Atropine 0.01% Eyedrops for Evolutive Myopia Treatment in Children

NCT04252989 | Recruiting

• 1 other identifier: IRBN962019/CHUSTE
• Study Type: observational
• Target: 50
• Locations: 1 country
• Sites: 1

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.

Conditions

Myopia; Children

Keywords

atropine

Outcome Measures

Primary Outcomes (8)

• 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 Outcomes (1)

• undesirable events collection

  every 6 months up to age 18 years

Study Arms (1)

Children with active myopia treated with ATROPINE eye drops

Other: data collection

Interventions

data collection OTHER

* 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...)

Children with active myopia treated with ATROPINE eye drops

Eligibility Criteria

• Age: Up to 18 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

Children with active myopia treated with ATROPINE 0.01% eye drops

You may qualify if:

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

You may not qualify if:

• non compliance with treatment

Sponsors & Collaborators

• Centre Hospitalier Universitaire de Saint Etienne: lead

Study Sites (1)

CHU de Saint Etienne

Saint-Etienne, 42055, France

RECRUITING

MeSH Terms

Conditions

Myopia

Interventions

Data Collection

Condition Hierarchy (Ancestors)

Refractive Errors; Eye Diseases

Intervention Hierarchy (Ancestors)

Epidemiologic Methods; Investigative Techniques; Health Care Evaluation Mechanisms; Quality of Health Care; Health Care Quality, Access, and Evaluation; Public Health; Environment and Public Health

Study Officials

• Marie Caroline TRONE

  CHU de Saint Etienne

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Marie Caroline TRONE

CONTACT

04 77 82 94 28; m.caroline.trone@chu-st-etienne.fr

Marie PEURIERE

CONTACT

04 77 82 92 72; marie.peuriere@chu-st-etienne.fr

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 15, 2020
• First Posted: February 5, 2020
• Study Start: December 18, 2019
• Primary Completion (Estimated): December 1, 2027
• Study Completion (Estimated): December 1, 2027
• Last Updated: March 18, 2025

Record last verified: 2025-03

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)