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

Last updated: January 10, 2022
Sponsor: Shanghai Eye Disease Prevention and Treatment Center
Overall Status: Active - Recruiting

Phase

N/A

Condition

Myopia

Treatment

N/A

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:

  • The BCVA of distant vision is at least 0.5, near vision is at least 1.0, Titmus stereovision is less than 80 seconds, far exotropia is less than 10 prism degrees, faresotropia is less than 6-8 prism degrees, and astigmatism is equal to or less than - 2.50 D;
  • Myopia progressed more than 0.5D in the past year;
  • Have normal thinking and language communication skills, and be able to activelycooperate with the treatment as required;
  • Written informed consent of guardian and child.

Exclusion

Exclusion Criteria:

  • Diseases of the study eye: keratitis, keratoconus, congenital cataract, glaucoma,fundus diseases; present situation with anterior segment or posterior segmentinflammation, such as acute conjunctivitis, iridocyclitis;
  • Systemic diseases affecting drug use: albinism, epilepsy, serious mental andneurological diseases, congenital heart disease, arrhythmia;
  • Atropine allergy;
  • Very low birth weight infants with birth weight less than 1500g;
  • Receiving other treatment to control the development of myopia, includinganticholinergic drugs such as atropine, or participated in other functional framelens, multifocal soft lens in the past one year;
  • Other situations that not suitable for participating in the trial as judged by theresearcher

Study Design

Total Participants: 357
Study Start date:
July 04, 2021
Estimated Completion Date:
August 01, 2025

Connect with a study center

  • Shanghai Eye Disease Prevention & Treatment Center

    Shanghai, Shanghai 200040
    China

    Active - Recruiting

  • Shanghai General Hospital

    Shanghai,
    China

    Active - Recruiting

  • Shanghai Ninth People's Hospital

    Shanghai,
    China

    Active - Recruiting

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