Effectiveness of 0.01% Atropine Sulfate Solution in Controlling of Myopia Progression in Children

Study Overview
=================
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.

Official Title
-----------------
Open Prospective With Historical Control Clinical Study of 0.01 % Atropine Sulfate Effectiveness in Controlling of Myopia Progression in Children

Conditions
-----------------
Myopia

Intervention / Treatment
-----------------
* Combination Product: 0.01% Atropine sulfate solution in Comfort Drops (AVIZOR S.A., Spain)


Participation Criteria
=================
Eligibility Criteria
-----------------
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.

Ages Eligible for Study
-----------------
Minimum Age: 7 Years
Maximum Age: 17 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Interventional Model Description: Open prospective clinical trial with historical control
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: experimental<br>0.01% Atropine Sulfate solution in Comfort Drops, nightly instillations to both eyes | Combination Product: 0.01% Atropine sulfate solution in Comfort Drops (AVIZOR S.A., Spain)<br>* nightly instillations of 0.01% Atropine sulfate solution in Comfort Drops (AVIZOR S.A., Spain) in both eyes for 12 months<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | 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 | 

Secondary Outcome Measures

| Outcome Measure | 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 | 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 | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
myopia, low dose atropine, progressive myopia, atropine in non-asian population