Back to Clinical Trials
N/ARecruiting

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

Sponsored by Nova Eye, Inc.

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.

Where this study is enrolling

  • Berkeley Eye Center

    Sugar Land, Texas

    Call 281-478-9889

    This research site can be reached directly by phone. Call to ask about this study.

    Create a free account to get updates on similar Clinical Trials for your conditions.

Who can participate

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

Only the research team can confirm whether you qualify. The intake questionnaire is the best way to find out.

Completing a questionnaire on Clinably does not enroll you in a clinical trial or confirm your eligibility. Only the research team can determine whether you qualify to participate. These results are based on the information you provide and are intended to help you start a conversation with the research team.

Trial data sourced from ClinicalTrials.gov.