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      Choroidal Detachment after XEN Gel Stent Implantation

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          Abstract

          Background

          The purpose of this study is to estimate the incidence of choroidal detachment (CD) after XEN gel stent implant surgery and to evaluate the associated factors.

          Methods

          We reviewed the clinical charts of 126 patients who underwent XEN implantation between March 1, 2016, and December 31, 2018 at the University Eye Clinic of Genoa. Ocular, demographics, and perioperative factor were registered and analysed. Univariate and multivariate logistic analysis were performed to investigate factors associated with CD occurrence.

          Results

          Of the 126 patients, 25 (19.8%) developed a choroidal detachment after XEN gel stent implant surgery. The mean period between surgery and CD detection was 5.84 ± 1.77 days. The mean intraocular pressure (IOP) at the time of CD diagnosis was 6.4 ± 3.1 mmHg. Age (OR = 1.10, p < 0.019), early postoperative IOP (OR = 0.70, p < 0.001), and number of preoperative IOP-lowering drugs (OR = 5.70, p < 0.001) were significantly associated with CD presence. Complete resolution was observed in all the cases. Wide-field imaging and ultrasonography were useful tools to diagnose and follow up CD until resolution.

          Conclusions

          When carefully investigated, CD is a relatively common complication after XEN gel stent implant procedure. Older age, lower postoperative IOP, and higher number of preoperative IOP-lowering drugs were significantly associated with the development of CD.

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          Most cited references36

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          Minimally-invasive glaucoma surgeries (MIGS) for open angle glaucoma: A systematic review and meta-analysis

          Carlo Lavia, Laura Dallorto, Milena Maule … (2017)
          Background MIGS have been developed as a surgical alternative for glaucomatous patients. Purpose To analyze the change in intraocular pressure (IOP) and glaucoma medications using different MIGS devices (Trabectome, iStent, Excimer Laser Trabeculotomy (ELT), iStent Supra, CyPass, XEN, Hydrus, Fugo Blade, Ab interno canaloplasty, Goniscopy-assisted transluminal trabeculotomy) as a solo procedure or in association with phacoemulsification. Methods Randomized control trials (RCT) and non-RCT (non randomized comparative studies, NRS, and before-after studies) were included. Studies with at least one year of follow-up in patients affected by primary open angle glaucoma, pseudoexfoliative glaucoma or pigmentary glaucoma were considered. Risk of Bias assessment was performed using the Cochrane Risk of Bias and the ROBINS-I tools. The main outcome was the effect of MIGS devices compared to medical therapy, cataract surgery, other glaucoma surgeries and other MIGS on both IOP and use of glaucoma medications 12 months after surgery. Outcomes measures were the mean difference in the change of IOP and glaucoma medication compared to baseline at one and two years and all ocular adverse events. The current meta-analysis is registered on PROSPERO (reference n° CRD42016037280). Results Over a total of 3,069 studies, nine RCT and 21 case series with a total of 2.928 eyes were included. Main concerns about risk of bias in RCTs were lack of blinding, allocation concealment and attrition bias while in non-RCTs they were represented by patients’ selection, masking of participants and co-intervention management. Limited evidence was found based on both RCTs and non RCTs that compared MIGS surgery with medical therapy or other MIGS. In before-after series, MIGS surgery seemed effective in lowering both IOP and glaucoma drug use. MIGS showed a good safety profile: IOP spikes were the most frequent complications and no cases of infection or BCVA loss due to glaucoma were reported. Conclusions Although MIGS seem efficient in the reduction of the IOP and glaucoma medication and show good safety profile, this evidence is mainly derived from non-comparative studies and further, good quality RCTs are warranted.
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            Treatment outcomes in the Tube Versus Trabeculectomy (TVT) study after five years of follow-up.

