Atropine 0.01% Eyedrops for Evolutive Myopia Treatment in Children
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: data collection.
- Who it may be relevant to
- Registry conditions: Myopia, Children. Basic parameters: up to 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- France
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
Atropine 0.01% Eyedrops for Evolutive Myopia Treatment in Children. MYOPSTOP
Overview
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.
Interventions
- 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...)
Primary outcome measures
- previous refractions [Time frame: every 6 months up to age 18 years]
- refraction of parents [Time frame: every 6 months up to age 18 years]
- intra-ocular pression [Time frame: every 6 months up to age 18 years]
- objective refraction after "fog" [Time frame: every 6 months up to age 18 years]
- cycloplegia with SKIACOL [Time frame: every 6 months up to age 18 years]
- slit lamp [Time frame: every 6 months up to age 18 years]
- dilated eye exam [Time frame: every 6 months up to age 18 years]
- biometrics [Time frame: every 6 months up to age 18 years]
Secondary outcome measures (1)
- undesirable events collection [Time frame: every 6 months up to age 18 years]
Eligibility criteria
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Observational model
- Cohort
Study locations
France · 1 center
- CHU de Saint Etienne — Saint-Etienne
Identifiers
NCT: NCT04252989 · IRBN962019/CHUSTE