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

Myopia Clinical Trial

Official title:

A Randomized Controlled Trial to Alter Ocular Accommodation in Myopic Teenager With Chinese Ocular Exercise

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01756287
• Other study ID #: 2011CB504601
• Status: Completed
• Phase: N/A
• First received: December 20, 2012
• Last updated: June 17, 2014
• Start date: August 2012
• Est. completion date: November 2013

Study information

• Verified date: June 2014
• Source: Beijing Tongren Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: China: Ministry of Science and Technology
• Study type: Interventional

Clinical 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 190
• Est. completion date: November 2013
• Est. primary completion date: November 2013
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 10 Years to 16 Years

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Myopia

Intervention

Other:
• Chinese ocular exercise
A kind of massage around the acupuncture points around the eye.

Locations

Country	Name	City	State
China	Shi-Ming Li	Anyang	Henan

Sponsors (1)

Lead Sponsor	Collaborator
Beijing Tongren Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Self evaluation of the improvement after the intervention		Before and after the intervention immediately, about 5 minutes	No
Primary	Distant and near visual acuity		Before and after the intervention immediately, about 5 minutes	No
Secondary	Ocular accommodation		Before and after the intervention immediately, about 5 minutes	No