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NCT Number: NCT05564091

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

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.

Recruiting

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Key information

Conditions

Primary Open Angle Glaucoma Eye Diseases Glaucoma Glaucoma, Open-Angle Ocular Hypertension

Age range

55 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Bonn Eye Clinic, Bonn, Germany

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Cataract surgery combined with ab-interno canaloplasty utililzing the iTrack Advance canaloplasty device

Device

360 degree microcatheterization and viscodilation of Schlemm's canal

cataract surgery

Procedure

Cataract surgery alone

Other names: Phacoemulsification

Primary outcomes

  1. 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

  2. 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

Secondary outcomes

  1. Reduction in mean Intraocular Pressure (IOP) at 24-months compared to baseline

    Time frame: 24 months

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

  2. Reduction in glaucoma medications at 24-months compared to baseline

    Time frame: 24 months

    The number of glaucoma medications will be recorded at 24-months compared to baseline

Study contacts

Contact information is provided by the study sponsor or research team.

Mike Pickrel

CONTACT

[email protected]

800-391-2316

Sponsors and collaborators

Lead sponsor

Nova Eye, Inc.

Industry

Collaborators

  • Nova Eye Medical GmbH

Registry information

Acronym: CATALYST

Important dates

Study start
2022
Primary completion
2027
Study completion
2027
First posted
Oct 3, 2022
Registry last updated
Apr 18, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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