Atropine 0.01% Eyedrops for Evolutive Myopia Treatment in Children

Atropine 0.01% Eyedrops for Evolutive Myopia Treatment in Children. MYOPSTOP

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.

Study Overview

• Status: Recruiting
• Conditions: Children; Myopia
• Intervention / Treatment: Other: data collection

• Study Type: Observational
• Enrollment (Estimated): 50

Contacts and Locations

• Study Contact: Name: Marie Caroline TRONE; Phone Number: +33 04 77 82 94 28; Email: m.caroline.trone@chu-st-etienne.fr
• Study Contact Backup: Name: Marie PEURIERE; Phone Number: +33 04 77 82 92 72; Email: marie.peuriere@chu-st-etienne.fr

Study Locations

• France
  • Saint Etienne, France, 42055
    • Recruiting
    • CHU de Saint Etienne
    • Contact: Marie Caroline TRONE, MD; Phone Number: +33 (0)4 77 82 92 72; Email: m.caroline.trone@chu-st-etienne.fr
    • Principal Investigator: Philippe GAIN, MD PhD
    • Sub-Investigator: Gilles THURET, MD PhD
    • Sub-Investigator: Caroline RONIN, MD
    • Sub-Investigator: Hala ALROUMI, MD
    • Sub-Investigator: Alexandre CLAVEL, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: No older than 16 years (Child, Adult)
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

Children with active myopia treated with ATROPINE 0.01% eye drops

Description

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 Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Retrospective

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Children with active myopia treated with ATROPINE eye drops	Other: data collection; Demographic data: age, sex; Ophthalmological history: refraction of parents, previous refractions; Ophthalmological data at each examination: intra-ocular pression, objective refraction after "fog", cycloplegia with SKIACOL, slit lamp, dilated eye exam, biometrics; Potential undesirable events (halos, photophobia...)

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Centre Hospitalier Universitaire de Saint Etienne
• Investigators: Principal Investigator: Marie Caroline TRONE, CHU de Saint Etienne

Study record dates

Study Major Dates

• Study Start (Actual): December 18, 2019
• Primary Completion (Estimated): December 1, 2027
• Study Completion (Estimated): December 1, 2027

Study Registration Dates

• First Submitted: January 15, 2020
• First Submitted That Met QC Criteria: January 31, 2020
• First Posted (Actual): February 5, 2020

Study Record Updates

• Last Update Posted (Actual): March 8, 2024
• Last Update Submitted That Met QC Criteria: March 7, 2024
• Last Verified: March 1, 2024

More Information

Terms related to this study

• Keywords: atropine
• Additional Relevant MeSH Terms: Eye Diseases; Refractive Errors; Myopia
• Other Study ID Numbers: IRBN962019/CHUSTE

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No