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Introduction: To compare outcomes of phacoemulsification combined with endoscopic cyclophotocoagulation (phaco/ECP), first generation iStent implantation (phaco/iStent), or both (phaco/iStent/ECP) in patients with open-angle glaucoma., Methods: A retrospective chart review was performed on patients at the University of Colorado Department of Ophthalmology. Outcomes included intraocular pressure (IOP), medication use, best corrected visual acuity (BCVA), and surgical complications were analyzed. Success was defined as IOP reduction of ≥ 20% and/or reduction by at least one glaucoma medication., Results: A total of 394 eyes were included in the study. There were 170 eyes (43.1%) in the phaco/ECP group, 175 eyes (44.4%) in the phaco/iStent group, and 49 eyes (12.4%) in the phaco/iStent/ECP group. The mean pre-operative IOP was 15.9 mmHg for phaco/ECP, 15.8 mmHg for phaco/iStent, and 15.2 mmHg for phaco/iStent/ECP. At 24 months, the mean IOP was 13.7 mmHg (p < 0.0001), 14.2 mmHg (p = 0.0001), and 13.0 mmHg (p = 0.0007), respectively. The mean pre-operative number of glaucoma medications was 2.0 for phaco/ECP, 1.4 for phaco/iStent, and 2.2 for phaco/iStent/ECP and at 24 months post-surgery decreased to, 1.8 (p = 0.011), 0.9 (p < 0.0001), and 1.7 (p = 0.01), respectively. The success rate at 24 months was 54.4% for phaco/ECP, 75.3% for phaco/iStent, and 55.6% for phaco/iStent/ECP., Conclusion: Phacoemulsification when combined with ECP, iStent, or both, lowered IOP and glaucoma medication reliance at 24 months. The success rate for phaco/iStent was significantly higher than phaco/ECP. When iStent was added to phaco/ECP, the success rate was higher at earlier postoperative visits compared to the phaco/ECP alone., (© 2023. The Author(s), under exclusive licence to Springer Healthcare Ltd., part of Springer Nature.)

This study evaluated the early outcomes of the hypotensive efficacy and safety profile of ab externo phaco-canaloplasty versus first-generation iStent bypass implantation combined with phacoemulsification in patients with primary open-angle glaucoma (POAG). In total, 82 patients with POAG comprising 92 eyes were divided into phaco-canaloplasty (Group PC, ( n = 47) or iStent combined with phacoemulsification (Group PiS, n = 45) groups. Primary outcome measures were intraocular pressure (IOP) reduction and number of glaucoma medications. Secondary outcome measures were best-corrected visual acuity (BCVA), endothelial cell density (EECD), changes in anterior chamber depth (ACD), and complication rate. The follow-up period was approximately 6 months. Preoperative IOPs were 17.30 (15.00; 19.85) mmHg and 17.50 (15.10; 20.90) mmHg in the PC and PiS groups, respectively ( p = 0.876). At the end of the follow-up, IOP decreased to 15.00 (13.00; 16.00) mmHg and 15.00 (14.00; 17.00) mmHg in the PC and PiS groups, respectively ( p = 0.438). Medication usage decreased from 2.08 to 0.12 and 1.40 to 0.04 in PC and PiS eyes, respectively. Most patients in both groups were medication-free at 6 months follow-up. After 6 months of observation, EECD in PC and PiS groups decreased from 2309.50 (2032.00; 2533.00) to 1966.50 (1262.00; 2353.50) and 2160.00 (1958.50; 2372.50), to1231.00 (1089.00; 2050.00), respectively ( p = 0.037). Pre-surgery BCVA was 0.80 (0.50; 1.00) and 0.60 (0.40; 1.00) in PC and PiS eyes, respectively ( p = 0.456). Follow-up BCVA was 0.95 (0.60; 1.00) for PC and 1.00 (1.00; 1.00) for PiS. Hyphema and corneal oedema were noted on the first day post-surgery in both groups. Subsequent complications included a transient increase in IOP in the PC group. Phaco-canaloplasty and iStent bypass implantation combined with phacoemulsification significantly lowered IOP and decreased medication burden. All eyes in both groups maintained or exhibited improved BCVA relative to baseline. Both surgeries had low postoperative complication rates and exhibited comparable safety profiles over 6-month follow-up in patients with POAG.

Introduction: We report 2-year outcomes after implantation of iStent trabecular micro-bypass stent with phacoemulsification, in Japanese patients with mild-moderate open-angle glaucoma (OAG)., Methods: This was a 24-month, prospective, longitudinal, observational, post-marketing study conducted between July 2017 and September 2020. Patients consisted of adults with OAG on antiglaucoma medications who had cataract surgery combined with one iStent implantation. Outcome measures included intraocular pressure (IOP), antiglaucoma medications, treatment success rates (defined as eyes having lower IOP with same or reduced number of medications from baseline, or same IOP with reduced number of medications from baseline, and not requiring secondary glaucoma surgeries postoperatively), and safety. Outcomes were analyzed in the overall cohort and in glaucoma subtypes: primary OAG, normal-tension glaucoma, and exfoliative glaucoma., Results: Overall, 232 eyes were enrolled. At 24 months, mean ± standard deviation IOP decreased from 17.6 ± 4.0 mmHg preoperatively to 14.3 ± 3.0 mmHg (p < 0.05), and mean number of medications reduced from 2.2 ± 1.2 preoperatively to 0.7 ± 1.2 (p < 0.05). Similar trends were observed across glaucoma subtypes. In the overall cohort, 96.7%, 95.3%, and 93.7% of patients achieved treatment success at 6, 12, and 24 months, respectively. There were 67.6% medication-free eyes at 24 months compared to 3.2% medication-free eyes preoperatively (p < 0.0001). Safety profile was favorable over the 2-year period., Conclusions: Following iStent implantation with phacoemulsification, clinically relevant and statistically significant reductions in IOP and number of medications were observed in Japanese eyes with OAG over 2 years, with favorable safety profile. These reductions were observed across all glaucoma subtypes., (© 2022. The Author(s).)

