At a glance
ClinicalIndex Comparison RecordN/ACompleted· 70 enrolled
Drug / intervention
OMNI® Surgical Systemdevice
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
A Multicenter Clinical Study To Assess The Long-Term Safety And Effectiveness Of The OMNI® Surgical System In Combination With Cataract Surgery In Eyes With Open Angle Glaucoma (GEMINI 2.0)
In Brief
An observational study evaluating OMNI® Surgical System for Glaucoma, Open-Angle. Completed, enrolled 70 participants across 4 sites.
Detailed 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
Study Details
Study Typeobservational
Allocation--
Masking--
Primary Purpose--
ConditionsGlaucoma, Open-Angle
CountriesUnited States
Collaborators--
Timeline
N/ACompletedFinished
20222023202420252026
Enrollment StartSep 2021
First PostedSep 2021
Primary CompletionAug 2023
TodayJul 2026
First PostedSep 16, 2021
Enrollment StartSep 1, 2021
Primary CompletionAug 21, 2023
TodayJul 2, 2026
Enrollment to primary: 2.0 yearsPosted 4.8 years ago
Interventions
OMNI® Surgical Systemdevice
The OMNI® Surgical System is indicated for canaloplasty (microcatheterization and transluminal viscodilation of Schlemm's canal) followed by trabeculotomy (cutting of trabecular meshwork) to reduce intraocular pressure in adult patients with primary open-angle glaucoma.