Atropine 0.01% Eyedrops for Evolutive Myopia Treatment in Children

Myopia Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04252989
• Other study ID #: IRBN962019/CHUSTE
• Status: Recruiting
• Start date: December 18, 2019
• Est. completion date: December 2027

Study information

• Verified date: March 2024
• Source: Centre Hospitalier Universitaire de Saint Etienne
• Contact: Marie Caroline TRONE
• Phone: 04 77 82 94 28
• Email: m.caroline.trone[@]chu-st-etienne.fr
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 50
• Est. completion date: December 2027
• Est. primary completion date: December 2027
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A to 18 Years

Eligibility

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

Related Conditions & MeSH terms

• Children
• Myopia

Intervention

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...)

Locations

Country	Name	City	State
France	CHU de Saint Etienne	Saint Etienne

Sponsors (1)

Lead Sponsor	Collaborator
Centre Hospitalier Universitaire de Saint Etienne

Country where clinical trial is conducted

France, 

Outcome

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