NCT04427995

Standalone OMNI Surgical System for Open-angle Glaucoma

• Status: Terminated
• Phase: —
• Study type: Observational
• Enrollment: 30 (actual)
• Sponsor: Iqbal Ahmed · Academic / Other
• Sex: All
• Age: 30 Years – 95 Years
• Healthy volunteers: —

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.

Conditions

• Open Angle Glaucoma

Interventions

Type	Name	Description
DEVICE	OMNI surgical system	GATT + viscodilation

Timeline

• Start date: 2019-03-25
• Primary completion: 2021-03-31
• Completion: 2021-04-01
• First posted: 2020-06-11
• Last updated: 2021-07-26

Locations

1 site across 1 country: Canada

Regulatory

• FDA-regulated device study