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

Primary Purpose

Myopia

Status
Completed
Phase
Phase 1
Locations
Korea, Republic of
Study Type
Interventional
Intervention
massager
Sponsored by
Korean Medicine Hospital of Pusan National University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Myopia focused on measuring Myopia, Children, Acupressure, Refractive error, Axial length, Korean medicine

Eligibility Criteria

7 Years - 12 Years (Child)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Pusan National University Korean Medicine Hospital

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

single arm

Arm Description

A series of acupressure sessions within six months from the baseline

Outcomes

Primary Outcome Measures

Refractive error
Change from baseline in the refractive erros will be used.

Secondary Outcome Measures

Axial length
Change from baseline in the axial length will be used.

Full Information

First Posted
February 13, 2014
Last Updated
September 2, 2015
Sponsor
Korean Medicine Hospital of Pusan National University
Collaborators
Korea Institute of Oriental Medicine
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1. Study Identification

Unique Protocol Identification Number
NCT02064660
Brief Title
The Efficacy and Safety of Periocular Acupoint Stimulation on Myopia Progression in Children
Official Title
An Integrative Medical Approach of Acupoint Stimulation for Children With Myopia : A Pilot Study
Study Type
Interventional

2. Study Status

Record Verification Date
September 2015
Overall Recruitment Status
Completed
Study Start Date
December 2013 (undefined)
Primary Completion Date
December 2014 (Actual)
Study Completion Date
December 2014 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Korean Medicine Hospital of Pusan National University
Collaborators
Korea Institute of Oriental Medicine

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Myopia
Keywords
Myopia, Children, Acupressure, Refractive error, Axial length, Korean medicine

7. Study Design

Primary Purpose
Prevention
Study Phase
Phase 1
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
20 (Actual)

8. Arms, Groups, and Interventions

Arm Title
single arm
Arm Type
Experimental
Arm Description
A series of acupressure sessions within six months from the baseline
Intervention Type
Device
Intervention Name(s)
massager
Other Intervention Name(s)
proprietary name : Nurieye-1
Intervention Description
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.
Primary Outcome Measure Information:
Title
Refractive error
Description
Change from baseline in the refractive erros will be used.
Time Frame
6 months
Secondary Outcome Measure Information:
Title
Axial length
Description
Change from baseline in the axial length will be used.
Time Frame
6 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
7 Years
Maximum Age & Unit of Time
12 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ki-bong Kim
Organizational Affiliation
Pusan National University Korean Medicine Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Pusan National University Korean Medicine Hospital
City
Yangsan
State/Province
Gyeongsangnamdo
ZIP/Postal Code
626-770
Country
Korea, Republic of

12. IPD Sharing Statement

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

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