Primary Open Angle GlaucomaMAGICNCT05786196
Multicenter Glaucoma Study Investigating Standalone Canaloplasty
A study testing Ab-interno canaloplasty utilizing the iTrack Advance device and Ab-interno canaloplasty utilizing the OMNI Surgical System in people with Primary Open Angle Glaucoma, run by Nova Eye, Inc. at 5 sites in 3 countries.
Trial summary
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. 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?
- Ab-interno canaloplasty utilizing the iTrack Advance device and Ab-interno canaloplasty utilizing the OMNI Surgical System
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 86 participants
- Where
- 5 sitesin 3 countries
- Study dates
- 9 May 2023to Dec 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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
- 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
Show all 10Show fewer
- 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
Who cannot join
- Any of the following prior treatments for glaucoma (study eye):
- Laser trabeculoplasty
- Selective Laser Trabeculoplasty (SLT) conducted within 6-months of the Screening Visit ii. Prior Argon Laser Trabeculoplasty
- iStent or iStent Inject within 180 days of the Screening Visit
- Endocyclophotocoagulation (ECP) or Micropulse laser
- Trabeculectomy or other bleb forming procedure including Xen, Express, and glaucoma draining device/valve
Show all 21Show fewer
- Prior canaloplasty (ab interno and ab externo)
- Prior goniotomy, or trabeculotomy (ab externo and ab interno)
- Hydrus microstent
- Suprachoroidal stent (e.g., Cypass, iStent Supra, MINIject)
- 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
Trial locations and contacts
5 sites in 3 countries. Contact the study team or a site near you to ask about taking part.
5 sites in 3 countries
United Kingdom3 sites, 3 recruiting
- Recruiting
Princess Alexandra Eye Pavilion, NHS Lothian
Edinburgh
Andrew Tatham, MD
- Recruiting
St. Paul's Eye Unit, Liverpool University
Liverpool
Neeru Vallabh, PhD
- Recruiting
Manchester Royal Eye Hospital
Manchester
Leon Au, MD
Germany1 site, 1 recruiting
- Recruiting
Breyer Kaymak Klabe Augenchirurgie
Düsseldorf
Karsten Klabe, MD
Spain1 site, 1 recruiting
- Recruiting
Hospital Clinico San Carlos, Servicio de Oftalmologia
Madrid
Jose Martinez de la Casa, MD
About this study
Official title: 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.
- Conditions
- Primary Open Angle Glaucoma
- Being tested
- Ab-interno canaloplasty utilizing the iTrack Advance device, Ab-interno canaloplasty utilizing the OMNI Surgical System
- 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.
Ab-interno canaloplasty utilizing the iTrack Advance deviceDevice
360 degree microcatheterization and viscodilation of Schlemm's canal
Ab-interno canaloplasty utilizing the OMNI Surgical SystemDevice
360 degree microcatheterization and viscodilation of Schlemm's canal
| Study group | Role | What they receive |
|---|---|---|
| iTrack Advance | Active comparator | Ab-interno canaloplasty utilizing the iTrack Advance microcatheter device (Nova Eye, Inc.) Receives: Device: Ab-interno canaloplasty utilizing the iTrack Advance device |
| OMNI Surgical System | Active comparator | Ab-interno canaloplasty utilizing the OMNI Surgical System Receives: Device: Ab-interno canaloplasty utilizing the OMNI Surgical System |
What is being measured
The primary outcome is the main question the study is designed to answer.
