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| Name | Class |
|---|---|
| Ecouter Voir | UNKNOWN |
| Hoya Lens France | UNKNOWN |
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Myopia is the most common refractive disorder in the world. Many strategies have been developed to control myopia in children. Among them, the instillation of low-concentration atropine eyedrops has been proven to be effective in numerous publications. Nevertheless, the spreading of atropine use is limited by: (1) its uneven availability, (2) a proportion of children with no or poor response, (3) some issues of long-term compliance (4) the possibility of a rebound effect after treatment cessation.
Among the non-drug myopia control strategies, corrective lenses including the Defocus Incorporated Multiple Segments® (DIMS®) technology have demonstrated their effectiveness in a previous study (Hong Kong) when compared to monofocal lenses.
The aim of this study is to compare the efficacy of DIMS lenses alone versus atropine 0.05% eyedrops + monofocal lenses, on the evolution of ocular axial length at 2 years in myopic children.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| DIMS® | Experimental | Defocus Incorporated Multiple Segments® lenses |
|
| Low-concentration atropine + monofocal lenses | Active Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Defocus Incorporated Multiple Segments® (DIMS®) lenses | Device | Daily wear for 24 months. Lenses have a central monofocal optical zone correcting spherical or spherocylindrical ametropia, surrounded by a ring made up of 300 defocusing pellets. This lens geometry reduces the phenomenon of blurred image projected in the retinal periphery, encountered when myopic eyes are corrected with monofocal lenses. |
| Measure | Description | Time Frame |
|---|---|---|
| Axial length measurements | Difference between the mean of 6 axial length measurements (in mm) acquired with the IOLMaster 500® at 24 months and the mean of 6 axial length measurements at inclusion | Inclusion, 24 months |
| Spherical equivalent | Difference in spherical equivalent (in diopters) under cycloplegia on autorefractometer at 24 months and at preinclusion | Pre inclusion (screening consultation in the 15 days preceding inclusion), 24 months |
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Inclusion Criteria:
Diagnosis of myopia - measured under cycloplegia - defined by:
Not benefiting and never having benefited from a myopia control strategy (orthokeratology, soft defocusing lenses, low concentration atropine eye drops, peripheral defocusing corrective lenses)
Written consent of both parents
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Gilles MARTIN, MD | Hôpital Fondation Adolphe de Rothschild | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hôpital Fondation Adolphe de Rothschild | Paris | 75019 | France |
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|
|
| Atropine 0.05% eyedrops | Drug | One drop each evening in both eyes for 24 months. |
|
|
| Monofocal lenses | Device | Daily wear for 24 months |
|
| ID | Term |
|---|---|
| D009216 | Myopia |
| ID | Term |
|---|---|
| D012030 | Refractive Errors |
| D005128 | Eye Diseases |
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| ID | Term |
|---|---|
| D007909 | Lenses |
| D001285 | Atropine |
| D009883 | Ophthalmic Solutions |
| ID | Term |
|---|---|
| D055096 | Optical Devices |
| D004864 | Equipment and Supplies |
| D001286 | Atropine Derivatives |
| D014326 | Tropanes |
| D053961 | Azabicyclo Compounds |
| D001372 | Aza Compounds |
| D009930 | Organic Chemicals |
| D001533 | Belladonna Alkaloids |
| D012991 | Solanaceous Alkaloids |
| D000470 | Alkaloids |
| D006571 | Heterocyclic Compounds |
| D019086 | Bridged Bicyclo Compounds, Heterocyclic |
| D006572 | Heterocyclic Compounds, Bridged-Ring |
| D019999 | Pharmaceutical Solutions |
| D012996 | Solutions |
| D004364 | Pharmaceutical Preparations |
| D045506 | Therapeutic Uses |
| D020228 | Pharmacologic Actions |
| D020164 | Chemical Actions and Uses |
| D020313 | Specialty Uses of Chemicals |
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