RESUMO
To evaluate the effectiveness of the PRESERFLO MicroShunt (PFM) in reducing intraocular pressure (IOP) ex vivo in porcine eyes using an infusion pump system and to simulate various IOP conditions, In this study, porcine eyes received increasing flows between 2 and 20 µL/min. IOP measurements were taken under conditions with and without the PFM [PFM (+) and PFM (-), respectively]. In the PFM (-) group, IOP increased from 7.4 mmHg to 46.3 mmHg as the flow rate increased from 2 µL/min to 20 µL/min. The rate of IOP reduction (%ΔIOP) rose with increasing flow rates, although the absolute IOP values achieved with the PFM insertion also increased. The correlation between IOPs in the PFM (-) conditions and the %ΔIOP was modeled as %ΔIOP = 22.4 Ln [PFM(-) IOP] - 41.7. According to this equation, IOP reduction by PFM insertion is 0% at IOPs of 6.4 mmHg or lower. IOP reductions of 10%, 20%, 30%, and 40% were observed when the pre-insertion IOPs were 10.1, 15.7, 24.6, and 38.4 mmHg, respectively. Achievable post-insertion IOP levels of ≤21 mmHg, ≤18 mmHg, ≤15 mmHg, and ≤12 mmHg corresponded to the initial IOPs of 33 mmHg, 26 mmHg, 20 mmHg, and 14.8 mmHg, respectively. In conclusion, the PFM effectively reduced IOP within a specific range of IOP values in an ex vivo experimental system. In clinical situations, the PFM is unlikely to be effective at low IOP levels. At higher levels, the PFM reduces IOP, but it may be insufficient to achieve the target IOP.
RESUMO
This study aims to investigate the pressure characteristics of the PRESERFLO MicroShunt, a microinvasive glaucoma device, using an in vitro setup. Additionally, the study explores the impact of the scleral tissue surrounding the device on its pressure and lumen area. Ten PRESERFLO MicroShunts were subjected to an in vitro experimental setup. A constant flow of physiological saline was maintained at 2 µL/min using an infusion syringe pump. The PRESERFLO was connected to a pressure transducer via a 23 G needle. Pressure characteristics were measured under three different conditions: without sclera [sclera (-)], passing through sclera at a 90° angle (sclera 90°), and passing through sclera at a 30° angle (sclera 30°). The lumen area of the device was measured using microscopic observation. We observed peak and trough pressures in this experimental setting; the peak pressure (6.76 mmHg) was significantly higher than the trough pressure of 4.74 mmHg (p = 0.0020) in the sclera (-) condition. Compared to sclera (-), the peak pressures were significantly higher in the sclera 90° (7.81 mmHg, p = 0.0020) and the sclera 30° (7.96 mmHg, p = 0.0039) conditions. Additionally, compared to sclera (-), the trough pressure was significantly higher in the sclera 90° (6.25 mmHg, p = 0.0039) and the sclera 30° (5.76 mmHg, p = 0.037) conditions. The lumen area was significantly smaller in the sclera 90° condition (3515 µm2) than the sclera (-) condition (3927 µm2, p = 0.0078). The study found that when the distal end of PRESERFLO MicroShunt was free and in air, it exhibited both peak and trough pressures. The presence of scleral tissue surrounding the PRESERFLO MicroShunt affects its lumen area and pressure characteristics. Understanding these effects can provide valuable insights into the device's performance.
RESUMO
Purpose: The purpose of this study was to assess the pressure characteristics of the Ahmed Glaucoma Valve (AGV) and possible effects of air trapped in the tube. Method: Physiologic saline was pumped through 17 AGVs using a syringe infusion pump, and the flow pressure was measured by a set of pressure transducers. During the infusion at a rate of 2 µL/minute, the pressure measurement was repeated twice in each AGV to determine the repriming pressures with/without air (1 µL) in the tube. Results: After a pressure surge occurred during the initial priming, the pressure decreased suddenly and then became constant. The repriming pressure, determined as the peak pressure before valve opening, was significantly (P < 0.0001, paired t-test) higher with air (26.5 ± 6.8 mm Hg) than without air (12.1 ± 3.8 mm Hg), whereas the constant pressures after repriming was equivalent between with (10.6 ± 3.7 mm Hg) and without (10.4 ± 2.9 mm Hg) air conditions (P = 0.68). Conclusions: Air in the AGV tube causes increased repriming pressure of about two-fold compared to repriming without air. This pressure increment caused by air in the capillary-sized tube might occur because of the effects of viscosity pressure and capillary pressure. Translational Relevance: To ensure stable surgical results, surgeons are advised to not allow air to remain in the tube. Pars plana tube insertion of the AGV combined with gas tamponade surgery may result in higher-than-expected intraocular pressure. Conversely, injection of air/gas can avoid postoperative hypotony when the AGV is implanted in eyes with a high risk of hypotony.