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A Clinical Study To Assess The Safety And Effectiveness Of The OMNI® Surgical System | Clinical Trials | Clareo Health

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

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)

NCT05044793•Sight Sciences, Inc.

View on ClinicalTrials.gov

Summary

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

Eligibility

Age

All ages

Sex

ALL

Healthy Volunteers

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)

Locations (4)

Grene Vision Group

Wichita, Kansas, United States

Oklahoma Eye Surgeons

Oklahoma City, Oklahoma, United States

Northern Ophthalmics

Jenkintown, Pennsylvania, United States

El Paso Eye Surgeons

El Paso, Texas, United States

Key Dates

Start Date

September 1, 2021

Primary Completion Date

August 21, 2023

Completion Date

August 21, 2023

Last Updated

January 22, 2025

Enrollment

ACTUAL participants

Conditions

Glaucoma, Open-Angle

Interventions

OMNI® Surgical System

DEVICE

Feasibility Clinical Evaluation of the Calibreye System

NCT05885022

Glaucoma, Open-Angle

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RECRUITINGNA

Evaluation of Phacogoniotomy in Medically-controlled POAG

NCT06201455

Glaucoma, Open-AngleCataract Complicated+1 more

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RECRUITINGNA

Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: January 22, 2025Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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

Inclusion Criteria

Exclusion Criteria

Feasibility Clinical Evaluation of the Calibreye System

Evaluation of Phacogoniotomy in Medically-controlled POAG

Results of Patients With Glaucoma Undergoing Minimally Invasive Glaucoma Surgery in Conjunction With Cataract Surgery

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