The purpose of these studies was to evaluate clinical, functional, and histopathological features of glaucoma drainage implants (GDIs) fabricated from novel, custom‐tailored expanded polytetrafluoroethylene (ePTFE). Implants of matching footprints were fabricated from silicone (Control) and novel, bilayered ePTFE. ePTFE implants included: (a) one that inflated with aqueous humor (AH) (High), (b) one that inflated with a lower profile (Low), (c) an uninflated implant not connected to the anterior chamber (Flat), and (d) one filled with material that did not allow AH flow (Filled). All implants were placed in adult New Zealand White rabbits and followed over 1–3 months with clinical exams and intraocular pressure. The permeability of tissue capsules surrounding GDIs was assessed using constant‐flow perfusion with fluoresceinated saline at physiologic flow rates. After sacrifice, quantitative histopathological measures of capsule thickness were compared among devices, along with qualitative assessment of cellular infiltration and inflammation. Capsular thickness was significantly reduced in blebs over ePTFE (61.4 ± 53 μm) versus silicone implants (193.6 ± 53 μm, p = .0086). AH exposure did not significantly alter capsular thickness, as there was no significant difference between High and Filled (50.9 ± 29, p = .34) implants. Capsules around ePTFE implants demonstrated permeability with steady‐state pressure: flow relationships at physiologic flow rates and rapid pressure decay with flow cessation, while pressure in control blebs increased even at low flow rates and showed little decay. Perfused fluorescein dye appeared beyond the plate border only in ePTFE implants. ePTFE implants are associated with thinner, more permeable capsules compared to silicone implants simulating presently used devices.

中文翻译：

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一种新颖的双层膨化聚四氟乙烯青光眼植入物，可形成一种可渗透的薄胶囊，与房水暴露无关

这些研究的目的是评估由定制的新型膨胀聚四氟乙烯（ePTFE）制造的青光眼引流植入物（GDI）的临床，功能和组织病理学特征。匹配的脚印植入物是由有机硅（对照）和新型双层ePTFE制成的。ePTFE植入物包括：（a）用房水（AH）充气（高）的充气物，（b）用低轮廓的充气物（低）的充气物，（c）未与前房连接的未充气的植入物（Flat）， （d）一种填充了不允许AH流动的材料（已填充）。所有植入物均置于成年新西兰白兔体内，并在1-3个月内进行临床检查和眼压。在生理流率下，通过用荧光素盐水恒流灌注来评估GDIs周围组织胶囊的渗透性。处死后，比较装置之间胶囊厚度的定量组织病理学测量，以及对细胞浸润和炎症的定性评估。与硅胶植入物（193.6±53μm）相比，ePTFE（61.4±53μm）上的囊泡厚度明显减少。p = .0086）。AH暴露并没有显着改变囊的厚度，因为高和植入（50.9±29，p = 0.34）植入物之间没有显着差异。ePTFE植入物周围的胶囊在稳态压力下表现出渗透性：在生理流速下的流动关系以及在停止流动时压力迅速衰减，而即使在低流速下，控制气泡中的压力也增加并且几乎没有衰减。灌注的荧光素染料仅在ePTFE植入物中才出现在板边界之外。与模拟当前使用的设备的有机硅植入物相比，ePTFE植入物与更薄，更易渗透的胶囊相关。