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

Last updated: February 14, 2024
Sponsor: Nova Eye, Inc.
Overall Status: Active - Recruiting

Phase

N/A

Condition

Glaucoma

Eye Disorders/infections

Eye Disease

Treatment

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

Cataract surgery

Clinical Study ID

NCT05564091
NE 03021
  • Ages > 55
  • All Genders

Study 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. Subjects will be followed for 12 months.

Eligibility Criteria

Inclusion

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

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 glaucomadrainage device/valve.
  • Prior canaloplasty (ab-interno and ab-externo)
  • Suprachoroidal stent (e.g., Cypass, iStent Supra, XEN)
  • Concurrent IOP-lowering procedure other than use of the iTrackTM Advance canaloplastydevice 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 neovascularglaucoma, pigmentary glaucoma or pseudo exfoliative glaucoma.

Study Design

Total Participants: 78
Treatment Group(s): 2
Primary Treatment: Cataract surgery combined with ab-interno canaloplasty utililzing the iTrack Advance canaloplasty device
Phase:
Study Start date:
September 08, 2022
Estimated Completion Date:
October 31, 2025

Connect with a study center

  • University of Bonn Eye Clinic

    Bonn,
    Germany

    Active - Recruiting

  • St. Johannes Hospital

    Dortmund,
    Germany

    Active - Recruiting

  • Augencentrum Köln Ophthalmology

    Köln,
    Germany

    Active - Recruiting

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