This is prospective, non-randomized, single-arm study to assess the safety and effectiveness of lowering intraocular pressure with the Beacon Aqueous Microshunt. A total of 65 subjects will be enrolled at five centers. The primary endpoint will be assessed at 12 month follow-up.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
10
The Beacon Aqueous Microshunt is an implantable device designed to lower intraocular pressure (IOP) in glaucoma patients by shunting aqueous humor from the anterior chamber of the eye to the surface of the eye. Because there are no physiologic sources of outflow resistance, the device can be engineered to target an IOP that is low enough to halt the progression to blindness in a patient suffering from glaucoma.
University Eye Hospital
Bochum, Germany
Universitatsklinikum Schleswig-Holstein
Lübeck, Germany
Reduction in IOP
Overall responder rate, with responder defined as a subject with a diurnal intra-ocular pressure equal to or lower than the individually pre-determined target IOP.
Time frame: 12 Months
Adverse Event Rate
Rate of all AEs
Time frame: 12 Months
Mean Change from Baseline in IOP
Change in IOP at follow-up compared to baseline
Time frame: 12 Months
Responder Rate for 20% reduction
Defined as a subject achieving at least 20% reduction from baseline in IOP
Time frame: 12 Months
Reduction in IOP lowering medication
Change in number of medications at follow-up compared to baseline
Time frame: 12 Months
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