Myopia
Conditions
Keywords
myopia, low dose atropine, progressive myopia, atropine in non-asian population
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 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.
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 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.
Interventions
COMBINATION_PRODUCT0.01% 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
Sponsors
The V.P. Vyhodcev Eye Hospital
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
Open prospective clinical trial with historical control
Eligibility
Sex/Gender
ALL
Age
7 Years to 17 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| change in axial length | baseline - 12 months | Change in axial length elongation from baseline to 12 months, as measured using IOLMaster, compared with historical data |
| change in myopic progression rate | baseline - 12 months | Change in myopic progression rate measured as the difference between cycloplegic refraction from baseline to 12 months, compared with historical data. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| change in difference between manifest and cycloplegic refractions | baseline - 12 months | change in difference between manifest and cycloplegic (tropicamide 0.5%) refractions, measured with autorefractometer, compared with historical data |
| change in positive relative accommodation | baseline - 12 months | change in positive relative accommodation, measured in maximal spectacles correction by using concave lenses until the image blurs |
| tear production | baseline - 12 months | result of Schirmer I test |
Countries
Russia
Outcome results
None listed