Purpose: To evaluate the impact of trabecular micro bypass stents (iStent Inject) on refractive outcomes with toric intraocular lens (IOL) in glaucomatous eyes., Methods: We identified glaucomatous eyes receiving a toric IOL between October 2017 and December 2020. Eyes with iStent implantation were included in the study group and eyes undergoing isolated phacoemulsification served as controls. Corrected and uncorrected visual acuity, manifest refraction, intraocular pressure (IOP), and number of hypotensive drugs three months after surgery were evaluated., Results: 26 eyes comprised the study group and 41 eyes the control group. Mean postoperative refractive cylinder was 0.26D in the control and 0.11D in the iStent group, with 63% and 85% of eyes with a cylinder of 0 and 85% and 92% of eyes with a cylinder ≤ 0.5D respectively. The mean absolute difference between target and outcome spherical equivalent was 0.26D in the control and 0.22D in the iStent group, with all eyes within 0.75D of target. LogMar uncorrected postoperative vision in eyes targeted for emmetropia was 0.04 in the control and 0.03 in the iStent group. There was a statistically significant reduction in IOP and number of hypotensive drugs in both groups, with a mean decrease in IOP of 8.6% in the control and 15.7% in the iStent group. The number of hypotensive drugs dropped from 1.63 ± 0.80 to 1.34 ± 0.91 in the control group and from 2.12 ± 0.65 to 0.44 ± 0.71 in the iStent group., Conclusion: Toric IOLs provide predictable refractive outcomes in glaucomatous eyes undergoing combined phacoemulsification with iStent implantation, reducing postoperative spectacle dependence., (© 2022. The Author(s), under exclusive licence to Springer Nature B.V.)

Purpose: Evaluate the efficacy, safety, and complication rates of phacoemulsification cataract surgery when combined with either gonioscopy-assisted transluminal trabeculotomy (GATT) or iStent Inject., Methods: This is a retrospective case-control study to compare the surgical outcomes of combined phacoemulsification cataract surgery with either GATT (phaco-GATT) or iStent Inject (phaco-iStent). Both groups had at least 1-year follow-up. The primary outcome measures were IOP and number of glaucoma medications (NGMs) at 1 year. Secondary outcomes measures were best corrected visual acuity (BCVA) and intra- or postoperative complications within the first year of follow-up. Success was defined as intraocular pressure (IOP) < 21 mmHg and ≥ 20% reduction in IOP at 1 year regardless of the NGM., Results: Each group included 37 patients. The median baseline IOP (24 vs 17) and NGM (3 vs 2) were higher in the phaco-GATT group (p < 0.001). Phaco-GATT achieved a 38% (p < 0.0001) reduction in IOP compared to 13.2% (p < 0.001) in the phaco-iStent group at 1-year follow-up. The reduction in IOP and NGM was significantly higher in the phaco-GATT group (p < 0.01). After adjusting for baseline IOP, the reduction in IOP at 12 months was still significantly higher in the phaco-GATT group (p = 0.042). At 1 year, 86.4% of patients in the phaco-GATT group met the success criteria compared to 35.1% in the phaco-iStent group. Safety outcomes were slightly favourable in the phaco-iStent group., Conclusion: Phaco-GATT and phaco-iStent showed a significant reduction in IOP and NGM, with phaco-GATT having a significantly higher reduction. Phaco-iStent appears to have a higher safety profile and is probably preferable in monocular patients and those with a high risk of bleeding., (© 2021. Crown.)

Purpose: To compare the outcomes of iStent vs. iStent inject implantation combined with phacoemulsification., Methods: This single center retrospective comparative case series included subjects with open angle glaucoma who underwent iStent or iStent inject implantation combined with phacoemulsification with ≥1 year follow-up. The main outcome measures were in-group and between-group changes in intraocular pressure (IOP) and medication number, proportion of eyes that achieved IOP ≤15 mmHg, and surgical success defined as 20% IOP reduction from baseline at 6/12 months. Univariate/multivariate regression analyses were done to identify predictors of surgical failure., Results: One hundred ninety-seven eyes of 148 patients were included (122 iStent, 75 iStent inject). Both groups achieved significant IOP and medication reduction at months 6/12 (P < 0.05). At month 6, IOP was significantly lower in iStent inject vs. iStent eyes (P = 0.003), but the difference was insignificant by month 12 (P = 0.172). Medication number was comparable in both groups at months 6/12 (P > 0.05). More iStent inject eyes achieved IOP ≤15 mmHg at month 6 (P = 0.003) and 12 (P = 0.047). Surgical success was comparable in both groups at months 6/12 (P > 0.05). Kaplan-Meier survival analysis showed similar cumulative rate of surgical failure at year-1 in both groups (P = 0.644). The multivariate model identified older age (P = 0.017) and lower baseline IOP (P = 0.002) as the strongest predictors of surgical failure., Conclusion: Compared to iStent, iStent inject achieved lower IOP at month 6 and higher proportion of eyes achieved IOP ≤15 mmHg at month 6/12. However, surgical success was similar in both groups. Predictors of surgical failure were older age and lower baseline IOP rather than the stent type., Competing Interests: None

