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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:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| experimental | Experimental | 0.01% Atropine Sulfate solution in "Comfort Drops", nightly instillations to both eyes |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 0.01% Atropine sulfate solution in "Comfort Drops" ("AVIZOR S.A.", Spain) | Combination Product | nightly instillations of 0.01% Atropine sulfate solution in "Comfort Drops" ("AVIZOR S.A.", Spain) in both eyes for 12 months |
| Measure | Description | Time Frame |
|---|---|---|
| change in axial length | Change in axial length elongation from baseline to 12 months, as measured using IOLMaster, compared with historical data | 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. | baseline - 12 months |
| Measure | Description | Time Frame |
|---|---|---|
| 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 | baseline - 12 months |
| change in positive relative accommodation |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The V.P. Vyhodcev Eye Hospital | Recruiting | Omsk | 644024 | Russia |
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| ID | Term |
|---|---|
| D009216 | Myopia |
| D047728 | Myopia, Degenerative |
| ID | Term |
|---|---|
| D012030 | Refractive Errors |
| D005128 | Eye Diseases |
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Open prospective clinical trial with historical control
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change in positive relative accommodation, measured in maximal spectacles correction by using concave lenses until the image blurs |
| baseline - 12 months |
| tear production | result of Schirmer I test | baseline - 12 months |