Not provided
Not provided
Not provided
Not provided
Significant risks (e.g., infection, endothelial cell loss) and high rate of channel plugging associated with product use.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Beacon Aqueous Microshunt | Device | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 12 Months |
| Adverse Event Rate | Rate of all AEs | 12 Months |
| Measure | Description | Time Frame |
|---|---|---|
| Mean Change from Baseline in IOP | Change in IOP at follow-up compared to baseline | 12 Months |
| Responder Rate for 20% reduction | Defined as a subject achieving at least 20% reduction from baseline in IOP |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Active Neovascular Glaucoma in the study eye.
Pigmentary Glaucoma in the study eye.
Pseudoexfoliative Glaucoma in the study eye.
Any eye disease associated with the formation of free-floating material or tissue in the anterior chamber of the eye.
Corneal conditions in the study eye that may inhibit normal incisional healing (e.g. Fuch's dystrophy) or impair visualization of the implant inside the anterior chamber.
Anticipated need for ocular surgery within one year in the study eye.
Contact lens use in the study eye.
Clinically significant inflammation or infection in the study eye within 60 days prior to the preoperative visit (e.g., blepharitis, conjunctivitis, keratitis, uveitis, herpes simplex infection) or any systemic infection. For purposes of this study, clinically significant is considered any such condition requiring prescription therapy.
Other clinical conditions:
Participation in any other clinical trial during participation in this trial.
Life expectancy <1 year.
Clinically significant macular degeneration in the study eye.
Patients who have undergone surgery in the trial eye within the last 6 months.
Planned combined cataract surgery.
If both eyes of a prospective trial participant are eligible, the eye with the highest intraocular pressure will be selected for implant.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University Eye Hospital | Bochum | Germany | ||||
| Universitatsklinikum Schleswig-Holstein |
Not provided
Not provided
Not provided
Not provided
Not provided
| ID | Term |
|---|---|
| D005902 | Glaucoma, Open-Angle |
| ID | Term |
|---|---|
| D005901 | Glaucoma |
| D009798 | Ocular Hypertension |
| D005128 | Eye Diseases |
Not provided
Not provided
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.
Not provided
Not provided
Not provided
Not provided
| 12 Months |
| Reduction in IOP lowering medication | Change in number of medications at follow-up compared to baseline | 12 Months |
| Lübeck |
| 23538 |
| Germany |