Purpose: To explore the demographic and clinical variables associated with intraocular pressure (IOP) lowering after cataract extraction (CE) alone or CE in combination with the iStent (Glaukos Corporation) placement (CE+IS)., Design: Retrospective data extraction and survival analysis of consecutive patients identified over a 2-year period., Participants: Patients with mild to moderate glaucoma who underwent CE (48 eyes of 32 patients) or CE+IS (61 eyes of 37 patients) were analyzed., Methods: Inability to reduce the number of medications or the IOP by at least 20% compared with baseline on 2 consecutive visits was considered surgical failure. Using Cox proportional hazards models, survival analysis was performed, and demographic and clinical variables were evaluated as risk factors., Main Outcome Measures: Time to failure after surgical procedure., Results: CE+IS had lower odds of failure than CE alone (hazard ratio [HR], 2.01; P = 0.047). In White patients, CE+IS showed greater odds of success compared with CE alone (HR, 2.86; P = 0.007). For non-White patients, no difference was found in the outcomes for the 2 procedures (HR, 0.59; P = 0.48). In the multivariate analysis, non-White race (HR, 8.75; P = 0.0002) and longer axial length (HR, 1.61; P = 0.03) were associated with greater hazard of failure after CE+IS. In the CE group, greater odds of failure were associated with steeper corneal curvature (HR, 1.74; P = 0.008), shallower anterior chamber (HR, 0.22; P = 0.008), and longer axial length (HR, 1.58; P = 0.01)., Conclusions: Addition of the iStent to CE improved the duration of IOP lowering in White patients, but not in non-White patients. Associations between IOP lowering after CE and biometric parameters may allow for leveraging these clinical parameters for better case selection for these procedures., (Copyright © 2020 American Academy of Ophthalmology. Published by Elsevier Inc. All rights reserved.)

Introduction: To assess the effect of iStent trabecular microbypass implantation combined with phacoemulsification on intraocular pressure (IOP) and glaucoma medications and to compare this to outcomes of phacoemulsification alone in patients with mild to moderate primary open-angle glaucoma (POAG) depending on initial IOP., Materials and Methods: Eighty subjects with cataract and POAG were randomized 1:1 into either iStent implantation and cataract surgery (iStent group) (n = 44) or cataract surgery alone (control group) (n = 36). Groups were divided according to initial IOP (after washout period) into IOP <26 mm Hg and IOP ≥26 mm Hg. Patients were assessed preoperatively and at postoperative day 1, week 1, and months 1, 3, 6, 12, and 24. Outcome measures included best-corrected visual acuity, IOP, and glaucoma medications., Results: Postoperatively at 24 months, mean IOP decreased from 20.93 ± 1.28 to 17.79 ± 2.50 mm Hg in the IOP subgroup <26 mm Hg and from 26.00 ± 0.00 to 19.86 ± 2.19 in the subgroup ≥26 mm Hg in the control group. In the iStent group <26 mm Hg, IOP decreased from 22.04 ± 1.64 to 15.57 ± 2.13 mm Hg and from 26.6 ± 1.09 to 17.06 ± 2.43 mm Hg in the iStent group ≥26 mm Hg., Conclusion: In patients with open-angle glaucoma and cataract, iStent implantation combined with cataract surgery reduced IOP significantly through 2 years, with greater reductions achieved versus phacoemulsification alone. In patients with baseline IOP <26 mm Hg, surgery reduced IOP and medication use significantly declined through 2 years, with greater reductions achieved versus patients with baseline IOP ≥26 mm Hg. The study was registered at ClinicalTrials.gov under the number NCT03807869., (© 2020 S. Karger AG, Basel.)

Purpose: We conducted a retrospective study to evaluate the intraocular pressure (IOP) lowering effect, the success rates, and the risk of bleeding events of patients receiving an iStent inject combined with phacoemulsification under anticoagulation therapy compared with a matched control group., Methods: In this retrospective study, sixty-four eyes underwent an iStent inject implantation combined with phacoemulsification at two centers. Thirty-two eyes received surgery while under anticoagulation therapy, and another thirty-two eyes served as a control group matched for visual acuity, IOP, and medication score. Success was defined as criteria A and B (IOP < 18/21 mmHg, > 20% IOP reduction, no resurgery) and criteria C (IOP ≤ 15 mmHg, IOP reduction ≥ 40%, no resurgery). The clinical goal of the study was to determine the difference between the study and control groups with respect to IOP, medication score, and the frequency of intraoperative and postoperative bleeding events., Results: After a mean follow-up time of 1 year, the IOP lowered 28% from 20.1 ± 4.8 to 14.5 ± 3.7 mmHg in the group of 64 eyes. The medication score lowered 38% from 2.1 ± 1.1 to 1.3 ± 1.2. The two groups with and without anticoagulant agents did not significantly differ in postoperative IOP, medication score, success rates, or number of bleeding events., Conclusion: We conclude that in cataract surgery combined with the iStent inject a discontinuation of anticoagulant agents might not be necessary. It might be a good option in glaucoma surgery when anticoagulation treatment should not be interrupted and the target pressure is not very low.

Importance: Use of the trabecular micro-bypass stent with cataract surgery is well established to be safe and effective in primary open-angle glaucoma. This is the first study to exclusively evaluate use of the device in pigmentary glaucoma., Background: This study aimed to investigate the safety and efficacy of a trabecular micro-bypass stent in combination with cataract surgery in pigmentary glaucoma., Design: Retrospective, consecutive case series., Participants: Twenty-four eyes of 12 patients with pigmentary glaucoma implanted with one trabecular micro-bypass stent with concomitant cataract surgery., Methods: Baseline data was collected and compared to the following postoperative time points: 1 day, 1 week, 1 month out to 36 months (M36) after the procedure., Main Outcome Measures: These included intraocular pressure (IOP), number of glaucoma medications and need for additional surgery., Results: At M36 there was a 25% reduction in IOP to 14.68 ± 3.0 (P < .01) from 19.50 ± 6.7 mmHg at baseline. The mean number of glaucoma medications was 0.75 ± 1.0 prior to the surgery and 0.59 ± 0.6 (P > .05) at 36 M. At the 36 M time-point, 95% of eyes had IOP ≤ 18 mmHg and 68% of eyes were ≤ 15 mmHg. No eyes underwent a secondary glaucoma procedure., Conclusions and Relevance: The insertion of a single trabecular micro-bypass stent in combination with cataract surgery effectively provides a sustained reduction in IOP up to 3 years after surgery in patients with pigmentary glaucoma. The safety profile is favourable with low rate of IOP spikes and no patients requiring additional surgery., (© 2019 Royal Australian and New Zealand College of Ophthalmologists.)

