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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE3

Total Enrollment

70 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-02-17

Study Completion Date

2021-08-31

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Myopia

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Open prospective clinical trial with historical control

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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experimental

0.01% Atropine Sulfate solution in "Comfort Drops", nightly instillations to both eyes

Group Type EXPERIMENTAL

0.01% Atropine sulfate solution in "Comfort Drops" ("AVIZOR S.A.", Spain)

Intervention Type COMBINATION_PRODUCT

nightly instillations of 0.01% Atropine sulfate solution in "Comfort Drops" ("AVIZOR S.A.", Spain) in both eyes for 12 months

Interventions

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0.01% 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

Intervention Type COMBINATION_PRODUCT

Eligibility Criteria

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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.

Minimum Eligible Age

7 Years

Maximum Eligible Age

17 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No