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      Treatment of Open-Angle Glaucoma with iStent Implantation Combined with Phacoemulsification in Polish Caucasian Population

      case-report

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          Abstract

          Purpose

          The aim of this investigation was to evaluate the impact of iStent (the first-generation trabecular bypass) implantation with phacoemulsification on the intraocular pressure (IOP) and glaucoma medication in subjects with mild to moderate open-angle glaucoma (OAG) and cataract in a Polish Caucasian population.

          Patients and Methods

          This prospective case series covered 78 eyes of (57 Polish Caucasian patients) that had undergone iStent implantation in conjunction with cataract surgery. Patients were surveyed preoperatively and at postoperative day 1, week 1, and months 1, 3, 6, 12, and 24. Pre- and postoperative outcome measurements included visual acuity, IOP, and medication burden. Intraoperative and postoperative complications were noted for the safety profile. For effective treatment, an IOP reduction ≥20% was assumed, regardless of the use of IOP-lowering drops. Complete surgical success was defined as an IOP ≤ 15 mmHg, medications free, and a qualified surgical success as IOP ≤ 15 mmHg with or without medications.

          Results

          Post-operatively at two years, mean IOP reduced from 18.5 mmHg to 16.1 mmHg. The mean medication burden dropped from 1.8 to 0.4 at the end of follow-up. Preoperatively, 2 (2.6%) eyes were medication free, but by postoperative month 24, 53 (68%) eyes were medication-free ( p < 0.05). Effective treatment was achieved in 50 cases (64%) at the end of follow-up period. Kaplan–Meier cumulative incidence of qualified success was 51.9% after 24 months, CI 95 [41.9%; 64.4%], while cumulative incidence of complete success after 2 years of observation was 35.1%, CI 95 [25.9%; 47.5%].

          Conclusion

          The iStent device combined with a cataract surgery served to decrease, significantly and positively, both IOP and medication use in the 24-months follow-up in patients with coexistent OAG and cataract in Polish patients.

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          Most cited references31

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          Reduction of intraocular pressure and glaucoma progression: results from the Early Manifest Glaucoma Trial.

          To provide the results of the Early Manifest Glaucoma Trial, which compared the effect of immediately lowering the intraocular pressure (IOP), vs no treatment or later treatment, on the progression of newly detected open-angle glaucoma. Randomized clinical trial. Two hundred fifty-five patients aged 50 to 80 years (median, 68 years) with early glaucoma, visual field defects (median mean deviation, -4 dB), and a median IOP of 20 mm Hg, mainly identified through a population screening. Patients with an IOP greater than 30 mm Hg or advanced visual field loss were ineligible. Patients were randomized to either laser trabeculoplasty plus topical betaxolol hydrochloride (n = 129) or no initial treatment (n = 126). Study visits included Humphrey Full Threshold 30-2 visual field tests and tonometry every 3 months, and optic disc photography every 6 months. Decisions regarding treatment were made jointly with the patient when progression occurred and thereafter. Glaucoma progression was defined by specific visual field and optic disc outcomes. Criteria for perimetric progression were computer based and defined as the same 3 or more test point locations showing significant deterioration from baseline in glaucoma change probability maps from 3 consecutive tests. Optic disc progression was determined by masked graders using flicker chronoscopy plus side-by-side photogradings. After a median follow-up period of 6 years (range, 51-102 months), retention was excellent, with only 6 patients lost to follow-up for reasons other than death. On average, treatment reduced the IOP by 5.1 mm Hg or 25%, a reduction maintained throughout follow-up. Progression was less frequent in the treatment group (58/129; 45%) than in controls (78/126; 62%) (P =.007) and occurred significantly later in treated patients. Treatment effects were also evident when stratifying patients by median IOP, mean deviation, and age as well as exfoliation status. Although patients reported few systemic or ocular conditions, increases in clinical nuclear lens opacity gradings were associated with treatment (P =.002). The Early Manifest Glaucoma Trial is the first adequately powered randomized trial with an untreated control arm to evaluate the effects of IOP reduction in patients with open-angle glaucoma who have elevated and normal IOP. Its intent-to-treat analysis showed considerable beneficial effects of treatment that significantly delayed progression. Whereas progression varied across patient categories, treatment effects were present in both older and younger patients, high- and normal-tension glaucoma, and eyes with less and greater visual field loss.
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            Micro-invasive glaucoma surgery: current perspectives and future directions.

