Parylene-C Microbore Tubing: A Simpler Shunt for Reducing Intraocular Pressure.

Abstract

Current minimally-invasive glaucoma surgery (MIGS) devices promise to control elevated levels of intraocular pressure (IOP) while avoiding many of the downsides of traditional glaucoma surgery. However, there remains room for improvement in performance metrics, including drainage efficacy, device longevity, and time to implant, as outlined by benchmarks set forth by the Audacious Goals Initiative. We introduce a better shunt, which achieves similar or improved pre-clinical safety and efficacy outcomes to commercial MIGS devices, while reducing surgical profile and implantation time. We developed a parylene-based microbore glaucoma drainage device capable of modulating IOP via a minimally-invasive implantation procedure. We surgically implanted microbore tubing in five healthy New Zealand White rabbits and measured IOP levels biweekly using handheld applanation tonometry to assess device efficacy in lowering and maintaining IOP. After 6 weeks, the rabbits were euthanized and eyes were enucleated to evaluate inflammatory and histologic response to a foreign-body implant. This device is the only one that fulfills the 10-minute benchmark for implantation time compared to other commercial MIGS devices. In 4 of 5 animals implanted, post-op IOP in the experimental eye dropped by an average of 16.17%. Histopathologic evaluation revealed localized evidence of minor inflammatory reaction and tissue irritation, as well as minimal fibrosis along the tube-tissue interface. Based on these findings, this device stands as a promising platform to lowering IOP, particularly in patients with mild to moderate glaucoma requiring no need for cataract intervention, withouteliciting a severe biological response.