This study will prospectively assess the clinical effect of ab-interno transluminal viscoelastic delivery and trabeculotomy performed using the OMNI Surgical System in combination with Cataract Extraction on intraocular pressure (IOP) and the use of IOP-lowering medications in patients with mild-moderate open angle glaucoma (OAG).
This prospective, multicenter, single-arm, post-market clinical study will evaluate the impact of ab-interno transluminal viscoelastic delivery and trabeculotomy using OMNI Surgical System in conjunction with cataract surgery on IOP and the use of hypotensive medications in patients with mild to moderate open angle glaucoma.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
209
Ab-interno transluminal viscoelastic delivery and trabeculotomy using OMNI Surgical System
Eye Center South
Dothan, Alabama, United States
Barnet Delaney Perkins Eye Center
Lake Havasu City, Arizona, United States
Vold Vision
Change in Mean Unmedicated Diurnal IOP
Change in mean unmedicated diurnal IOP from baseline to 12 months
Time frame: 12 months
Change in Mean Number of IOP-Lowering Medications
Reduction in mean number of IOP-lowering medications from screening to 12 months
Time frame: 12 months
Percent of Eyes With a ≥20% Reduction in Unmedicated DIOP
First Secondary Effectiveness endpoint/Percent of eyes with a ≥20% reduction in unmedicated DIOP at 12 months
Time frame: 12 months
Percent of Eyes With Unmedicated Diurnal IOP Between 6 and 18 mmHg Inclusive at 12 Months
Second Secondary Effectiveness Endpoint: Unmedicated DIOP ≥ 6 mmHg and ≤ 18 mmHg at 12 Months/Percent of eyes with unmedicated DIOP between 6 and 18 mmHg inclusive at 12 months
Time frame: 12 months
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Fayetteville, Arkansas, United States
Your Eye Specialists
Weston, Florida, United States
Omni Eye Services
Atlanta, Georgia, United States
Eye Physicians and Surgeons, LLP
Iowa City, Iowa, United States
Grene Vision Group
Wichita, Kansas, United States
Vance Thompson Vision - MT
Bozeman, Montana, United States
Vance Thompson Vision - NE
Omaha, Nebraska, United States
Vance Thompson Vision - ND
West Fargo, North Dakota, United States
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