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

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.

Study Overview

• Status: Completed
• Conditions: Myopia
• Intervention / Treatment: 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 Type: Interventional
• Enrollment (Actual): 190
• Phase: Not Applicable

Contacts and Locations

Study Locations

• China
  • Henan
    • Anyang, Henan, China, 455000
      • Shi-Ming Li

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 10 years to 16 years (CHILD)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: TRIPLE

Number of Arms

3

Arms and Interventions

Participant Group / 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Distant and near visual acuity	Before and after the intervention immediately, about 5 minutes

Secondary Outcome Measures

Outcome Measure	Time Frame
Ocular accommodation	Before and after the intervention immediately, about 5 minutes

Other Outcome Measures

Outcome Measure	Time Frame
Self evaluation of the improvement after the intervention	Before and after the intervention immediately, about 5 minutes

Collaborators and Investigators

• Sponsor: Beijing Tongren Hospital
• Investigators: Principal Investigator: Ningli Wang, MD, PhD, Beijing Tongren Eye Center, Beijing Tongren Hospital, Capital Medical University, Beijing, China

Publications and helpful links

General 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.

Study record dates

Study Major Dates

• Study Start: August 1, 2012
• Primary Completion (ACTUAL): November 1, 2013
• Study Completion (ACTUAL): November 1, 2013

Study Registration Dates

• First Submitted: December 20, 2012
• First Submitted That Met QC Criteria: December 20, 2012
• First Posted (ESTIMATE): December 25, 2012

Study Record Updates

• Last Update Posted (ESTIMATE): June 18, 2014
• Last Update Submitted That Met QC Criteria: June 17, 2014
• Last Verified: June 1, 2014

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Eye Diseases; Refractive Errors; Myopia
• Other Study ID Numbers: 2011CB504601