Cataract surgery combined with canaloplasty for glaucoma patients

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This clinical trial compares the outcomes of cataract surgery performed alongside ab-interno canaloplasty using the iTrack Advance device against cataract surgery alone in patients with mild to moderate primary open-angle glaucoma. It is a multicenter, randomized, single-masked trial that will follow participants for 24 months to assess the effectiveness of the combined procedure. The goal is to determine if the addition of canaloplasty can improve intraocular pressure management in these patients.

Why it matters

Who can join: the full rules

Inclusion Criteria:

* 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 Criteria:

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.
* 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

Where it's running

• Berkeley Eye Center
  Sugar Land, Texas, United States Recruiting
• University of Bonn Eye Clinic
  Bonn, Germany Recruiting
• Augencentrum Köln Ophthalmology
  Cologne, Germany Recruiting
• St. Johannes Hospital
  Dortmund, Germany Recruiting

Study contacts

• Principal investigator: Norbert Koerber, MD — Augencentrum Köln Ophthalmology
• Study coordinator: Mike Pickrel
• Email: MPickrel@Nova-Eye.com
• Phone: 800-391-2316

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.