PreserFlo® MicroShunt: An Overview of This Minimally Invasive Device for Open-Angle Glaucoma (original) (raw)
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Safety and Effectiveness of the PRESERFLO® MicroShunt in Primary Open-Angle Glaucoma
Ophthalmology Glaucoma, 2021
This is a PDF file of an article that has undergone enhancements after acceptance, such as the addition of a cover page and metadata, and formatting for readability, but it is not yet the definitive version of record. This version will undergo additional copyediting, typesetting and review before it is published in its final form, but we are providing this version to give early visibility of the article. Please note that, during the production process, errors may be discovered which could affect the content, and all legal disclaimers that apply to the journal pertain.
Ophthalmology Glaucoma, 2021
This is a PDF file of an article that has undergone enhancements after acceptance, such as the addition of a cover page and metadata, and formatting for readability, but it is not yet the definitive version of record. This version will undergo additional copyediting, typesetting and review before it is published in its final form, but we are providing this version to give early visibility of the article. Please note that, during the production process, errors may be discovered which could affect the content, and all legal disclaimers that apply to the journal pertain.
Ophthalmology and Therapy
Introduction: The implantation of the PRE-SERFLO TM MicroShunt (PMS) device has been shown to significantly lower increased intraocular pressure (IOP) in patients with primary open-angle glaucoma (POAG). However, guidelines on best practice for patient selection and pre-/peri-/postoperative care management are lacking. The aim of this modified Delphi panel was to achieve expert consensus on the role of the PMS to treat patients with glaucoma in Europe. Methods: Twelve European glaucoma surgeons experienced with the PMS procedure participated in a three-round modified Delphi panel. A targeted literature review and expert steering committee guided round 1 questionnaire development. Consensus was set at a pre-defined threshold of at least 70% of panellists selecting 'Strongly disagree'/'Disagree' or
Scientific Reports
To assess the effectiveness and safety of the Preserflo Microshunt (PMS) implantation combined with cataract surgery in open-angle glaucoma (OAG) patients. Retrospective, open-label study conducted on insufficiently controlled OAG patients, who underwent a PMS implant procedure with mitomycin-C 0.2%, either alone or in combination with cataract surgery, and were followed for at least 12 months. Success was defined as an intraocular pressure (IOP) ≤ 18 mmHg and a reduction of at least 20% without (complete) or with (qualified) hypotensive medication. Fifty-eight eyes were included in the study, 35 eyes underwent PMS alone and 23 underwent PMS + Phaco. In the overall study sample, mean IOP was significantly lowered from 21.5 ± 3.3 mmHg at baseline to 14.6 ± 3.5 mmHg at month 12 (p
Eye and Vision, 2019
Trabeculectomy remains the ‘gold standard’ intraocular pressure (IOP)-lowering procedure for moderate-to-severe glaucoma; however, this approach is associated with the need for substantial post-operative management. Micro-invasive glaucoma surgery (MIGS) procedures aim to reduce the need for intra- and post-operative management and provide a less invasive means of lowering IOP. Generally, MIGS procedures are associated with only modest reductions in IOP and are targeted at patients with mild-to-moderate glaucoma, highlighting an unmet need for a less invasive treatment of advanced and refractory glaucoma. The PRESERFLO® MicroShunt (formerly known as InnFocus MicroShunt) is an 8.5 mm-long (outer diameter 350 μm; internal lumen diameter 70 μm) glaucoma drainage device made from a highly biocompatible, bioinert material called poly (styrene-block-isobutylene-block-styrene), or SIBS. The lumen size is sufficiently small that at normal aqueous flow hypotony is avoided, but large enough t...
International Ophthalmology
Purpose The aim this study is to determine anterior chamber parameters variations induced by PreserFlo MicroShunt implantation, in the early post-operative days. Methods This is a prospective observational study on 48 eyes undergoing PreserFlo MicroShunt implantation alone (n = 30) or combined with phacoemulsification (n = 18). Anterior chamber depth (ACD) and volume (ACV), central corneal thickness (CCT) and total corneal astigmatism (TCA) were evaluated pre-operatively, post-operatively at day-1 and at 1 week with the Pentacam tomography. Results Intraocular pressure decreased significantly from 20.9 ± 4.0 to 8.0 ± 2.8 mmHg (p < 0.0001) and to 10.8 ± 3.7 mmHg (p = 0.0001) at day-1 and week-1, respectively. TCA varied significantly from baseline (1.5 ± 1.2 D) to both day 1 follow up (2.7 ± 1.9 D, p = 0.0003) and week 1 follow up (2.2 ± 1.6 D, p = 0.02). Nevertheless, only K1 showed a transient flattening at day 1, while K2 value didn’t show any statistical variation in the early...
