N/A
Completed N=70
A Clinical Study To Assess The Safety And Effectiveness Of The OMNI® Surgical System
Glaucoma, Open-Angle
Source: ClinicalTrials.gov NCT05044793 ↗
Enrolled (actual)
70
Serious AEs
1.4%
Results posted
Jan 2025
Primary outcomePrimary: Primary Safety Endpoint — 0; 0 adverse event
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
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Primary Safety Endpoint |
0; 0 | — |
Eligibility Criteria
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)
Data sourced from ClinicalTrials.gov (NCT05044793). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.