Introduction: This study evaluated 10-year results of implanting one iStent trabecular micro-bypass stent during cataract surgery in eyes with open-angle glaucoma (OAG) or ocular hypertension. Methods: This retrospective, non-randomized study examined 10-year outcomes of iStent trabecular micro-bypass stent implantation with cataract surgery by one surgeon in eyes with OAG [including primary OAG (POAG) and pseudoexfoliative glaucoma (PXG)] or ocular hypertension at a multi-specialty German ophthalmology center. Study visits were conducted preoperatively and at 2.5, 3, 5, and 10 years postoperatively; examinations included intraocular pressure (IOP), medications, corrected-distance visual acuity (CDVA), and adverse events. Results: A total of 63 eyes of 45 patients with OAG (n = 60 eyes) or ocular hypertension (n = 3 eyes) and data through 10 years were analyzed. Mean preoperative IOP was 18.6 ± 4.4 mmHg on 1.83 ± 1.03 mean medications. At study visits through 10 years postoperative, mean IOP reduced by 12.9–19.0% (p < 0.005 at all points), and mean medication burden reduced by 37.8–51.4% (p ≤ 0.006 at all points). At 10 years postoperatively, 77.8% of eyes had IOP ≤ 18 mmHg and 47.6% had IOP ≤ 15 mmHg (vs. 50.8% and 25.4% preoperatively, respectively; p = 0.016). One-third (33.3%) of eyes were medication-free vs. 3.2% preoperatively (p < 0.001); 17.5% were on 2–5 medications (vs. 55.6% preoperatively, p = 0.005); and 93.7% of eyes were on the same or fewer medications vs. preoperative. Post-phacoemulsification CDVA improvement was maintained; no filtering surgeries were completed over 10-year follow-up. Conclusions: Significant and safe IOP and medication reductions were observed through 10 years after iStent implantation with cataract surgery in patients with OAG or ocular hypertension. [ABSTRACT FROM AUTHOR]

Introduction: This study reports the long-term intraocular pressure (IOP)-lowering efficacy and safety of a single trabecular microbypass stent (iStent®; Glaukos Corp., San Clemente, CA, USA) for medically controlled open-angle glaucoma in Korean patients. Methods: This retrospective observational study included 42 eyes of 35 patients with primary open-angle glaucoma (POAG). All subjects underwent single first-generation iStent® implantation with phacoemulsification by a single surgeon with 5 years follow-up. The primary outcomes were changes in IOP and the number of antiglaucoma medications compared to the preoperative values. The secondary outcome was the proportion of eyes with IOP ≤ 18 mmHg without medication, ≤ 15 mmHg without medication, and ≤ 18 mmHg with or without medication. Adverse events and need for secondary glaucoma surgery were also recorded. Results: The mean IOP decreased from 15.8 ± 2.8 to 13.8 ± 1.7 mmHg and the mean number of medications was reduced from 2.24 ± 1.18 to 0.83 ± 1.12, respectively, at year 5. At 3 and 5 years, 80.6% and 78.6% of eyes, respectively, were receiving fewer medications than preoperative numbers. In contrast, only 50% of eyes on four preoperative medications showed medication reductions at 5 years. At years 3 and 5, 61.3% and 53.5% of eyes achieved IOP ≤ 18 mmHg without medication, whereas 90.3% and 89.3% of eyes achieved ≤ 18 mmHg regardless of medication use, respectively. Four eyes required additional glaucoma surgery (two Ahmed glaucoma valve implantations, one trabeculectomy, and one XEN 45 Gel Stent implantation), and all were receiving four preoperative antiglaucoma medications. Transient IOP elevation (14.3%) was the most common complication, followed by five hyphema, one stent obstruction, one stent malposition, and one severe anterior chamber reaction. Conclusion: This study demonstrated a good safety profile and sustained IOP reduction after the implantation of a single trabecular microbypass stent (iStent®) with phacoemulsification in Korean patients. The majority of subjects with POAG showed a relatively good response; however, eyes receiving a higher number of medications preoperatively (especially four medications) had difficulty achieving a low target IOP. [ABSTRACT FROM AUTHOR]

Introduction: The purpose of this study was to compare the surgical outcomes between ab interno trabeculotomy (LOT) and iStent inject W implantation (iStent) both combined with cataract surgery, matching the background factors including age, intraocular pressure (IOP), medication score, central corneal thickness (CCT), and axial length. Methods: A total of 100 eyes from 75/79 patients with primary open-angle glaucoma were included in the LOT/iStent groups. The background factors were matched between the two groups using the propensity score. Results: There were no significant differences in age, IOP, medication score, CCT, and axial length, preoperatively. The postoperative medication scores were 1.3 ± 1.2 and 1.2 ± 1.2 in the LOT and iStent groups. The postoperative IOPs were 12.8 ± 2.8 and 13.1 ± 2.4 mmHg in the LOT and iStent groups, respectively. The changes in the medication score were − 0.64 ± 1.4 and − 0.44 ± 1.6 in the LOT and iStent groups, respectively. The changes in the IOP were − 2.1 ± 3.3 and − 1.5 ± 3.0 mmHg in the LOT and iStent groups, respectively. These values were not significantly different between the two groups. The postoperative IOP and changes in the IOP were significantly associated with preoperative IOP and CCT. There was no significant difference in the occurrence of postoperative complications (hyphema, 11.0% and 6.0%, and transient ocular hypertension, 8.0% and 5.0%, in the LOT and iStent groups, respectively). Conclusion: LOT and iStent have similar surgical outcomes with sufficient safety. Postoperative IOP was significantly associated with preoperative IOP and CCT in both groups. [ABSTRACT FROM AUTHOR]

