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This paper evaluates the effectiveness and safety of XEN63 stent, either standalone or in combination with phacoemulsification, in patients with primary open-angle glaucoma (POAG). Eighty eyes from 80 patients with medically uncontrolled POAG were assigned to undergo XEN63 implant. The primary outcome was the surgical success, defined as an intraocular pressure (IOP) lowering from preoperative values ≥ 20% and an IOP absolute value between 6 and 18 mmHg, with or without antiglaucoma medications. Forty-three (53.7%) eyes underwent XEN63-standalone and 37(46.2%) eyes a XEN63 + Phacoemulsification procedure. Success rate was 68.8% (55/80) eyes in the overall study sample, 69.8% (30/43) eyes in the XEN63-standalone group; and 67.6% (25/37) eyes in the XEN63 + Phaco group (p = 0.6133). Preoperative IOP was significantly lowered from 22.1 ± 4.9 mmHg and 19.8 ± 3.7 mmHg to 14.7 ± 5.3 mmHg and 13.8 ± 3.4 mmHg in the XEN63-standalone and XEN63 + Phaco groups, respectively (p < 0.0001 each, respectively); without significant differences between them at any of the time-points measured. Preoperative number of ocular-hypotensive drugs was significantly reduced from 2.3 ± 0.8 to 0.3 ± 0.7 drugs, from 2.5 ± 0.7 to 0.3 ± 0.7 drugs; and from 2.0 ± 0.8 to 0.3 ± 0.7 drugs, in the overall, XEN63-standalone, and XEN63 + Phaco groups, respectively. Regarding safety, 3(42.5%) eyes had transient hypotony at some point during the study, although only in one (1.2%) eye was clinically significant. Four (5.0%) eyes underwent a needling, 4 (5.0%) eyes underwent surgical-bleb-revision, 1 (1.2%) eye required a device replacement and 1 (1.2%) eye a device removal due to maculopathy. XEN63, either alone or in combination with phacoemulsification, significantly lowered IOP and reduced the number of ocular hypotensive medications. The rate of ocular hypotony was relatively high, although it was clinically relevant only in one eye., (© 2024. The Author(s).)

Objectives: To assess the efficacy and safety of combined phacoemulsification and excimer laser trabeculostomy (ELT) in eyes with cataract and mild controlled glaucoma or ocular hypertension (OHT)., Methods: Single-centre analysis of eyes that underwent phacoemulsification and ELT between 2017 and 2021. Change in intraocular pressure (IOP), glaucoma medication requirements, corrected distance visual acuity (CDVA), complications and re-interventions were evaluated. Success was defined as a reduction ≥20% from preoperative IOP, an IOP ≤ 14 mmHg or a reduction in glaucoma medication requirements with an IOP equal or lower than the preoperative IOP., Results: Mean follow-up was 658 ± 64 days. Mean preoperative IOP was 17.76 ± 4.88 mmHg, it decreased to 15.35 ± 3.10 mmHg at 1 year (n = 37) (p = 0.006) and to 14.00 ± 3.78 at 3 years (n = 8) (p = 0.074). Mean number of glaucoma medication requirements decreased from 2.02 ± 1.0 preoperatively to 1.02 ± 0.96 at 1 year (n = 37) (p < 0.001) and to 1.63 ± 0.92 at 3 years (n = 8) (p = 0.197). Complete success was achieved in 17.7% of eyes and qualified success in 54.8%. Two eyes of 2 patients had early postoperative hyphema. Two eyes of 1 patient underwent filtering surgery 2 months after the procedure, and 2 eyes of 1 patient underwent laser trabeculoplasty 3.8 years after the procedure due to uncontrolled IOP., Conclusions: Combined phacoemulsification and ELT is effective and safe in eyes with mild glaucoma or OHT and cataract. It significantly reduced IOP and glaucoma medication requirements 1 year after surgery., (Copyright © 2023 Sociedad Española de Oftalmología. Published by Elsevier España, S.L.U. All rights reserved.)

