Multicenter Ab-interno Glaucoma Study Investigating Canaloplasty
(MAGIC Trial)
Recruiting at 6 trial locations
SP
Overseen byShamil Patel, MD, MBA
Age: 18+
Sex: Any
Travel: May Be Covered
Time Reimbursement: Varies
Trial Phase: Academic
Waitlist Available
Sponsor: Nova Eye, Inc.
No Placebo Group
Trial Summary
What is the purpose of this trial?
A prospective, multicenter, randomized, single-masked clinical trial to evaluate the effectiveness outcomes of canaloplasty performed as a standalone procedure with the iTrack microcatheter to the Omni surgical system, and to compare the effectiveness of two types of Ophthalmic Viscoelastic Device (OVD).
Research Team
SP
Shamil Patel, MD, MBA
Principal Investigator
Eye Physicians and Surgeons of Arizona
Eligibility Criteria
Inclusion Criteria
Diagnosed with mild to moderate open angle Glaucoma.
Visual Field test (Humphrey SITA standard 24-2) with mean deviation better than or equal to -12.0 dB
IOP < or = to 36 mmHG while on one to four ocular hypotensive medications
See 2 more
Treatment Details
Interventions
- ab-interno canaloplasty using the iTrack surgical system with Healon GV Pro (Procedure)
- Ab-interno canaloplasty using the iTrack surgical system with Healon Pro (Procedure)
- Ab-interno canaloplasty using the Omni surgical system with Healon GV Pro (Procedure)
- Ab-interno canaloplasty using the Omni surgical system with Healon Pro (Procedure)
- Canaloplasty using the iTrack microcatheter with Healon GV Pro (Procedure)
- Canaloplasty using the iTrack microcatheter with Healon Pro (Procedure)
- Canaloplasty using the Omni surgical system with Healon GV Pro (Procedure)
- Canaloplasty using the Omni surgical system with Healon Pro (Procedure)
Participant Groups
4Treatment groups
Active Control
Group I: iTrack canaloplasty microcatheter with Healon ProActive Control1 Intervention
Patients will be randomized to the iTrack microcatheter (canaloplasty) with Healon Pro (ophthalmic viscoelastic device)
Group II: OMNI surgical system with Healon ProActive Control1 Intervention
Patients will be randomized to the OMNI surgical system (canaloplasty) with Healon Pro (ophthalmic viscoelastic device)
Group III: iTrack canaloplasty microcatheter with Healon GV ProActive Control1 Intervention
Patients will be randomized to the iTrack microcatheter (canaloplasty) with Healon GV Pro (ophthalmic viscoelastic device)
Group IV: OMNI surgical system with Healon GV ProActive Control1 Intervention
Patients will be randomized to the OMNI surgical system (canaloplasty) with Healon GV Pro (ophthalmic viscoelastic device)
Find a Clinic Near You
Who Is Running the Clinical Trial?
Nova Eye, Inc.
Lead Sponsor
Trials
3
Recruited
240+