Primary Open Angle GlaucomaMAGICNCT04769453

Multicenter Ab-interno Glaucoma Study Investigating Canaloplasty

A study testing Canaloplasty using the iTrack microcatheter with Healon GV Pro, Canaloplasty using the Omni surgical system with Healon GV Pro and Canaloplasty using the iTrack microcatheter with Healon Pro in people with Primary Open Angle Glaucoma, run by Nova Eye, Inc. at 7 sites in United States.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record

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Trial 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). Read more about this study

Who is it for?: Ages 22 years and older
Conditions the study is for: Primary Open Angle Glaucoma
What is being tested?: Canaloplasty using the iTrack microcatheter with Healon GV Pro, Canaloplasty using the Omni surgical system with Healon GV Pro and Canaloplasty using the iTrack microcatheter with Healon Pro
Type of treatment: Medical device
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 20 participants
Where: 7 sitesUnited States
Study dates: 29 Apr 2021to 26 Jan 2023
Phase: Interventional
Are there results?: None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 22 years and older
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

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

Who cannot join

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

Show all 9Show fewer

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

Trial locations and contacts

7 sites in 1 country.

City, postcode or hospital

7 sites in 1 country

United States7 sites

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

Other trials in United States

About this study

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

Conditions: Primary Open Angle Glaucoma
Being tested: Canaloplasty using the iTrack microcatheter with Healon GV Pro, Canaloplasty using the Omni surgical system with Healon GV Pro, Canaloplasty using the iTrack microcatheter with Healon Pro, Canaloplasty using the Omni surgical system with Healon Pro
Keywords: Canaloplasty
Medical subject headings: Glaucoma, Open-Angle

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Canaloplasty using the iTrack microcatheter with Healon GV ProDevice
360 degree microcatheterization and viscodilation of Schlemm's canal
Canaloplasty using the Omni surgical system with Healon GV ProDevice
360 degree microcatheterization and viscodilation of Schlemm's canal
Canaloplasty using the iTrack microcatheter with Healon ProDevice
360 degree microcatheterization and viscodilation of Schlemm's canal
Canaloplasty using the Omni surgical system with Healon ProDevice
360 degree microcatheterization and viscodilation of Schlemm's canal

Study groups in NCT04769453
Study group	Role	What they receive
iTrack canaloplasty microcatheter with Healon GV Pro	Active comparator	Patients will be randomized to the iTrack microcatheter (canaloplasty) with Healon GV Pro (ophthalmic viscoelastic device) Receives: Device: Canaloplasty using the iTrack microcatheter with Healon GV Pro
OMNI surgical system with Healon GV Pro	Active comparator	Patients will be randomized to the OMNI surgical system (canaloplasty) with Healon GV Pro (ophthalmic viscoelastic device) Receives: Device: Canaloplasty using the Omni surgical system with Healon GV Pro
iTrack canaloplasty microcatheter with Healon Pro	Active comparator	Patients will be randomized to the iTrack microcatheter (canaloplasty) with Healon Pro (ophthalmic viscoelastic device) Receives: Device: Canaloplasty using the iTrack microcatheter with Healon Pro
OMNI surgical system with Healon Pro	Active comparator	Patients will be randomized to the OMNI surgical system (canaloplasty) with Healon Pro (ophthalmic viscoelastic device) Receives: Device: Canaloplasty using the Omni surgical system with Healon Pro

What is being measured

The primary outcome is the main question the study is designed to answer.

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
Measured: 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.
Measured: 12 months
Visual acuity at 12 months compared to baseline visual acuity
Best corrected visual acuity (BCVA) will be assessed using the standard Snellen eye chart
Measured: 12 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

29 Apr 202126 Jan 2023

First posted24 Feb 2021
Study start29 Apr 2021
Primary completion26 Jan 2023
Study completion26 Jan 2023

Why it stopped: Sponsor-initiated, suspension of study due to modification of key parameters.