Purpose: Compare 12-month (12 M) safety and efficacy of endoscopic cyclophotocoagulation (ECP) + cataract surgery (Group 1) versus ECP + cataract surgery + iStent inject trabecular micro-bypass implantation (Group 2) in Brazilian patients with open-angle glaucoma (OAG)., Methods: This prospective, multicenter, comparative case series included patients with OAG and cataract who were randomized to receive treatment in Group 1 or Group 2. Outcomes included mean and percent reduction versus preoperative in intraocular pressure (IOP) and number of glaucoma medications; visual acuity; occurrence of adverse events; and rate of secondary surgeries., Results: Preoperatively, Groups 1 and 2 had similar mean IOP (mean ± standard deviation 22.1 ± 3.6 and 22.0 ± 2.5 mmHg, respectively) and mean number of medications (3.3 ± 0.6 and 3.4 ± 0.6 medications, respectively). At all follow-up timepoints through 12 M, both groups achieved significant IOP and medication reductions versus preoperative (IOP p < 0.001 and number of medications p < 0.001 for both groups). At 12 M, IOP reductions were 24.2% (Group 1) and 43.6% (Group 2) (p < 0.001); mean medication reductions were 50.2% and 71.5%, respectively. Mean postoperative IOP and number of medications were higher in Group 1 than Group 2 (IOP p < 0.01 all visits, medication p < 0.01 at 6 M and 12 M). Adverse events were generally mild and infrequent in both groups., Conclusion: Both treatment groups (ECP + phacoemulsification, with/without iStent inject implantation) achieved significant and safe reductions in IOP and medications versus preoperative in Brazilian OAG patients. Percent reductions were significantly greater, and mean IOP and medications were significantly lower, in the group receiving iStent inject., Clinical Trial Registration (ctr): CAAE project identification #20053019.5.0000.5078. Protocol #3.587.147. Clinical Trial Database of the Federal University of Goiás, Brazil. Registration Date: September 19, 2019., (© 2022. The Author(s).)

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.)

Purpose: To evaluate the therapeutic success, and risk factors for combined phacoemulsification and Kahook Dual Blade excisional goniotomy (Phaco/KDB) in primary angle-closure glaucoma (PACG)., Methods: A retrospective review was conducted on glaucoma patients who underwent Phaco/KDB between September 2019 and August 2021 at 2 ophthalmology centers. Complete success was defined as unmedicated intraocular pressure (IOP) ≤ 18 mmHg with no further glaucoma surgery, while the medicated IOP ≤ 18 mmHg was defined as qualified success with lesser medications than at baseline., Results: Seventy-two eyes (64 patients) with a mean age of 67.1 ± 8.1 years were included in this study, and 70.2% were female. The mean medicated baseline IOP decreased from 23.4 ± 8.1 to 16.6 ± 3.9 mmHg at an average of 11.6 ± 3.7 months of follow-up (- 29.1%; P < 0.00). Medications decreased from 2.6 ± 1.3 to 0.4 ± 0.9 (- 82.6%; P < 0.001). Complete success and qualified success were achieved in 65.3% and 79.2% of eyes, respectively. Male gender [hazard ratio (HR): 6.00 (1.57-22.9); P = 0.009] was observed a risk factor for surgical failure, whereas higher axial length (HR:0.37 (0.16-0.86); P = 0.021), and a combined circumferential goniosynechialysis procedure (HR: 0.13 (0.02-0.74); P = 0.022) lowered the risk of surgical failure. Hyphema, postoperative shallowing anterior chamber, and IOP spike were the most common complications. The cumulative survival proportion for qualified success at 12 months was 82.5% ± 0.05 (95% CI, 0.70-0.90)., Conclusion: Phaco/KDB provided acceptable therapeutic success rate and may, therefore, be recommended in patients with coexisting cataract and PACG. Identifying patients with risk factors preoperatively may help clinicians predict surgical success., (© 2022. The Author(s), under exclusive licence to Springer-Verlag GmbH Germany, part of Springer Nature.)

