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This single-center, prospective study will assess safety and effectiveness of 360 degree viscodilation followed by up to 360 degree trabeculotomy used in patients with early or moderate open-angle glaucoma in a real-world setting either as a standalone procedure in pseudophakic patients (or phakic) or combined with phacoemulsification cataract procedures.
Medication usage, IOP and secondary surgical procedures necessary for IOP control will be analyzed during the follow-up period.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| OMNI as a standalone procedure | Active Comparator |
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| OMNI combined with cataract surgery | Active Comparator |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| OMNI as a standalone procedure | Procedure | It uses a single, self-sealing clear corneal incision with ab-interno transluminal 360 degree viscodilation of Schlemm's canal followed by up to 360 degree trabeculotomy performed using the OMNI Surgical System as a standalone procedure. |
| Measure | Description | Time Frame |
|---|---|---|
| Proportion of eyes with a 20% reduction from baseline in IOP at 12 months on the same number, or fewer, ocular hypotensive medications as at the pre-operative baseline | 1 year | |
| Number of Participants wih Postoperative complications | 1 year |
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Inclusion Criteria:
Exclusion Criteria:
Any of the following prior treatments for glaucoma:
Forms of glaucoma other than OAG including: acute angle closure, traumatic, congenital, malignant, uveitic or neovascular glaucoma
Under treatment with oral carbonic anhydrase inhibitor at the preoperative visit
Clinically significant ocular pathology, other than age-related cataract and glaucoma. (e.g. wet AMD, uveitis, corneal edema, proliferative diabetic retinopathy, optic neuritis in medical history)
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| Name | Affiliation | Role |
|---|---|---|
| Iwona Grabska-Liberek, MD, PhD | Ophthalmology Clinic Centre of Postgraduate Medical Education, Warsaw, Poland | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Orlowski Hospital, Centre of Postgraduate Medical Education | Warsaw | 00-401 | Poland |
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| ID | Term |
|---|---|
| D005902 | Glaucoma, Open-Angle |
| D002386 | Cataract |
| D005128 | Eye Diseases |
| D005901 | Glaucoma |
| ID | Term |
|---|---|
| D009798 | Ocular Hypertension |
| D007905 | Lens Diseases |
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| ID | Term |
|---|---|
| D002387 | Cataract Extraction |
| ID | Term |
|---|---|
| D054140 | Refractive Surgical Procedures |
| D013508 | Ophthalmologic Surgical Procedures |
| D013514 | Surgical Procedures, Operative |
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To prospectively assess the clinical effect of ab-interno transluminal viscodilation and trabeculotomy performed using the OMNI Surgical System as a standalone procedure or in combination with cataract extraction on intraocular pressure (IOP) and the use of ocular hypotensive medications in patients with open-angle glaucoma (OAG).
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| OMNI combined with cataract surgery | Procedure | Phacoemulsification with intraocular lens implantation is performed. Then, ab-interno transluminal 360 degree viscodilation of Schlemm's canal followed by up to 360 degree trabeculotomy performed using the OMNI Surgical System. |
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