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

NCT04338373 · Status: UNKNOWN · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 70

Last updated 2020-04-09

No results posted yet for this study

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.

Conditions

  • Myopia

Interventions

COMBINATION_PRODUCT

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

Sponsors & Collaborators

  • The V.P. Vyhodcev Eye Hospital

    lead OTHER

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
7 Years
Max Age
17 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-02-17
Primary Completion
2021-08-31
Completion
2021-08-31

Countries

  • Russia

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04338373 on ClinicalTrials.gov