Open Prospective With Historical Control Clinical Study of 0.01 % Atropine Sulfate Effectiveness in Controlling of Myopia Progression in Children
Overview
- Phase
- Phase 3
- Intervention
- Not specified
- Conditions
- Myopia
- Sponsor
- The V.P. Vyhodcev Eye Hospital
- Enrollment
- 70
- Locations
- 1
- Primary Endpoint
- change in axial length
- Last Updated
- 6 years ago
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.
Investigators
Daria Afanasyeva
Principal Investigator
The V.P. Vyhodcev Eye Hospital
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.
Outcomes
Primary Outcomes
change in axial length
Time Frame: 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
Time Frame: 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 Outcomes
- change in difference between manifest and cycloplegic refractions(baseline - 12 months)
- change in positive relative accommodation(baseline - 12 months)
- tear production(baseline - 12 months)