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

NCT02064660 | Completed Phase 1 DMC

• 1 other identifier: blueicek
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

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

Keywords

Myopia; Children; Acupressure; Refractive error; Axial length; Korean medicine

Outcome Measures

Primary Outcomes (1)

• Refractive error

  Change from baseline in the refractive erros will be used.

  6 months

Secondary Outcomes (1)

• Axial length

  6 months

Study Arms (1)

single arm

EXPERIMENTAL

A series of acupressure sessions within six months from the baseline

Device: massager

Interventions

massager 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.

Also known as: proprietary name : Nurieye-1

single arm

Eligibility Criteria

• Age: 7 Years - 12 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• Aged 7-12 years
• Spherical equivalent greater than -5D
• Individuals without strabismus, anistopia
• Willingness to participate in the study

You may not qualify if:

• 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.

Sponsors & Collaborators

• Korean Medicine Hospital of Pusan National University: lead
• Korea Institute of Oriental Medicine: collaborator

Study Sites (1)

Pusan National University Korean Medicine Hospital

Yangsan, Gyeongsangnam-do, 626-770, South Korea

Location

MeSH Terms

Conditions

Myopia; Refractive Errors

Condition Hierarchy (Ancestors)

Eye Diseases

Study Officials

• Ki-bong Kim

  Pusan National University Korean Medicine Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: February 13, 2014
• First Posted: February 17, 2014
• Study Start: December 1, 2013
• Primary Completion: December 1, 2014
• Study Completion: December 1, 2014
• Last Updated: September 3, 2015

Record last verified: 2015-09

Locations

KR (1)