Topical 0.01% Atropine for the Control of Fast Progressing Myopia

Childhood Clinical Trial

— Myopie-STOP  

Official title:

Topical 0.01% Atropine for the Control of Fast Progressing Myopia

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT04173780
• Other study ID #: 7343
• Status: Active, not recruiting
• Phase: Phase 2/Phase 3
• Start date: February 12, 2020
• Est. completion date: July 2024

Study information

• Verified date: August 2023
• Source: University Hospital, Strasbourg, France
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Myopia prevalence has dramatically increased worldwide in recent years in the general population and among children. Progressive myopia increases gradually with growth until the age of 20-25 years. At the same time, there is a remarkable increase in the prevalence of severe myopia (more than -6 diopters). Severe myopia is associated with many complications, which can lead to blindness. There is thus an increase in the number of myopic patients in general, and severe myopic patients in particular.

The management of myopia and its complications is therefore a major public health issue.

All the means likely to slow the evolution of myopia (thus to limit the prevalence of strong myopia) must be developed to limit the consequences. 0.01% Atropine seems to be a drug with a great interest to slow down the progression of myopia.

The aim of the present study is to evaluate the efficacy at 1 year of 0.01% atropine (1 drop per day administered for 1 year) on the reduction of fast progressing myopia in children aged 4 to 12, compared to a control group (instillation of a placebo).

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 160
• Est. completion date: July 2024
• Est. primary completion date: June 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 4 Years to 12 Years

Eligibility

Inclusion Criteria:

Children from 4 to 12 years

• Myopia from -1 to -6

• Fast progressing myopia (>0.75 diopter / year)

• Informed consent obtained

Exclusion Criteria:

Astigmatism > 1.5 diopters

• Anisometropia > 2 diopters

• Concomitant pathology of anterior or posterior segments

• Other ocular diseases (Ocular inflammation, strabismus …)

• Atropine hypersensitivity or allergy

Related Conditions & MeSH terms

• Childhood
• Myopia
• Myopia Progressing

Intervention

Drug:
• Atropine 0.01%
1 drop per day in both eyes for 1 year
• Placebo
1 drop per day in both eyes for 1 year

Locations

Country	Name	City	State
France	CHU de Strasbourg	Strasbourg

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Strasbourg, France

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Myopia in spherical diopters	Automatic measurement of myopia in spherical diopters under cycloplegia	12 months
Primary	Myopia in spherical diopters	Automatic measurement of myopia in spherical diopters under cycloplegia	9 months
Primary	Myopia in spherical diopters	Automatic measurement of myopia in spherical diopters under cycloplegia	6 months
Primary	Myopia in spherical diopters	Automatic measurement of myopia in spherical diopters under cycloplegia	3 months
Secondary	Axial length		12 months
Secondary	Axial length		6 months
Secondary	Axial length		3 months
Secondary	Axial length		9 months
Secondary	Adverse events		12 months
Secondary	Adverse events		9 months
Secondary	Adverse events		6 months
Secondary	Adverse events		3 months
Secondary	Quality of life questionnaire		12 months
Secondary	Quality of life questionnaire		9 months
Secondary	Quality of life questionnaire		6 months
Secondary	Quality of life questionnaire		3 months