This prospective, non-randomized, interventional clinical study evaluated the efficacy and safety profile of first-generation iStent bypass implantation versus ab externo canaloplasty, both combined with phacoemulsification, in patients with primary open-angle glaucoma (POAG) after 12-month follow-up. A total of 138 patients with POAG and their 138 eyes (69 phaco-iStent and 69 phacocanaloplasty) were included. Postoperatively at 12 months, the mean intraocular pressure (IOP) decreased from 18.44 ± 3.88 to 15.51 ± 2.50 mmHg and from 17.20 ± 4.04 to 14.97 ± 2.37 mmHg in the phaco-iStent (PiS) and phacocanaloplasty (PC) groups, respectively (p = 0.480). In both groups, 35.7% achieved >20% IOP reduction from baseline. A total of 86% and 71.4% of the eyes were medication-free at 12 months in the PiS and PC groups, respectively. In both groups, all eyes showed improvement in best-corrected visual acuity compared with baseline and demonstrated similar safety profiles throughout the 12-month follow-up period. This study showed equal hypotensive effects of PiS and PC. Both procedures significantly reduced the IOP and the requirement for IOP-lowering medications for at least 12 months postoperatively, with no significant differences between the groups. [ABSTRACT FROM AUTHOR]

Minimally invasive glaucoma surgery (MIGS) has revolutionized glaucoma care with its favorable safety profile and ability to delay or minimize the need for traditional, bleb-based procedures. Microstent device implantation is a type of angle-based MIGS, which reduces intraocular pressure (IOP) through bypass of the juxtacanalicular trabecular meshwork (TM) and facilitation of aqueous outflow into the Schlemm's canal. Although there are limited microstent devices on the market, multiple studies have evaluated the safety and efficacy of iStent® (Glaukos Corp.), iStent Inject® (Glaukos Corp.), and Hydrus® Microstent (Alcon) in the treatment of mild-to-moderate open-angle glaucoma, with and without concurrent phacoemulsification. This review attempts to provide a comprehensive evaluation of injectable angle-based microstent MIGS devices in the treatment of glaucoma. [ABSTRACT FROM AUTHOR]

aime E Dickerson Jr,4,5 Dan Q Nguyen61Eugene and Marilyn Glick Eye Institute, Indiana School of Medicine, Indianapolis, IN, USA; 2Royal Surrey County Hospital, Guildford, England, UK; 3Valid Insight, Macclesfield, England, UK; 4Sight Sciences, Menlo Park, CA, USA; 5North Texas Eye Research Institute, University of North Texas Health Science Center, Fort Worth, TX, USA; 6Mid-Cheshire Hospitals NHS Foundation Trust, Crewe, UKCorrespondence: Francesca Torelli, Valid Insight, Ropewalks, Newton St, Macclesfield, SK11 6QJ, UK, Tel +44 203 750 9833 Ext 703, Email [email protected] Introduction: Selective laser trabeculoplasty (SLT) and minimally invasive glaucoma surgery (MIGS) are increasingly used options for mild-to-moderate open-angle glaucoma (OAG) care. While most MIGS devices are indicated for use in combination with cataract surgery only, with phacoemulsification playing a role in lowering IOP, newer technologies can also be used as standalone glaucoma surgery. Methods: This systematic literature review (SLR) aimed to assess the clinical, economic, and humanistic outcomes of MIGS and SLT for the treatment of OAG and was conducted according to PRISMA guidelines. Studies that assessed MIGS or SLT in at least one treatment arm versus any other glaucoma treatment in adults with mild-to-moderate OAG were included. Clinical, humanistic (health-related quality of life [HRQoL] and patient burden), and economic data were extracted, and the methodological quality of included studies was evaluated. Results: A total of 2720 articles were screened, and 81 publications were included. Fifty-eight reported clinical outcomes. The majority assessed iStent or iStent inject (n=41), followed by OMNI (n=9), gonioscopy-assisted transluminal trabeculotomy (GATT) or the Kahook Dual Blade (KDB) (n=7), Hydrus (n=6), SLT (n=5), Xen Gel Stent (n=2), PreserFlo (n=1), and iTrack (n=1). IOP reduction was observed across prospective studies, varying from − 31% to − 13.7% at month 6 and from − 39% to − 11.4% at year 1 versus baseline. Most adverse events were transient and non-serious. Limited humanistic and economic data were identified. Conclusion: Given their established efficacy and safety, there is a rationale for wider use of MIGS in mild-to-moderate OAG. Of the MIGS devices, iStent and OMNI have the largest clinical evidence base supporting their sustained effectiveness. [ABSTRACT FROM AUTHOR]

Purpose: To compare the outcomes of iStent vs. iStent inject implantation combined with phacoemulsification. Methods: This single center retrospective comparative case series included subjects with open angle glaucoma who underwent iStent or iStent inject implantation combined with phacoemulsification with ≥1 year follow-up. The main outcome measures were in-group and between-group changes in intraocular pressure (IOP) and medication number, proportion of eyes that achieved IOP ≤15 mmHg, and surgical success defined as 20% IOP reduction from baseline at 6/12 months. Univariate/multivariate regression analyses were done to identify predictors of surgical failure. Results: One hundred ninety-seven eyes of 148 patients were included (122 iStent, 75 iStent inject). Both groups achieved significant IOP and medication reduction at months 6/12 (P < 0.05). At month 6, IOP was significantly lower in iStent inject vs. iStent eyes (P = 0.003), but the difference was insignificant by month 12 (P = 0.172). Medication number was comparable in both groups at months 6/12 (P > 0.05). More iStent inject eyes achieved IOP ≤15 mmHg at month 6 (P = 0.003) and 12 (P = 0.047). Surgical success was comparable in both groups at months 6/12 (P > 0.05). Kaplan–Meier survival analysis showed similar cumulative rate of surgical failure at year-1 in both groups (P = 0.644). The multivariate model identified older age (P = 0.017) and lower baseline IOP (P = 0.002) as the strongest predictors of surgical failure. Conclusion: Compared to iStent, iStent inject achieved lower IOP at month 6 and higher proportion of eyes achieved IOP ≤15 mmHg at month 6/12. However, surgical success was similar in both groups. Predictors of surgical failure were older age and lower baseline IOP rather than the stent type.

