This is a prospective, non-randomized, single-arm early feasibility study to assess the safety and feasibility of lowering intraocular pressure with the Brown Glaucoma Implant. A total of up to 10 subjects will be enrolled at three centers. Subjects will be followed for 24 months, with the primary assessments completed 6 months after implant.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
8
The Brown Glaucoma Implant (BGI) 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.
Minnesota Eye Consultants
Bloomington, Minnesota, United States
iWorks Laser and Vision Center
Dayton, Ohio, United States
Glaucoma Associates of Texas
Dallas, Texas, United States
Overall Responder Rate
Responder rate defined as achieving at least 20% reduction from baseline in intra-ocular pressure (IOP)
Time frame: 6 Months
Adverse Event Rate
Rate of all AEs
Time frame: 6 Months
Mean Change From Baseline in IOP
Mean change in diurnal IOP since the baseline visit
Time frame: Baseline, 6 Months
Alternative Responder Rate
Responder rate defined as achieving follow-up IOP less than or equal to 14mmHg
Time frame: 6 Months
Change in IOP-lowering Medications
Mean change in number of glaucoma medications since baseline
Time frame: Baseline, 6 Months
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