Purpose: Combined phacoemulsification plus excimer laser trabeculostomy (phaco-ELT) is a minimally invasive surgery that effectively reduces intraocular pressure (IOP) in patients with glaucoma and a concomitant diagnosis of cataract. The aim of this study was to evaluate the long-term treatment success as well as safety of phaco-ELT over an 8-year follow-up period., Methods: Patients with a diagnosis of primary or secondary glaucoma or ocular hypertension and a visually significant cataract who underwent a combined phaco-ELT between January 1, 2008, and December 31, 2010, were included. Data for IOP, the number of IOP-lowering medications (meds), best-corrected visual acuity, complications, and subsequent surgeries to lower IOP were collected preoperatively (baseline) and intraoperatively as well as at 1 day, 1 week, 1 month, 3 months, 6 months, 9 months, 1 year, and every 6 months thereafter to 8 years postoperatively., Results: One hundred sixty-one eyes of 128 patients were included. After 8 years of follow-up, the long-term treatment success rate with IOP ≤ 21 mmHg was 50.2%. No serious intra- or postoperative complications occurred. The mean IOP decreased significantly from 19.3 (±4.8) mmHg at baseline to 15.4 (±3.2, p =0.0040) mmHg at 8 years. Additionally, meds remained below baseline after 8 years of follow-up and were reduced significantly for up to 4 years. Only 25.5% of the eyes required a subsequent surgery to lower IOP during the follow-up period., Conclusion: Combined phaco-ELT is a safe procedure without serious intra- or postoperative complications, which has a positive long-term effect regarding IOP and meds. Remarkably, the mean IOP-lowering effect remained stable and was reduced ≥ 20% from baseline after 3 months for the remainder of the follow-up duration, whereas the number of meds was reduced significantly for up to 4 years. Furthermore, only 25.5% of the eyes required a subsequent surgery to control IOP throughout the whole follow-up of 8 years., (© 2021. The Author(s), under exclusive licence to Springer-Verlag GmbH Germany, part of Springer Nature.)

Purpose: To assess the 3-year effectiveness and safety of the XEN gel stent implanted ab interno in open-angle glaucoma (OAG)., Methods: This study was a multicentre, retrospective chart review of consecutive patients with OAG who underwent ab-interno gel stent placement alone or combined with phacoemulsification between 1 January 2014 and 1 October 2015. Outcome measures included mean changes in intraocular pressure (IOP) and IOP-lowering medication count from medicated baseline at 1, 2, 3 (primary outcome) and 4 years (if available) postimplantation. Intraoperative complications, adverse events of special interest (AESIs) and secondary surgical interventions (SSIs) were recorded., Results: The safety and effectiveness populations included 212 eyes (primary and secondary) and 174 eyes (primary), respectively. Mean IOP and medication decreased from 20.7 mmHg and 2.5 at baseline (n = 163 primary/first implanted eyes) to 13.9 mmHg and 1.1 medications (n = 76) at 3 years postimplantation, respectively. Mean changes from baseline in IOP (-5.6, -6.2 and -6.6 mmHg) and IOP-lowering medication count (-1.8, -1.6 and -1.4) were statistically significant at 1, 2 and 3 years postimplantation, respectively. Results appeared comparable when implantation was performed with (n = 76) or without (n = 98) phacoemulsification. In primary eyes with 4-year IOP and medication count data (n = 27), mean IOP was 14.0 mmHg on 1.3 medications at 4 years postimplantation. Fifteen (7.1%) eyes had intraoperative complications, 31 (14.6%) experienced 46 postoperative AESIs, and 26 (12.3%) required SSI., Conclusion: The gel stent effectively lowered IOP and IOP-lowering medication count over 3 years, with a predictable and acceptable safety profile, when implanted via the traditional ab-interno technique., (© 2021 AbbVie Inc. Acta Ophthalmologica published by John Wiley & Sons Ltd on behalf of Acta Ophthalmologica Scandinavica Foundation.)

Purpose: To evaluate the efficacy and complication profile of excimer laser trabeculostomy (ELT), an emerging laser-based trabecular minimally invasive glaucoma surgery (MIGS), combined with cataract surgery in routine clinical practice., Patients and Methods: Single-site, retrospective, interventional study. Preoperative and postoperative clinical data of patients with cataract and open-angle glaucoma (OAG) who underwent combined phacoemulsification and ELT were collected and analyzed at preoperative day, one week postoperatively, and after one, two, three, six, nine and 12 months. Main outcome measure was intraocular pressure (IOP). Qualified and complete success were defined as an IOP less than 21mmHg and an IOP reduction ≥20% from preoperative medicated IOP with or without adjuvant medical treatment, respectively., Results: Thirty-four eyes of 29 patients were included; 29 eyes completed 1-year follow-up. The mean preoperative IOP under medications was 20.9±2.6mmHg (±standard deviation, SD) and decreased significantly at one year (16.3±1.9; p<0.0001). The mean number of IOP-lowering medications decreased from 1.7±0.7 to 0.3±0.8 (p<0.0001) at the 12-month follow-up. At one year, 81% of eyes were medication free. Qualified and complete success was obtained in 62% and 58% of eyes, respectively. Two eyes had postoperative hyphema, three eyes had transient IOP spikes and one patient underwent a subsequent filtering surgery at three months., Conclusion: Combining ELT with phacoemulsification in eyes with cataract and mild to moderate OAG significantly reduced IOP and medication use without meaningful complications after one-year follow-up in a real world clinical practice setting., (Copyright © 2021 The Authors. Published by Elsevier España, S.L.U. All rights reserved.)

