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 Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
70
nightly instillations of 0.01% Atropine sulfate solution in "Comfort Drops" ("AVIZOR S.A.", Spain) in both eyes for 12 months
The V.P. Vyhodcev Eye Hospital
Omsk, Russia
RECRUITINGchange in axial length
Change in axial length elongation from baseline to 12 months, as measured using IOLMaster, compared with historical data
Time frame: baseline - 12 months
change in myopic progression rate
Change in myopic progression rate measured as the difference between cycloplegic refraction from baseline to 12 months, compared with historical data.
Time frame: baseline - 12 months
change in difference between manifest and cycloplegic refractions
change in difference between manifest and cycloplegic (tropicamide 0.5%) refractions, measured with autorefractometer, compared with historical data
Time frame: baseline - 12 months
change in positive relative accommodation
change in positive relative accommodation, measured in maximal spectacles correction by using concave lenses until the image blurs
Time frame: baseline - 12 months
tear production
result of Schirmer I test
Time frame: baseline - 12 months
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.