The purpose of this study is to evaluate the safety and effectiveness of the OMNI® Surgical System in subjects who have undergone canaloplasty and trabeculotomy using OMNI® Surgical System without any concomitant surgery in pseudophakic eyes with mild to moderate primary open angle glaucoma (POAG) at least 150 days prior to enrollment.
Study Type
OBSERVATIONAL
Enrollment
28
The OMNI® Surgical System is indicated for canaloplasty (microcatheterization and transluminal viscodilation of Schlemm's canal) followed by trabeculotomy (cutting of trabecular meshwork) to reduce intraocular pressure in adult patients with primary open-angle glaucoma.
Eye Specialists of Georgia
Atlanta, Georgia, United States
Grene Vision Group
Wichita, Kansas, United States
Minnesota Eye Consultants
Bloomington, Minnesota, United States
Change in Intraocular Pressure (IOP)
Percent change in unmedicated diurnal intraocular pressure (DIOP/washout) or medicated intraocular pressure (IOP/no washout) compared to baseline.
Time frame: 18 months
Change in Number of Medications
Mean change in the number of ocular hypotensive medications compared to baseline.
Time frame: 18 months
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Northern New Jersey Eye Institute
Orange, New Jersey, United States
Oklahoma Eye Surgeons
Oklahoma City, Oklahoma, United States
University Eye Specialists
Maryville, Tennessee, United States
El Paso Eye Surgeons
El Paso, Texas, United States
Ophthalmology Associates - Fort Worth
Fort Worth, Texas, United States
Utah Eye Centers
Ogden, Utah, United States
Virginia Eye Consultants
Norfolk, Virginia, United States