Status:
UNKNOWN
Effectiveness of 0.01% Atropine Sulfate Solution in Controlling of Myopia Progression in Children
Lead Sponsor:
The V.P. Vyhodcev Eye Hospital
Conditions:
Myopia
Eligibility:
All Genders
7-17 years
Phase:
PHASE3
Brief 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 myop...
Detailed 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 te...
Eligibility Criteria
Inclusion
- 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
- congenital myopia;
- onset of myopia at 6 years old or earlier;
- allergic reactions to any eye drops in anamnesis;
- concomitant eye disorders, including strabismus.
Key Trial Info
Start Date :
February 17 2020
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
August 1 2021
Estimated Enrollment :
70 Patients enrolled
Trial Details
Trial ID
NCT04338373
Start Date
February 17 2020
End Date
August 1 2021
Last Update
April 9 2020
Active Locations (1)
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1
The V.P. Vyhodcev Eye Hospital
Omsk, Russia, 644024