            Steven Gedde, Joyce C Schiffman, William Feuer … (2012)
            To report 5-year treatment outcomes in the Tube Versus Trabeculectomy (TVT) Study. Multicenter randomized clinical trial. Seventeen clinical centers. Patients 18 to 85 years of age who had previous trabeculectomy and/or cataract extraction with intraocular lens implantation and uncontrolled glaucoma with intraocular pressure (IOP) ≥18 mm Hg and ≤40 mm Hg on maximum tolerated medical therapy. Tube shunt (350-mm(2) Baerveldt glaucoma implant) or trabeculectomy with mitomycin C ([MMC]; 0.4 mg/mL for 4 minutes). IOP, visual acuity, use of supplemental medical therapy, and failure (IOP >21 mm Hg or not reduced by 20%, IOP ≤5 mm Hg, reoperation for glaucoma, or loss of light perception vision). A total of 212 eyes of 212 patients were enrolled, including 107 in the tube group and 105 in the trabeculectomy group. At 5 years, IOP (mean ± SD) was 14.4 ± 6.9 mm Hg in the tube group and 12.6 ± 5.9 mm Hg in the trabeculectomy group (P = .12). The number of glaucoma medications (mean ± SD) was 1.4 ± 1.3 in the tube group and 1.2 ± 1.5 in the trabeculectomy group (P = .23). The cumulative probability of failure during 5 years of follow-up was 29.8% in the tube group and 46.9% in the trabeculectomy group (P = .002; hazard ratio = 2.15; 95% confidence interval = 1.30 to 3.56). The rate of reoperation for glaucoma was 9% in the tube group and 29% in the trabeculectomy group (P = .025). Tube shunt surgery had a higher success rate compared to trabeculectomy with MMC during 5 years of follow-up in the TVT Study. Both procedures were associated with similar IOP reduction and use of supplemental medical therapy at 5 years. Additional glaucoma surgery was needed more frequently after trabeculectomy with MMC than tube shunt placement. Copyright © 2012 Elsevier Inc. All rights reserved.
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              Performance and Safety of a New Ab Interno Gelatin Stent in Refractory Glaucoma at 12 Months.

              Barbara Niksch, Davinder S Grover, William Flynn … (2017)
              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.
              Article 0 comments Cited 97 times – based on 0 reviews     Review now
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                Author and article information

                Contributors
                Carlo Alberto Cutolo:
                ORCID: https://orcid.org/0000-0002-2433-0704
                Journal
                Journal ID (nlm-ta): J Ophthalmol
                Journal ID (iso-abbrev): J Ophthalmol
                Journal ID (publisher-id): JOPH
                Title: Journal of Ophthalmology
                Publisher: Hindawi
                ISSN (Print): 2090-004X
                ISSN (Electronic): 2090-0058
                Publication date Collection: 2021
                Publication date (Electronic): 6 March 2021
                Volume: 2021
                Electronic Location Identifier: 6674505
                Affiliations
                1Clinica Oculistica, Department of Neuroscience Rehabilitation Ophthalmology Genetics Maternal and Child Health (DiNOGMI), University of Genoa, Genoa, Italy
                2IRCCS Ospedale Policlinico San Martino, Genoa, Italy
                Author notes

                Academic Editor: Biju B. Thomas

                Author information
                https://orcid.org/0000-0002-2433-0704
                https://orcid.org/0000-0003-4255-5058
                https://orcid.org/0000-0002-0524-2637
                Article
                DOI: 10.1155/2021/6674505
                PMC ID: 7960055
                PubMed ID: 33747555
                SO-VID: f57a63e5-31dc-4b69-be45-939db2cb4387
                Copyright © Copyright © 2021 Carlo Alberto Cutolo et al.
                License:

                This is an open access article distributed under the Creative Commons Attribution License, which permits unrestricted use, distribution, and reproduction in any medium, provided the original work is properly cited.

                History
                Date received : 29 December 2020
                Date revision received : 2 February 2021
                Date accepted : 16 February 2021
                Funding
                Funded by: Ministero dell'Istruzione, dell'Università e della Ricerca
                Award ID: legge 232 del 2016
                Categories
                Subject: Research Article

                ScienceOpen disciplines: Ophthalmology & Optometry
                Data availability:
                ScienceOpen disciplines: Ophthalmology & Optometry

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