Purpose: To evaluate the efficacy and safety profile of Kahook Dual Blade ab interno trabeculectomy combined with phacoemulsification compared to stand-alone conventional cataract surgery., Methods: A single-center longitudinal, randomized controlled trial was conducted. Patients older than 18 years with coexisting cataract and open-angle glaucoma or ocular hypertension were invited to participate. Preoperative and postoperative clinical data were collected and analyzed preoperatively and at months 1, 3, 6, and 12 after the procedure. Main outcome measures included best corrected visual acuity, intraocular pressure, number of glaucoma medications, endothelial cell count, and standard automated perimetry., Results: Forty-two eyes from 33 patients were randomly allocated to the combined cataract and KDB (treatment, n = 21) or cataract alone (control, n = 21) groups. Intraocular pressure decreased from 17.9 ± 3.5 to 16.0 ± 2.2 mmHg and from 17.3 ± 2.5 to 15 ± 3.2 mmHg at the last visit in the treatment and control groups (p = 0.47). The use of glaucoma medications was reduced from a median (IQR) 1 (1-2) to 0 (0-0) in the treatment group and from 1 (1-2) to 0 (0-1) in the control group, with no significant differences between groups at the 12-month visit (p = 0.47). Best corrected visual acuity, endothelial cell count, and standard automated perimetry remained similar during follow-up in both groups., Conclusions: In patients with well-controlled, mild-to-moderate glaucoma, adding ab interno trabeculectomy with KDB to phacoemulsification might not be more effective than phacoemulsification alone to reach mid-teens IOP values. Both procedures showed similar safety profiles., Trial Registration: ClinicalTrials.gov Identifier: NCT04202562, December 17, 2019 retrospectively registered., (© 2021. The Author(s), under exclusive licence to Springer-Verlag GmbH Germany, part of Springer Nature.)

Purpose: To report 3-year outcomes of the HORIZON study comparing cataract surgery (CS) with Hydrus Microstent (Ivantis, Inc) implantation versus CS alone., Design: Multicenter randomized clinical trial., Participants: Five hundred fifty-six eyes from 556 patients with cataract and primary open-angle glaucoma (POAG) treated with 1 or more glaucoma medication, washed out diurnal intraocular pressure (IOP) of 22 to 34 mmHg, and no prior incisional glaucoma surgery., Methods: After phacoemulsification, eyes were randomized 2:1 to receive a Hydrus Microstent or no stent. Follow-up included comprehensive eye examinations through 3 years., Main Outcome Measures: Outcome measures included IOP, medical therapy, reoperation rates, visual acuity, adverse events, and changes in corneal endothelial cell counts., Results: Three hundred sixty-nine eyes were randomized to microstent treatment and 187 to CS only. Preoperative IOP, medication use, washed-out diurnal IOP, and glaucoma severity did not differ between the two treatment groups. At 3 years, IOP was 16.7 ± 3.1 mmHg in the microstent group and 17.0 ± 3.4 mmHg in the CS group (P = 0.85). The number of glaucoma medications was 0.4 ± 0.8 in the microstent group and 0.8 ± 1.0 in the CS group (P < 0.001), and 73% of microstent group eyes were medication free compared with 48% in the CS group (P < 0.001). The microstent group included a higher proportion of eyes with IOP of 18 mmHg or less without medications compared with the CS group (56.2% vs. 34.6%; P < 0.001), as well as IOP reduction of at least 20%, 30%, or 40% compared with CS alone. The cumulative probability of incisional glaucoma surgery was lower in the microstent group (0.6% vs. 3.9%; hazard ratio, 0.156; 95% confidence interval, 0.031-0.773; P = 0.020). No difference was found in postoperative corneal endothelial cell loss between groups. No procedure- or device-related serious adverse events resulting in vision loss occurred in either group., Conclusions: Combined CS and microstent placement for mild to moderate POAG is safe, more effective in lowering IOP with fewer medications, and less likely to result in further incisional glaucoma filtration surgery than CS alone at 3 years., (Copyright © 2020 American Academy of Ophthalmology. Published by Elsevier Inc. All rights reserved.)

