Study Stopped
Sponsor-initiated, suspension of study due to modification of key parameters.
Multicenter Ab-interno Glaucoma Study Investigating Canaloplasty
MAGIC
1 other identifier
interventional
20
1 country
7
Brief Summary
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).
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable
Started Apr 2021
7 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
February 18, 2021
CompletedFirst Posted
Study publicly available on registry
February 24, 2021
CompletedStudy Start
First participant enrolled
April 29, 2021
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 26, 2023
CompletedStudy Completion
Last participant's last visit for all outcomes
January 26, 2023
CompletedMarch 15, 2023
March 1, 2023
1.7 years
February 18, 2021
March 13, 2023
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Reduction in mean Intraocular pressure (IOP) and glaucoma medication use at 12 months post-intervention
IOP will be measured at each study visit using Goldmann applanation tonometry
12 months
Secondary Outcomes (2)
Complications intra-operatively and post-operatively associated with the iTrack canaloplasty microcatheter compared to complications intra-operatively and post-operatively with the OMNI surgical system.
12 months
Visual acuity at 12 months compared to baseline visual acuity
12 months
Study Arms (4)
iTrack canaloplasty microcatheter with Healon GV Pro
ACTIVE COMPARATORPatients will be randomized to the iTrack microcatheter (canaloplasty) with Healon GV Pro (ophthalmic viscoelastic device)
OMNI surgical system with Healon GV Pro
ACTIVE COMPARATORPatients will be randomized to the OMNI surgical system (canaloplasty) with Healon GV Pro (ophthalmic viscoelastic device)
iTrack canaloplasty microcatheter with Healon Pro
ACTIVE COMPARATORPatients will be randomized to the iTrack microcatheter (canaloplasty) with Healon Pro (ophthalmic viscoelastic device)
OMNI surgical system with Healon Pro
ACTIVE COMPARATORPatients will be randomized to the OMNI surgical system (canaloplasty) with Healon Pro (ophthalmic viscoelastic device)
Interventions
360 degree microcatheterization and viscodilation of Schlemm's canal
360 degree microcatheterization and viscodilation of Schlemm's canal
360 degree microcatheterization and viscodilation of Schlemm's canal
360 degree microcatheterization and viscodilation of Schlemm's canal
Eligibility Criteria
You may qualify if:
- 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
- Shaffer grade of \> or = III in all four quadrants
- Able and willing to comply with the Protocol and follow up visits for 12 months
You may not qualify if:
- Laser trabeculoplasty other than selective laser trabeculoplasty (SLT)
- History of iStent or iStent inject within 180 days of the screening visit
- History of ECP or Micropulse laser
- Trabeculectomy or other bleb forming procedure including Xen, Express and glaucoma drainage device/valves
- Prior canaloplasty (ab interno and ab externo)
- Prior goniotomy or trabeculotomy
- History of Hydrus microstent or suprachoroidal stent
- History of cataract surgery within 6 months of screening
- Acute angle closure, traumatic, congenital, malignant, uveitic or neovascular glaucoma, pigmentary or pseudoexfoliative glaucoma
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Nova Eye, Inc.lead
Study Sites (7)
Arizona Advanced Eye Research Institute
Glendale, Arizona, 85306, United States
Beverly Hills Institute of Ophthalmology
Beverly Hills, California, 90210, United States
Coastal Vision
Orange, California, 92868, United States
Dean McGee Eye Institute
Oklahoma City, Oklahoma, 73104, United States
Cataract and Laser Institute of Southern Oregon
Medford, Oregon, 97501, United States
El Paso Eye Surgeons
El Paso, Texas, 79902, United States
Eye Centers of Racine and Kenosha
Kenosha, Wisconsin, 53142, United States
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Shamil Patel, MD, MBA
Eye Physicians and Surgeons of Arizona
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- PARTICIPANT
- Purpose
- TREATMENT
- Intervention Model
- FACTORIAL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
February 18, 2021
First Posted
February 24, 2021
Study Start
April 29, 2021
Primary Completion
January 26, 2023
Study Completion
January 26, 2023
Last Updated
March 15, 2023
Record last verified: 2023-03
Data Sharing
- IPD Sharing
- Will not share