Study of the Beacon Aqueous Microshunt in Patients With Refractory Glaucoma
This is a prospective, multicenter, single-arm clinical study to evaluate the safety and effectiveness of Beacon Aqueous Microshunt in patients with refractory glaucoma.
|Condition or Disease||Intervention/Treatment||Phase|
Arms and Interventions
|Experimental: Beacon Aqueous Microshunt|
Device: Beacon Aqueous Microshunt
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.
Primary Outcome Measures
- Effectiveness [12 Months]
20% mean diurnal IOP reduction from baseline, on the same number or fewer topical IOP-lowering medications
- Safety [12 Months]
Rate of occurrence of serious procedure-related and/or device-related adverse events.
Secondary Outcome Measures
- Responder rate defined as achieving at least 20% mean diurnal IOP reduction from baseline [12 Months]
- Mean Change from baseline in IOP [12 Months]
- Schirmer tear test - mean change from baseline [12 Months]
Refractory glaucoma: Prior failure of filtering/cilioablative procedure and/or uncontrolled IOP on maximum-tolerated medication (i.e. >=4 classes of topical lowering medications, or fewer in the case of tolerability or efficacy issues).
Primary open-angle or traumatic glaucoma.
Medicated DIOP ≥20 mmHg and ≤45 mmHg on maximum-tolerated medical therapy.
Best-corrected baseline visual acuity of light perception or better in study eye.
Participant has the understanding, ability, and willingness to fully comply with study procedures and postoperative care instructions.
Participant understands and signs the informed consent.
No light perception vision.
Pigmentary glaucoma in study eye.
Pseudoexfoliation syndrome in study eye.
Need for glaucoma surgery combined with other ocular procedures in the study eye at the time of implant (e.g. cataract surgery, penetrating keratoplasty, or retinal surgery).
Unwilling to discontinue contact lens use in the study eye after surgery.
Any condition that prevents the device implantation in the superior region of the study eye.
Life expectancy <1 year.
Contacts and Locations
|1||Icon Eye Care||Grand Junction||Colorado||United States||81501|
|2||Minnesota Eye Consultants||Bloomington||Minnesota||United States||55431|
|3||iWorks Laser and Vision Center||Dayton||Ohio||United States||45405|
|4||Prism Eye Institute||Oakville||Ontario||Canada||L6H0J8|
|5||Institut de l'oeil des Laurentides||Boisbriand||Qubec||Canada||J7H 0E8|
|6||Cliniques d' ophtalmologie Bellevue||Montréal||Qubec||Canada||H1V1G5|
Sponsors and Collaborators
Study Documents (Full-Text)None provided.