Trials / Recruiting
RecruitingNCT05786196
Multicenter Glaucoma Study Investigating Standalone Canaloplasty
Multicenter Glaucoma Study Investigating Standalone Canaloplasty, Randomized Controlled Trial: iTrack Advance (Nova Eye, Inc.) Compared to OMNI (Sight Sciences)
- Status
- Recruiting
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 86 (estimated)
- Sponsor
- Nova Eye, Inc. · Industry
- Sex
- All
- Age
- 22 Years
- Healthy volunteers
- Not accepted
Summary
A multicenter, randomized, clinical trial to evaluate the efficacy of canaloplasty performed as a standalone procedure using the iTrack™ Advance canaloplasty device (Nova Eye, Inc.) as compared to the OMNI® Surgical System (Sight Sciences) in patients with mild to moderate primary open-angle glaucoma.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DEVICE | Ab-interno canaloplasty utilizing the iTrack Advance device | 360 degree microcatheterization and viscodilation of Schlemm's canal |
| DEVICE | Ab-interno canaloplasty utilizing the OMNI Surgical System | 360 degree microcatheterization and viscodilation of Schlemm's canal |
Timeline
- Start date
- 2023-05-09
- Primary completion
- 2026-12-01
- Completion
- 2026-12-01
- First posted
- 2023-03-27
- Last updated
- 2025-04-18
Locations
5 sites across 3 countries: Germany, Spain, United Kingdom
Regulatory
- FDA-regulated device study
Source: ClinicalTrials.gov record NCT05786196. Inclusion in this directory is not an endorsement.