Multicenter Glaucoma Study Investigating Standalone Canaloplasty (MAGIC)

April 15, 2025 updated by: Nova Eye, Inc.

Multicenter Glaucoma Study Investigating Standalone Canaloplasty, Randomized Controlled Trial: iTrack Advance (Nova Eye, Inc.) Compared to OMNI (Sight Sciences)

A multicenter, randomized, clinical trial to evaluate the efficacy of canaloplasty performed as a standalone procedure using the iTrack™ Advance canaloplasty device (Nova Eye, Inc.) as compared to the OMNI® Surgical System (Sight Sciences) in patients with mild to moderate primary open-angle glaucoma.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
86

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • 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 Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Locations

  • Germany
      • Düsseldorf, Germany
        • Recruiting
        • Breyer Kaymak Klabe Augenchirurgie
        • Contact:
          • Karsten Klabe, MD
  • Spain
      • Madrid, Spain
        • Recruiting
        • Hospital Clinico San Carlos, Servicio de Oftalmologia
        • Contact:
          • Jose Martinez de la Casa, MD
  • United Kingdom
      • Edinburgh, United Kingdom
        • Recruiting
        • Princess Alexandra Eye Pavilion, NHS Lothian
        • Contact:
          • Andrew Tatham, MD
      • Liverpool, United Kingdom
        • Recruiting
        • St. Paul's Eye Unit, Liverpool University
        • Contact:
          • Neeru Vallabh, PhD
      • Manchester, United Kingdom
        • Recruiting
        • Manchester Royal Eye Hospital
        • Contact:
          • Leon Au, MD

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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

22 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Male or female subjects, 22 years or older at the time of surgery
  • Diagnosed with mild to moderate primary open angle glaucoma
  • Candidate for canaloplasty surgery: i.e., catheterization of Schlemm's canal and subsequent viscodilation of Schlemm's canal, without trabeculotomy
  • Intolerance to medical therapy OR need/willingness to reduce medications
  • At the Screening Visit, IOP of ≤ 30 mmHg while on 1-4 ocular hypotensive medications
  • At the Baseline Visit, unmedicated IOP ≥ 21mmHg and ≤ 36 mmHg, and ≥ 3mmHg higher than medicated IOP
  • Shaffer grade of ≥ 3 in all four quadrants
  • Central corneal thickness ≥ 480µm and ≤ 620 µm
  • Able and willing to comply with the study procedures and attend all follow-up visits
  • Understands and signs the informed consent

Exclusion Criteria:

  • Any of the following prior treatments for glaucoma (study eye):

    1. Laser trabeculoplasty

      i. Selective Laser Trabeculoplasty (SLT) conducted within 6-months of the Screening Visit ii. Prior Argon Laser Trabeculoplasty

    2. iStent or iStent Inject within 180 days of the Screening Visit
    3. Endocyclophotocoagulation (ECP) or Micropulse laser
    4. Trabeculectomy or other bleb forming procedure including Xen, Express, and glaucoma draining device/valve
    5. Prior canaloplasty (ab interno and ab externo)
    6. Prior goniotomy, or trabeculotomy (ab externo and ab interno)
    7. Hydrus microstent
    8. Suprachoroidal stent (e.g., Cypass, iStent Supra, MINIject)
    9. Concurrent IOP-lowering procedure other than use of the iTrack Advance canaloplasty device OR the OMNI Surgical System at the time of surgery (e.g., ECP, CPC, etc.)
  • Acute angle closure, traumatic, congenital, malignant, uveitic or neovascular glaucoma, pigmentary glaucoma or pseudoexfoliative glaucoma
  • Cataract surgery within 6 months of the Screening Visit in the study eye
  • History of fellow eye with cataract surgery within 30 days of Screening
  • Subjects at significant risk by a washout of ocular hypotensive medication, and/or subjects where the unmedicated IOP is expected to exceed the upper limit of 36 mmHg
  • Use of systemic medications (either current, within 30 calendar days of Screening exam, or anticipated) that may cause an increase in IOP, (e.g., systemic steroids including inhaled and oral steroids used on a regular basis)
  • Ocular and/or systemic diseases that could affect the corneal endothelium (such as corneal endothelial dystrophy, intraocular inflammation and infection, or congenital abnormalities)
  • History of penetrating keratoplasty or another corneal transplant
  • BCVA of 20/200 or worse in the fellow eye not due to cataract
  • Previous treatment with OMNI or iTrack (Note: permitted if fellow eye only was treated)
  • BCVA of 20/50 or worse in the study eye not due to posterior capsular opacification

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: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Active Comparator: iTrack Advance
Ab-interno canaloplasty utilizing the iTrack Advance microcatheter device (Nova Eye, Inc.)
Device: Ab-interno canaloplasty utilizing the iTrack Advance device
360 degree microcatheterization and viscodilation of Schlemm's canal
Active Comparator: OMNI Surgical System
Ab-interno canaloplasty utilizing the OMNI Surgical System
Device: Ab-interno canaloplasty utilizing the OMNI Surgical System
360 degree microcatheterization and viscodilation of Schlemm's canal

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
The mean change in unmedicated Intraocular pressure (IOP) at Month-12 compared to baseline
Time Frame: 12 months
IOP will be measured at each visit with Goldmann applanation tonometry
12 months
Percentage of eyes achieving a 20% or greater reduction in unmedicated Intraocular pressure (IOP) at Month-12 compared to baseline and without any other intervention (medication or secondary surgery)
Time Frame: 12 months
IOP will be measured at each visit with Goldmann applanation tonometry
12 months

Collaborators and Investigators

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

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Nova Eye, Inc.

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Nova Eye Medical GmbH

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • 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)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
May 9, 2023

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
December 1, 2026

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 1, 2026

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
March 14, 2023

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 14, 2023

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
March 27, 2023

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
April 18, 2025

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 15, 2025

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
April 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • NE 05021

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.

Clinical Trials on Primary Open Angle Glaucoma

Clinical Trials on Ab-interno canaloplasty utilizing the iTrack Advance device

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Cookie Settings

We use cookies to ensure that we give you the best experience on our website. For more details carefully read our Privacy and Cookies Policy. ...>>>You can change your preferences or withdraw your consent at any time by deleting the cookies from your website or computer as described in the policy. Please accept it and choose your preferences by ticking the corresponding boxes in the "Manage Settings" section below. Please carefully read our Terms of Service before you proceed with using any part of this website.
«Manage Settings