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Recruiting Observational

Atropine 0.01% Eyedrops for Evolutive Myopia Treatment in Children

NCT04252989 · tracked via the Priya Life Science France tracker
Phase
Observational
Started
2019-12-18
Last updated
2025-03-18

Condition(s) studied

MyopiaChildren

Investigational drug(s) / intervention(s)

data collection

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...)

Study 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.

Eligibility

Sex
ALL
Min age
—
Max age
18 Years
Healthy volunteers
No
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

Primary outcome measure(s)

  • previous refractions — every 6 months up to age 18 years
    effectiveness of ATROPINE 0.01% eyedrops in our current clinical practice
  • 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
  • cycloplegia with SKIACOL — 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
  • dilated eye exam — 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

Trial sites (1)

FacilityCityRegionStatus
CHU de Saint Etienne Saint-Etienne France Recruiting
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT04252989 on ClinicalTrials.gov ↗ ← All trials in France