The Efficacy and Safety of Periocular Acupoint Stimulation on Myopia Progression in Children

Myopia Clinical Trial

Official title:

An Integrative Medical Approach of Acupoint Stimulation for Children With Myopia : A Pilot Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02064660
• Other study ID #: blueicek
• Status: Completed
• Phase: Phase 1
• First received: February 13, 2014
• Last updated: September 2, 2015
• Start date: December 2013
• Est. completion date: December 2014

Study information

• Verified date: September 2015
• Source: Korean Medicine Hospital of Pusan National University
• Contact: n/a
• Is FDA regulated: No
• Health authority: Korea: Institutional Review Board
• Study type: Interventional

Clinical Trial Summary

Myopia is widely one of the three commonly detected refractive errors. Myopia is usually managed by correction through glasses or contact lenses. Other alternative available include surgery, drugs and acupuncture. There are various therapeutic approaches and different points can be used in acupuncture treatment for myopia, such as auricular acupuncture, acupressure body acupuncture. However, the mechanism of acupuncture therapy for myopia is largely unknown. Furthermore, little information exists regarding the effects and safety of acupuncture for degenerative myopia in children.

The investigators aimed to assess the overall effectiveness, safety of periocular acupressure for children with myopia

The hypotheses of this study are as follows:

Periocular acupressure is effective for myopia progression delay.

The study aims to include 56 participants.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 20
• Est. completion date: December 2014
• Est. primary completion date: December 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 7 Years to 12 Years

Eligibility

Inclusion Criteria:

• Aged 7-12 years

• Spherical equivalent greater than -5D

• Individuals without strabismus, anistopia

• Willingness to participate in the study

Exclusion Criteria:

• The presence of a related disease such as cataract, glaucoma, or other eye disease.

• Individuals who were received ocular or scalp trauma.

• Individuals who were received ocular surgery and had ocular wound.

• Individuals who were adapted bifocal lense.

• Individuals suffering fever or bad conditions.

• Individuals suffering systemic or neurologic disease.

• Indibiduals who were receiving other therapy during the period of study

• Individuals who did not comply with the treatment which affected myopia progression.

Study Design

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Prevention

Related Conditions & MeSH terms

• Myopia

Intervention

Device:
• massager
The patients will be doing self-stimulation using acupressure device, The acupuncture treatment will be applied two times per day for six months. Acupressure divice will stimulate for 14 minutes. Examples of acupuncture points to be used might include GB1, GB14, TE23, ST1, ST2, BL01, BL02, the Extra-point Tae-yang, In-dang.

Locations

Country	Name	City	State
Korea, Republic of	Pusan National University Korean Medicine Hospital	Yangsan	Gyeongsangnamdo

Sponsors (2)

Lead Sponsor	Collaborator
Korean Medicine Hospital of Pusan National University	Korea Institute of Oriental Medicine

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Refractive error	Change from baseline in the refractive erros will be used.	6 months	No
Secondary	Axial length	Change from baseline in the axial length will be used.	6 months	No