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

Phase 3

• Conditions: Myopia
• Interventions: Combination Product: 0.01% Atropine sulfate solution in "Comfort Drops" ("AVIZOR S.A.", Spain)

• Registration Number: NCT04338373
• Lead Sponsor: The V.P. Vyhodcev Eye Hospital

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.

Study Timeline

• Study Start: 2020-02-17
• Status Verified: 2020-04
• Study First Submitted: 2020-04-04
• Study First Submitted QC: 2020-04-04
• Study First Posted: 2020-04-08
• Last Update Submitted: 2020-04-08
• Last Update Posted: 2020-04-09
• Primary Completion: 2021-08
• Study Completion: 2021-08

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 70

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
experimental	0.01% Atropine sulfate solution in "Comfort Drops" ("AVIZOR S.A.", Spain)	0.01% Atropine Sulfate solution in "Comfort Drops", nightly instillations to both eyes

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (1)

The V.P. Vyhodcev Eye Hospital; 🇷🇺 Omsk, Russian Federation