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      One-year outcomes following implantation of second-generation trabecular micro-bypass stents in conjunction with cataract surgery for various types of glaucoma or ocular hypertension: multicenter, multi-surgeon study

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          Abstract

          Purpose

          To assess the utility and safety of implanting two second-generation trabecular micro-bypass stents following cataract surgery in eyes with mild to advanced glaucoma or ocular hypertension (OHT).

          Patients and methods

          Retrospective study of iStent ®inject trabecular micro-bypass implantation with cataract surgery by five surgeons at five sites in Australia. Eyes had mild to advanced glaucoma (predominantly primary open-angle, appositional angle-closure, or pseudoexfoliative glaucoma) or OHT and cataract requiring surgery. Effectiveness measures included intraocular pressure (IOP); medication burden; and proportions of eyes with no medications, ≥2 medications, stable or decreased medications vs preoperative, and IOP ≤18 mmHg. Safety measures included visual acuity, cup-to-disc ratio (CDR), visual field (VF), complications, adverse events, and secondary surgical interventions. Patients have been followed for 12 months, and follow-up is ongoing.

          Results

          Of the 290 total eyes that underwent surgery, 165 eyes had 12-month outcomes at the time of data collection and are included in this report. In these eyes, mean Month 12 IOP reduced by 23.2% from 18.27±5.41 mmHg preoperatively to 14.04±2.98 mmHg ( P<0.001), with 95.8% of eyes achieving Month 12 IOP of ≤18 mmHg vs 60.6% preoperatively. Mean number of medications at 12 months decreased by 71.5%, 0.47±0.95 vs 1.65±1.28 preoperatively; 76.4% of eyes were on zero medications vs 17.6% preoperatively ( P<0.001); 14.5% of eyes were on ≥2 medications vs 46.7% preoperatively ( P<0.001); and 98.2% of eyes maintained or reduced medications vs their preoperative regimen. Favorable safety included no stent-related intraoperative complications; limited and transient postoperative adverse events; and stable CDR, VF, and visual acuity. Three eyes with more advanced disease underwent additional glaucoma surgeries.

          Conclusion

          iStent inject implantation with cataract surgery significantly and safely reduced medications and IOP in eyes with various types and severities of glaucoma within a multicenter, multi-provider, real-life setting.

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          Most cited references33

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          Prevalence of ocular surface disease in glaucoma patients.

          To examine the prevalence of ocular surface disease (OSD) in glaucoma patients. This was a cross-sectional study. One hundred and one patients, 18 years of age or older, with open-angle glaucoma or ocular hypertension were consecutively recruited for the study. Patients with a history of use of cyclosporine, steroids, topical ocular nonsteroidal anti-inflammatory drugs, or punctal plugs within the last 3 months were excluded. Each patient completed an Ocular Surface Disease Index questionnaire and underwent evaluation by Schirmer test, corneal and conjunctival lissamine green staining, and tear break-up time. Using Ocular Surface Disease Index for measuring symptoms of dry eye, 60 (59%) patients reported symptoms in at least 1 eye. Severe symptoms were reported by 27 (27%) patients. Schirmer testing showed 62 (61%) patients with decrease in tear production in at least 1 eye. Severe tear deficiency was presented in 35 (35%) patients. Corneal and conjunctival lissamine green staining showed positive results in 22 (22%) patients. None had severe staining. Tear break-up time showed abnormal tear quality in 79 (78%) patients and severe decrease in tear quality was found in at least 1 eye in 66 (65%) patients. Multivariate logistic regression models were used to investigate the association between the number of benzalkonium chloride (BAK)-containing eyedrops and results on the clinical tests of OSD. After adjustment for age and sex, each additional BAK-containing eyedrop was associated with an approximately 2 times higher odds of showing abnormal results on the lissamine green staining test (odds ratio=2.03; 95% confidence interval: 1.06 to 3.89; P=0.034). A large proportion of patients with open-angle glaucoma or ocular hypertension had signs and/or symptoms of OSD in at least 1 eye. The coexistence of OSD and the use of BAK-containing medications may impact vision-related quality of life in this patient population.
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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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              • Article: not found

              Cataract surgery with trabecular micro-bypass stent implantation in patients with mild-to-moderate open-angle glaucoma and cataract: two-year follow-up.

