Atropine 0.01% Eyedrops for Evolutive Myopia Treatment in Children

NCT ID: NCT04252989

Last Updated: 2025-03-18

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Total Enrollment

50 participants

Study Classification

OBSERVATIONAL

Study Start Date

2019-12-18

Study Completion Date

2027-12-31

Brief Summary

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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.

Detailed Description

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Conditions

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Myopia Children

Study Design

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Observational Model Type

COHORT

Study Time Perspective

RETROSPECTIVE

Study Groups

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Children with active myopia treated with ATROPINE eye drops

data collection

Intervention Type 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...)

Interventions

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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...)

Intervention Type OTHER

Eligibility Criteria

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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
Maximum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Centre Hospitalier Universitaire de Saint Etienne

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Marie Caroline TRONE

Role: PRINCIPAL_INVESTIGATOR

CHU de Saint Etienne

Locations

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CHU de Saint Etienne

Saint-Etienne, , France

Site Status RECRUITING

Countries

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France

Central Contacts

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Marie Caroline TRONE

Role: CONTACT

04 77 82 94 28 ext. +33

Marie PEURIERE

Role: CONTACT

04 77 82 92 72 ext. +33

Facility Contacts

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Marie Caroline TRONE, MD

Role: primary

(0)4 77 82 92 72 ext. +33

Other Identifiers

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IRBN962019/CHUSTE

Identifier Type: -

Identifier Source: org_study_id

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