Standalone OMNI Surgical System for Open-angle Glaucoma
NCT04427995 · Status: TERMINATED · Type: OBSERVATIONAL · Enrollment: 30
Last updated 2021-07-26
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.
Conditions
Interventions
- DEVICE
-
OMNI surgical system
GATT + viscodilation
Sponsors & Collaborators
-
OMNI Medical Services, LLC
collaborator NETWORK -
Iqbal Ahmed
lead OTHER
Principal Investigators
-
Iqbal Ahmed, MD · Prism Eye Institute
Eligibility
- Min Age
- 30 Years
- Max Age
- 95 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2019-03-25
- Primary Completion
- 2021-03-31
- Completion
- 2021-04-01
- FDA Device
- Yes
Countries
- Canada
Study Locations
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