Purpose: Evaluate the efficacy, safety, and complication rates of phacoemulsification cataract surgery when combined with either gonioscopy-assisted transluminal trabeculotomy (GATT) or iStent Inject. Methods: This is a retrospective case-control study to compare the surgical outcomes of combined phacoemulsification cataract surgery with either GATT (phaco-GATT) or iStent Inject (phaco-iStent). Both groups had at least 1-year follow-up. The primary outcome measures were IOP and number of glaucoma medications (NGMs) at 1 year. Secondary outcomes measures were best corrected visual acuity (BCVA) and intra- or postoperative complications within the first year of follow-up. Success was defined as intraocular pressure (IOP) < 21 mmHg and ≥ 20% reduction in IOP at 1 year regardless of the NGM. Results: Each group included 37 patients. The median baseline IOP (24 vs 17) and NGM (3 vs 2) were higher in the phaco-GATT group (p < 0.001). Phaco-GATT achieved a 38% (p < 0.0001) reduction in IOP compared to 13.2% (p < 0.001) in the phaco-iStent group at 1-year follow-up. The reduction in IOP and NGM was significantly higher in the phaco-GATT group (p < 0.01). After adjusting for baseline IOP, the reduction in IOP at 12 months was still significantly higher in the phaco-GATT group (p = 0.042). At 1 year, 86.4% of patients in the phaco-GATT group met the success criteria compared to 35.1% in the phaco-iStent group. Safety outcomes were slightly favourable in the phaco-iStent group. Conclusion: Phaco-GATT and phaco-iStent showed a significant reduction in IOP and NGM, with phaco-GATT having a significantly higher reduction. Phaco-iStent appears to have a higher safety profile and is probably preferable in monocular patients and those with a high risk of bleeding. [ABSTRACT FROM AUTHOR]

Introduction: This retrospective comparative study assessed real-world effectiveness and safety of first-generation (iStent®) and second-generation (iStent inject®) trabecular micro-bypass stents with cataract surgery in patients with open-angle glaucoma (OAG). Material and Methods: Through a 24-month postoperative follow-up, the effectiveness was quantified by intraocular pressure (IOP) reduction; mean glaucoma medication reduction; proportional analysis of eyes meeting IOP cutoffs (< 18, < 15, < 12 mmHg) either with or without medications; and proportional analysis of medication burden. Safety measures included visual acuity, adverse events, and secondary surgery. Results: A total of 82 consecutive eyes (39 iStent, 43 iStent inject) with a 24-month follow-up were analyzed. Most eyes (74.4%) had primary open-angle glaucoma, with the remainder having pseudoexfoliative or pigmentary glaucoma; all eyes had mild-to-moderate disease. At 24 months postoperative, the mean IOP was lower, and the percent reduction from baseline was greater, in iStent inject eyes (26.0% reduction, 17.7mmHg to 13.1mmHg) than in iStent eyes (9.8% reduction, 16.4mmHg to 14.8mmHg) (between-groups comparison, p=0.019). Within each group, the postoperative IOP reduction was greater in eyes with higher baseline IOP (p< 0.001). Medication burden decreased significantly in both groups, from 1.74 to 0.51 mean medications for iStent (70.7% reduction, p< 0.0001), and 2.19 to 0.65 for iStent inject (70.3% reduction, p< 0.0001). Both groups exhibited excellent safety. Conclusion: iStent or iStent inject with phacoemulsification produced significant IOP and medication reductions, with effects enduring for two years. IOP reductions were greater for iStent inject than for iStent. Within each group, higher preoperative IOP was associated with greater postoperative IOP reduction. [ABSTRACT FROM AUTHOR]

Purpose: To achieve a highly balanced comparison of trabecular bypass stenting (IS2, iStent inject) with ab interno trabeculectomy (T, Trabectome) by exact matching. Methods: Fifty-three IS2 eyes were matched to 3446 T eyes. Patients were matched using exact matching by baseline intraocular pressure (IOP), the number of glaucoma medications, and glaucoma type, and using nearest neighbor matching by age. Individuals without a close match were excluded. All surgeries were combined with phacoemulsification. Results: A total of 78 eyes (39 in each group) could be matched as exact pairs with a baseline IOP of 18.3 ± 5.1 mmHg and glaucoma medications of 2.7 ± 1.2 in each. IOP in IS2 was reduced to 14.6 ± 4.2 mmHg at 3 months and in T to a minimum of 13.1 ± 3.2 mmHg at 1 month. In IS2, IOP began to rise again at 6 months, eventually exceeding baseline. At 24 months, IOP in IS2 was 18.8 ± 9.0 mmHg and in T 14.2 ± 3.5 mmHg. IS2 had a higher average IOP than T at all postoperative visits (p < 0.05 at 1, 12, 18 months). Glaucoma medications decreased to 2.0 ± 1.5 in IS2 and to 1.5 ± 1.4 in T. Conclusion: T resulted in a larger and sustained IOP reduction compared with IS2 where a rebound occurred after 6 months to slightly above preoperative values. [ABSTRACT FROM AUTHOR]

Purpose: We conducted a retrospective study to evaluate the intraocular pressure (IOP) lowering effect, the success rates, and the risk of bleeding events of patients receiving an iStent inject combined with phacoemulsification under anticoagulation therapy compared with a matched control group. Methods: In this retrospective study, sixty-four eyes underwent an iStent inject implantation combined with phacoemulsification at two centers. Thirty-two eyes received surgery while under anticoagulation therapy, and another thirty-two eyes served as a control group matched for visual acuity, IOP, and medication score. Success was defined as criteria A and B (IOP < 18/21 mmHg, > 20% IOP reduction, no resurgery) and criteria C (IOP ≤ 15 mmHg, IOP reduction ≥ 40%, no resurgery). The clinical goal of the study was to determine the difference between the study and control groups with respect to IOP, medication score, and the frequency of intraoperative and postoperative bleeding events. Results: After a mean follow-up time of 1 year, the IOP lowered 28% from 20.1 ± 4.8 to 14.5 ± 3.7 mmHg in the group of 64 eyes. The medication score lowered 38% from 2.1 ± 1.1 to 1.3 ± 1.2. The two groups with and without anticoagulant agents did not significantly differ in postoperative IOP, medication score, success rates, or number of bleeding events. Conclusion: We conclude that in cataract surgery combined with the iStent inject a discontinuation of anticoagulant agents might not be necessary. It might be a good option in glaucoma surgery when anticoagulation treatment should not be interrupted and the target pressure is not very low. [ABSTRACT FROM AUTHOR]

