OMNI in Open-angle Glaucoma Treatment

Study Overview
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Brief Summary
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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.

Official Title
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Evaluation of the Effectiveness of the New Surgical Method OMNI in the Treatment of Adult Patients With Open-angle Glaucoma

Conditions
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Open Angle Glaucoma, Cataract, Eye Diseases, Glaucoma

Intervention / Treatment
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* Procedure: OMNI as a standalone procedure
* Procedure: OMNI combined with cataract surgery


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: diagnosed with open-angle glaucoma including pigmentary and pseudoexfoliative glaucoma 0-3 topical ocular hypotensive medications at preoperative baseline. Fixed combinations counted as number of components Open angles (Shaffer grade ≥3) early or moderate glaucoma (based on visual field) Subjects with a combined procedure should have had uncomplicated cataract surgery (i.e. intact and centered capsulorrhexis, intact posterior capsular bag, no evidence of zonular dehiscence or rupture, well centered IOL) Exclusion Criteria: Any of the following prior treatments for glaucoma: Suprachoroidal stent Laser trabeculoplasty ≤6 months prior to OMNI procedure Trabecular bypass implanted ≤6 months prior to OMNI procedure Trabeculectomy or other bleb forming procedure including Xen, Express, glaucoma draining device/valve Prior canaloplasty, goniotomy, or trabeculotomy 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)

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: 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).
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: OMNI as a standalone procedure<br> | Procedure: OMNI as a standalone procedure<br>* 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.<br>|
| Active Comparator: OMNI combined with cataract surgery<br> | Procedure: OMNI combined with cataract surgery<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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glaucoma, open-angle glaucoma, cataract, glaucoma surgery, ophthalmology, OMNI