Purpose: To compare 12-month clinical results of spatula-shaped and dual-blade microhooks ab interno trabeculotomy with phacoemulsification., Study Design: Retrospective comparative study., Methods: We conducted a retrospective chart review of Japanese open-angle glaucoma patients who underwent ab interno trabeculotomy with phacoemulsification with a 12-month follow-up. Two types of trabecular hook were used: the spatula-shaped Tanito Trabeculotomy ab interno Micro-hook ® and the Kahook Dual Blade ® . Changes in intraocular pressure (IOP) and medication scores comprised the main outcome metrics. We also analyzed and compared patient demographics and the occurrence of complications., Results: Trabeculotomy was performed using a spatula-shaped hook in 17 eyes and a dual-blade hook in 15 eyes. Significant reductions in IOP (p < 0.001) and medication scores (p < 0.001) were noted in both groups after the 1-month time point. The percentage changes of IOP from baseline at each time point were not significantly different between groups, though there was a significant difference in medication scores at 12 months (p = 0.0192). Postoperative complications occurred similarly in both groups; one case in the dual-blade group required additional filtration surgery., Conclusions: Ab interno trabeculotomy with phacoemulsification was effective in lowering IOP both with spatula-shaped and with double-blade microhooks. At 12 months more medications were used postoperatively in the spatula-shaped microhook group; however, the reductions in the medication scores from baseline were statistically significant in both groups.

Objective: To evaluate the efficacy and safety of the bilateral simultaneous XEN (BISIXEN) surgery in open-angle glaucoma patients., Methods: Retrospective analysis of a prospective data base conducted on uncontrolled glaucoma patients who underwent BISIXEN surgery. Primary endpoint measure was the incidence of sight-threatening complications. Secondary endpoints included intraocular pressure (IOP) reduction and in number of required antiglaucoma medications., Results: Ten patients (20 eyes) were included in the analysis. Median (95% confidence interval) follow-up was 12.0 (7.0-12.0) months, with 14 eyes having a follow-up of 12 months. No sight-threatening complications, such as endophthalmitis, retinal detachment, corneal decompensation, or intraocular hemorrhages were observed in any eye of study sample. Mean IOP decreased significantly from 25.2 (21.5-28.9) mm Hg at baseline to 15.1 (13.4-16.8) mm Hg at the last follow-up visit (p = 0.0001). Mean number of antiglaucoma medications was significantly reduced from 2.9 (2.5 to 3.3) drugs at baseline to 0.40 (0.00-0.70) at the end of the study (p < 0.0001). At the last study visit, 14 (70.0%) eyes had an IOP ≥ 6 and ≤ 18 mm Hg without treatment. Two eyes needed surgical revision and three ones needed a new glaucoma surgery: two underwent Ahmed valves (one eye with aniridia and the other previously operated on) and one underwent non-penetrating deep sclerectomy., Conclusions: Bilateral simultaneous XEN implantation may be a feasible strategy in those patients with high anesthetic risk.

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.

Background: Glaucoma surgery have been developed to lower intraocular pressure in a less invasive manner than traditional glaucoma surgery. The purpose of this article is to determine the outcome of using combined phacoemulsification technique, ab-interno trabeculectomy dual blade and endoscopic cyclophotocoagulation (ECP) surgeries in patients with primary open angle glaucoma., Methods: A retrospective case series was performed on 27 consecutive eyes with both primary open-angle glaucoma (POAG) and cataract; each eye was treated with combined phacoemulsification, ab-interno trabeculectomy-Kahook Dual Blade and Endocyclophotocoagulation at Instituto de ojos Oftalmosalud, Lima, Peru, between April 2017 and May 2017., Inclusion Criteria: 1) Patients with uncontrolled mild to advanced POAG (according to Glaucoma Grading Scale HODAPP) 2) cataract condition 3) treatment with two or more glaucoma medications due to rapid progression in the visual fields (at least two in a short period of time). Intraocular pressure (IOP), best corrected visual acuity (BCVA) logMAR and number of glaucoma medications were recorded prior to the study, at day 1, week 1, and 1,3,6 and 9 months after surgery. Primary outcome measure was surgical success defined in terms of IOP < 14 mmHg either with no medications (complete success) or with medications (qualified success)., Results: A total of 27 eyes from 27 patients were included. The mean basal IOP was 17.0 ± 3.7 mmHg and postoperatively was 11.6 ± 1.9 mmHg and 11.4 ± 1.8 mmHg (P < 0.001) at 6 and 9 months respectively. Glaucoma medications decreased from 1.9 ± 1.4 to 0.56 ± 1.05 at 9 month follow-ups (P < 0.001). Preoperative best corrected visual acuity (BCVA) showed and improvement from 0.4 ± 0.4 LogMAR to 0.2 ± 0.4 logMAR at 9 months. The main complication was blood reflux intra-operatively (66.7%), which resolved without re-operation. The mean IOP was reduced by 32.9% from baseline and the surgical success was 92,6%, (complete success 70,3% and qualified success 29,6%) at 9 months., Conclusions: In patients with POAG, combined treatment with phacoemulsification, ab-interno trabeculectomy and endoscopic cyclophotocoagulation effectively reduced IOP and glaucoma medication dependence.

