Standalone OMNI Surgical System for Open-angle Glaucoma

NCT04427995 · Status: TERMINATED · Type: OBSERVATIONAL · Enrollment: 30

Last updated 2021-07-26

No results posted yet for this study

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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Entities

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04427995 on ClinicalTrials.gov