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| ID | Type | Description | Link |
|---|---|---|---|
| HYDRUS I | Other Identifier | Germany: Federal Institute for Drugs and Medical Devices |
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The purpose of this study is to evaluate the ocular hypotensive effect of the Hydrus Aqueous Implant (Standard and Low-Profile), as determined by the change in IOP from baseline (preoperative) and change in the number of glaucoma medications from baseline.
This is a prospective, multi-center study that will examine subjects with documented mild to advanced primary open angle glaucoma (POAG), who may or may not have a cataract requiring removal and placement of an intraocular lens.
Study subjects will be grouped by the severity of their disease (either mild/moderate or advanced). If all inclusion and exclusion criteria are met subjects in all four groups will be implanted with the Hydrus Aqueous Implant. Subjects in whom a cataract is present will undergo standard cataract removal and IOL implantation concurrent with implantation of the Hydrus.
Postoperatively, subjects will undergo a complete ophthalmic evaluation at regularly scheduled intervals.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Hydrus Aqueous Implant | Experimental | Hydrus implanted into Schlemm's Canal. |
|
| IOL placement and Hydrus implant | Other | Cataract Extraction with IOL placement and Hydrus implant into Schlemm's canal |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| prestudy topical glaucoma medications | Drug | Reintroduction of prestudy topical glaucoma medications, introduced one medication at a time during each study visit, as necessary. |
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| Measure | Description | Time Frame |
|---|---|---|
| Change in IOP of study eye between each randomized group | Effectiveness will be determined by comparing the IOP at the baseline (pre-operative) visit to the the IOP at the 12 month post-operative visit. | Baseline & One year |
| Measure | Description | Time Frame |
|---|---|---|
| Change in glaucoma medications | Calculate the change in the number of glaucoma medications from baseline (pre-operative) visit to the 12-month post-operative visit. | Baseline & One year |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Prof. Dr. Manfred Tetz, MD | Augentagesklinik Spreebogen Berlin | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University Medical Center Vienna | Vienna | A-1090 | Austria | |||
| Aurelios Augenzentrum |
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| ID | Term |
|---|---|
| D005902 | Glaucoma, Open-Angle |
| ID | Term |
|---|---|
| D005901 | Glaucoma |
| D009798 | Ocular Hypertension |
| D005128 | Eye Diseases |
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| Recklinghausen |
| Erlbruch |
| Germany |
| Berlin | 10559 | Germany |
| Universitatsmedizin der Johannes Gutenberg-Universitat Mainz Augenklinik und Poliklinik | Mainz | 55131 | Germany |
| Tijuana | Estado de Baja California | Mexico |