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Phase IV clinical trial to evaluate whether there is a significant difference in the control of myopia progression in myopic children treated with 0.025% atropine and DIMS spectacle lenses compared to 0.025% atropine and single vision (SV) lenses. Open-label, randomized, parallel clinical trial with 2 arms, involving 111 patients in total. The primary efficacy endpoint will be the change in cycloplegic spherical equivalent refraction (SER) and axial length (AL) compared to baseline values.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| DIMS Lenses | Experimental | Atropine 0,025% + DIMS Lenses |
|
| Monofocal Lenses | Active Comparator | Atropine 0,025% + monofocal (single vision) Lenses |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Atropine 0,025% | Drug | Atropine 0,025% (1 drop per day) |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Cycloplegic spherical equivalent refraction (SER) change | Cycloplegic spherical equivalent refraction (SER) change | 2 years (24 months) |
| Axial length (AL) change | Axial length (AL) change | 2 years (24 months) |
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Inclusion criteria
Exclusion criteria
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Noemi Guemes | Madrid | Madrid | 28040 | Spain |
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| ID | Term |
|---|---|
| D009216 | Myopia |
| ID | Term |
|---|---|
| D012030 | Refractive Errors |
| D005128 | Eye Diseases |
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| DIMS Lenses |
| Device |
Use of peripheral defocus lenses with DIMS technology, the design of which simultaneously introduces myopic defocus and provides clear vision to the wearer at all viewing distances. |
|
| Monofocal lenses | Device | Use of monofocal lenses. |
|