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The purpose of this study is to evaluate the safety and efficacy of the iStent trabecular micro-bypass stent in reducing intraocular pressure (IOP) in subjects with newly diagnosed open-angle glaucoma and subjects diagnosed with Ocular hypertension.
The study will compare the reduction in IOP of those subjects implanted with two Glaukos micro-stents with the reduction in IOP for patients receiving only primary medical therapy (Xalatan - Latanoprost) or cataract surgery alone. Both groups will undergo routine cataract surgery.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1 | Active Comparator |
| |
| 2 | Placebo Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Glaucoma Surgery | Device | Comparing the effect in reducing IOP with two Trabecular Bypass Microstents Versus none in patients undergoing cataract surgery, with early open angle glaucoma or ocular hypertension. |
| Measure | Description | Time Frame |
|---|---|---|
| Efficacy | 24 months |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Head of Clinical Affairs | Glaukos Corporation | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Vienna Medical Hospital | Vienna | A-1090 | Austria | |||
| Mainz University |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 20207977 | Derived | Fernandez-Barrientos Y, Garcia-Feijoo J, Martinez-de-la-Casa JM, Pablo LE, Fernandez-Perez C, Garcia Sanchez J. Fluorophotometric study of the effect of the glaukos trabecular microbypass stent on aqueous humor dynamics. Invest Ophthalmol Vis Sci. 2010 Jul;51(7):3327-32. doi: 10.1167/iovs.09-3972. Epub 2010 Mar 5. |
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| cataract surgery only | Procedure | Subjects will undergo routine cataract surgery only (no stent implant). |
|
|
| Mainz |
| Germany |
| Augenklinik der Technischen Universitat | Munich | 81675 | Germany |
| Universitats- Augenklinik | Würzburg | D-97080 | Germany |
| The Netherlands Ophthalmic Research Institute | Amsterdam | Netherlands |
| Ophthalmic Clinic | Rotterdam | Netherlands |
| Clinico San Carlos | Madrid | 28040 | Spain |
| Instituto Oftalmológico de Aragón | Zaragoza | 50007 | Spain |
| Beyoglu Eye Research and Education Hospital | Istanbul | Turkey (Türkiye) |
| ID | Term |
|---|---|
| D005902 | Glaucoma, Open-Angle |
| D005901 | Glaucoma |
| D002386 | Cataract |
| ID | Term |
|---|---|
| D009798 | Ocular Hypertension |
| D005128 | Eye Diseases |
| D007905 | Lens Diseases |
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| ID | Term |
|---|---|
| D018918 | Phacoemulsification |
| ID | Term |
|---|---|
| D002387 | Cataract Extraction |
| D054140 | Refractive Surgical Procedures |
| D013508 | Ophthalmologic Surgical Procedures |
| D013514 | Surgical Procedures, Operative |
| D059708 | Ultrasonic Surgical Procedures |
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