Early Evaluation of the Beacon Aqueous Microshunt in Patients Refractory to Drug Therapy in the E… (NCT03634319) | Clinical Trial Compass
TerminatedNot Applicable
Early Evaluation of the Beacon Aqueous Microshunt in Patients Refractory to Drug Therapy in the European Union
Stopped: Significant risks (e.g., infection, endothelial cell loss) and high rate of channel plugging associated with product use.
Germany10 participantsStarted 2018-06-01
Plain-language summary
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.
Who can participate
Age range22 Years
SexALL
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Inclusion criteria
✓. Age 22 years and older.
✓. Diagnosed with mild, moderate or severe open-angle glaucoma (OAG).
✓. Best corrected vision acuity 20/25 or worse in the study eye.
✓. Inadequate medical control of IOP, or target IOP not reached with intraocular pressure in the study eye greater than or equal to 20 mmHg.
✓. At least two contiguous clock hours of intact conjunctiva near the limbus between clock hours of 09:00 and 03:00 in the study eye.
✓. Adequate space in the anterior chamber of the study eye sufficient to support implant with the BAM, defined as two contiguous clock hours of scleral spur visualization via gonioscopy, without compression, in the superior 180 degrees of the anterior angle.
✓. Any IOP-lowering medications should be stabilized at least 30 days prior to baseline measurements.
✓. Able and willing to comply with protocol requirements.
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.