The mean change in unmedicated Intraocular pressure (IOP) at Month-12 compared to baseline
IOP will be measured at each visit with Goldmann applanation tonometry
Measured: 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)
IOP will be measured at each visit with Goldmann applanation tonometry
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Mar 2023
- Study start9 May 2023
- Primary completionDec 2026 (estimated)
- Study completionDec 2026 (estimated)
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
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 86 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Nova Eye, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Nova Eye Medical GmbH
- Responsible party
- Sponsor
- Investigators
- Shamil Patel, MD, MBA, Principal investigator, Eye Physicians and Surgeons of Arizona
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05786196
- Sponsor's protocol ID
- NE 05021
- Acronym
- MAGIC
- Status last verified
- Apr 2025
- First submitted
- 14 Mar 2023
- Last updated
- 18 Apr 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Multicenter Glaucoma Study Investigating Standalone Canaloplasty, Randomized Controlled Trial: iTrack Advance (Nova Eye, Inc.) Compared to OMNI (Sight Sciences)
- ClinicalTrials.gov ID
- NCT05786196
- Acronym / sponsor ID
- MAGIC / NE 05021
- Conditions
- Primary Open Angle Glaucoma
- Keywords
- Canaloplasty
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 86 participants (estimated)
- Lead sponsor
- Nova Eye, Inc.Industry (pharma, biotech, devices)
- Collaborators
- Nova Eye Medical GmbH
- Study start
- 9 May 2023 (actual)
- Primary completion
- Dec 2026 (estimated)
- Study completion
- Dec 2026 (estimated)
- First posted
- 27 Mar 2023 (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.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| iTrack Advance | Active comparator | Device: Ab-interno canaloplasty utilizing the iTrack Advance deviceAb-interno canaloplasty utilizing the iTrack Advance microcatheter device (Nova Eye, Inc.) |
| OMNI Surgical System | Active comparator | Device: Ab-interno canaloplasty utilizing the OMNI Surgical SystemAb-interno canaloplasty utilizing the OMNI Surgical System |
Who may qualify
- Ages
- 22 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- 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
Key exclusion criteria (21 listed)
- Any of the following prior treatments for glaucoma (study eye):
- 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
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 |
|---|---|---|
| Ab-interno canaloplasty utilizing the iTrack Advance device360 degree microcatheterization and viscodilation of Schlemm's canal | Device | iTrack Advance |
| Ab-interno canaloplasty utilizing the OMNI Surgical System360 degree microcatheterization and viscodilation of Schlemm's canal | Device | OMNI Surgical System |
Primary outcome
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
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Apr 2025.
- Individual participant dataSharing planned: No
Related trials for Primary Open Angle Glaucoma
Active, not recruiting
OMNI 3.1 Surgical System in Subjects With Primary Open-Angle Glaucoma
Primary Open Angle Glaucoma
Not yet recruiting
Evaluation the Safety and Effectiveness of the GORE GDI in Adult Subjects With Primary Open-angle Glaucoma in Whom Previous Medical and Surgical Treatment Have Failed.
Glaucoma, Primary Open Angle
Not yet recruitingPhase 4
The Effect of Lumify™ on Ocular Redness, Intraocular Pressure, and Eyelid Position in Glaucoma Patients
Glaucoma, Glaucoma, Open-Angle
Not yet recruitingPhase 2
Nicotinamide for Retinal Protection in Primary Open-Angle Glaucoma (NADIR Trial)
Glaucoma, Open-angle, Primary Open Angle Glaucoma (POAG)
Enrolling by invitationPhase 1/2
Topical Insulin for Glaucoma (TING2)
Open Angle Glaucoma, Primary Open Angle Glaucoma
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.
Shamil Patel, MD, MBA principal investigator
Eye Physicians and Surgeons of Arizona
5 sites in 3 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Ab-interno canaloplasty utilizing the iTrack Advance device and Ab-interno canaloplasty utilizing the OMNI Surgical System in people with Primary Open Angle Glaucoma, run by Nova Eye, Inc. at 5 sites in 3 countries.
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 10 inclusion and 21 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: looking for participants now, as of the sponsor's last update on 18 Apr 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites in United Kingdom, Germany, Spain. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Mike Pickrel (1-800-391-2316, mpickrel@nova-eye.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The mean change in unmedicated Intraocular pressure (IOP) at Month-12 compared to baseline (time frame: 12 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 18 Apr 2025.