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Myopia Control by Combining Auricular Acupoint and Atropine Eyedrops

C

China Medical University, China

Status and phase

Completed
Phase 1

Conditions

Myopia

Treatments

Drug: 0.5 % atropine
Drug: 0.25 % atropine
Procedure: 0.25 % atropine+auricular acupoints

Study type

Interventional

Funder types

Other

Identifiers

NCT00457717
DMR94-IRB-49

Details and patient eligibility

About

This study was designed to compare the difference of using atropine eyedrops alone from atropine combined with the stimulation of auricular acupoints therapy in reducing myopia progression.

Full description

A total of 64 school-aged children with myopia, fulfilling eligibility criteria, were recruited. They were randomly assigned to three arms:

  1. 21 treated with the 0.25 % atropine each night (0.25A).
  2. 20 treated with the 0.5 % atropine each night (0.5A).
  3. 23 treated with 0.25 % atropine each night together with stimulation of auricular acupoints(0.25A+E).

This protocol was proceeded for at least 6 months.The differences in post-treatment effects of these three groups were statistically accessed.

Sex

All

Ages

6 to 15 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

  • all included patients, age from 6 to 15 years, had myopia (spherical equivalent > -0.5 D) after cycloplegic refraction,
  • The astigmatism and anisometropia were less than 2.0 D,
  • IOP was less than 21 mmHg.

Exclusion criteria

  • the presence of related disease such as infection, ulceration, eyelid disease, ocular and auricular disorders,
  • individuals with amblyopia or strabismus,
  • individuals received any other therapies in the period of study,
  • individuals suffering some sort of haemostasis disorder,
  • individuals did not follow the treatment (eyedrops and/or stimulation of auricular acupoints) over seven days

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Single Blind

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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