A prospective, nonrandomized, open label study to evaluate the safety and IOP lowering effectiveness of the Streamline Surgical System, in patients with mild-to-moderate open angle glaucoma undergoing cataract surgery.
A prospective, nonrandomized, open label study to evaluate the safety and IOP lowering effectiveness of the Streamline Surgical System, a viscoelastic delivery device, in patients with mild-to-moderate open angle glaucoma undergoing cataract surgery. This is a 12 month study conducted outside the US. Approximately 60 subjects will be enrolled.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
45
The Streamline System is a device that delivers viscoelastic into Schlemm's Canal.
Clinica 20/20
San José, CR, Costa Rica
Centro Laser
Santo Domingo, DR, Dominican Republic
Clinica Laser y Ultrasonido Ocular de Puebla
Puebla City, Mexico
proportion of unmedicated eyes with IOP reduction of > 20% from Baseline at Month 12.
Primary Endpoint
Time frame: 12 months
Adverse Events
Assess intraoperative and post operative AEs
Time frame: 12 months
Mean IOP change
Mean IOP change in unmedicated IOP from baseline to M12
Time frame: 12 months
Number of topical glaucoma medications
Number of topical glaucoma medications used at screening compared to Month 12
Time frame: 12 months
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