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Atropine 0.01% Eyedrops for Evolutive Myopia Treatment in Children

Sponsor
Centre Hospitalier Universitaire de Saint Etienne (Other)
Overall Status
Recruiting
CT.gov ID
NCT04252989
Collaborator
(none)
50
Enrollment
1
Location
95.4
Anticipated Duration (Months)
0.5
Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Other: data collection

Study Design

Study Type:
Observational
Anticipated Enrollment :
50 participants
Observational Model:
Cohort
Time Perspective:
Retrospective
Official Title:
Atropine 0.01% Eyedrops for Evolutive Myopia Treatment in Children. MYOPSTOP
Actual Study Start Date :
Dec 18, 2019
Anticipated Primary Completion Date :
Dec 1, 2027
Anticipated Study Completion Date :
Dec 1, 2027

Arms and Interventions

Arm Intervention/Treatment
Children with active myopia treated with ATROPINE eye drops

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...)

Outcome Measures

Primary Outcome Measures

  1. previous refractions [every 6 months up to age 18 years]

    effectiveness of ATROPINE 0.01% eyedrops in our current clinical practice

  2. refraction of parents [every 6 months up to age 18 years]

    effectiveness of ATROPINE 0.01% eyedrops in our current clinical practice

  3. intra-ocular pression [every 6 months up to age 18 years]

    effectiveness of ATROPINE 0.01% eyedrops in our current clinical practice

  4. objective refraction after "fog" [every 6 months up to age 18 years]

    effectiveness of ATROPINE 0.01% eyedrops in our current clinical practice

  5. cycloplegia with SKIACOL [every 6 months up to age 18 years]

    effectiveness of ATROPINE 0.01% eyedrops in our current clinical practice

  6. slit lamp [every 6 months up to age 18 years]

    effectiveness of ATROPINE 0.01% eyedrops in our current clinical practice

  7. dilated eye exam [every 6 months up to age 18 years]

    effectiveness of ATROPINE 0.01% eyedrops in our current clinical practice

  8. biometrics [every 6 months up to age 18 years]

    effectiveness of ATROPINE 0.01% eyedrops in our current clinical practice

Secondary Outcome Measures

  1. undesirable events collection [every 6 months up to age 18 years]

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

Eligibility Criteria

Criteria

Ages Eligible for Study:
N/A to 18 Years
Sexes Eligible for Study:
All
Accepts 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

Contacts and Locations

Locations

Site City State Country Postal Code
1 CHU de Saint Etienne Saint Etienne France 42055

Sponsors and Collaborators

  • Centre Hospitalier Universitaire de Saint Etienne

Investigators

  • Principal Investigator: Marie Caroline TRONE, CHU de Saint Etienne

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Centre Hospitalier Universitaire de Saint Etienne
ClinicalTrials.gov Identifier:
NCT04252989
Other Study ID Numbers:
  • IRBN962019/CHUSTE
First Posted:
Feb 5, 2020
Last Update Posted:
Feb 5, 2020
Last Verified:
Dec 1, 2019
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Centre Hospitalier Universitaire de Saint Etienne
atropine
Additional relevant MeSH terms:
Myopia

Study Results

No Results Posted as of Feb 5, 2020