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

Sight Sciences

Status: Completed

Conditions: Glaucoma, Open-Angle

Treatments: Device: OMNI® Surgical System

Study type: Observational

Funder types: Industry

Identifiers

NCT05044793

07408

Details and patient eligibility

About

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

Enrollment: 70 patients

Sex: All

Volunteers: No 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)

Trial design

70 participants in 2 patient groups

Cohort A

Description:

Subjects who had a surgical washout of ocular hypotensive medications with post-washout DIOP of 21-36mmHg and were treated with OMNI Surgical System for OAG in combination with cataract extraction at least 700 days prior to study enrollment.

Treatment:

Device: OMNI® Surgical System

Cohort B

Description:

Subjects without a surgical washout of ocular hypotensive medications with pre-surgical medicated IOP≥18 mmHg and on 1 to 5hypotensive medications and were treated with OMNI Surgical System for OAG in combination with cataract extraction at least 700 days prior to study enrollment.

Treatment:

Device: OMNI® Surgical System