Standalone OMNI Surgical System for Open-angle Glaucoma

Study Overview
=================
Brief Summary
-----------------
The emergence of minimally invasive glaucoma surgeries (MIGS) has seen a variety of potential innovative surgical alternatives to help better control intraocular pressure (IOP). The OMNI™ Surgical System (Sight Sciences, Menlo Park, CA, USA) is a promising MIGS procedure. It combines two procedures known as trabeculotomy and viscodilation of Schlemm's canal in one hand held device without the need for additional incisions or extra instrumentation. The device recently received FDA approval in the United States for certain indications in ophthalmic surgery. To date, no study has examined the effect of standalone viscodilation and trabeculotomy on glaucoma drop burden and IOP.

Detailed Description
-----------------
The emergence of minimally invasive glaucoma surgeries (MIGS) has seen a variety of potential innovative surgical alternatives to help better control intraocular pressure (IOP).1 The OMNI™ Surgical System (Sight Sciences, Menlo Park, CA, USA) is a promising procedure which targets the conventional outflow pathway.2 This device treats the trabecular meshwork, Schlemm's canal and the distal collector channels, all conventional pathway points of aqueous outflow resistance. Its designed microcatheter allows for cannulation of Schlemm's canal, dilation using the controlled delivery of viscoelastic as well as a trabeculotomy by stripping the trabecular meshwork will retracting the catheter.3 Goniotomy-assisted transluminal trabeculotomy (GATT) has shown promising results in using an ab interno approach to cleave the trabecular meshwork.4 Alternatively, viscodilation alone has also shown an IOP lowering effect. 5 The OMNI Surgical System combines both procedures in one hand held device without the need for additional incisions or extra instrumentation. The device recently received FDA approval in the United States for delivery of small amounts of viscoelastic fluid during ophthalmic surgery and to cut trabecular meshwork tissue during trabeculotomy procedures.6 To date, no study has examined the effect of standalone viscodilation and trabeculotomy on glaucoma drop burden and IOP.

Official Title
-----------------
Standalone OMNI Surgical System for Open-angle Glaucoma

Conditions
-----------------
Open Angle Glaucoma

Intervention / Treatment
-----------------
* Device: OMNI surgical system


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria Patients aged 30-95 with primary or pigmentary / pseudoexfolliative / juvenile / normal pressure open angle glaucoma or combined mechanism glaucoma. An IOP of 10-40 mmHg on maximum tolerated medical therapy who are either progressing, above IOP target, or poorly adherent or tolerant to medical therapy. Phakic or pseudophakic eyes and previous laser trabeculoplasty will be included. Exclusion Criteria: Other forms of glaucoma, prior incisional glaucoma surgery, prior corneal graft (PKP, DALK, DSAEK, DMEK), Shafer angle grading <2 in 2 or more quadrants.

Ages Eligible for Study
-----------------
Minimum Age: 30 Years
Maximum Age: 95 Years

Sexes Eligible for Study
-----------------
All

Study Plan
=================
How is the study designed?
-----------------

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Oen Angle Glaucoma<br>• Patients aged 30-95 with primary or pigmentary / pseudoexfolliative / juvenile / normal pressure open angle glaucoma or combined mechanism glaucoma with IOP of 10-40 mmHg on maximum tolerated medical therapy who are either progressing, above IOP target, or poorly adherent or tolerant to medical therapy. Phakic or pseudophakic eyes and previous laser trabeculoplasty will be included. | Device: OMNI surgical system<br>* GATT + viscodilation<br>* Other names: OMNI surgical systems;|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Lower Intraocular Pressure and medication dependence | Change in IOP less than or equal to baseline with a medication reduction to 1 or less or an IOP change of 20% or less from baseline with medication | Postoperative week 1, month 1, month 3, annually | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Examine the adverse event profile of the OMNI surgical system in patients with open angle glaucoma. | Absence of the following complications: 1. ) Starting after POM1: shallow AC w/ iridocorneal touch, any hyphema, corneal edema, wound leak/dehiscience, choroidal effusion, malignant glaucoma, dellen/non-healing epithelial defect, ptosis, diplopia, and/or; 2.) At any point: additional glaucoma surgery, loss of light perception vision, vitreous hemorrhage, ≥2mm hyphema, hypotony maculopathy, macular edema, choroidal effusion/hemorrhage requiring drainage, suprachoroidal hemorrhage, retinal detachment, endophthalmitis | 1 month post operatively |