Topical 0.01% Atropine for the Control of Fast Progressing Myopia

Study Overview
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Brief Summary
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Myopia prevalence has dramatically increased worldwide in recent years in the general population and among children. Progressive myopia increases gradually with growth until the age of 20-25 years. At the same time, there is a remarkable increase in the prevalence of severe myopia (more than -6 diopters). Severe myopia is associated with many complications, which can lead to blindness. There is thus an increase in the number of myopic patients in general, and severe myopic patients in particular. 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).

Official Title
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Topical 0.01% Atropine for the Control of Fast Progressing Myopia

Conditions
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Myopia Progressing, Childhood

Intervention / Treatment
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* Drug: Atropine 0.01%
* Drug: Placebo


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Children from 4 to 12 years Myopia from -1 to -6 Fast progressing myopia (>0.75 diopter / year) Informed consent obtained Exclusion Criteria: Astigmatism > 1.5 diopters Anisometropia > 2 diopters Concomitant pathology of anterior or posterior segments Other ocular diseases (Ocular inflammation, strabismus …) Atropine hypersensitivity or allergy

Ages Eligible for Study
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Minimum Age: 4 Years
Maximum Age: 12 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Atropine 0.01%<br> | Drug: Atropine 0.01%<br>* 1 drop per day in both eyes for 1 year<br>|
| Placebo Comparator: Placebo<br> | Drug: Placebo<br>* 1 drop per day in both eyes for 1 year<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Myopia in spherical diopters | Automatic measurement of myopia in spherical diopters under cycloplegia | 12 months | 
| Myopia in spherical diopters | Automatic measurement of myopia in spherical diopters under cycloplegia | 9 months | 
| Myopia in spherical diopters | Automatic measurement of myopia in spherical diopters under cycloplegia | 6 months | 
| Myopia in spherical diopters | Automatic measurement of myopia in spherical diopters under cycloplegia | 3 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Axial length |  | 12 months | 
| Axial length |  | 6 months | 
| Axial length |  | 3 months | 
| Axial length |  | 9 months | 
| Adverse events |  | 12 months | 
| Adverse events |  | 9 months | 
| Adverse events |  | 6 months | 
| Adverse events |  | 3 months | 
| Quality of life questionnaire |  | 12 months | 
| Quality of life questionnaire |  | 9 months | 
| Quality of life questionnaire |  | 6 months | 
| Quality of life questionnaire |  | 3 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Myopia (Progressing), Childhood, Atropine 0,01%