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| Name | Class |
|---|---|
| Nova Eye Medical GmbH | INDUSTRY |
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A prospective, multicenter, randomized, single-masked, post-market clinical trial comparing cataract surgery in conjunction with ab-interno canaloplasty utilizing the iTrack Advance canaloplasty device (Nova Eye, Inc.) to cataract surgery only in patients with mild to moderate, primary open angle glaucoma. Subjects will be followed for 24 months.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Cataract surgery combined with ab-interno canaloplasty | Active Comparator | Ab-interno canaloplasty utilizing the iTrack Advance canaloplasty device (Nova Eye, Inc.) |
|
| Control: Cataract surgery | Other | Cataract surgery alone |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Cataract surgery combined with ab-interno canaloplasty utililzing the iTrack Advance canaloplasty device | Device | 360 degree microcatheterization and viscodilation of Schlemm's canal |
| Measure | Description | Time Frame |
|---|---|---|
| Reduction in mean Intraocular Pressure (IOP) at 12 months compared to baseline | IOP will be measured at each study visit using Goldmann applanation tonometry | 12 months |
| Reduction in number of glaucoma medications at 12 months compared to baseline | The number of glaucoma medications will be recorded at 12 months compared to baseline | 12 months |
| Measure | Description | Time Frame |
|---|---|---|
| Reduction in mean Intraocular Pressure (IOP) at 24-months compared to baseline | IOP will be measured at each study visit using Goldmann applanation tonometry | 24 months |
| Reduction in glaucoma medications at 24-months compared to baseline |
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Inclusion Criteria:
Exclusion Criteria:
Any of the following prior treatments for glaucoma (study eye):
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Mike Pickrel | Contact | 800-391-2316 | MPickrel@Nova-Eye.com |
| Name | Affiliation | Role |
|---|---|---|
| Norbert Koerber, MD | Augencentrum Köln Ophthalmology | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Berkeley Eye Center | Recruiting | Sugar Land | Texas | 77478 | United States |
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| Cataract surgery | Procedure | Cataract surgery alone |
|
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The number of glaucoma medications will be recorded at 24-months compared to baseline
| 24 months |
| University of Bonn Eye Clinic | Recruiting | Bonn | Germany |
|
| Augencentrum Köln Ophthalmology | Recruiting | Cologne | Germany |
|
| St. Johannes Hospital | Recruiting | Dortmund | Germany |
|
| ID | Term |
|---|---|
| D005902 | Glaucoma, Open-Angle |
| ID | Term |
|---|---|
| D005901 | Glaucoma |
| D009798 | Ocular Hypertension |
| D005128 | Eye Diseases |
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| ID | Term |
|---|---|
| D002387 | Cataract Extraction |
| D018918 | Phacoemulsification |
| ID | Term |
|---|---|
| D054140 | Refractive Surgical Procedures |
| D013508 | Ophthalmologic Surgical Procedures |
| D013514 | Surgical Procedures, Operative |
| D059708 | Ultrasonic Surgical Procedures |
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