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Ab externo implantation of the MicroShunt, a poly (styrene-block-isobutylene-block-styrene) surgical device for the treatment of primary open-angle glaucoma: a review
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-...
Autores principales: | , , , |
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Formato: | Online Artículo Texto |
Lenguaje: | English |
Publicado: |
BioMed Central
2019
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Materias: | |
Acceso en línea: | https://www.ncbi.nlm.nih.gov/pmc/articles/PMC6857290/ https://www.ncbi.nlm.nih.gov/pubmed/31807606 http://dx.doi.org/10.1186/s40662-019-0162-1 |
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author | Sadruddin, Omar Pinchuk, Leonard Angeles, Raymund Palmberg, Paul |
author_facet | Sadruddin, Omar Pinchuk, Leonard Angeles, Raymund Palmberg, Paul |
author_sort | Sadruddin, Omar |
collection | PubMed |
description | 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 to avoid being blocked by sloughed cells or pigment. The MicroShunt achieves the desired pressure range in the eye by draining aqueous humor from the anterior chamber to a bleb formed under the conjunctiva and Tenon’s capsule. The device is implanted ab externo with intraoperative Mitomycin C via a minimally invasive (relative to incisional surgery) surgical procedure, enabling precise control of placement without the need for gonioscopy, suture tension control, or suture lysis. The implantation procedure can be performed in combination with cataract surgery or as a standalone procedure. The MicroShunt received Conformité Européenne (CE) marking in 2012 and is intended for the reduction of IOP in eyes of patients with primary open-angle glaucoma in which IOP remains uncontrolled while on maximum tolerated medical therapy and/or in which glaucoma progression warrants surgery. Three clinical studies assessing the long-term safety and efficacy of the MicroShunt have been completed; a Phase 3 multicenter, randomized clinical study comparing the MicroShunt to primary trabeculectomy is underway. In preliminary studies, the MicroShunt effectively reduced IOP and use of glaucoma medications up to 3 years after implantation, with an acceptable safety profile. This article summarizes current literature on the unique properties of the MicroShunt, the preliminary efficacy and safety findings, and discusses its potential use as an alternative to trabeculectomy for glaucoma surgery. |
format | Online Article Text |
id | pubmed-6857290 |
institution | National Center for Biotechnology Information |
language | English |
publishDate | 2019 |
publisher | BioMed Central |
record_format | MEDLINE/PubMed |
spelling | pubmed-68572902019-12-05 Ab externo implantation of the MicroShunt, a poly (styrene-block-isobutylene-block-styrene) surgical device for the treatment of primary open-angle glaucoma: a review Sadruddin, Omar Pinchuk, Leonard Angeles, Raymund Palmberg, Paul Eye Vis (Lond) Review 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 to avoid being blocked by sloughed cells or pigment. The MicroShunt achieves the desired pressure range in the eye by draining aqueous humor from the anterior chamber to a bleb formed under the conjunctiva and Tenon’s capsule. The device is implanted ab externo with intraoperative Mitomycin C via a minimally invasive (relative to incisional surgery) surgical procedure, enabling precise control of placement without the need for gonioscopy, suture tension control, or suture lysis. The implantation procedure can be performed in combination with cataract surgery or as a standalone procedure. The MicroShunt received Conformité Européenne (CE) marking in 2012 and is intended for the reduction of IOP in eyes of patients with primary open-angle glaucoma in which IOP remains uncontrolled while on maximum tolerated medical therapy and/or in which glaucoma progression warrants surgery. Three clinical studies assessing the long-term safety and efficacy of the MicroShunt have been completed; a Phase 3 multicenter, randomized clinical study comparing the MicroShunt to primary trabeculectomy is underway. In preliminary studies, the MicroShunt effectively reduced IOP and use of glaucoma medications up to 3 years after implantation, with an acceptable safety profile. This article summarizes current literature on the unique properties of the MicroShunt, the preliminary efficacy and safety findings, and discusses its potential use as an alternative to trabeculectomy for glaucoma surgery. BioMed Central 2019-11-15 /pmc/articles/PMC6857290/ /pubmed/31807606 http://dx.doi.org/10.1186/s40662-019-0162-1 Text en © The Author(s). 2019 Open AccessThis article is distributed under the terms of the Creative Commons Attribution 4.0 International License (http://creativecommons.org/licenses/by/4.0/), which permits unrestricted use, distribution, and reproduction in any medium, provided you give appropriate credit to the original author(s) and the source, provide a link to the Creative Commons license, and indicate if changes were made. The Creative Commons Public Domain Dedication waiver (http://creativecommons.org/publicdomain/zero/1.0/) applies to the data made available in this article, unless otherwise stated. |
spellingShingle | Review Sadruddin, Omar Pinchuk, Leonard Angeles, Raymund Palmberg, Paul Ab externo implantation of the MicroShunt, a poly (styrene-block-isobutylene-block-styrene) surgical device for the treatment of primary open-angle glaucoma: a review |
title | Ab externo implantation of the MicroShunt, a poly (styrene-block-isobutylene-block-styrene) surgical device for the treatment of primary open-angle glaucoma: a review |
title_full | Ab externo implantation of the MicroShunt, a poly (styrene-block-isobutylene-block-styrene) surgical device for the treatment of primary open-angle glaucoma: a review |
title_fullStr | Ab externo implantation of the MicroShunt, a poly (styrene-block-isobutylene-block-styrene) surgical device for the treatment of primary open-angle glaucoma: a review |
title_full_unstemmed | Ab externo implantation of the MicroShunt, a poly (styrene-block-isobutylene-block-styrene) surgical device for the treatment of primary open-angle glaucoma: a review |
title_short | Ab externo implantation of the MicroShunt, a poly (styrene-block-isobutylene-block-styrene) surgical device for the treatment of primary open-angle glaucoma: a review |
title_sort | ab externo implantation of the microshunt, a poly (styrene-block-isobutylene-block-styrene) surgical device for the treatment of primary open-angle glaucoma: a review |
topic | Review |
url | https://www.ncbi.nlm.nih.gov/pmc/articles/PMC6857290/ https://www.ncbi.nlm.nih.gov/pubmed/31807606 http://dx.doi.org/10.1186/s40662-019-0162-1 |
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