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      Real-World Retrospective Consecutive Study of Ab Interno XEN 45 Gel Stent Implant with Mitomycin C in Black and Afro-Latino Patients with Glaucoma: 40% Required Secondary Glaucoma Surgery at 1 Year

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          Abstract

          PURPOSE:

          The aim of this study was to determine the postoperative course after the ab interno XEN45 Gel Stent implantation in Black and Afro-Latino, patients with glaucoma.

          METHODS:

          This was a single-center, retrospective study. All patients with glaucoma who underwent ab interno XEN implantation were included in the study. All of the patients were Black and Afro-Latino making up the demographics of the local community. Investigated parameters were intraocular pressure (IOP), the number of medications, visual acuity, IOP-follow-up, intraoperative and postoperative complications, and additionally performed surgeries.

          RESULTS:

          Of 20 eyes that had undergone the procedure with 1-year follow-up, eight failed before 12 months requiring additional glaucoma surgery. Of the 12 that were successful at 1 year, 9 (75%) eyes underwent XEN + cataract surgery and 3 (25%) had XEN surgery alone. Of the eyes that completed 12-month follow-up, the mean medicated IOP was 15.3 ± 6.2 mmHg at baseline, and 12.9 ± 4.5 mmHg at 12 months, a 16% IOP reduction. Mean medications dropped from 3.58 ± 0.7 preoperatively to 1.75 ± 1.5 at 12 months.

          CONCLUSIONS:

          The ab interno XEN gel implant as a standalone procedure or combined with cataract surgery demonstrated a safe and sustained IOP reduction for only 60% of patients after 12 months. In Black and Afro-Latino patients receiving the ab interno XEN implant, 40% of patients needed additional surgery within 12 months.

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          Most cited references15

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          Prevalence of open-angle glaucoma among adults in the United States.

          To estimate the prevalence and distribution of open-angle glaucoma (OAG) in the United States by age, race/ethnicity, and gender. Summary prevalence estimates of OAG were prepared separately for black, Hispanic, and white subjects in 5-year age intervals starting at 40 years. The estimated rates were based on a meta-analysis of recent population-based studies in the United States, Australia, and Europe. These rates were applied to 2000 US census data and to projected US population figures for 2020 to estimate the number of the US population with OAG. The overall prevalence of OAG in the US population 40 years and older is estimated to be 1.86% (95% confidence interval, 1.75%-1.96%), with 1.57 million white and 398 000 black persons affected. After applying race-, age-, and gender-specific rates to the US population as determined in the 2000 US census, we estimated that OAG affects 2.22 million US citizens. Owing to the rapidly aging population, the number with OAG will increase by 50% to 3.36 million in 2020. Black subjects had almost 3 times the age-adjusted prevalence of glaucoma than white subjects. Open-angle glaucoma affects more than 2 million individuals in the United States. Owing to the rapid aging of the US population, this number will increase to more than 3 million by 2020.
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            Aqueous humor in glaucomatous eyes contains an increased level of TGF-beta 2.

            By using the highly sensitive and specific technique of enzyme-linked immunosorbent assay, we investigated the presence and amount of transforming growth factor-beta 2 (TGF-beta 2) in samples of aqueous humor obtained from 15 patients who had a clinically established diagnosis of advanced primary open-angle glaucoma (POAG), as well as from ten age-matched normal human subjects undergoing cataract surgery. The total amount of TGF-beta 2 in the samples of normal aqueous humor ranged from 0.41 to 2.24 ng ml-1 (mean +/- S.D.: 1.48 +/- 0.68 ng ml-1) of which 4.88 to 37.05% (11.99 +/- 9.95%) was intrinsically active. Compared with normal subjects, the aqueous humor from POAG patients had a statistically significantly greater amount of total TGF-beta 2 (2.70 +/- 0.76 ng ml-1, P < 0.01), as well as a higher level of intrinsically active TGF-beta 2 (0.45 +/- 0.28 ng ml-1, P < 0.05) which corresponded to 1.09 to 60.84% (18.33 +/- 15.50%) of the total amount. No linear correlation was found between the age of the subjects and the protein concentration of the aqueous humor from either normal or glaucomatous eyes, nor between the age of the patient and the total amount of TGF-beta 2. The negligible amount of TGF-beta 2 present in serum argues against its influx into the aqueous humor after breakdown of the blood-aqueous barrier that is known to occur in glaucomatous eyes; rather, our present findings support the concept of the intraocular derivation of this cytokine.(ABSTRACT TRUNCATED AT 250 WORDS)
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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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                Author and article information

                Journal
                Middle East Afr J Ophthalmol
                Middle East Afr J Ophthalmol
                MEAJO
                Middle East African Journal of Ophthalmology
                Wolters Kluwer - Medknow (India )
                0974-9233
                0975-1599
                Oct-Dec 2019
                29 January 2020
                : 26
                : 4
                : 229-234
                Affiliations
                [1 ] Department of Ophthalmology, New York Eye and Ear of Mount Sinai, Icahn School of Medicine at Mount Sinai, New York, NY, USA
                [2 ] Department of Ophthalmology, Advance Eyecare of New York, New York, NY, USA
                Author notes
                Address for correspondence: Dr. Daniel Laroche, 49 West 127 th Street, New York 10027, NY, USA. E-mail: dlarochemd@ 123456aol.com
                Article
                MEAJO-26-229
                10.4103/meajo.MEAJO_126_19
                7034147
                32153335
                e96eca16-9103-4f0a-95ee-65083b265c13
                Copyright: © 2020 Middle East African Journal of Ophthalmology

                This is an open access journal, and articles are distributed under the terms of the Creative Commons Attribution-NonCommercial-ShareAlike 4.0 License, which allows others to remix, tweak, and build upon the work non-commercially, as long as appropriate credit is given and the new creations are licensed under the identical terms.

                History
                : 17 August 2019
                : 24 October 2019
                : 20 January 2020
                Categories
                Original Article

                Ophthalmology & Optometry
                glaucoma,migs,xen
                Ophthalmology & Optometry
                glaucoma, migs, xen

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