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

September 2, 2015 updated by: Ki-Bong, Kim, Korean Medicine Hospital of Pusan National University

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

20

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Korea, Republic of
    • Gyeongsangnamdo
      • Yangsan, Gyeongsangnamdo, Korea, Republic of, 626-770
        • Pusan National University Korean Medicine Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

7 years to 12 years (CHILD)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: PREVENTION
  • Allocation: NA
  • Interventional Model: SINGLE_GROUP
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: single arm
A series of acupressure sessions within six months from the baseline
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.
Other Names:
  • proprietary name : Nurieye-1

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Refractive error
Time Frame: 6 months
Change from baseline in the refractive erros will be used.
6 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Axial length
Time Frame: 6 months
Change from baseline in the axial length will be used.
6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Korean Medicine Hospital of Pusan National University

Collaborators

Korea Institute of Oriental Medicine

Investigators

  • Principal Investigator: Ki-bong Kim, Pusan National University Korean Medicine Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

December 1, 2013

Primary Completion (ACTUAL)

December 1, 2014

Study Completion (ACTUAL)

December 1, 2014

Study Registration Dates

First Submitted

February 13, 2014

First Submitted That Met QC Criteria

February 13, 2014

First Posted (ESTIMATE)

February 17, 2014

Study Record Updates

Last Update Posted (ESTIMATE)

September 3, 2015

Last Update Submitted That Met QC Criteria

September 2, 2015

Last Verified

September 1, 2015

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • blueicek

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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