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.)

Purpose: To evaluate the success, safety, and complication rates of gonioscopy-assisted transluminal trabeculotomy (GATT) combined with cataract surgery., Methods: A retrospective study was conducted for 32 patients who underwent GATT combined with phacoemulsification and intraocular lens implantation. Patients with primary open-angle glaucoma were enrolled. The primary outcome measures were visual acuity, intraocular pressure (IOP), the number of antiglaucoma medications used, and complications., Results: The average preoperative visual acuity of the patients was logMAR 1.57 ± 1.2, and the average postoperative visual acuity was logMAR 0.39 ± 0.38. A significant increase in visual acuity was observed post-surgery (P < 0.05). The average preoperative IOP was 34.2 ± 10.6 mmHg. In the 3 rd postoperative month, the average IOP was 10.5 ± 2.2 mmHg, and in the 6 th postoperative month, the average IOP was 11.2 ± 2.4 mmHg. In all postoperative follow-ups, IOP was significantly lower than that during the preoperative period (P < 0.05). A decrease of 2.7 ± 0.6 on average was detected in the number of glaucoma medications used in the postoperative period compared to the preoperative period, and the average decrease in the number of active ingredients post-surgery was 3.5 ± 0.8. The most frequent complication was hyphaema (31.2%). In only one patient (3.1%), the surgery was considered to have failed due to the development of deep hypotony., Conclusion: Performing GATT in the same session as cataract surgery does not reduce the efficacy of GATT, yet this procedure reduces the incidence of the most frequent complication of GATT, i.e. hyphaema. Therefore, in convenient cases, combined surgery can safely be performed., Competing Interests: None

Purpose: To analyze the 5-year results of trabectome ab interno trabeculectomy of a single glaucoma center., Method: In this retrospective interventional single-center case series, data of 93 patients undergoing ab interno trabeculotomy between September 2010, and December 2012 were included. Kaplan-Meier analysis was performed using success criteria defined as postoperative intraocular pressure (IOP) ≤ 21 mmHg, and > 20% reduction from preoperative IOP, and no need for further glaucoma surgery. Risk factors for failure were identified using Cox proportional hazards ratio (HR)., Results: The retention rate for 5-year follow-up was 66%. The cumulative probability of success at 1, 2, 3, 4, and 5 years was 82.6%, 76.7%, 73.9%, 72.3%, and 67.5%. Risk factors for failure were lower baseline IOP (HR = 0.27, P = 0.001), younger age (HR = 0.25, P = 0.02), and higher central corneal thickness (HR = 0.18, P = 0.01). Exfoliative glaucoma was associated with a higher success rate (HR = 0.39, P = 0.02). IOP was decreased significantly from 20.0 ± 5.6 mmHg at baseline to 15.6 ± 4.6 mmHg at 5-year follow-up (P = 0.001). The baseline number of glaucoma medications was 1.8 ± 1.2, which decreased to 1.0 ± 1.2 medications at 5 years., Conclusion: Trabectome surgery was associated with a good long-term efficacy and safety profile in this single-center case series with a high retention rate.

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]