            There is an increasing interest and availability of micro-invasive glaucoma surgery (MIGS) procedures. It is important that this increase is supported by sound, peer-reviewed evidence. This article will define MIGS, review relevant publications in the period of annual review and discuss future directions. The results of the pivotal trial comparing a trabecular micro-bypass stent (iStent, Glaukos Corporation, Laguna Hills, CA, USA) combined with phacoemulsification to phacoemulsification alone showed a significantly higher percentage of patients with unmedicated intraocular pressure (IOP) ≤ 21 mmHg, and a comparable safety profile. Initial results are published regarding a second-generation micro-bypass stent (iStent inject, Glaukos Corporation, Laguna Hills, CA, USA), a canalicular scaffold (Hydrus, Ivantis Inc., Irvine, CA, USA) and an ab interno suprachoroidal microstent (CyPass, Transcend Medical, Menlo Park, CA, USA), showing a decrease in mean postoperative IOP. Phaco-Trabectome (Ab interno trabeculectomy Trabectome, NeoMedix Inc., Tustin, CA, USA) was compared to phacotrabeculectomy and showed less IOP reduction, less postoperative complications, and a similar success rate. Similar success rates were found with the comparison of excimer laser trabeculostomy (ELT, AIDA, Glautec AG, Nurnberg, Germany) and selective laser trabeculoplasty. A number of publications review the importance of the location of implantable devices, intraoperative gonioscopy, cost-effectiveness and quality-of-life studies, and randomized clinical trials. MIGS procedures offer reduction in IOP, decrease in dependence on glaucoma medications and an excellent safety profile. Their role within our glaucoma treatment algorithm continues to be clarified and differs from the role of more invasive glaucoma surgeries such as trabeculectomy or glaucoma drainage devices.
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              Randomized evaluation of the trabecular micro-bypass stent with phacoemulsification in patients with glaucoma and cataract.

              To assess the safety and efficacy of the iStent trabecular micro-bypass stent (Glaukos Corporation, Laguna Hills, CA) in combination with cataract surgery in subjects with mild to moderate open-angle glaucoma. Prospective, randomized, open-label, controlled, multicenter clinical trial. A total of 240 eyes with mild to moderate open-angle glaucoma with intraocular pressure (IOP) ≤24 mmHg controlled on 1 to 3 medications were randomized to undergo cataract surgery with iStent implantation (treatment group) or cataract surgery only (control). Fifty additional subjects were enrolled to undergo cataract surgery with iStent implantation under protocol expansion. Data in this report are based on the first 240 eyes enrolled. Implantation of the iStent trabecular micro-bypass stent in conjunction with cataract surgery or cataract surgery only. The primary efficacy measure was unmedicated IOP ≤21 mmHg at 1 year. A secondary measure was unmedicated IOP reduction ≥20% at 1 year. Safety measures included best-corrected visual acuity (BCVA), slit-lamp observations, complications, and adverse events. The study met the primary outcome, with 72% of treatment eyes versus 50% of control eyes achieving the criterion (P<0.001). At 1 year, IOP in both treatment groups was statistically significantly lower from baseline values. Sixty-six percent of treatment eyes versus 48% of control eyes achieved ≥20% IOP reduction without medication (P = 0.003). The overall incidence of adverse events was similar between groups with no unanticipated adverse device effects. Pressure reduction on fewer medications was clinically and statistically significantly better 1 year after stent plus cataract surgery versus cataract surgery alone, with an overall safety profile similar to that of cataract surgery alone. Copyright © 2011 American Academy of Ophthalmology. Published by Elsevier Inc. All rights reserved.
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                Author and article information

                Journal
                Clin Ophthalmol
                Clin Ophthalmol
                opth
                clinop
                Clinical Ophthalmology (Auckland, N.Z.)
                Dove
                1177-5467
                1177-5483
                10 February 2021
                2021
                : 15
                : 473-480
                Affiliations
                [1 ]Department of Ophthalmology, Military Institute of Medicine , Warsaw, Poland
                [2 ]Department of Ophthalmology, Medical University of Bialystok , Białystok, Poland
                Author notes
                Correspondence: Joanna Konopińska Department of Ophthalmology, Medical University of Białystok , M. Sklodowska-Curie 24A STR, Białystok, 15-276, PolandTel +48-857468372Fax +48-857468604 Email joannakonopinska@o2.pl
                Author information
                http://orcid.org/0000-0001-7156-3036
                http://orcid.org/0000-0002-9088-6938
                http://orcid.org/0000-0001-6654-0550
                http://orcid.org/0000-0003-0429-6649
                Article
                293637
                10.2147/OPTH.S293637
                7882442
                33603324
                25480f1d-d020-4216-b16d-946afc9c2472
                © 2021 Kozera et al.

                This work is published and licensed by Dove Medical Press Limited. The full terms of this license are available at https://www.dovepress.com/terms.php and incorporate the Creative Commons Attribution – Non Commercial (unported, v3.0) License ( http://creativecommons.org/licenses/by-nc/3.0/). By accessing the work you hereby accept the Terms. Non-commercial uses of the work are permitted without any further permission from Dove Medical Press Limited, provided the work is properly attributed. For permission for commercial use of this work, please see paragraphs 4.2 and 5 of our Terms ( https://www.dovepress.com/terms.php).

                History
                : 28 November 2020
                : 26 January 2021
                Page count
                Figures: 1, Tables: 8, References: 31, Pages: 8
                Categories
                Clinical Trial Report

                Ophthalmology & Optometry
                istent first generation,trabecular by-pass,medication burden,microinvasive glaucoma surgery,open-angle glaucoma

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