Purpose: To determine the quality of life (QOL) in glaucoma patients undergoing combined cataract and minimally invasive glaucoma surgery from various perspectives ranging from personal, social, occupational life, and economic status. Settings and Design: A cross-sectional study design at King Fahd Hospital of the University, Khobar, Saudi Arabia. Methods: Patients undergoing phacoemulsification in conjunction with various forms of minimally invasive glaucoma surgery (MIGS) for each patient, including either Kahook Dual Blade (KDB) goniotomy, iStent, iStent inject and gonioscopy-assisted transluminal trabeculotomy (GATT), were included in the study between 2018 and 2019. Data were collected through a self-administered questionnaire based on the Visual Function Questionnaire (VFQ-25) for the 25-item National Eye Institute. Results: The study included 93 eyes of 78 patients (40 males and 38 females) who had MIGS: 50 KDB, 13 iStent, 23 iStent inject, and 7 GATT. An overall reduction in the number of anti-glaucoma medications (p< 0.001) was statistically significant. In the study, 36.6% of patients had a better social life, but 85.2% had no change in occupational life. Eventually, 86% were satisfied with the operation's outcome, and 79% confirmed that the overall quality of life improved after the procedure. Conclusion: Evaluating QOL is a crucial component of glaucoma treatment. More research is needed on MIGS and their relationship to QOL. In the future, MIGS may provide the desired outcomes in controlling glaucoma and improving the QOL. [ABSTRACT FROM AUTHOR]

Introduction: This real-world retrospective case series assessed 12-month effectiveness and safety following implantation of iStent® or iStent inject® trabecular micro-bypass with cataract surgery. Methods: Consecutive patients were implanted with either iStent (comprising 1 stent) or iStent inject (comprising 2 stents), together with cataract surgery. Most patients had primary open-angle glaucoma. Effectiveness outcomes through 12 months included intraocular pressure (IOP) and glaucoma medications. Proportional analyses were completed for eyes achieving IOP ≤ 18 mmHg, IOP ≤ 15 mmHg, or IOP reduction ≥ 20% from preoperative; and eyes on 0 medications or ≥ 2 medications. Safety outcomes included adverse events, secondary surgeries, visual acuity, and visual fields. Results: This analysis included 137 eyes (67 iStent, 70 iStent inject) with cataract and mild to moderate glaucoma or ocular hypertension. Over 73% of eyes in both groups had early disease, and ~ 22% had prior glaucoma surgery. At 12 months postoperatively, mean IOP decreased from 18.4 ± 4.2 mmHg to 14.2 ± 2.5 mmHg in iStent eyes (p < 0.0001), and from 20.4 ± 5.6 mmHg to 14.4 ± 2.1 mmHg in iStent inject eyes (p < 0.0001). The IOP reduction was significantly greater for iStent inject eyes than iStent eyes (6.0 mmHg versus 4.2 mmHg reduction, p = 0.034). Both groups had high proportions of patients achieving the 12-month IOP endpoints, although consistently greater proportions reached these endpoints after iStent inject than iStent: 95.7% versus 92.5% had IOP ≤ 18 mmHg, respectively; 74.3% versus 71.6% had IOP ≤ 15 mmHg, respectively; and 68.6% versus 62.7% had IOP reduction ≥ 20% from baseline, respectively. Mean medication burden at 12 months decreased from 1.8 ± 0.7 to 0.3 ± 0.5 medications in iStent eyes (84.0% reduction, p < 0.0001), and from 1.3 ± 0.9 to 0.1 ± 0.3 medications in iStent inject eyes (94.7% reduction, p < 0.0001). Significantly more iStent inject eyes were medication-free at 12 months than iStent eyes (92.9% versus 76.1% medication-free, respectively; p = 0.0068). Favorable safety included few adverse events, no secondary glaucoma surgeries, and stable visual acuity and visual fields in both groups. Conclusion: Significant and safe IOP and medication reductions were achieved through 12 months after iStent or iStent inject implantation with cataract surgery. iStent inject eyes had greater absolute IOP reduction and more eyes medication-free versus iStent eyes. Funding: Glaukos Corporation. [ABSTRACT FROM AUTHOR]

Purpose: To compare 6-month surgical outcomes of patients who underwent phacoemulsification (Phaco) combined with iStent implantation (iStent) versus excisional goniotomy using Kahook Dual Blade (KDB). Methods: Retrospective comparative case series of 58 iStent-Phaco eyes and 44 KDB-Phaco eyes operated upon by a single surgeon between 2016 and 2018. Preoperative, intraoperative, and postoperative intraocular pressure (IOP) and IOP-lowering medication data were collected. The primary outcome was the proportion of eyes using ≥1 fewer IOP-lowering medication at Month 6 while maintaining IOP ≤ 18 mmHg. Results: Baseline IOP was 17.2 (standard error 0.7) in the KDB-Phaco group using a mean of 1.9 (0.2) medications; at Month 6, mean IOP was 14.8 mmHg P=0.002) on 1.0 (0.2) medications (P<0.002). Baseline IOP was 16.7 (0.4) in the iStent-Phaco group using a mean of 1.4 (0.1) medications; at Month 6, mean IOP was 14.2 mmHg (P<0.002) on 1.4 (0.1) medications P=0.374). Changes in IOP and medications were not significantly different between groups (P>0.05). Significantly more KDB-Phaco eyes than iStent-Phaco eyes (43.2% vs 17.2%, P=0.004) were using ≥1 fewer medications while maintaining IOP ≤18 mmHg at Month 6. Adverse events were uncommon and similar in nature and frequency between groups with the exception that more KDB-Phaco eyes than iStent-Phaco eyes (8 [18.2%] versus 1 [1.7%]) experienced an IOP elevation presumed to be related to steroid use. Conclusion: KDB-Phaco and iStent-Phaco provided comparable IOP and medication reductions. The proportion of eyes able to discontinue 1 or more medications while maintaining IOP ≤ 18 mmHg was significantly greater in eyes undergoing KDB-Phaco. [ABSTRACT FROM AUTHOR]