Alex D Meyer,1 Delcora Huggins,2 Imani Nwokeji,3 Lorraine M Provencher1,2,4 1Cincinnati Eye Institute, Cincinnati, OH, USA; 2University of Cincinnati, College of Medicine, Cincinnati, OH, USA; 3City College of New York (CUNY), School of Medicine, New York, NY, USA; 4Vance Thompson Vision, Omaha, NE, USACorrespondence: Lorraine M Provencher, Vance Thompson Vision, 4909 S 118th St, Omaha, NE, USA, 68137, Tel +1 402 506-9970, Fax +1 402 315-9753, Email lorraine.provencher@vancethompsonvision.comPurpose: To assess the efficacy and safety of goniotomy using a uniquely shaped trapezoidal, serrated dual blade (TDB), designed to accommodate variability in patient anatomy, in reducing intraocular pressure (IOP) or anti-glaucoma medications (AGM) in adult glaucoma patients when combined with cataract surgery.Patients and Methods: Retrospective consecutive case series of patients with glaucoma who underwent phacoemulsification with TDB-goniotomy were included. Preoperative, intraoperative, and postoperative data were collected over 6 months. The primary outcome measure was surgical success, defined as IOP reduction ≥ 20% from baseline at 6 months, and/or reduction of at least 1 AGM. Postoperative adverse events were collected as a secondary outcome measure.Results: Sixty-five eyes of 46 patients were included with data available on 53 eyes at 6 months. Primary open-angle (38%), primary angle-closure (37%), and mixed-mechanism glaucoma (11%) were the most common diagnoses. Most cases were severe (48%) or moderate (32%) stage. At the 6-month mark, surgical success was achieved in 92% of eyes by either or both criteria. Mean preoperative IOP decreased from 18.4 mmHg (SE 0.83) to 13.0 mmHg (SE 0.37) (p< 0.001) at postoperative month 6. Mean AGM decreased from 2.46 (SE 0.19) preoperatively to 1.45 (SE 0.17) (p< 0.001). The most common postoperative complication was an IOP spike at postoperative week 1 (11%). No serious adverse events occurred related to the goniotomy.Conclusion: TDB-goniotomy in combination with cataract surgery safely and effectively lowered IOP and reduced AGM burden in adults with various types and severities of glaucoma over 6-months of follow-up.Plain Language Summary: There are many tools available to perform goniotomy, a popular minimally invasive glaucoma surgery, but data is lacking on many of these devices. This study sought to determine the safety and efficacy of excisional goniotomy using a uniquely shaped trapezoidal dual blade (TDB) in combination with cataract surgery for adult glaucoma patients. At 6 months, the primary outcome measure of intraocular pressure (IOP) reduction ≥ 20% from baseline and/or reduction of at least 1 anti-glaucoma medication was met by 92% of eyes. Six months postoperatively, there was a statistically significant decrease in mean IOP from 18.4 mmHg to 13.0 mmHg and mean antiglaucoma medications from 2.5 to 1.5. Therefore, TDB-goniotomy in combination with cataract surgery can safely decrease IOP and/or antiglaucoma medications in a mixed population of various glaucoma types and severities.Keywords: minimally invasive glaucoma surgery, MIGS, goniotomy, glaucoma, phacoemulsification

Purpose: Despite holding promise, reports of using MIGS in severe glaucoma are scarce, and none has described combining multiple MIGS in this population. To the best of our knowledge, this is the largest study to report outcomes of phacoemulsification and MIGS (Phaco/MIGS) in patients with severe glaucoma. Methods: This retrospective review comprised 327 clinical visits of 71 patients with severe glaucoma who underwent Phaco/MIGS with iStent, endocyclodestruction, Kahook Dual Blade, Hydrus Microstent, or a combination of these MIGS (cMIGS) performed between 2016 and 2021. Primary outcomes included intraocular pressure (IOP) and medication burden evaluated by Generalized Estimating Equations, as well as Kaplan–Meier Estimates. Further analyses compared the efficacy of cMIGS and single Phaco/MIGS (sMIGS), procedure duration, visual acuity, and complications. Results: Mean preoperative IOP was 16.7 mmHg ± 5.8 (SD) on 2.3 ± 1.9 medications overall (N = 71), 16.9 ± 6.3 mmHg on 1.7 ± 1.9 medications in the sMIGS group (N = 37), and 16.4 ± 5.3 mmHg on 2.9 ± 1.6 medications in the cMIGS group (N = 34). Throughout 12 months, Phaco/MIGS led to significant reduction patterns in IOP (p < 0.001) and medications (p = 0.03). At 12 months, 47.5%, 87.5%, and 64.7% of the patients achieved IOP ≤ 12 mmHg, 17 mmHg, or predetermined goal IOP, respectively, without additional medication or procedure. Mean 12-month IOP was 13.5 ± 3.1 mmHg on 1.8 ± 1.7 medications. After adjusting for baseline medication burden, the reduction pattern in IOP (p < 0.05) was different between cMIGS and sMIGS, favoring cMIGS, and the groups had similar reduction patterns in medications (p = 0.75). Conclusion: The use of Phaco/MIGS in patients with cataract and severe glaucoma may significantly reduce IOP and medication burden throughout 12 months and, thus, may serve as a stepping stone in severe glaucoma patients with visually significant cataract before proceeding with more invasive glaucoma surgery. This effect may be potentiated by the combination effect of cMIGS. Plain Language Summary: Many patients with cataract and mild or moderate glaucoma who undergo cataract surgery also benefit from microinvasive glaucoma surgery (MIGS) performed at the same time, but the role of MIGS in patients with severe glaucoma and cataract is not clear. We report that combined cataract surgery and MIGS were associated with significant reductions in eye pressure in patients with severe glaucoma for more than 12 months. [ABSTRACT FROM AUTHOR]

