This is a prospective, multicenter, single-arm clinical study to evaluate the safety and effectiveness of Beacon Aqueous Microshunt in patients with refractory glaucoma.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
10
The Beacon Aqueous Microshunt (BAM) is an implantable device intended to reduce intraocular pressure (IOP) in patients with refractory glaucoma by shunting aqueous humor from the anterior chamber to the surface of the eye.
Icon Eye Care
Grand Junction, Colorado, United States
Minnesota Eye Consultants
Bloomington, Minnesota, United States
iWorks Laser and Vision Center
Dayton, Ohio, United States
Institut de l'oeil des Laurentides
Boisbriand, Qubec, Canada
Effectiveness via Intraocular Pressure Reduction
20% mean diurnal IOP reduction from baseline, on the same number or fewer topical IOP-lowering medications
Time frame: 12 Months
Safety via Serious and Adverse Event Reporting
Rate of occurrence of serious procedure-related and/or device-related adverse events.
Time frame: 12 Months
Responder rate defined as achieving at least 20% mean diurnal IOP reduction from baseline
Time frame: 12 Months
Mean Change from baseline in IOP
Time frame: 12 Months
Schirmer tear test - Mean change from baseline
Time frame: 12 Months
Proportion of Eyes Achieving Specific IOP Targets (≤18 mmHg, ≤17 mmHg, ≤16 mmHg, ≤15 mmHg, ≤14 mmHg, ≤13 mmHg, and ≤12 mmHg) compared to baseline
Time frame: 12 Months
Number of topical IOP-lowering medications - Mean change from baseline
Time frame: 12 Months
Kaplan-Meier Analysis of Failure
Glaucoma-related secondary surgical intervention with or without device explant, device explant alone, or not achieving \>20% IOP reduction on the same number of medications or fewer
Time frame: 12 Months
Rate of ocular and non-ocular adverse events
Time frame: 12 Months
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