Purpose: To present long-term, real-world outcomes after implanting one trabecular micro-bypass stent with cataract surgery for primary open-angle glaucoma (POAG) in a predominantly Hispanic patient population. Patients and methods: This retrospective, consecutive case series evaluated intraocular pressure (IOP), medications, and safety through 36 months after implanting one iStent®, during phacoemulsification cataract surgery. Eyes were stratified into 2 subgroups classified by preoperative IOP and surgical goal. The Controlled Group had IOP <18 mmHg on ≥1 medications, and goal to reduce medications. The Uncontrolled Group had IOP ≥18 mmHg and/or maximum tolerated medication load, and goal to reduce IOP. Assessments included IOP, medications, visual fields (VF), retinal nerve fiber layer thickness (RNFL), adverse events, and secondary surgeries. Results: Of 168 total operated eyes, 87 eyes (49 Controlled, 38 Uncontrolled) completed 36 months of follow-up and comprise the Consistent Cohort in this report. At baseline, 79.6% (39/49) of Controlled eyes and 71.1% (27/38) of Uncontrolled eyes were from Hispanic patients. In the Controlled Group desiring medication reduction, mean medications were reduced by 77.3% (2.6 medications preoperatively vs 0.6 at 36 months; p<0.001. All Controlled eyes maintained or reduced medications versus preoperative; no eyes were on ≥3 medications (vs 61.2% preoperatively); and 58.3% were medication-free (vs 0% preoperatively). In the Uncontrolled Group desiring IOP reduction, mean IOP decreased by 31.2% (19.4 mmHg preoperatively vs 13.4 mmHg at 36 months; p<0.001), 91.7% of eyes achieved IOP ≤18 mmHg, 69.4% reached IOP ≤15 mmHg, and 77.8% decreased IOP ≥20% vs baseline. Uncontrolled eyes also experienced a 45.3% medication reduction (2.2 medications preoperatively vs 1.2 at 36 months; p<0.001). Favorable safety included no intraoperative complications, and stable VF and RNFL through 36 months. Conclusion: In this predominantly Hispanic patient cohort, significant IOP and medication reductions were sustained safely through 36 months after iStent implantation during cataract surgery. [ABSTRACT FROM AUTHOR]

Purpose: To evaluate the safety and efficacy of the iStent trabecular microbypass stent in combination with cataract surgery in patients with open-angle glaucoma (OAG). Methods: Retrospective, consecutive case series from October 2012 to December 2015 with no exclusion criteria. The series comprised of 350 eyes with OAG and cataract. Data were collected both preoperatively and postoperatively at day 1 week 1, months 1, 3, 6, 12, 18, and 24. Data included intraocular pressure (IOP), number of glaucoma medications, visual acuity, the incidence of postoperative IOP pressure spikes of greater than ≥15 mmHg at any time point, and need for additional surgery. Results: The mean preoperative IOP was 19.13±6.34 mmHg. At 2 years postoperation, mean IOP was 15.17±3.53 mmHg (P<0.0001). The mean number of glaucoma medications was 1.19±1.00 preoperatively and 0.61±0.96 (P<0.0001) at 2 years postoperation. At 1 day postoperatively, 31 eyes (12.4%) experienced an IOP increase of 15 mmHg above their baseline IOP that responded to topical therapy. Two patients required additional tube shunt surgery. Conclusion: The insertion of the iStent trabecular microbypass stent in combination with cataract surgery effectively lowers IOP in OAG patients. The magnitude of IOP reduction was more significant in patients with higher preoperative pressure. Medication use was also significantly reduced postoperatively. The safety profile appears favorable with a low rate of IOP spikes and only two eyes (<1%) requiring additional surgery. [ABSTRACT FROM AUTHOR]

Glaucoma is the leading cause of irreversible blindness worldwide. The only proven factor in slowing the progression of glaucomatous neuropathy is lower intraocular pressure (IOP), which can be achieved with pharmacology, laser therapy, or surgery. However, these treatments are associated with various adverse effects, including corneal endothelial cell loss (CECL). In recent years, several novel surgeries for reducing the IOP, collectively referred to as minimally invasive glaucoma surgery (MIGS), have been developed, one of which is the iStent. However, the long-term effects of such surgeries remain unknown. We compared a group of patients with open-angle glaucoma and cataract who underwent phacoemulsification alone with a group of patients with similar demographic and clinical characteristics who underwent simultaneous phacoemulsification and iStent implantation. Overall, 26 eyes of 22 subjects who underwent a combined phacoemulsification-iStent procedure and 26 eyes of 24 subjects who underwent cataract surgery were included. Before surgery, endothelial cells accounted to 2228.65 ± 474.99 in iStent group and 2253.96 ± 404.76 in the control group (p = 0.836). After surgery, their number declined to 1389.77 ± 433.26 and 1475.31 ± 556.45, respectively (p = 0.509). There was no statistically significant difference in CECL between the two groups 18–24 months after surgery, despite increased manipulation in the anterior chamber and the presence of an implant in the trabecular meshwork in those with an iStent implant. Thus, iStent bypass implantation is a safe treatment in terms of CECL for mild-to-moderate open-angle glaucoma. [ABSTRACT FROM AUTHOR]