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      One-Year Outcomes of Second-Generation Trabecular Micro-Bypass Stents (iStent Inject) Implantation with Cataract Surgery in Different Glaucoma Subtypes and Severities

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          Abstract

          Purpose

          To assess the 1-year efficacy and safety of the implantation of two second-generation trabecular micro-bypass stents (iStent Inject ®) with concomitant cataract surgery in various subtypes and severities of glaucoma.

          Methods

          This single-surgeon, consecutive case series from a Canadian academic ophthalmology center included subjects with cataract, glaucoma, and the need to reduce intraocular pressure (IOP) and/or medications. The 12-month outcomes included mean IOP and medication burden as well as the proportions of eyes with IOP ≤ 18, ≤ 15, and ≤ 12 mmHg compared to baseline. Other measures included corrected distance visual acuity (CDVA), cup-to-disc ratio (CDR), visual field mean deviation (VF MD), retinal nerve fiber layer (RNFL) thickness, ganglion cell inner plexiform layer (GCIPL) thickness, and adverse events.

          Results

          In 118 eyes, mean IOP reduced from 17.00 ± 3.82 mmHg preoperatively to 13.97 ± 2.65 mmHg at the 12-month follow-up mark (17.8% reduction, p < 0.001), and mean medication burden decreased from 2.31 ± 1.33 preoperatively to 1.03 ± 1.10 medications (56% reduction, p < 0.001). After 12 months, 93% of eyes achieved IOP ≤ 18 mmHg (versus 69% preoperatively), 70% of eyes achieved IOP ≤ 15 mmHg (versus 42% preoperatively), and 29% of eyes achieved IOP ≤ 12 mmHg (versus 7% preoperatively). For all eyes, topical medications were either maintained or decreased from baseline, with ≥ 1 medication eliminated from the preoperative regimen for 83% of eyes and ≥ 2 medications eliminated for 36% of eyes. Visual acuity improved significantly, consistent with expectations for cataract surgery, while CDR, VF MD, and RNFL and GCIPL thicknesses remained stable. Safety was favorable, with no intraoperative complications and few transient adverse events postoperatively.

          Conclusion

          iStent Inject implantation with cataract surgery safely reduced IOP and medication burden in a real-world clinical population with mild to severe glaucoma, and stabilized visual field, as well as RNFL and GCIPL thicknesses on OCT.

          Funding

          The Rapid Service Fees were funded by Glaukos Corporation.

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          Most cited references39

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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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              • Record: found
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              • Article: not found

              The Most Common Barriers to Glaucoma Medication Adherence: A Cross-Sectional Survey.

              To evaluate the frequency of 11 commonly cited barriers to optimal glaucoma medication adherence among glaucoma patients and to identify barriers contributing to poor adherence.
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                Author and article information

                Contributors
                pavloh@igmtl.com
                Journal
                Ophthalmol Ther
                Ophthalmol Ther
                Ophthalmology and Therapy
                Springer Healthcare (Cheshire )
                2193-8245
                2193-6528
                19 September 2019
                19 September 2019
                December 2019
                : 8
                : 4
                : 563-575
                Affiliations
                [1 ]GRID grid.14709.3b, ISNI 0000 0004 1936 8649, Faculty of Medicine, , McGill University, ; Montreal, QC Canada
                [2 ]Montreal Glaucoma Institute, Montreal, QC Canada
                [3 ]GRID grid.86715.3d, ISNI 0000 0000 9064 6198, Department of Ophthalmology, , University of Sherbrooke, ; Sherbrooke, QC Canada
                [4 ]GRID grid.14848.31, ISNI 0000 0001 2292 3357, Department of Ophthalmology, , University of Montreal, ; Montreal, QC Canada
                Author information
                http://orcid.org/0000-0003-0016-3478
                Article
                214
                10.1007/s40123-019-00214-z
                6858422
                31538316
                a859f825-aebd-4a3d-9bef-31cd1a124c0a
                © The Author(s) 2019
                History
                : 9 August 2019
                Categories
                Original Research
                Custom metadata
                © The Author(s) 2019

                cataract,istent inject,glaucoma,micro-invasive glaucoma surgery (migs),stent,trabecular micro-bypass

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