The Effect and Safety of Different Doses of Atropine on Myopic Progression of Highly Myopic Children: Multi-centered Randomized Clinical Trial

Last updated: March 10, 2026
Sponsor: Shanghai Eye Disease Prevention and Treatment Center
Overall Status: Completed

Phase

N/A

Condition

Myopia

Treatment

Atropine

Clinical Study ID

NCT04699357
SHDC12019111
  • Ages 6-12
  • All Genders

Study Summary

Objective: to evaluate the efficacy of different concentrations of atropine eye drops in controlling the progression (diopter, axial length) of high myopia in young children, and to compare the compliance, adverse reaction and regression rate of different concentrations of atropine eye drops in myopia control.

Intervention: Group 1 (0.01% atropine group), Group 2 (0.04% atropine group), Group 3 (0.1% atropine group). During the 2-year intervention period after entering the group, each concentration of atropine eye drops were given every night at a fixed time before going to bed, one drop each time, implemented by parents (supervision), and the wechat small program was completed.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • At least one eye with cycloplegic optometric spherical equivalent of -5.00 to -10.00D and best corrected distant visual acuity of at least 0.5 and near visualacuity of at least 1.0, Titmus Stereo acuity ≤ 80 seconds, Vision with externaloccultation of ≤ 10 prismatic diopters , vision with internal occultation of ≤ 6-8prismatic diopters, and astigmatism equal to or less than -2.50D;

  • Myopia progression greater than 0.5D in the past year;

  • Possess normal cognitive and verbal communication abilities to actively cooperatewith the prescribed treatment;

  • Written informed consent from the guardian and the child.

Exclusion

Exclusion Criteria:

  • Diseases of the study eye: keratitis, cone cornea, congenital cataract, glaucoma,fundus diseases; combined with inflammation of the anterior or posterior segment ofthe eye, such as acute conjunctivitis, iridocyclitis;

  • Systemic diseases affecting the use of drugs: albinism, epilepsy, severepsychoneurological disorders, congenital heart disease, cardiac arrhythmias;

  • Atropine allergy;

  • Very low birth weight less than 1500 g;

  • Previous treatment with anticholinergics including atropine within the previous 1year, or use of OK lenses, multifocal soft lenses within 3 months;

  • Other conditions judged by the investigator to be unsuitable for participation inthe trial.

Study Design

Total Participants: 219
Treatment Group(s): 1
Primary Treatment: Atropine
Phase:
Study Start date:
July 04, 2021
Estimated Completion Date:
September 01, 2024

Connect with a study center

  • Shanghai Eye Disease Prevention & Treatment Center

    Shanghai, Shanghai Municipality 200040
    China

    Site Not Available

  • Shanghai General Hospital

    Shanghai,
    China

    Site Not Available

  • Shanghai Ninth People's Hospital

    Shanghai,
    China

    Site Not Available

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