Atropine 0.01% Eyedrops for Evolutive Myopia Treatment in Children

Recruiting

• Conditions: Children; Myopia

• Registration Number: NCT04252989
• Lead Sponsor: Centre Hospitalier Universitaire de Saint Etienne

Brief Summary

Prevalence of myopia and its complications has been increasing over the past decades, especially among children and adolescents. It reaches record levels in Asia: nearly 80% of the population in some regions in 2012 where the investigators speak in terms of epidemic.

ATROPINE 0.01% eyedrops one drop per day is today an evolutive myopia treatment, whose results are promising.

The investigators use this eye drops in our clinical practice at hospital of Saint-Etienne since 2017.

Few clinical data have been published so far concerning the French population.

The investigators would like to build a database so that the investigators can publish our results and share our experience.

Detailed Description

Not available

Study Timeline

• Study Start: 2019-12-18
• Study First Submitted: 2020-01-15
• Study First Submitted QC: 2020-01-31
• Study First Posted: 2020-02-05
• Status Verified: 2025-03
• Last Update Submitted: 2025-03-17
• Last Update Posted: 2025-03-18
• Primary Completion: 2027-12
• Study Completion: 2027-12

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 50

Inclusion Criteria

• Children with active myopia treated with ATROPINE 0.01% eye drops
• patient affiliated with a social security organization
• agreement of both parents

Exclusion Criteria

• non compliance with treatment

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
refraction of parents	every 6 months up to age 18 years	effectiveness of ATROPINE 0.01% eyedrops in our current clinical practice
intra-ocular pression	every 6 months up to age 18 years	effectiveness of ATROPINE 0.01% eyedrops in our current clinical practice
objective refraction after "fog"	every 6 months up to age 18 years	effectiveness of ATROPINE 0.01% eyedrops in our current clinical practice
slit lamp	every 6 months up to age 18 years	effectiveness of ATROPINE 0.01% eyedrops in our current clinical practice
previous refractions	every 6 months up to age 18 years	effectiveness of ATROPINE 0.01% eyedrops in our current clinical practice
dilated eye exam	every 6 months up to age 18 years	effectiveness of ATROPINE 0.01% eyedrops in our current clinical practice
cycloplegia with SKIACOL	every 6 months up to age 18 years	effectiveness of ATROPINE 0.01% eyedrops in our current clinical practice
biometrics	every 6 months up to age 18 years	effectiveness of ATROPINE 0.01% eyedrops in our current clinical practice

Secondary Outcome Measures

Name	Time	Method
undesirable events collection	every 6 months up to age 18 years	measured the tolerance of ATROPINE 0.01% eyedrops. Number of participants with treatment-related adverse events.

Trial Locations

Locations (1)

CHU de Saint Etienne; 🇫🇷 Saint Etienne, France