
Secondary Outcome Measure Information:
Title
Ocular accommodation
Time Frame
Before and after the intervention immediately, about 5 minutes
Other Pre-specified Outcome Measures:
Title
Self evaluation of the improvement after the intervention
Time Frame
Before and after the intervention immediately, about 5 minutes

10. Eligibility

Sex
All
Minimum Age & Unit of Time
10 Years
Maximum Age & Unit of Time
16 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: 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 Exclusion Criteria: 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ningli Wang, MD, PhD
Organizational Affiliation
Beijing Tongren Eye Center, Beijing Tongren Hospital, Capital Medical University, Beijing, China
Official's Role
Principal Investigator
Facility Information:
Facility Name
Shi-Ming Li
City
Anyang
State/Province
Henan
ZIP/Postal Code
455000
Country
China

12. IPD Sharing Statement

Citations:
PubMed Identifier
25742161
Citation
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.
Results Reference
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Efficacy of Chinese Ocular Exercise on Visual Acuity and Ocular Accommodation in Myopic Teenager

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