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NCT Number: NCT04252989

Atropine 0.01% Eyedrops for Evolutive Myopia Treatment in Children

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.

Recruiting

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Key information

Conditions

Myopia Children Eye Diseases Refractive Errors

Age range

Up to 18 year

Sex eligibility

All sexes

Study type

Observational

Primary location

CHU de Saint Etienne

Saint-Etienne, 42055, France

Location status: Recruiting

Location contact

Alexandre CLAVEL, MD

SUB_INVESTIGATOR

Caroline RONIN, MD

SUB_INVESTIGATOR

Gilles THURET, MD PhD

SUB_INVESTIGATOR

Hala ALROUMI, MD

SUB_INVESTIGATOR

Marie Caroline TRONE, MD

CONTACT

[email protected]

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

Philippe GAIN, MD PhD

PRINCIPAL_INVESTIGATOR

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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...)

Primary outcomes

  1. previous refractions

    Time frame: every 6 months up to age 18 years

    effectiveness of ATROPINE 0.01% eyedrops in our current clinical practice

  2. refraction of parents

    Time frame: every 6 months up to age 18 years

    effectiveness of ATROPINE 0.01% eyedrops in our current clinical practice

  3. intra-ocular pression

    Time frame: every 6 months up to age 18 years

    effectiveness of ATROPINE 0.01% eyedrops in our current clinical practice

  4. objective refraction after "fog"

    Time frame: every 6 months up to age 18 years

    effectiveness of ATROPINE 0.01% eyedrops in our current clinical practice

  5. cycloplegia with SKIACOL

    Time frame: every 6 months up to age 18 years

    effectiveness of ATROPINE 0.01% eyedrops in our current clinical practice

  6. slit lamp

    Time frame: every 6 months up to age 18 years

    effectiveness of ATROPINE 0.01% eyedrops in our current clinical practice

  7. dilated eye exam

    Time frame: every 6 months up to age 18 years

    effectiveness of ATROPINE 0.01% eyedrops in our current clinical practice

  8. biometrics

    Time frame: every 6 months up to age 18 years

    effectiveness of ATROPINE 0.01% eyedrops in our current clinical practice

Secondary outcomes

  1. undesirable events collection

    Time frame: every 6 months up to age 18 years

    measured the tolerance of ATROPINE 0.01% eyedrops. Number of participants with treatment-related adverse events.

Study contacts

Contact information is provided by the study sponsor or research team.

Marie Caroline TRONE

CONTACT

[email protected]

04 77 82 94 28 ext. +33

Marie PEURIERE

CONTACT

[email protected]

04 77 82 92 72 ext. +33

Sponsors and collaborators

Lead sponsor

Centre Hospitalier Universitaire de Saint Etienne

Other

Registry information

Official study title

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

Important dates

Study start
2019
Primary completion
2027
Study completion
2027
First posted
Feb 5, 2020
Registry last updated
Mar 18, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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