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

The V.P. Vyhodcev Eye Hospital

Status and phase: Unknown; Phase 3

Conditions: Myopia

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

Study type: Interventional

Funder types: Other

Identifiers

NCT04338373

2020-01

Details and patient eligibility

About

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.

Full 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.

Enrollment: 70 estimated patients

Sex: All

Ages: 7 to 17 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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70 participants in 1 patient group

experimental

Experimental group

Description:

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

Treatment:

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