To gain early evidence of safety and assess the effectiveness of the intraocular pressure (IOP)-lowering effectiveness of the OMNI 3.0 Surgical System in primary open-angel glaucoma (POAG).
To assess the safety of the OMNI 3.0 Surgical System and gain early evidence on intraocular pressure (IOP) -lowering effectiveness in subjects with mild-moderate primary open-angle glaucoma (POAG).
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
25
Canaloplasty and trabeculotomy.
Panama Eye Center
Panama City, Panama
RECRUITINGPrimary Effectiveness Endpoint
Proportion of subjects with a ≥ 20% reduction from baseline in mean IOP at the 3-month post-operative endpoint and on the same or fewer medications as preoperatively.
Time frame: 3 months
Secondary Effectiveness Endpoint 1
Change in mean Intraocular Pressure (IOP) at 3 months post-operatively
Time frame: 3 months
Secondary Effectiveness Endpoint 2
Average number of ocular hypotensive medications used at 3 months
Time frame: 3 months
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