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TerminatedNCT04769453MAGICUpdated Mar 15, 2023

Multicenter Ab-interno Glaucoma Study Investigating Canaloplasty

An interventional study of Canaloplasty using the iTrack microcatheter with Healon GV Pro and Canaloplasty using the Omni surgical system with Healon GV Pro in Primary Open Angle Glaucoma, sponsored by Nova Eye, Inc.. Terminated at 7 sites in United States. Open to participants aged 22 Years and older. Per ClinicalTrials.gov, last updated 2023-03-15.

Sponsored by Nova Eye, Inc. · Not applicable, Interventional, and Treatment

Why this study was terminated
Sponsor-initiated, suspension of study due to modification of key parameters.

From the registry’s dates

  • Primary completion was Jan 2023, 3 years 8 months ago, and no results have been posted to the registry.
Phase
Not applicable
Study type
Interventional
Enrollment
20
Allocation
Randomized
Ages
22 Years and older
Sex
All
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Study 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).

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Conditions studied

  • Primary Open Angle Glaucoma

Keywords

  • Canaloplasty
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In context

Glaucoma

1,818 studies on the registry are indexed under Glaucoma; 231 are open to participants now.

This study's enrollment of 20 is below the median of 65 across 1,272 interventional studies indexed under Glaucoma.

Browse Glaucoma studies →

Lead sponsor

Nova Eye, Inc. is the lead sponsor of 3 studies on the registry; 2 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
22 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

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. Shaffer 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

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
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Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Factorial assignment
Masking
Single (Participant)
Enrollment
20 participants (actual)

Study arms

  • 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

  • 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

  • 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

  • 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

Interventions

  • DeviceCanaloplasty using the iTrack microcatheter with Healon GV Pro

    360 degree microcatheterization and viscodilation of Schlemm's canal

  • DeviceCanaloplasty using the Omni surgical system with Healon GV Pro

    360 degree microcatheterization and viscodilation of Schlemm's canal

  • DeviceCanaloplasty using the iTrack microcatheter with Healon Pro

    360 degree microcatheterization and viscodilation of Schlemm's canal

  • DeviceCanaloplasty using the Omni surgical system with Healon Pro

    360 degree microcatheterization and viscodilation of Schlemm's canal

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What researchers measure

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

    Time frame: 12 months

Secondary outcomes

  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

    Best corrected visual acuity (BCVA) will be assessed using the standard Snellen eye chart

    Time frame: 12 months

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Study locations

7 sites
  • 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
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References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Mar 15, 2023, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT04769453
Lead sponsor
Nova Eye, Inc.
Responsible party
Sponsor
First posted
Feb 24, 2021
Start date
Apr 29, 2021
Primary completion
Jan 26, 2023
Completion
Jan 26, 2023
Last update
Mar 15, 2023

Study contacts

Shamil Patel, MD, MBA
principal investigator · Eye Physicians and Surgeons of Arizona

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
Yes
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is terminated, as verified in Mar 2023. You cannot join it, but the record below documents what was studied.

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