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.
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
Laser Trabeculoplasty
Endocyclophotocoagulation (ECP) or Micropulse laser
iStent or iStent Inject
Hydrus Microstent
Factorial
Cataract surgery combined with ab-interno canaloplasty utililzing the iTrack Advance canaloplasty device
Device360 degree microcatheterization and viscodilation of Schlemm's canal
Cataract surgery
Procedure/SurgeryCataract surgery alone
Reduction in mean Intraocular Pressure (IOP) at 12 months compared to baseline
IOP will be measured at each study visit using Goldmann applanation tonometry
Reduction in number of glaucoma medications at 12 months compared to baseline
The number of glaucoma medications will be recorded at 12 months compared to baseline
Reduction in mean Intraocular Pressure (IOP) at 24-months compared to baseline
IOP will be measured at each study visit using Goldmann applanation tonometry
Reduction in glaucoma medications at 24-months compared to baseline
The number of glaucoma medications will be recorded at 24-months compared to baseline
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Nova Eye, Inc.
Lead sponsor
Nova Eye Medical GmbH
Collaborator
