Clinical Trials Logo
  1. Home
  2. Open-Angle Glaucoma
  3. NCT04427995

Standalone OMNI Surgical System for Open-angle Glaucoma — OMNIgl  

Open Angle Glaucoma Clinical Trial

Official title:
Standalone OMNI Surgical System for Open-angle Glaucoma

Clinical Trial 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.

Clinical Trial 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. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT04427995
Study type Observational
Source Prism Eye Institute
Contact
Status Terminated
Phase
Start date March 25, 2019
Completion date April 1, 2021
View Details
See also
  Status Clinical Trial Phase
Completed NCT03284853 - Safety and Efficacy Study of PG324 (Netarsudil/Latanoprost 0.02% / 0.005%) Ophthalmic Solution Compared to GANFORT® Ophthalmic Solution in Open Angle Glaucoma or Ocular Hypertension Phase 3
Terminated NCT03611530 - CoQun Study - (COQUN): a Study to Evaluate the Effects of CoQun in Patients Affected by Open-angle Glaucoma N/A
Not yet recruiting NCT06441643 - Next Generation Rocklatan Phase 2
Not yet recruiting NCT02868502 - Different Glaucoma Treatments Effect on Intraocular Pressure Fluctuation With Postural Change in Eyes With Open-angle Glaucoma N/A
Completed NCT02628223 - 180 Degree vs. 360 Degree Selective Laser Trabeculoplasty as Initial Therapy for Glaucoma N/A
Completed NCT02272569 - STARflo European Safety and Efficacy Study N/A
Completed NCT01936389 - A Prospective Study to Assess the Hypotensive Efficacy of Rho-Kinase Inhibitor AR-12286 Ophthalmic Solution 0.5% and 0.7% in Patients With Exfoliation Syndrome and Ocular Hypertension or Glaucoma Phase 2
Completed NCT00941525 - Central Corneal Thickness and 24-hour Fluctuation of Intraocular Pressure Phase 4
Completed NCT00539526 - Evaluation of Hyperemia With the Use of Ocular Prostaglandin Analogues Phase 4
Completed NCT00121147 - Additivity Study: Additive Effect on Eye Pressure of Azopt and Alphagan P to Travatan N/A
Active, not recruiting NCT05035394 - Swedish Microinvasive Glaucoma Surgery Study (SMIGS) N/A
Completed NCT03450629 - Evaluation of Safety and Efficacy of PDP-716 Phase 3
Active, not recruiting NCT06061718 - Travoprost Intraocular Implant in Conjunction With Cataract Surgery Phase 3
Recruiting NCT05241938 - PSLT Compared to Prostaglandin Analogue Eye Drops N/A
Completed NCT01342406 - Effects of Selective Laser Trabeculoplasty on Aqueous Humor Dynamics
Completed NCT02250612 - SYL040012, Treatment for Open Angle Glaucoma Phase 2
Completed NCT01937312 - Effect of SIMBRINZA® Suspension as an Added Therapy to a Prostaglandin Analogue Phase 4
Completed NCT01937299 - Effect of SIMBRINZA® Suspension as an Added Therapy to TRAVATAN Z® Phase 4
Terminated NCT01983579 - TF (SENSIMED Triggerfish) in Intraocular Anti-VEGF (Vascular Endothelial Growth Factor) Injection Phase 4
Completed NCT01229982 - A Study Evaluating the Latanoprost Punctal Plug Delivery System (L-PPDS) in Subjects With Ocular Hypertension or Open-Angle Glaucoma Phase 2