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Other trials for Primary Open Angle GlaucomaStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase N/A
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Factorial
Masking: Single blind
Who is masked: Participant
Enrolment: 20 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT04769453
Sponsor's protocol ID: NE 01021
Acronym: MAGIC
Status last verified: Mar 2023
First submitted: 18 Feb 2021
Last updated: 15 Mar 2023
Results posted: No
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: Yes
Individual data sharing: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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All Primary Open Angle Glaucoma trials

Study at a glance

From the registry record, last updated by the sponsor on 15 Mar 2023. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Multicenter Ab-interno Glaucoma Study Investigating Canaloplasty, Randomized, Controlled Trial: iTrack (Nova Eye Medical) Compared to Omni (Sight Sciences)
ClinicalTrials.gov ID: NCT04769453
Acronym / sponsor ID: MAGIC / NE 01021
Conditions: Primary Open Angle Glaucoma
Keywords: Canaloplasty
Study type: Interventional
Recruitment status: TerminatedReason stopped: Sponsor-initiated, suspension of study due to modification of key parameters.
Enrolment: 20 participants (actual)
Lead sponsor: Nova Eye, Inc.Industry (pharma, biotech, devices)
Study start: 29 Apr 2021 (actual)
Primary completion: 26 Jan 2023 (actual)
Study completion: 26 Jan 2023 (actual)
First posted: 24 Feb 2021 (actual)
Results: Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Factorial
Masking: Single blind (participant)
Number of arms: 4

Arm	Type	Receives
iTrack canaloplasty microcatheter with Healon GV Pro	Active comparator	Device: Canaloplasty using the iTrack microcatheter with Healon GV ProPatients will be randomized to the iTrack microcatheter (canaloplasty) with Healon GV Pro (ophthalmic viscoelastic device)
OMNI surgical system with Healon GV Pro	Active comparator	Device: Canaloplasty using the Omni surgical system with Healon GV ProPatients will be randomized to the OMNI surgical system (canaloplasty) with Healon GV Pro (ophthalmic viscoelastic device)
iTrack canaloplasty microcatheter with Healon Pro	Active comparator	Device: Canaloplasty using the iTrack microcatheter with Healon ProPatients will be randomized to the iTrack microcatheter (canaloplasty) with Healon Pro (ophthalmic viscoelastic device)
OMNI surgical system with Healon Pro	Active comparator	Device: Canaloplasty using the Omni surgical system with Healon ProPatients will be randomized to the OMNI surgical system (canaloplasty) with Healon Pro (ophthalmic viscoelastic device)

Who may qualify

Ages: 22 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (5 listed)

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

Key exclusion criteria (9 listed)

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)

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Canaloplasty using the iTrack microcatheter with Healon GV Pro360 degree microcatheterization and viscodilation of Schlemm's canal	Device	iTrack canaloplasty microcatheter with Healon GV Pro
Canaloplasty using the Omni surgical system with Healon GV Pro360 degree microcatheterization and viscodilation of Schlemm's canal	Device	OMNI surgical system with Healon GV Pro
Canaloplasty using the iTrack microcatheter with Healon Pro360 degree microcatheterization and viscodilation of Schlemm's canal	Device	iTrack canaloplasty microcatheter with Healon Pro
Canaloplasty using the Omni surgical system with Healon Pro360 degree microcatheterization and viscodilation of Schlemm's canal	Device	OMNI surgical system with Healon Pro

Primary outcome

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

2 secondary outcomes

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
Visual acuity at 12 months compared to baseline visual acuity
Time frame: 12 months

Results and safety

The study was stopped early (reason given: Sponsor-initiated, suspension of study due to modification of key parameters.). Results are not available in the source record.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 15 Mar 2023.
Individual participant dataSharing planned: No

Related trials for Primary Open Angle Glaucoma

RecruitingObservational study
PRESERFLO™ MicroShunt XI Observational PMCF Study With no Control Group
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Glaucoma, Visual Field Loss, and Their Association With Life Space in Older Adults
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Not yet recruiting
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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Shamil Patel, MD, MBA principal investigator

Eye Physicians and Surgeons of Arizona

7 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: stopped early, as of the sponsor's last update on 15 Mar 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 7 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study was stopped early (reason given: Sponsor-initiated, suspension of study due to modification of key parameters.). Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Reduction in mean Intraocular pressure (IOP) and glaucoma medication use at 12 months post-intervention (time frame: 12 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04769453.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Mar 2023; AzTrials last refreshed its copy on 29 Oct 2026.