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Sponsor-initiated, suspension of study due to modification of key parameters.
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A prospective, multicenter, randomized, single-masked clinical trial to evaluate the effectiveness outcomes of canaloplasty performed as a standalone procedure with the iTrack microcatheter to the Omni surgical system, and to compare the effectiveness of two types of Ophthalmic Viscoelastic Device (OVD).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| iTrack canaloplasty microcatheter with Healon GV Pro | Active Comparator | Patients will be randomized to the iTrack microcatheter (canaloplasty) with Healon GV Pro (ophthalmic viscoelastic device) |
|
| OMNI surgical system with Healon GV Pro | Active Comparator | Patients will be randomized to the OMNI surgical system (canaloplasty) with Healon GV Pro (ophthalmic viscoelastic device) |
|
| iTrack canaloplasty microcatheter with Healon Pro | Active Comparator | Patients will be randomized to the iTrack microcatheter (canaloplasty) with Healon Pro (ophthalmic viscoelastic device) |
|
| OMNI surgical system with Healon Pro | Active Comparator | Patients will be randomized to the OMNI surgical system (canaloplasty) with Healon Pro (ophthalmic viscoelastic device) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Canaloplasty using the iTrack microcatheter with Healon GV Pro | Device | 360 degree microcatheterization and viscodilation of Schlemm's canal |
|
| Measure | Description | Time Frame |
|---|---|---|
| Reduction in mean Intraocular pressure (IOP) and glaucoma medication use at 12 months post-intervention | IOP will be measured at each study visit using Goldmann applanation tonometry | 12 months |
| Measure | Description | Time Frame |
|---|---|---|
| Complications intra-operatively and post-operatively associated with the iTrack canaloplasty microcatheter compared to complications intra-operatively and post-operatively with the OMNI surgical system. | 12 months | |
| Visual acuity at 12 months compared to baseline visual acuity |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Shamil Patel, MD, MBA | Eye Physicians and Surgeons of Arizona | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Arizona Advanced Eye Research Institute | Glendale | Arizona | 85306 | United States | ||
| Beverly Hills Institute of Ophthalmology |
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| Canaloplasty using the Omni surgical system with Healon GV Pro | Device | 360 degree microcatheterization and viscodilation of Schlemm's canal |
|
| Canaloplasty using the iTrack microcatheter with Healon Pro | Device | 360 degree microcatheterization and viscodilation of Schlemm's canal |
|
| Canaloplasty using the Omni surgical system with Healon Pro | Device | 360 degree microcatheterization and viscodilation of Schlemm's canal |
|
Best corrected visual acuity (BCVA) will be assessed using the standard Snellen eye chart
| 12 months |
| Beverly Hills |
| California |
| 90210 |
| United States |
| Coastal Vision | Orange | California | 92868 | United States |
| Dean McGee Eye Institute | Oklahoma City | Oklahoma | 73104 | United States |
| Cataract and Laser Institute of Southern Oregon | Medford | Oregon | 97501 | United States |
| El Paso Eye Surgeons | El Paso | Texas | 79902 | United States |
| Eye Centers of Racine and Kenosha | Kenosha | Wisconsin | 53142 | United States |
| ID | Term |
|---|---|
| D005902 | Glaucoma, Open-Angle |
| ID | Term |
|---|---|
| D005901 | Glaucoma |
| D009798 | Ocular Hypertension |
| D005128 | Eye Diseases |
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