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NCT05044793 Clinical Trial

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

Glaucoma, Open-Angle Clinical Trial

Official 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)

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT05044793
Other study ID # 07408
Secondary ID
Status Completed
Phase
First received
Last updated
Start date September 30, 2021
Est. completion date August 21, 2023

Study information
Verified date January 2024
Source Sight Sciences, Inc.
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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

Recruitment information / eligibility
Status Completed
Enrollment 72
Est. completion date August 21, 2023
Est. primary completion date August 21, 2023
Accepts healthy volunteers No
Gender All
Age group N/A and older
Eligibility 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)

Study Design

Related Conditions & MeSH terms

Intervention

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.

Locations
Country Name City State
United States El Paso Eye Surgeons El Paso Texas
United States Northern Ophthalmics Jenkintown Pennsylvania
United States Oklahoma Eye Surgeons Oklahoma City Oklahoma
United States Grene Vision Group Wichita Kansas

Sponsors (1)
Lead Sponsor Collaborator
Sight Sciences, Inc.

Country where clinical trial is conducted

United States, 

Outcome
Type Measure Description Time frame Safety issue
Primary Change in intraocular pressure (IOP) Change in unmedicated mean diurnal IOP (DIOP) 24months
Primary Change in number of medications Change in the number of ocular hypotensive medications 24months
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