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
Sponsors and collaborators
Nova Eye, Inc.
Lead sponsor
Nova Eye Medical GmbH
Collaborator