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Completed

NCT Number: NCT05044793

A Clinical Study To Assess The Safety And Effectiveness Of The OMNI® Surgical System

The purpose of this study is to evaluate the long-term safety and effectiveness of the OMNI® Surgical System in subjects who were treated under protocol #06213

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Key information

Conditions

Glaucoma, Open-Angle Eye Diseases Glaucoma Ocular Hypertension

Sex eligibility

All sexes

Study type

Observational

Primary location

Grene Vision Group, Wichita, Kansas, United States

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Participated in, received treatment, and completed Protocol #06213

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, contraindicate washout, place the subject at risk of significant vision loss during the study period (e.g., wet age macular degeneration (AMD), corneal edema, Fuch's dystrophy, active intraocular infection or inflammation within 30 days prior to Screening Visit, etc.), or interfere with compliance to elements of the study protocol (e.g., returning to Investigator's office for follow-up visits)

Treatment and study plan

OMNI® Surgical System

Device

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.

Primary outcomes

  1. Primary Safety Endpoint

    Time frame: 12 months

    Rate of occurrence of sight-threatening adverse events

Other outcomes

  1. Change in Intraocular Pressure (IOP)

    Time frame: 12 months

    Mean change in IOP

  2. Change in Hypotensive Medications

    Time frame: 12 months

    Reduction in number of hypotensive medications from baseline to 36 months

  3. Number of Participants With ≥20% Reduction in IOP From Baseline to 36 Months

    Time frame: 12 months

    For subjects in cohort A : ≥20% reduction in unmedicated diurnal IOP from baseline to 36 months For subjects in cohort B: ≥20% reduction in mean medicated IOP from baseline to 36 months

  4. Number of Participants With Intraocular Pressure (IOP) Between 6 and 18mmHg Inclusive.

    Time frame: 12 months

    For cohort A: unmedicated diurnal IOP between 6 and 18 mmHg inclusive For cohort B: medicated IOP between 6 and 18 mmHg inclusive

Sponsors and collaborators

Lead sponsor

Sight Sciences, Inc.

Industry

Registry information

Official study title

A Multicenter Clinical Study To Assess The Long-Term Safety And Effectiveness Of The OMNI® Surgical System In Combination With Cataract Surgery In Eyes With Open Angle Glaucoma (GEMINI 2.0)

Important dates

Study start
2021
Primary completion
2023
Study completion
2023
First posted
Sep 16, 2021
Registry last updated
Jan 22, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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