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The aim of this project is to compare trabeculectomy with Preserflo / Innfocus Microshunt in patients with Primary Angle Open Glaucoma and Pseudoexfoliation Glaucoma regarding the reduction of intraocular pressure.
The study is a prospective, randomized, monocentric, part blinded, controlled non-inferiority study of glaucoma patients.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Microshunt | Experimental | Patients will be treated with Preserflo / Innfocus Microshunt (Santen Pharmaceutical Co., Ltd.). |
|
| Trabeculectomy | Active Comparator | Patients will be treated with trabeculectomy. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Preserflo / Innfocus Microshunt | Device | The Microshunt features an 8.5-mm tube with an outer diameter of 350 µm and a 70-µm diameter lumen. Implantation creates a subconjunctival bleb and lowers intraocular pressure by increasing aqueous humor outflow. |
| Measure | Description | Time Frame |
|---|---|---|
| Difference in intraocular pressure | The primary endpoint is the difference between intraocular pressure after microshunt implantation vs trabeculectomy. | 1 year |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Teresa Rauchegger, Dr. | Contact | +43 512 504 24184 | teresa.rauchegger@i-med.ac.at | |
| Barbara Teuchner, Dr. | Contact | +43 512 504 24184 | barbara.teuchner@i-med.ac.at |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Medical University Innsbruck | Innsbruck | Tyrol | 6020 | Austria |
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| ID | Term |
|---|---|
| D005902 | Glaucoma, Open-Angle |
| D017889 | Exfoliation Syndrome |
| ID | Term |
|---|---|
| D005901 | Glaucoma |
| D009798 | Ocular Hypertension |
| D005128 | Eye Diseases |
| D007499 | Iris Diseases |
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| ID | Term |
|---|---|
| D014130 | Trabeculectomy |
| ID | Term |
|---|---|
| D018463 | Filtering Surgery |
| D013508 | Ophthalmologic Surgical Procedures |
| D013514 | Surgical Procedures, Operative |
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| Trabeculectomy | Other | Trabeculectomy is the most commonly performed surgical procedure and is considered the gold standard. |
|
| D014603 |
| Uveal Diseases |