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A prospective, nonrandomized, open label study to evaluate the safety and IOP lowering effectiveness of the Streamline Surgical System, in patients with mild-to-moderate open angle glaucoma undergoing cataract surgery.
A prospective, nonrandomized, open label study to evaluate the safety and IOP lowering effectiveness of the Streamline Surgical System, a viscoelastic delivery device, in patients with mild-to-moderate open angle glaucoma undergoing cataract surgery. This is a 12 month study conducted outside the US. Approximately 60 subjects will be enrolled.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Streamline | Experimental | Streamline Surgical System |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Streamline Surgical System | Device | The Streamline System is a device that delivers viscoelastic into Schlemm's Canal. |
|
| Measure | Description | Time Frame |
|---|---|---|
| proportion of unmedicated eyes with IOP reduction of > 20% from Baseline at Month 12. | Primary Endpoint | 12 months |
| Measure | Description | Time Frame |
|---|---|---|
| Adverse Events | Assess intraoperative and post operative AEs | 12 months |
| Mean IOP change | Mean IOP change in unmedicated IOP from baseline to M12 |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Clinica 20/20 | San José | CR | 10108 | Costa Rica | ||
| Centro Laser |
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Prospective, non-randomized, open label
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| 12 months |
| Number of topical glaucoma medications | Number of topical glaucoma medications used at screening compared to Month 12 | 12 months |
| Santo Domingo |
| DR |
| 10124 |
| Dominican Republic |
| Clinica Laser y Ultrasonido Ocular de Puebla | Puebla City | 72530 | Mexico |
| ID | Term |
|---|---|
| D005902 | Glaucoma, Open-Angle |
| ID | Term |
|---|---|
| D005901 | Glaucoma |
| D009798 | Ocular Hypertension |
| D005128 | Eye Diseases |
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