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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Enrollment
78
360 degree microcatheterization and viscodilation of Schlemm's canal
Cataract surgery alone
Berkeley Eye Center
Sugar Land, Texas, United States
RECRUITINGUniversity of Bonn Eye Clinic
Bonn, Germany
RECRUITINGAugencentrum Köln Ophthalmology
Cologne, Germany
RECRUITINGReduction in mean Intraocular Pressure (IOP) at 12 months compared to baseline
IOP will be measured at each study visit using Goldmann applanation tonometry
Time frame: 12 months
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
Time frame: 12 months
Reduction in mean Intraocular Pressure (IOP) at 24-months compared to baseline
IOP will be measured at each study visit using Goldmann applanation tonometry
Time frame: 24 months
Reduction in glaucoma medications at 24-months compared to baseline
The number of glaucoma medications will be recorded at 24-months compared to baseline
Time frame: 24 months
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St. Johannes Hospital
Dortmund, Germany
RECRUITING