Effectiveness of 0.01% Atropine Sulfate Solution in Controlling of Myopia Progression in Children

Last updated: April 8, 2020
Sponsor: The V.P. Vyhodcev Eye Hospital
Overall Status: Active - Recruiting

Phase

3

Condition

Myopia

Treatment

N/A

Clinical Study ID

NCT04338373
2020-01
  • Ages 7-17
  • All Genders

Study Summary

Increasing number of myopic children and significant complications of high myopia enhance the necessity of effective control strategy. Instillations of low-dose atropine have been shown to reduce myopia progression in Asian populations but its effect in non-Asian populations is still unclear. This open prospective study with historical control is designed to investigate if 0.01% atropine can reduce myopia progression in Russian children, taking into account a change of difference between manifest and cycloplegic refraction, as well as, myopia progression rate at the time of recruitment.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • myopia progression rate of 0.5D or more per year;

  • myopia with astigmatism of 1.0D or less;

  • axial length and cycloplegic refraction data obtained 6 months before recruiting orearlier

  • signed informed consent.

Exclusion

Exclusion Criteria:

  • congenital myopia;

  • onset of myopia at 6 years old or earlier;

  • allergic reactions to any eye drops in anamnesis;

  • concomitant eye disorders, including strabismus.

Study Design

Total Participants: 70
Study Start date:
February 17, 2020
Estimated Completion Date:
August 31, 2021

Study Description

The study is designed to test the following hypotheses:

  • 0.01% atropine one drop nightly is safe and with no significant side effects.

  • nightly instillations of 0.01% atropine does not influence tear production.

  • 0.01% atropine one drop nightly reduces the progression of childhood myopia in Russian children.

  • nightly instillations of 0.01% atropine decreases the manifest refraction and, consequently, difference between manifest and cycloplegic refractions.

  • effectiveness of 0.01% atropine depends on the age and myopia progression rate at the time the therapy was started.

Connect with a study center

  • The V.P. Vyhodcev Eye Hospital

    Omsk, 644024
    Russian Federation

    Active - Recruiting

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