Primary Open Angle GlaucomaCATALYSTNCT05564091
Cataract Surgery in Conjunction With Ab-interno Canaloplasty Compared to Cataract Surgery Only in Patients With Mild to Moderate Primary Open-Angle Glaucoma
A study testing Cataract surgery combined with ab-interno canaloplasty utililzing the iTrack Advance canaloplasty device and Cataract surgery in people with Primary Open Angle Glaucoma, run by Nova Eye, Inc. at 4 sites in 2 countries.
Trial summary
A prospective, multicenter, randomized, single-masked, post-market clinical trial comparing cataract surgery in conjunction with ab-interno canaloplasty utilizing the iTrack Advance canaloplasty device (Nova Eye, Inc.) to cataract surgery only in patients with mild to moderate, primary open angle glaucoma. Read more about this study
- Who is it for?
- Ages 55 years and older
- Conditions the study is for
- Primary Open Angle Glaucoma
- What is being tested?
- Cataract surgery combined with ab-interno canaloplasty utililzing the iTrack Advance canaloplasty device and Cataract surgery
- Type of treatment
- Medical device, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 78 participants
- Where
- 4 sitesin 2 countries
- Study dates
- 8 Sep 2022to Jul 2027
- 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 55 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Mild to moderate, primary open angle glaucoma
- Characteristics consistent with mild to moderate glaucoma
- Use of 1 - 4 ocular hypotensive medications at the Screening exam and meets the IOP (intraocular pressure) criteria
- Visually significant cataract
Who cannot join
- Any of the following prior treatments for glaucoma (study eye):
- Laser Trabeculoplasty
- Endocyclophotocoagulation (ECP) or Micropulse laser
- iStent or iStent Inject
- Hydrus Microstent
- Trabeculectomy or other bleb forming procedure including Xen, Express, and glaucoma drainage device/valve.
Show all 12Show fewer
- Prior canaloplasty (ab-interno and ab-externo)
- Prior goniotomy, or trabeculotomy (ab-interno or ab-externo)
- Suprachoroidal stent (e.g., Cypass, iStent Supra, XEN, MINIject)
- Concurrent IOP-lowering procedure other than use of the iTrackTM Advance canaloplasty device at the time of surgery (e.g., ECP, CPC, etc.)
- Previous treatment with iTrack (Note: permitted if fellow eye only was treated)
- Acute angle closure, traumatic, congenital, malignant, uveitic or neovascular glaucoma
Trial locations and contacts
4 sites in 2 countries. Contact the study team or a site near you to ask about taking part.
4 sites in 2 countries
Germany3 sites, 3 recruiting
- Recruiting
University of Bonn Eye Clinic
Bonn
Karl Mercieca, MD
- Recruiting
Augencentrum Köln Ophthalmology
Cologne
Norbert Koerber, MD, nkoerber@gmx.de
- Recruiting
St. Johannes Hospital
Dortmund
Markus Kohlhaas, MD
United States1 site, 1 recruiting
- Recruiting
Berkeley Eye Center
Sugar Land, Texas, 77478
Morgan Micheletti, MD
About this study
A prospective, multicenter, randomized, single-masked, post-market clinical trial comparing cataract surgery in conjunction with ab-interno canaloplasty utilizing the iTrack Advance canaloplasty device (Nova Eye, Inc.) to cataract surgery only in patients with mild to moderate, primary open angle glaucoma. Subjects will be followed for 24 months.
- Conditions
- Primary Open Angle Glaucoma
- Being tested
- Cataract surgery combined with ab-interno canaloplasty utililzing the iTrack Advance canaloplasty device, Cataract surgery
- 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.
Cataract surgery combined with ab-interno canaloplasty utililzing the iTrack Advance canaloplasty deviceDevice
360 degree microcatheterization and viscodilation of Schlemm's canal
Cataract surgeryProcedure or surgery
Also called Phacoemulsification
Cataract surgery alone
| Study group | Role | What they receive |
|---|---|---|
| Cataract surgery combined with ab-interno canaloplasty | Active comparator | Ab-interno canaloplasty utilizing the iTrack Advance canaloplasty device (Nova Eye, Inc.) Receives: Device: Cataract surgery combined with ab-interno canaloplasty utililzing the iTrack Advance canaloplasty device |
| Control: Cataract surgery | Other | Cataract surgery alone Receives: Procedure: Cataract surgery |
What is being measured
The primary outcome is the main question the study is designed to answer.
