Myopia Clinical Trial
Official title:
Open Prospective With Historical Control Clinical Study of 0.01 % Atropine Sulfate Effectiveness in Controlling of Myopia Progression in Children
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.
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