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

Myopia Clinical Trial

Official title:

Open Prospective With Historical Control Clinical Study of 0.01 % Atropine Sulfate Effectiveness in Controlling of Myopia Progression in Children

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04338373
• Other study ID #: 2020-01
• Status: Recruiting
• Phase: Phase 3
• Start date: February 17, 2020
• Est. completion date: August 2021

Study information

• Verified date: April 2020
• Source: The V.P. Vyhodcev Eye Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 70
• Est. completion date: August 2021
• Est. primary completion date: August 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 7 Years to 17 Years

Eligibility

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.

Related Conditions & MeSH terms

• Myopia

Intervention

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

Locations

Country	Name	City	State
Russian Federation	The V.P. Vyhodcev Eye Hospital	Omsk

Sponsors (1)

Lead Sponsor	Collaborator
The V.P. Vyhodcev Eye Hospital

Country where clinical trial is conducted

Russian Federation, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	change in axial length	Change in axial length elongation from baseline to 12 months, as measured using IOLMaster, compared with historical data	baseline - 12 months
Primary	change in myopic progression rate	Change in myopic progression rate measured as the difference between cycloplegic refraction from baseline to 12 months, compared with historical data.	baseline - 12 months
Secondary	change in difference between manifest and cycloplegic refractions	change in difference between manifest and cycloplegic (tropicamide 0.5%) refractions, measured with autorefractometer, compared with historical data	baseline - 12 months
Secondary	change in positive relative accommodation	change in positive relative accommodation, measured in maximal spectacles correction by using concave lenses until the image blurs	baseline - 12 months
Secondary	tear production	result of Schirmer I test	baseline - 12 months