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      New XEN63 Gel Stent Implantation in Open-Angle Glaucoma: A Two-Year Follow-Up Pilot Study

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          Abstract

          Purpose

          The XEN gel stent was developed to reduce the risks of filtration surgery by standardizing the outflow of aqueous humor into the subconjunctival space. Recently, a modified version of the XEN63 gel stent was introduced. The goal of this study was to assess its efficacy and safety.

          Methods

          This is a prospective, nonrandomized, observational, consecutive case series study at a single tertiary centre. Patients with open-angle glaucoma with above target intraocular pressure (IOP) despite maximal tolerated medication were included. The primary outcome was a change of median IOP. Secondary outcomes included a change in the number of medications, complete success, needling and complication rates. Success was defined as a lowering of IOP > 20% from baseline and IOP ≤ 14 mmHg. Complete success indicated that the target IOP was reached without medications.

          Results

          Six patients were included. The median IOP decreased from 35.5 mmHg (25.0–40.0 mmHg) at baseline to 11.5 mmHg (4.0–15.0 mmHg, p = 0.03), and median IOP-lowering medication was reduced from 4.0 (3.0–4.0) at baseline to 0 (0–1.0, p = 0.03) after two years. Five patients (83.0%) had a complete success after two years. Two patients (33.0%) required a needling procedure. Three patients (50.0%) required an intervention due to symptomatic hypotony within the first three weeks postoperatively. Hypotony resolved completely or was asymptomatic after three months.

          Conclusion

          Our study demonstrated a statistically significant reduction in both IOP and number of IOP-lowering medications. Complications were well manageable and had no long-term sequelae.

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          Most cited references30

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          Performance and Safety of a New Ab Interno Gelatin Stent in Refractory Glaucoma at 12 Months.

          To evaluate the intraocular pressure (IOP)-lowering performance and safety of an ab interno gelatin stent (XEN 45 Gel Stent, Allergan plc, Irvine, California, USA), a minimally invasive glaucoma surgery device, in refractory glaucoma.
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            Ab interno approach to the subconjunctival space using a collagen glaucoma stent.

            This review considers a minimally invasive ab interno approach to glaucoma filtration surgery. Glaucoma filtration surgery can be defined as an attempt to lower intraocular pressure (IOP) by the surgical formation of an artificial drainage pathway from the anterior chamber to the subconjunctival space. Subconjunctival drainage of aqueous fluid has been a cornerstone of glaucoma surgery for more than a century. Varying techniques have been deployed to provide access to this space. Yet, despite numerous innovations in filtering surgery to achieve safe IOP reduction, too many short-term and long-term complications are associated with this surgery. This article describes the development of a new, soft, and permanent ab interno collagen implant (XEN gel stent) to optimize aqueous drainage to the subconjunctival space. Specific characteristics are critical in designing such an implant. Determining the optimum size of the device lumen to avoid hypotony while maximizing long-term outflow is crucial. Other topics discussed include material, length, diameter, flexibility, stability, and biocompatibility of the implant. Preclinical and human eye testing shows that the implant does not seem to occlude inside the lumen and the implant material does not appear to cause tissue reaction in the eye. The ab interno placement of the stent offers an alternative for lowering IOP with a minimally invasive procedure, minimum conjunctival tissue disruption, restricted flow to avoid hypotony, and long-term safety.
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              Fluid Dynamics of a Novel Micro-Fistula Implant for the Surgical Treatment of Glaucoma.

              The purpose of this study was to describe the fluidics of a novel non-valved glaucoma implant designed to prevent hypotony and compare the fluidics of this device with two commonly used non-valved glaucoma devices.
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                Author and article information

                Journal
                Clin Ophthalmol
                Clin Ophthalmol
                opth
                Clinical Ophthalmology (Auckland, N.Z.)
                Dove
                1177-5467
                1177-5483
                04 August 2023
                2023
                : 17
                : 2243-2249
                Affiliations
                [1 ]Centre for Ophthalmology, University Hospital Tuebingen , Tuebingen, Germany
                Author notes
                Correspondence: Bogomil Voykov, Centre for Ophthalmology, University Hospital Tuebingen , Elfriede-Aulhorn-Str. 7, Tuebingen, 72076, Germany, Tel +49 7071 2988088, Fax +49 7071 295455, Email bogomil.voykov@med.uni-tuebingen.de
                Author information
                http://orcid.org/0000-0002-1706-126X
                http://orcid.org/0009-0009-3375-702X
                http://orcid.org/0000-0002-4120-534X
                Article
                423519
                10.2147/OPTH.S423519
                10409639
                a78eda2b-9b8a-4e05-9bd7-f521f08012fe
                © 2023 Voykov et al.

                This work is published by Dove Medical Press Limited, and licensed under a Creative Commons Attribution License. The full terms of the License are available at http://creativecommons.org/licenses/by/4.0/. The license permits unrestricted use, distribution, and reproduction in any medium, provided the original author and source are credited.

                History
                : 21 June 2023
                : 13 July 2023
                Page count
                Figures: 4, Tables: 3, References: 30, Pages: 7
                Categories
                Original Research

                Ophthalmology & Optometry
                open-angle glaucoma,filtering surgery,minimally invasive surgery,glaucoma gel stent

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