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OpenTrials
Completed

NCT Number: NCT02064660

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

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.

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Key information

Conditions

Myopia Eye Diseases Refractive Errors

Age range

7 year–12 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Pusan National University Korean Medicine Hospital

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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.

Other names: proprietary name : Nurieye-1

Primary outcomes

  1. Refractive error

    Time frame: 6 months

    Change from baseline in the refractive erros will be used.

Secondary outcomes

  1. Axial length

    Time frame: 6 months

    Change from baseline in the axial length will be used.

Sponsors and collaborators

Lead sponsor

Korean Medicine Hospital of Pusan National University

Other

Collaborators

  • Korea Institute of Oriental Medicine

Registry information

Official study title

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

Important dates

Study start
2013
Primary completion
2014
Study completion
2014
First posted
Feb 17, 2014
Registry last updated
Sep 3, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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