Protocols for Pre-Clinical Testing Microshunts to Drain AQH for Glaucoma

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This chapter summarizes and describes most of the test methods used for pre-clinical testing of a permanently implantable glaucoma drainage device called the PRESERFLO® MicroShunt (InnFocus Inc./A Santen Co.) The tests are required by most medical device regulatory authorities as technical files or experimental data to demonstrate safety and subsequently to advance testing in humans to demonstrate efficacy and final approval for commercialization. There are many international standards and guidelines, such as the International Organization for Standardization (ISO), American Society for Testing and Materials (ASTM), United States Pharmacopeia (USP), and American National Standard Institute (ANSI), to name a few, which help in the harmonization of testing required to show the device is designed and functions as expected. Glaucoma drainage devices are typically shunts that divert aqueous humor from the anterior chamber to the exterior spaces of the eye by bypassing some of the common pathways, such as the trabecular meshwork or choroidal space. Some devices attempt to enhance the obstructed pathways and are made of metal, plastic, or degradable materials. The test methods described herein are compiled to educate the reader of pre-clinical tests required, with the understanding that each device model is unique, requiring customization of methods and/or tooling to accommodate the test requirements using the design at hand.