A major challenge for any glaucoma implant is their ability to provide long-term intraocular pressure lowering efficacy. The formation of a low-permeability fibrous capsule around the device often leads to obstructed drainage channels, which may impair the drainage function of devices. These foreign body-related limitations point to the need to develop biologically inert biomaterials to improve performance in reaching long-term intraocular pressure reduction. The aim of this study was to evaluate in vivo (in rabbits) the ocular biocompatibility and tissue integration of a novel suprachoroidal microinvasive glaucoma implant, MINIject™ (iSTAR Medical, Wavre, Belgium). In two rabbit studies, no biocompatibility issue was induced by the suprachoroidal, ab-externo implantation of the MINIject™ device. Clinical evaluation throughout the 6 post-operative months between the sham and test groups were similar, suggesting most reactions were related to the ab-externo surgical technique used for rabbits, rather than the implant material itself. Histological analysis of ocular tissues at post-operative months 1, 3 and 6 revealed that the implant was well-tolerated and induced only minimal fibroplasia and thus minimal encapsulation around the implant. The microporous structure of the device became rapidly colonized by cells, mostly by macrophages through cell migration, which do not, by their nature, impede the flow of aqueous humor through the device. Time-course analysis showed that once established, pore colonization was stable over time. No fibrosis nor dense connective tissue development were observed within any implant at any time point. The presence of pore colonization may be the process by which encapsulation around the implant is minimized, thus preserving the permeability of the surrounding tissues. No degradation nor structural changes of the implant occurred during the course of both studies. The novel MINIject™ microinvasive glaucoma implant was well-tolerated in ocular tissues of rabbits, with observance of biointegration, and no biocompatibility issues. Minimal fibrous encapsulation and stable cellular pore colonization provided evidence of preserved drainage properties over time, suggesting that the implant may produce a long-term ability to enhance aqueous outflow.

中文翻译：

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一种新型脉络膜上微创青光眼植入物：体内生物相容性和生物整合

任何青光眼植入物的主要挑战是它们提供长期降低眼内压功效的能力。器械周围形成低渗透性纤维囊常导致引流通道受阻，从而影响器械的引流功能。这些与异物相关的限制表明需要开发生物惰性生物材料以提高实现长期眼压降低的性能。本研究的目的是在体内（在兔子中）评估新型脉络膜上微创青光眼植入物 MINIject™（iSTAR Medical，Wavre，Belgium）的眼部生物相容性和组织整合。在两项兔子研究中，MINIject™ 装置的脉络膜上、腹外植入没有引起生物相容性问题。假手术组和试验组在整个术后 6 个月的临床评估相似，表明大多数反应与用于兔子的体外手术技术有关，而不是与植入材料本身有关。术后第 1、3 和 6 个月眼部组织的组织学分析显示，植入物耐受性良好，仅引起最小的纤维增生，因此植入物周围的包封最小。该装置的微孔结构迅速被细胞定殖，主要是巨噬细胞通过细胞迁移，就其性质而言，这些细胞不会阻碍房水通过该装置的流动。时程分析表明，一旦建立，孔隙定植随着时间的推移是稳定的。在任何时间点，任何植入物内均未观察到纤维化或致密结缔组织发育。孔定植的存在可能是使植入物周围的包封最小化的过程，从而保持周围组织的渗透性。在两项研究过程中，植入物均未发生退化或结构变化。新型 MINIject™ 微创青光眼植入物在兔眼组织中具有良好的耐受性，具有生物整合性，并且没有生物相容性问题。最小的纤维包裹和稳定的细胞孔定植提供了随着时间的推移保持引流特性的证据，表明植入物可能产生增强水流出的长期能力。在两项研究过程中，植入物均未发生退化或结构变化。新型 MINIject™ 微创青光眼植入物在兔眼组织中具有良好的耐受性，具有生物整合性，并且没有生物相容性问题。最小的纤维包裹和稳定的细胞孔定植提供了随着时间的推移保持引流特性的证据，表明植入物可能产生增强水流出的长期能力。在两项研究过程中，植入物均未发生退化或结构变化。新型 MINIject™ 微创青光眼植入物在兔眼组织中具有良好的耐受性，具有生物整合性，并且没有生物相容性问题。最小的纤维包裹和稳定的细胞孔定植提供了随着时间的推移保持引流特性的证据，表明植入物可能产生增强水流出的长期能力。