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

NCT ID: NCT02064660

Last Updated: 2015-09-03

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 20 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2013-12-31
• Study Completion Date: 2014-12-31

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.

Conditions

Myopia

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: PREVENTION
• Blinding Strategy: NONE

Study Groups

single arm

A series of acupressure sessions within six months from the baseline

Group Type: EXPERIMENTAL

massager

Intervention Type: DEVICE

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.

Interventions

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.

Intervention Type: DEVICE

Other Intervention Names

proprietary name : Nurieye-1

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.

• Minimum Eligible Age: 7 Years
• Maximum Eligible Age: 12 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Korea Institute of Oriental Medicine

OTHER_GOV

Sponsor Role: collaborator

Korean Medicine Hospital of Pusan National University

OTHER

Sponsor Role: lead

Responsible Party

Ki-Bong, Kim

Assistant Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Ki-bong Kim

Role: PRINCIPAL_INVESTIGATOR

Pusan National University Korean Medicine Hospital

Locations

Pusan National University Korean Medicine Hospital

Yangsan, Gyeongsangnam-do, South Korea

Countries

South Korea

Other Identifiers

blueicek

Identifier Type: -

Identifier Source: org_study_id