              To assess the long-term safety and efficacy of a single trabecular micro-bypass stent with concomitant cataract surgery versus cataract surgery alone for mild to moderate open-angle glaucoma. Twenty-nine investigational sites, United States. Prospective randomized controlled multicenter clinical trial. Eyes with mild to moderate glaucoma with an unmedicated intraocular pressure (IOP) of 22 mm Hg or higher and 36 mm Hg or lower were randomly assigned to have cataract surgery with iStent trabecular micro-bypass stent implantation (stent group) or cataract surgery alone (control group). Patients were followed for 24 months postoperatively. The incidence of adverse events was low in both groups through 24 months of follow-up. At 24 months, the proportion of patients with an IOP of 21 mm Hg or lower without ocular hypotensive medications was significantly higher in the stent group than in the control group (P=.036). Overall, the mean IOP was stable between 12 months and 24 months (17.0 mm Hg ± 2.8 [SD] and 17.1 ± 2.9 mm Hg, respectively) in the stent group but increased (17.0 ± 3.1 mm Hg to 17.8 ± 3.3 mm Hg, respectively) in the control group. Ocular hypotensive medication was statistically significantly lower in the stent group at 12 months; it was also lower at 24 months, although the difference was no longer statistically significant. Patients with combined single trabecular micro-bypass stent and cataract surgery had significantly better IOP control on no medication through 24 months than patients having cataract surgery alone. Both groups had a similar favorable long-term safety profile. Dr. Craven was an investigator in the clinical trial of the iStent. Dr. Katz is a consultant to Glaukos and was the medical monitor for the clinical trial of the iStent. Dr. Katz is a stockholder in Glaukos. Mr. Wells and Ms. Giamporcaro are employees of Glaukos. Copyright © 2012 ASCRS and ESCRS. Published by Elsevier Inc. All rights reserved.
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                Author and article information

                Journal
                Clin Ophthalmol
                Clin Ophthalmol
                Clinical Ophthalmology
                Clinical Ophthalmology (Auckland, N.Z.)
                Dove Medical Press
                1177-5467
                1177-5483
                2019
                13 March 2019
                : 13
                : 491-499
                Affiliations
                [1 ]Eye Associates, Sydney, NSW, Australia, colinandkylie@ 123456me.com
                [2 ]Fairfield Eye Surgery, Fairfield, NSW, Australia, colinandkylie@ 123456me.com
                [3 ]Glaucoma Unit, Sydney Eye Hospital, Sydney, NSW, Australia, colinandkylie@ 123456me.com
                [4 ]Discipline of Ophthalmology, The University of Sydney, Sydney, NSW, Australia, colinandkylie@ 123456me.com
                [5 ]Eye & Laser Centre Gold Coast, Southport, QLD, Australia
                [6 ]Vision Eye Institute, Melbourne, VIC, Australia
                [7 ]Laser Sight Laser Cataract & Lens Specialists, Sydney, NSW, Australia
                [8 ]Hunter Cataract & Eye Centre, Sydney, NSW, Australia
                Author notes
                Correspondence: Colin Clement, Eye Associates, Level 4, 187 Macquarie Street, Sydney 2000, NSW, Australia, Tel +61 29 247 9972, Email colinandkylie@ 123456me.com
                Article
                opth-13-491
                10.2147/OPTH.S187272
                6420788
                8d1df067-bc55-443a-ad39-7e4b7dddb987
                © 2019 Clement 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.

                Categories
                Case Series

                Ophthalmology & Optometry
                microinvasive glaucoma surgery,migs,glaucoma,istent inject,intraocular pressure,second-generation,medication,safety

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