Study to assess safety and performance of MINIject SO627 in patients with open angle glaucoma.
The study will evaluate the efficacy and safety of MINI SO627 and IOP (Intra- ocular pressure) lowering effects with or without the use of glaucoma medications. The procedure will be a stand alone surgery. Patient follow up with several examinations up to 24 months after surgery. The primary endpoint is the reduction in medicated mean diurnal IOP at 6 months follow up compared to medicated diurnal IOP at baseline visit.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
25
MINI SO627 is an integrated system comprising a minimally-invasive Glaucoma Drainage Implant (CS627) and a single operator delivery tool. The delivery tool is a single-use tool, designed for inserting the CS627 implant into the suprachoroidal space in the eye.
Clinica Oftalmologica del Caribe
Barranquilla, Colombia
Maxivision Eye Hospital
Hyderabad, Telangana, India
Panama Eye Center
Panama City, Panama
medicated diurnal IOP
Change in medicated diurnal IOP
Time frame: 6 months post surgery
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