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Multicenter Ab-interno Glaucoma Study Investigating Canaloplasty (MAGIC)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04769453
Recruitment Status : Suspended (Sponsor-initiated, suspension of study due to modification of key parameters.)
First Posted : February 24, 2021
Last Update Posted : November 26, 2021
Sponsor:
Information provided by (Responsible Party):
Nova Eye, Inc.

Study Description
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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).

Condition or disease Intervention/treatment Phase
Primary Open Angle Glaucoma Device: Canaloplasty using the iTrack microcatheter with Healon GV Pro Device: Canaloplasty using the Omni surgical system with Healon GV Pro Device: Canaloplasty using the iTrack microcatheter with Healon Pro Device: Canaloplasty using the Omni surgical system with Healon Pro Not Applicable

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 156 participants
Allocation: Randomized
Intervention Model: Factorial Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
Official Title: Multicenter Ab-interno Glaucoma Study Investigating Canaloplasty, Randomized, Controlled Trial: iTrack (Nova Eye Medical) Compared to Omni (Sight Sciences)
Actual Study Start Date : April 29, 2021
Estimated Primary Completion Date : June 2022
Estimated Study Completion Date : July 2022

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Glaucoma

Arms and Interventions
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Arm Intervention/treatment
Active Comparator: iTrack canaloplasty microcatheter with Healon GV Pro
Patients will be randomized to the iTrack microcatheter (canaloplasty) with Healon GV Pro (ophthalmic viscoelastic device)
 Device: Canaloplasty using the iTrack microcatheter with Healon GV Pro
360 degree microcatheterization and viscodilation of Schlemm's canal
Active Comparator: OMNI surgical system with Healon GV Pro
Patients will be randomized to the OMNI surgical system (canaloplasty) with Healon GV Pro (ophthalmic viscoelastic device)
 Device: Canaloplasty using the Omni surgical system with Healon GV Pro
360 degree microcatheterization and viscodilation of Schlemm's canal
Active Comparator: iTrack canaloplasty microcatheter with Healon Pro
Patients will be randomized to the iTrack microcatheter (canaloplasty) with Healon Pro (ophthalmic viscoelastic device)
 Device: Canaloplasty using the iTrack microcatheter with Healon Pro
360 degree microcatheterization and viscodilation of Schlemm's canal
Active Comparator: OMNI surgical system with Healon Pro
Patients will be randomized to the OMNI surgical system (canaloplasty) with Healon Pro (ophthalmic viscoelastic device)
 Device: Canaloplasty using the Omni surgical system with Healon Pro
360 degree microcatheterization and viscodilation of Schlemm's canal


Outcome Measures
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Primary Outcome Measures :
  1. Reduction in mean Intraocular pressure (IOP) and glaucoma medication use at 12 months post-intervention [ Time Frame: 12 months ]
    IOP will be measured at each study visit using Goldmann applanation tonometry


Secondary Outcome Measures :
  1. 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. [ Time Frame: 12 months ]
  2. Visual acuity at 12 months compared to baseline visual acuity [ Time Frame: 12 months ]
    Best corrected visual acuity (BCVA) will be assessed using the standard Snellen eye chart


Eligibility Criteria
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Ages Eligible for Study:   22 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Diagnosed with mild to moderate open angle Glaucoma.
  2. Visual Field test (Humphrey SITA standard 24-2) with mean deviation better than or equal to -12.0 dB
  3. IOP < or = to 36 mmHG while on one to four ocular hypotensive medications
  4. Schaffer grade of > or = III in all four quadrants
  5. Able and willing to comply with the Protocol and follow up visits for 12 months

Exclusion Criteria:

  1. Laser trabeculoplasty other than selective laser trabeculoplasty (SLT)
  2. History of iStent or iStent inject within 180 days of the screening visit
  3. History of ECP or Micropulse laser
  4. Trabeculectomy or other bleb forming procedure including Xen, Express and glaucoma drainage device/valves
  5. Prior canaloplasty (ab interno and ab externo)
  6. Prior goniotomy or trabeculotomy
  7. History of Hydrus microstent or suprachoroidal stent
  8. History of cataract surgery within 6 months of screening
  9. Acute angle closure, traumatic, congenital, malignant, uveitic or neovascular glaucoma, pigmentary or pseudoexfoliative glaucoma
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04769453


Locations
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United States, Arizona
Arizona Advanced Eye Research Institute
Glendale, Arizona, United States, 85306
United States, California
Beverly Hills Institute of Ophthalmology
Beverly Hills, California, United States, 90210
Coastal Vision
Orange, California, United States, 92868
United States, Oklahoma
Dean McGee Eye Institute
Oklahoma City, Oklahoma, United States, 73104
United States, Oregon
Cataract and Laser Institute of Southern Oregon
Medford, Oregon, United States, 97501
United States, Texas
El Paso Eye Surgeons
El Paso, Texas, United States, 79902
United States, Wisconsin
Eye Centers of Racine and Kenosha
Kenosha, Wisconsin, United States, 53142
Sponsors and Collaborators
Nova Eye, Inc.
Investigators
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Principal Investigator: Shamil Patel, MD, MBA Eye Physicians and Surgeons of Arizona
More Information
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Responsible Party: Nova Eye, Inc.
ClinicalTrials.gov Identifier: NCT04769453    
Other Study ID Numbers: NE 01021
First Posted: February 24, 2021    Key Record Dates
Last Update Posted: November 26, 2021
Last Verified: November 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Product Manufactured in and Exported from the U.S.: Yes
Keywords provided by Nova Eye, Inc.:
Canaloplasty
Additional relevant MeSH terms:
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Glaucoma
Glaucoma, Open-Angle
Ocular Hypertension
Eye Diseases
Hyaluronic Acid
 Adjuvants, Immunologic
Immunologic Factors
Physiological Effects of Drugs
Viscosupplements
Protective Agents