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

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age55+
SponsorNova Eye, Inc.

About this trial

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.

Eligibility criteria

Qualifiers

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

Disqualifiers

Laser Trabeculoplasty

Endocyclophotocoagulation (ECP) or Micropulse laser

iStent or iStent Inject

Hydrus Microstent

Trial design

Treatments tested in this trial

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

Treatment groups

78 Participants
are divided into 2 treatment groups

Sponsors and collaborators

Nova Eye, Inc.

Lead sponsor

Nova Eye Medical GmbH

Collaborator