Topical 0.01% Atropine for the Control of Fast Progressing Myopia
NCT ID: NCT04173780
Last Updated: 2024-08-29
Study Results
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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TERMINATED
PHASE2/PHASE3
60 participants
INTERVENTIONAL
2020-02-12
2024-06-03
Brief Summary
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The management of myopia and its complications is therefore a major public health issue.
All the means likely to slow the evolution of myopia (thus to limit the prevalence of strong myopia) must be developed to limit the consequences. 0.01% Atropine seems to be a drug with a great interest to slow down the progression of myopia.
The aim of the present study is to evaluate the efficacy at 1 year of 0.01% atropine (1 drop per day administered for 1 year) on the reduction of fast progressing myopia in children aged 4 to 12, compared to a control group (instillation of a placebo).
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
TRIPLE
Study Groups
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Atropine 0.01%
Atropine 0.01%
1 drop per day in both eyes for 1 year
Placebo
Placebo
1 drop per day in both eyes for 1 year
Interventions
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Atropine 0.01%
1 drop per day in both eyes for 1 year
Placebo
1 drop per day in both eyes for 1 year
Eligibility Criteria
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Inclusion Criteria
* Myopia from -1 to -6
* Fast progressing myopia (\>0.75 diopter / year)
* Informed consent obtained
Exclusion Criteria
* Anisometropia \> 2 diopters
* Concomitant pathology of anterior or posterior segments
* Other ocular diseases (Ocular inflammation, strabismus …)
* Atropine hypersensitivity or allergy
4 Years
12 Years
ALL
No
Sponsors
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University Hospital, Strasbourg, France
OTHER
Responsible Party
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Principal Investigators
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Arnaud SAUER, MD
Role: PRINCIPAL_INVESTIGATOR
University Hospital, Strasbourg, France
Locations
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CHU de Strasbourg
Strasbourg, , France
Countries
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Other Identifiers
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7343
Identifier Type: -
Identifier Source: org_study_id
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