A prospective, multicenter, randomized, single-masked clinical trial to evaluate the effectiveness outcomes of canaloplasty performed as a standalone procedure with the iTrack microcatheter to the Omni surgical system, and to compare the effectiveness of two types of Ophthalmic Viscoelastic Device (OVD).
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Enrollment
20
360 degree microcatheterization and viscodilation of Schlemm's canal
360 degree microcatheterization and viscodilation of Schlemm's canal
360 degree microcatheterization and viscodilation of Schlemm's canal
Arizona Advanced Eye Research Institute
Glendale, Arizona, United States
Beverly Hills Institute of Ophthalmology
Beverly Hills, California, United States
Coastal Vision
Orange, California, United States
Dean McGee Eye Institute
Oklahoma City, Oklahoma, United States
Reduction in mean Intraocular pressure (IOP) and glaucoma medication use at 12 months post-intervention
IOP will be measured at each study visit using Goldmann applanation tonometry
Time frame: 12 months
Complications intra-operatively and post-operatively associated with the iTrack canaloplasty microcatheter compared to complications intra-operatively and post-operatively with the OMNI surgical system.
Time frame: 12 months
Visual acuity at 12 months compared to baseline visual acuity
Best corrected visual acuity (BCVA) will be assessed using the standard Snellen eye chart
Time frame: 12 months
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360 degree microcatheterization and viscodilation of Schlemm's canal
Cataract and Laser Institute of Southern Oregon
Medford, Oregon, United States
El Paso Eye Surgeons
El Paso, Texas, United States
Eye Centers of Racine and Kenosha
Kenosha, Wisconsin, United States