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recruitment difficulties
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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).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Atropine 0.01% | Experimental |
| |
| Placebo | Placebo Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Atropine 0.01% | Drug | 1 drop per day in both eyes for 1 year |
| |
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Axial length | 12 months | |
| Axial length | 6 months | |
| Axial length |
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Inclusion Criteria:
Children from 4 to 12 years
Exclusion Criteria:
Astigmatism > 1.5 diopters
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| Name | Affiliation | Role |
|---|---|---|
| Arnaud SAUER, MD | University Hospital, Strasbourg, France | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| CHU de Strasbourg | Strasbourg | 67000 | France |
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| ID | Term |
|---|---|
| D009216 | Myopia |
| ID | Term |
|---|---|
| D012030 | Refractive Errors |
| D005128 | Eye Diseases |
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| Placebo |
| Drug |
1 drop per day in both eyes for 1 year |
|
| 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 |