A Clinical Study To Assess The Safety And Effectiveness Of The OMNI® Surgical System
Completed
- Conditions
- Glaucoma, Open-Angle
- 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
- 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
Related Research Topics
Explore scientific publications, clinical data analysis, treatment approaches, and expert-compiled information related to the mechanisms and outcomes of this trial. Click any topic for comprehensive research insights.
What are the long-term safety outcomes of the OMNI® Surgical System in open-angle glaucoma patients undergoing cataract surgery?
How does the OMNI® Surgical System compare to standard-of-care glaucoma treatments in terms of intraocular pressure reduction and medication use?
Are there specific biomarkers associated with improved outcomes following OMNI® Surgical System intervention in open-angle glaucoma?
What adverse events have been reported with the OMNI® Surgical System in combination with phacoemulsification for glaucoma management?
What are the potential synergistic effects of combining OMNI® Surgical System with other minimally invasive glaucoma surgery (MIGS) devices like the iStent or XEN Gel Stent?
Trial Locations
- 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
Grene Vision Group🇺🇸Wichita, Kansas, United States