Cataract Surgery in Conjunction With Ab-interno Canaloplasty Compared to Cataract Surgery Only in Patients With Mild to Moderate Primary Open-Angle Glaucoma
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.
Conditions studied
Primary Open Angle Glaucoma
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.
Interventions
- Device: Cataract surgery combined with ab-interno canaloplasty utililzing the iTrack Advance canaloplasty device — 360 degree microcatheterization and viscodilation of Schlemm's canal
- Procedure: Cataract surgery — Cataract surgery alone
Primary outcomes
- Reduction in mean Intraocular Pressure (IOP) at 12 months compared to baseline (12 months)
- Reduction in number of glaucoma medications at 12 months compared to baseline (12 months)
Eligibility information
Study locations
- Berkeley Eye Center, Sugar Land, Texas 77478 United States
- University of Bonn Eye Clinic, Bonn, Germany
- Augencentrum Köln Ophthalmology, Cologne, Germany
- St. Johannes Hospital, Dortmund, Germany
Source: ClinicalTrials.gov. Record last refreshed by Varda Clinical: 2026-09-27.