An Observational Multicenter Clinical Study To Assess The Safety And Effectiveness Of The OMNI® Surgical System In Pseudophakic Eyes With Primary Open Angle Glaucoma (ORION 2.0)

Sight Sciences

Status

Completed

Conditions

Glaucoma, Open-Angle

Treatments

Device: OMNI® Surgical System

Study type

Observational

Funder types

Industry

Identifiers

NCT04872348

07355

Details and patient eligibility

About

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.

Enrollment

28 patients

Sex

All

Volunteers

No Healthy Volunteers

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).