Cataract Surgery in Conjunction With Ab-interno Canaloplasty Compared to Cataract Surgery Only in Patients With Mild to Moderate Primary Open-Angle Glaucoma
Nova Eye, Inc.
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 24 months.
Eligibility
- Age range
- 55+ years
- Sex
- All
- Healthy volunteers
- No
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. *…
Interventions
- DeviceCataract surgery combined with ab-interno canaloplasty utililzing the iTrack Advance canaloplasty device
360 degree microcatheterization and viscodilation of Schlemm's canal
- ProcedureCataract surgery
Cataract surgery alone
Locations (4)
- Berkeley Eye CenterSugar Land, Texas
- University of Bonn Eye ClinicBonn
- Augencentrum Köln OphthalmologyCologne
- St. Johannes HospitalDortmund