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Cataract Surgery with Canaloplasty for Glaucoma

This study is looking at two ways to treat mild to moderate primary open-angle glaucoma (a common eye condition that damages the optic nerve) in people who also need cataract surgery. One group will have cataract surgery alone. The other group will have cataract surgery combined with a procedure called ab-interno canaloplasty, using the iTrack Advance canaloplasty device. This device helps drain fluid from the eye to lower eye pressure. Researchers want to see if adding canaloplasty helps reduce eye pressure and the number of glaucoma medications needed after 12 months. You might be able to join if you are 55 or older, have mild to moderate primary open-angle glaucoma, use 1-4 eye pressure medications, and have a significant cataract. The study status is currently unclear.

Study design
This is a randomized study comparing two treatments, involving 78 participants. Participants will be followed for 24 months.
What's involved
Not specified in the trial record.
Compensation
Not stated in the trial record.
Follow-up
Participants will be followed for 24 months after their treatment.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT05564091

Cataract Surgery in Conjunction With Ab-interno Canaloplasty Compared to Cataract Surgery Only in Patients With Mild to Moderate Primary Open-Angle Glaucoma

Recruiting
NAAges 55+InterventionalTreatment
Nova Eye, Inc.
~78 participants
Updated 2025-04-18 on ClinicalTrials.gov
What's tested:Cataract surgery combined with ab-interno canaloplasty utililzing the iTrack Advance canaloplasty deviceCataract surgery

At a glance

Recruiting sites
4 of 4 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Reduction in mean Intraocular Pressure (IOP) at 12 months compared to baseline
Measured over 12 months
+1 more outcome measured

Conditions

Primary Open Angle Glaucoma

Explore related trials

Primary Open Angle Glaucoma

Where it's being run

4 sites across 2 states
Germany3
Texas1

Study leadership

  • Norbert Koerber, MD · PRINCIPAL_INVESTIGATOR · Augencentrum Köln Ophthalmology

Who to contact

Mike Pickrel
[email protected]
800-391-2316
Email the study team

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Do you actually qualify for this trial?

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Eligibility criteria

Inclusion

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

Exclusion

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.
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

What this trial measures

  • Reduction in mean Intraocular Pressure (IOP) at 12 months compared to baseline12 months

    IOP will be measured at each study visit using Goldmann applanation tonometry

  • Reduction in number of glaucoma medications at 12 months compared to baseline12 months

    The number of glaucoma medications will be recorded at 12 months compared to baseline