Multicenter Ab-interno Glaucoma Study Investigating Canaloplasty (MAGIC)

March 13, 2023 updated by: Nova Eye, Inc.

Multicenter Ab-interno Glaucoma Study Investigating Canaloplasty, Randomized, Controlled Trial: iTrack (Nova Eye Medical) Compared to Omni (Sight Sciences)

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).

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

20

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Arizona
      • Glendale, Arizona, United States, 85306
        • Arizona Advanced Eye Research Institute
    • California
      • Beverly Hills, California, United States, 90210
        • Beverly Hills Institute of Ophthalmology
      • Orange, California, United States, 92868
        • Coastal Vision
    • Oklahoma
      • Oklahoma City, Oklahoma, United States, 73104
        • Dean McGee Eye Institute
    • Oregon
      • Medford, Oregon, United States, 97501
        • Cataract and Laser Institute of Southern Oregon
    • Texas
      • El Paso, Texas, United States, 79902
        • El Paso Eye Surgeons
    • Wisconsin
      • Kenosha, Wisconsin, United States, 53142
        • Eye Centers of Racine and Kenosha

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

22 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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:

  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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Factorial Assignment
  • Masking: Single

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
12 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
12 months
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
12 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Nova Eye, Inc.

Investigators

  • Principal Investigator: Shamil Patel, MD, MBA, Eye Physicians and Surgeons of Arizona

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

April 29, 2021

Primary Completion (Actual)

January 26, 2023

Study Completion (Actual)

January 26, 2023

Study Registration Dates

First Submitted

February 18, 2021

First Submitted That Met QC Criteria

February 21, 2021

First Posted (Actual)

February 24, 2021

Study Record Updates

Last Update Posted (Actual)

March 15, 2023

Last Update Submitted That Met QC Criteria

March 13, 2023

Last Verified

March 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • NE 01021

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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