A Clinical Study To Assess The Safety And Effectiveness Of The OMNI® Surgical System
Completed
- Conditions
- Glaucoma, Open-Angle
- Interventions
- Device: OMNI® Surgical System
- Registration Number
- NCT05044793
- Lead Sponsor
- Sight Sciences, Inc.
- Brief 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
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 70
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
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Arm && Interventions
Group Intervention Description Cohort A OMNI® Surgical System Pre-operative washout of ocular hypotensive medications with post-washout DIOP of 21-36mmHg Cohort B OMNI® Surgical System Pre-operative washout of ocular hypotensive medications with pre-operative medicated IOP ≥18 mmHg and on 1 to 5 hypotensive medications
- Primary Outcome Measures
Name Time Method Primary Safety Endpoint 12 months Rate of occurrence of sight-threatening adverse events
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (4)
Grene Vision Group
🇺🇸Wichita, Kansas, United States
Northern Ophthalmics
🇺🇸Jenkintown, Pennsylvania, United States
Oklahoma Eye Surgeons
🇺🇸Oklahoma City, Oklahoma, United States
El Paso Eye Surgeons
🇺🇸El Paso, Texas, United States