A study to assess the safety of the Helix Surgical System in cataract surgery and to gain early evidence of its effectiveness in lowering intraocular pressure (IOP) in subjects with mild to moderate primary open-angle glaucoma (POAG) and cataracts.
To assess the safety of the Helix Surgical System with cataract surgery and gain early evidence on intraocular pressure (IOP) -lowering effectiveness in subjects with mild-moderate primary open-angle glaucoma (POAG) and cataract.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
25
A handheld device to viscodilate up to 360 degrees of Schlemm's canal and collector channels that also enables intracanalicular scaffolding procedure to restore the aqueous outflow system of a glaucomatous eye.
Panama Eye Center
Panama City, Panama
RECRUITING≥ 20% change from baseline in mean IOP at the 3-month post-operative endpoint
Proportion of subjects with a ≥ 20% change 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
Change in mean IOP
Change in mean IOP at 3 months post-operatively
Time frame: 3 months
Average number of ocular hypotensive medications
Average number of ocular hypotensive medications used at 3 months
Time frame: 3 months
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