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The purpose of this study is to evaluate the efficacy of Saturno II association on the control of ocular inflammation post-phacoemulsification
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| SATURNO II | Experimental | 1 drop, 4 times a day, in the eye to be operated, 1 day before surgery until 15 days after surgery |
|
| Vigadexa® | Active Comparator | 1 drop, 4 times a day, in the eye to be operated, 1 day before surgery until 15 days after surgery |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| SATURNO II association | Drug | opthalmic solution, 4 times a day |
|
| Measure | Description | Time Frame |
|---|---|---|
| Control of ocular inflammation post-phacoemulsification as evaluated though the presence of cells in the anterior chamber | The inflammation will be evaluated though the presence of cells in the anterior chamber. For this, the number of cells per high-power field in the anterior chamber was counted and recorded on a scale where 0 indicates ≤ 5 cells, 1 = 5 to 10 cells, 2 = 11 to 20 cells, 3 = 21 to 50 cells, and 4 corresponds to ≥ 50 cells. | 16 days |
| Measure | Description | Time Frame |
|---|---|---|
| Incidence and severity of adverse events recorded during the study | 26 days |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Allegisa | Campinas | São Paulo | 13.084-791 | Brazil |
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| ID | Term |
|---|---|
| D002386 | Cataract |
| ID | Term |
|---|---|
| D007905 | Lens Diseases |
| D005128 | Eye Diseases |
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| ID | Term |
|---|---|
| D000077266 | Moxifloxacin |
| ID | Term |
|---|---|
| D024841 | Fluoroquinolones |
| D042462 | 4-Quinolones |
| D015363 | Quinolones |
| D011804 | Quinolines |
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| Vigadexa® | Drug | opthalmic solution, 4 times a day |
|
|
| D006574 |
| Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D006571 | Heterocyclic Compounds |