Evaluation of the ultrastructural and in vitro flow properties of the PRESERFLO MicroShunt

Abstract

Purpose: To measure the in vitro flow properties of the PRESERFLO implant for comparison with the theoretical resistance to flow. Methods: The PRESERFLO was designed to control the flow of aqueous humor according to the Hagen-Poiseuille (HP) equation. Scanning electron microscopy (SEM) was performed to analyze the ultrastructure, and flow measurements were carried out using a gravity-flow setup. Results: SEM images of the PRESERFLO showed luminal diameters of 67.73 x 65.95 mu m and 63.66 x 70.54 mu m. The total diameter was 337.2 mu m, and the wall was 154 mu m wide. The theoretical calculation of the resistance to flow (R) for an aqueous humor (AH) viscosity of 0.7185 centipoises (cP) was 1.3 mm Hg/(mu L/min). Hence, assuming a constant AH flow of 2 mu L/min, the pressure differential across the device (AP) was estimated to be 2.6 mm Hg. The gravity-flow experiment allowed us to measure the experimental resistance to flow, which was R-E = 1.301 mm Hg/(mu L/min), in agreement with the theoretical resistance to flow R given by the HP equation. Conclusions: The experimental and theoretical flow testing showed that the pressure drop across this device would not be large enough to avoid hypotony unless the resistance to outflow of the sub-Tenon space was sufficient to control the intraocular pressure in the early postoperative period. Translational Relevance: The fluid properties of glaucoma subconjunctival drainage devices determine their specific bleb-forming capacity and ability to avoid hypotony and therefore their safety and efficacy profile. Translational Relevance: The fluid properties of glaucoma subconjunctival drainage devices determine their specific bleb-forming capacity and ability to avoid hypotony and therefore their safety and efficacy profile.