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Slow enrollment, sites unable to obtain iStent Inject W from manufacturer
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| Name | Class |
|---|---|
| Alcon Research | INDUSTRY |
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The goal of the study is to prospectively evaluate and compare Hydrus microstent to the iStent Inject Wide in combination with cataract surgery in patients with mild to moderate open angle glaucoma. Hydrus and iStent are the two FDA approved trabecular meshwork targeting microstents to treat open angle glaucoma in conjunction with cataract surgery.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Combined cataract surgery with Hydrus microstent | Active Comparator |
| |
| Combined cataract surgery with iStent Inject W | Active Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Combined cataract surgery with Hydrus microstent | Device | Device designed to help lower intraocular pressure by improving aqueous outflow through the trabecular meshwork. Used in combination with cataract surgery. |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of subjects with complete success defined as intraocular pressure reduction > 25% from baseline And without secondary intervention to reduce IOP (medication, laser trabeculoplasty, or surgery) at 24 month. | 24 Months |
| Measure | Description | Time Frame |
|---|---|---|
| Intraoperative and postoperative adverse events rates | 24 Months | |
| Rates of secondary intervention to reduce intraocular pressure | 24 Months | |
| Rates of needing incisional glaucoma surgery as secondary intervention to control interocular pressure |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Diablo Eye Associates | Walnut Creek | California | 94598 | United States |
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| ID | Term |
|---|---|
| D005902 | Glaucoma, Open-Angle |
| ID | Term |
|---|---|
| D005901 | Glaucoma |
| D009798 | Ocular Hypertension |
| D005128 | Eye Diseases |
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| Combined cataract surgery with iStent Inject W | Device | Device designed to help lower intraocular pressure by improving aqueous outflow through the trabecular meshwork. Used in combination with cataract surgery. |
|
| 24 Months |