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Sponsor decision to close this extension study due to reduction in sample size.
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The purpose of this study is to evaluate long term safety and effectiveness of the STREAMLINE® SURGICAL SYSTEM
A Retrospective, nonrandomized, open-label study to evaluate the long term safety and IOP-lowering effectiveness of STREAMLINE® SURGICAL SYSTEM in patients with open-angle glaucoma who participated in the DF6-CL-20-01 protocol.
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| STREAMLINE® SURGICAL SYSTEM | Device | STREAMLINE® SURGICAL SYSTEM |
| Measure | Description | Time Frame |
|---|---|---|
| Change in IOP | From Screening to annual endpoints | 24months; 36 months; 48months, 60 months |
| Measure | Description | Time Frame |
|---|---|---|
| Number of IOP lowering medications | Compared to screening in DF6-CL-20-01 trial | 24months; 36 months; 48months, 60 months |
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Inclusion Criteria:
participated in the DF6-CL-20-01 trial.
Exclusion Criteria:
lost to follow up in the DF6-CL-20-01 trial
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Subjects who participated in the DF6-CL-20-01 trial
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Clinica 20/20 | San José | Costa Rica |
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| ID | Term |
|---|---|
| D005902 | Glaucoma, Open-Angle |
| D005901 | Glaucoma |
| ID | Term |
|---|---|
| D009798 | Ocular Hypertension |
| D005128 | Eye Diseases |
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