Purpose This review will provide an update on surgical techniques, outcomes, and complications for two new translimbal bleb-forming surgical glaucoma devices. Recent findings The XEN Gel Microstent and PreserFlo MicroShunt comprise a category of subconjunctival microinvasive glaucoma surgery developed with the aim of improving the predictability and safety profile of bleb-forming procedures. Both devices are made of noninflammatory material which limits postsurgical inflammation and scarring and have a valve-less intrinsic flow-limiting design, which decreases the risk of hypotony. There are various techniques of implantation for the XEN Gel Microstent each with their own advantages and disadvantages. Summary These devices have demonstrated promising outcomes in early experimental literature with similar intraocular pressure-lowering effects to traditional incisional surgery such as trabeculectomy or tube shunt surgery, but with fewer risks. Future randomized, prospective studies should be done to compare these gel stents and microshunts both to each other and to other traditional glaucoma surgeries.
One-year outcomes of microshunt implantation in pseudoexfoliation glaucoma
PLOS ONE, 2021
Purpose To compare the safety and efficacy of microshunt implantation augmented with Mitomycin C in patients with pseudoexfoliation glaucoma (PEXG) and primary open-angle glaucoma (POAG). Methods In this retrospective, single centre, interventional study, 46 eyes of 41 patients with PEXG (20 eyes) and POAG (26 eyes) underwent microshunt implantation. Definition of failure was an intraocular pressure (IOP) lower than 5 or higher than 17mmHg on two consecutive visits, an IOP reduction lower than 20% on two consecutive visits, the need of surgical revisions or reoperations or loss of light perception. Outcome was rated as complete success if achieved without medication, otherwise as qualified success. Furthermore, postoperative complications and interventions were compared between the two groups. Results Patient demographics were similar, except for older age in the PEXG group (70.9±8.6 versus 77.6±8; p = 0.02). Mean IOP dropped from 21.5±5.8mmHg (PEXG) and 18.2±4.5mmHg (POAG) at basel...
European Ophthalmic Review, 2019
Minimally Invasive Glaucoma Surgery with a New Ab-externo Subconjunctival Bypass-Current Status and Review of Literature T he PRESERFLO™MicroShunt (Santen, Osaka, Japan) is a new ab-externo, subconjunctival, minimally invasive glaucoma drainage device for surgical treatment of patients with early to advanced primary open angle glaucoma. It is made of a new polymer, 'SIBS' (poly[styrene-block-isobutylene-block-styrene]), and consists of an 8.5-mm long tube with an outer diameter of 350 μm and a lumen diameter of 70 μm. Placement of the device is combined with intraoperative application of mitomycin C (MMC). The MicroShunt received the CE Mark in 2012 but was only released for sale in the European market in 2019. Outside Europe, the device is currently being tested in Canada, Singapore, the USA and the Dominican Republic. Published evidence is still limited; however, study results to date show that a mean intraocular pressure (IOP) reduction of 30-55% from baseline can be achieved, with a substantial reduction in glaucoma medications. Current studies also suggest that an MMC concentration of 0.4 mg/mL is more effective than 0.2 mg/mL. Success rates (i.e., no failures [IOP ≥21 mmHg or <20% IOP reduction] with or without glaucoma medication) were found to vary between 80-100% at 1-2 years of followup. Adverse events (e.g. hyphema, hypotony, shallow anterior chamber or choroidal effusion in 10-25% of cases) were mild. They usually occurred within the first postoperative week and spontaneously resolved within 1-3 months. No long-term sight-threatening complications have been reported so far. Patients are usually satisfied with the procedure. Although more robust data are needed, these first studies suggest that the PRESERFLO MicroShunt is a promising new, minimally invasive procedure for glaucoma.