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

Phase 1

Completed

• Conditions: Myopia
• Interventions: Device: massager

• Registration Number: NCT02064660
• Lead Sponsor: Korean Medicine Hospital of Pusan National University

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2013-12
• Study First Submitted: 2014-02-13
• Study First Submitted QC: 2014-02-13
• Study First Posted: 2014-02-17
• Primary Completion: 2014-12
• Study Completion: 2014-12
• Status Verified: 2015-09
• Last Update Submitted: 2015-09-02
• Last Update Posted: 2015-09-03

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 20

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
single arm	massager	A series of acupressure sessions within six months from the baseline

Primary Outcome Measures

Name	Time	Method
Refractive error	6 months	Change from baseline in the refractive erros will be used.

Secondary Outcome Measures

Name	Time	Method
Axial length	6 months	Change from baseline in the axial length will be used.

Trial Locations

Locations (1)

Pusan National University Korean Medicine Hospital; 🇰🇷 Yangsan, Gyeongsangnamdo, Korea, Republic of