An Observational Multicenter Clinical Study To Assess The Safety And Effectiveness Of The OMNI® Surgical System In Pseudophakic Eyes With Primary Open Angle Glaucoma

Overview

The purpose of this study is to evaluate the safety and effectiveness of the OMNI® Surgical System in subjects who have undergone canaloplasty and trabeculotomy using OMNI® Surgical System without any concomitant surgery in pseudophakic eyes with mild to moderate primary open angle glaucoma (POAG) at least 150 days prior to enrollment.

Full Title of Study: “An Observational Multicenter Clinical Study To Assess The Safety And Effectiveness Of The OMNI® Surgical System In Pseudophakic Eyes With Primary Open Angle Glaucoma”

Study Type

  • Study Type: Observational
  • Study Design
    • Time Perspective: Retrospective
  • Study Primary Completion Date: January 2024

Interventions

  • Device: OMNI® Surgical System
    • The OMNI® Surgical System is indicated for canaloplasty (microcatheterization and transluminal viscodilation of Schlemm’s canal) followed by trabeculotomy (cutting of trabecular meshwork) to reduce intraocular pressure in adult patients with primary open-angle glaucoma.

Arms, Groups and Cohorts

  • Eyes receiving OMNI intervention after medication washout
  • Eyes receiving OMNI intervention without medication washout

Clinical Trial Outcome Measures

Primary Measures

  • Decrease in intraocular pressure (IOP)
    • Time Frame: 12 months
    • Decrease in unmedicated mean diurnal IOP (DIOP)
  • Decrease in number of medications
    • Time Frame: 12 months
    • Mean change in the number of ocular hypotensive medications.

Participating in This Clinical Trial

Inclusion Criteria

  • Treated with OMNI® Surgical System as a standalone procedure in pseudophakic eye with mild to moderate primary open angle glaucoma at least 150 days prior to enrollment. Exclusion Criteria:

  • Systemic disease that, in the opinion of the Investigator, would put the subject's health at risk and/or prevent completion of required study visits. – Ocular pathology which, in the Investigator's judgment, would either place the subject at increased risk of complications or contraindicate washout, place the subject at risk of significant vision loss during the study period or interfere with compliance to elements of the study protocol (e.g., returning to Investigator's office for follow-up visits).

Gender Eligibility: All

Minimum Age: N/A

Maximum Age: N/A

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Sight Sciences, Inc.
  • Provider of Information About this Clinical Study
    • Sponsor
  • Overall Contact(s)
    • Kavita Dhamdhere, MD, 877-266-1144, kdhamdhere@sightsciences.com

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