Development of a limbal fixation mechanism for a minimally invasive implantable glaucoma microstent

Glaucoma represents a chronic eye disease that becomes increasingly prevalent worldwide. Therapies are commonly based on the reduction of intraocular pressure (IOP). Implant devices for micro-invasive glaucoma surgery (MIGS) represent a promising therapy option in refractory cases but suffer from limitations in long term efficacy or from dislocation associated complications. Our approach of an innovative drug-eluting glaucoma microstent for MIGS was presented previously. Within the current work we developed concepts and prototypes of a mechanism for the fixation of our glaucoma microstent in the region of the corneal limbus. A tripod and a haptics design of the fixation mechanism were developed and manufactured. Semifinished products were tested with regard to dimensional stability and mechanical properties according to the standard ANSI Z80.27-2014. Considering the mechanical properties of ocular target tissues, a gelatin based in vitro model for the measurement of microstent retention force was developed. Retention force testing of microstent prototypes in vitro resulted in a proof of concept for the fixation mechanism. Future studies will focus on the use of smaller fixation fibers, for example commercially available suture material, and on an overall miniaturization of the fixation mechanism enabling the use of our applicator device with a 22G x 1½” cannula.