Open Angle Glaucoma Clinical Trial
Official title:
An Extension Trial to Evaluate the Long Term Safety and Effectiveness of the STREAMLINE® SURGICAL SYSTEM in Patients With Open-Angle Glaucoma Who Participated in the DF6-CL-20-01 Protocol.
The purpose of this study is to evaluate long term safety and effectiveness of the STREAMLINE® SURGICAL SYSTEM
| Status | Not yet recruiting |
| Enrollment | 20 |
| Est. completion date | May 30, 2029 |
| Est. primary completion date | April 30, 2029 |
| Accepts healthy volunteers | |
| Gender | All |
| Age group | N/A and older |
| Eligibility | Inclusion Criteria: participated in the DF6-CL-20-01 trial. Exclusion Criteria: lost to follow up in the DF6-CL-20-01 trial |
| Country | Name | City | State |
|---|---|---|---|
| Costa Rica | Clinica 20/20 | San José |
| Lead Sponsor | Collaborator |
|---|---|
| New World Medical, Inc. |
Costa Rica,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Change in IOP | From Screening to annual endpoints | 24months; 36 months; 48months, 60 months | |
| Secondary | Number of IOP lowering medications | Compared to screening in DF6-CL-20-01 trial | 24months; 36 months; 48months, 60 months |
| Status | Clinical Trial | Phase | |
|---|---|---|---|
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