Reduction in mean Intraocular Pressure (IOP) at 12 months compared to baseline
IOP will be measured at each study visit using Goldmann applanation tonometry
Measured: 12 months
Reduction in number of glaucoma medications at 12 months compared to baseline
The number of glaucoma medications will be recorded at 12 months compared to baseline
Measured: 12 months
Secondary outcomes (2)
Reduction in mean Intraocular Pressure (IOP) at 24-months compared to baseline
IOP will be measured at each study visit using Goldmann applanation tonometry
Measured: 24 months
Reduction in glaucoma medications at 24-months compared to baseline
The number of glaucoma medications will be recorded at 24-months compared to baseline
Measured: 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Oct 2022
- Study start8 Sep 2022
- Primary completionJun 2027 (estimated)
- Study completionJul 2027 (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
- Factorial
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 78 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
- Norbert Koerber, MD, Principal investigator, Augencentrum Köln Ophthalmology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05564091
- Sponsor's protocol ID
- NE 03021
- Acronym
- CATALYST
- Status last verified
- Apr 2025
- First submitted
- 29 Sep 2022
- 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
- Cataract Surgery in Conjunction With Ab-interno Canaloplasty Compared to Cataract Surgery Only in Patients With Mild to Moderate Primary Open-Angle Glaucoma
- ClinicalTrials.gov ID
- NCT05564091
- Acronym / sponsor ID
- CATALYST / NE 03021
- Conditions
- Primary Open Angle Glaucoma
- Keywords
- Canaloplasty
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 78 participants (estimated)
- Lead sponsor
- Nova Eye, Inc.Industry (pharma, biotech, devices)
- Collaborators
- Nova Eye Medical GmbH
- Study start
- 8 Sep 2022 (actual)
- Primary completion
- Jun 2027 (estimated)
- Study completion
- Jul 2027 (estimated)
- First posted
- 3 Oct 2022 (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 prospective, multicenter, randomized, single-masked, post-market clinical trial comparing cataract surgery in conjunction with ab-interno canaloplasty utilizing the iTrack Advance canaloplasty device (Nova Eye, Inc.) to cataract surgery only in patients with mild to moderate, primary open angle glaucoma. Subjects will be followed for 24 months.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Cataract surgery combined with ab-interno canaloplasty | Active comparator | Device: Cataract surgery combined with ab-interno canaloplasty utililzing the iTrack Advance canaloplasty deviceAb-interno canaloplasty utilizing the iTrack Advance canaloplasty device (Nova Eye, Inc.) |
| Control: Cataract surgery | Other | Procedure: Cataract surgeryCataract surgery alone |
Who may qualify
- Ages
- 55 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Mild to moderate, primary open angle glaucoma
- Characteristics consistent with mild to moderate glaucoma
- Use of 1 - 4 ocular hypotensive medications at the Screening exam and meets the IOP (intraocular pressure) criteria
- Visually significant cataract
Key exclusion criteria (12 listed)
- Laser Trabeculoplasty
- Endocyclophotocoagulation (ECP) or Micropulse laser
- iStent or iStent Inject
- Hydrus Microstent
- Trabeculectomy or other bleb forming procedure including Xen, Express, and glaucoma drainage device/valve.
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 |
|---|---|---|
| Cataract surgery combined with ab-interno canaloplasty utililzing the iTrack Advance canaloplasty device360 degree microcatheterization and viscodilation of Schlemm's canal | Device | Cataract surgery combined with ab-interno canaloplasty |
| Cataract surgeryAlso: PhacoemulsificationCataract surgery alone | Procedure or surgery | Control: Cataract surgery |
Primary outcome
Reduction in mean Intraocular Pressure (IOP) at 12 months compared to baseline
Time frame: 12 months
IOP will be measured at each study visit using Goldmann applanation tonometry
Reduction in number of glaucoma medications at 12 months compared to baseline
Time frame: 12 months
The number of glaucoma medications will be recorded at 12 months compared to baseline
2 secondary outcomes
Reduction in mean Intraocular Pressure (IOP) at 24-months compared to baseline
Time frame: 24 months
Reduction in glaucoma medications at 24-months compared to baseline
Time frame: 24 months
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
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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.
Norbert Koerber, MD principal investigator
Augencentrum Köln Ophthalmology
4 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Cataract surgery combined with ab-interno canaloplasty utililzing the iTrack Advance canaloplasty device and Cataract surgery in people with Primary Open Angle Glaucoma, run by Nova Eye, Inc. at 4 sites in 2 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 4 inclusion and 12 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 4 sites in Germany, 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?
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 (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?
Reduction in mean Intraocular Pressure (IOP) at 12 months 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; AzTrials last refreshed its copy on 6 Nov 2026.