Abstract
For moderate-to-severe glaucoma, trabeculectomy remains the “gold standard” intraocular pressure (IOP)-lowering treatment; nonetheless, this method requires extensive post-operative maintenance. Microinvasive glaucoma surgery (MIGS) treatments are designed to lessen intra- and post-operative care burden while offering an acceptable IOP decrease for individuals with mild to moderate glaucoma. The PreserFlo® MicroShunt (previously InnFocus MicroShunt) is an 8.5 mm glaucoma drainage device manufactured from poly(styrene-block-isobutylene-block-styrene) (SIBS), an extremely biocompatible and bioinert material. The lumen is narrow enough to prevent hypotony, but big enough to avoid being obstructed by sloughed cells or pigment. The device is implanted ab externo, as a stand-alone procedure or in conjunction with cataract surgery, with intraoperative mitomycin C, and a bleb is produced under the conjunctiva and Tenon’s capsule. The MicroShunt was CE-marked in 2012 and designed for primary open-angle glaucoma, the IOP of which remains uncontrolled after maximally tolerated topical treatment. Several clinical trials evaluating the MicroShunt’s long-term safety and effectiveness have been conducted, highlighting the effectiveness of the device over time, along with a tolerable safety profile. The present review aims to gather evidence of PreserFlo’s effectiveness and safety results almost 10 years after its introduction, and furthermore, to compare it with other MIGS and with the gold-standard trabeculectomy for glaucoma management.
Highlights
Thefirst firstnotable notableclinical clinicaldata dataabout aboutthe thesurgical surgicalsuccess successofofthis thistechnique techniquewere werepublished published in in2014, 2014,when whenRiss al.presented presentedthe theresults resultsof ofaaretrospective retrospectivetwo-center, two-center,two-surgeon two-surgeon analysis with a one-year follow-up after analysis with a one-year follow-up after InnFocus MicroShunt implantation [32].AAtotal total of of87
Evidence showed that individuals with PXG suffered from blood–aqueous barrier disruption following intraocular surgery [37,38], which may have increased the risk of early postoperative problems, in this research topical steroids treatment was not shown to be more extended or intense in the PXG subgroup. These results indicate that the MicroShunt might result in a limited inflammatory response and could offer a good safety profile in other types of open-angle glaucoma too [36]
Gizzi et al described a case of malignant glaucoma occurring 1 day after PreserFlo implant, requiring pars plana vitrectomy (PPV) in combination with clear lens extraction (CLE) and surgical irido-zonulo-hyaloidectomy, but keeping the device in place [62]
Summary
In order to improve long-term IOP reduction, laser and incisional surgical techniques, including trabeculectomy and tube shunt surgery, have been introduced [3,4,5,6] Both trabeculectomy and tube shunt surgery are invasive operations that need a significant amount of postoperative care [3,4,5]. The discovery of a novel synthetic thermoplastic elastomeric biomaterial (poly(styreneblock-isobutylene-block-styrene); SIBS) lead to the introduction of a SIBS-based glaucoma device named PreserFlo MicroShunt (MicroShunt, formerly known as the InnFocus MicroShunt) [13,14]. This product received Conformité Européenne marking in 2012, Health. The device’s proximal tip rests in the anterior chamber, parallel to the iris, while the distal tip sits under the conjunctiva and Tenon’s capsule, about 6 mm beyond the limbus, enabling aqueous humor to pass through the lumen to produce a posterior bleb after implantation [14,15]
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