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May 13, 2019 | Author: Admin
A new innovation in Glaucoma treatment. The Beacon Aqueous Microshunt (MicroOptix) – the brain child of David Brown, MD, 20 years in development-is 3.1 mm in length with an external flange width of 7 mm. It is implanted into a paracentesis-like incision, allowing aqueous to flow through a central channel.
Mitigation against retrograde flow of pathogens would be a concern for such an idea. However, Dr. Riedel said that this is prevented 1 ) by shear stress and 2) by the polyethylene glycol material that composes the central layer of the three-layer device. Polyethylene glycol is considered the gold standard of anti-bio fouling materials. It is super hydrophilic, and it prevents adherence of protein and bacteria to the channel wall, Dr. Riedel explained.
In a porcine animal model followed to 6 months, Dr. Riedel noted no infections and significant, persistent IOP lowering. An aggressive bacterial challenge with the device on eight animals did not result in eye infection, Dr. Riedel said.
Preliminary data from an early bird study in the U.S. and E.U. has shown a mean IOP ( eye pressure ) of 13 mm Hg at 6 months, compared to a baseline mean of 27 mm Hg that was medicated with no washout of patients. Eighty-seven percent of patients showed a 20% reduction in pressure compared to baseline and all patients except one were off all medications postop. Most patients, Dr. Riedel said, were vet or extremely comfortable at 6 months.
In terms of safety, there were no infections or uveitis, no dislocations or device migration, and no sight-threatening complications. There were there device blockages, two of which resolved completely with no or minimal in tervention. The third was remove for persistent blockage.
Dr. Riedel said investigators will soon conduct a prospective, multicenter study to evaluate safety and efficacy in refractory glaucoma.
