Trial | NCT04338373  Report issue

Title

Effectiveness of 0.01% Atropine Sulfate Solution in Controlling of Myopia Progression in Children
Open Prospective With Historical Control Clinical Study of 0.01 % Atropine Sulfate Effectiveness in Controlling of Myopia Progression in Children

  • Phase

    Phase 3

  • Study Type

    Interventional

  • Status

    Unknown status

  • Study Participants

    70
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.
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.
Study Started
Feb 17
2020
Primary Completion
Aug 31
2021
Anticipated
Study Completion
Aug 31
2021
Anticipated
Last Update
Apr 09
2020

Combination Product 0.01% Atropine sulfate solution in "Comfort Drops" ("AVIZOR S.A.", Spain)

nightly instillations of 0.01% Atropine sulfate solution in "Comfort Drops" ("AVIZOR S.A.", Spain) in both eyes for 12 months

experimental Experimental

0.01% Atropine Sulfate solution in "Comfort Drops", nightly instillations to both eyes

Criteria 

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 or earlier
signed informed consent.

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.
No Results Posted