Background: To assess the safety and 5-year efficacy of ab interno XEN 45 gel stent implantation with phacoemulsification in primary open-angle glaucoma (POAG). Methods: Single-centre, single-surgeon, retrospective case note review of consecutive OAG patients who underwent ab-interno gel stent placement combined with phacoemulsification. Surgeries were performed between 2/01/2014 and 2/01/2016. Primary outcome measures: mean reduction in intraocular pressure (IOP) and change in number of ocular hypotensive medications from baseline (follow-up range 1–7 years; mean 54 months). Secondary outcome measure: change in visual field mean deviation (VFMD) from baseline. Safety data included intraoperative and post-operative complications and adverse events. Failure was defined by IOP reduction < 20% despite maximum medical therapy, the need for further laser or surgical intervention. At 5 years, 75% of eyes were free from failure (95% CI 64 to 83%). Results: Ninety-one eyes were analysed. Mean (SD) IOP and medications decreased from 20.2 (6.4) mmHg and 2.9 (1.0) at baseline to 15.4 (3.6) mmHg (p < 0.001) and 1.5 (1.4) medications at 5 (p < 0.001) years. Baseline mean VFMD (SD) was − 10.3dB (8.5) reducing to − 10.9(8.2) (p < 0.01) at 5 years. Two (2%) eyes had intraoperative complications, 4 (4.3%) experienced post-operative AEs, and 13 (14%) required secondary surgical intervention (SSI). Conclusion: The gel stent combined with phacoemulsification was effective in reducing IOP and medications over 5 years, with an acceptable safety profile. Visual field change was clinically acceptable through the study period. [ABSTRACT FROM AUTHOR]

Purpose: To determine differing outcomes among either phakic or pseudophakic patients who received standalone XEN45 Gel Stent (Allergan, an AbbVie Company, CA, USA) implantation and patients who underwent combined surgery with phacoemulsification. Methods: This retrospective single-center study involved 180 eyes of 180 participants who underwent XEN45 Gel Stent implantation, of which 60 eyes received combined surgery with phacoemulsification (combined group). Standalone stent implantation was performed on 60 phakic (phakic group) and on 60 pseudophakic eyes (pseudophakic group). The groups were matched in a ratio of 1:1:1 based on multiple criteria. Successful surgery was defined by three scores: IOP at the longest follow-up of < 21 mmHg (Score A) or < 18 mmHg (Score B) and an IOP reduction > 20% or IOP ≤ 15 mmHg and an IOP reduction ≥ 40% (Score C). In all scores, one open conjunctival revision was allowed, and additional repeat surgery was considered a failure. Results: After an average follow-up time interval of 20.6 ± 12.6 months, there was a mean IOP-reduction by 37% among the entire cohort. Comparative analysis between the three groups did not show significant differences regarding postoperative IOP, postoperative medication score, side effects, revision rate, repeat surgery rate or success rate. A dysfunctional stent was detected in eight eyes (4%) during open conjunctival revision in 76 eyes. Conclusion: The clinical endpoints investigated did not differ significantly among either phakic or pseudophakic patients who received standalone stent implantation and patients who underwent combined surgery. However mean latency between primary stent implantation and first revision surgery after combined surgery was markedly shorter. [ABSTRACT FROM AUTHOR]

Purpose: This study aims to assess the effectiveness and safety of combining the Preserflo™ MicroShunt implant (MicroShunt) with a simultaneous Ologen™ implant in patients with glaucoma. Methods: We conducted a retrospective study on consecutive patients with medically uncontrolled glaucoma who underwent MicroShunt + Ologen implantation as a standalone procedure or in combination with phacoemulsification (combined procedure). Success was defined as achieving an intraocular pressure (IOP) of 6–15 mmHg at 18 months post surgery, with a preoperative IOP reduction of at least 20%, and without (complete success) or with (qualified success) the need for antiglaucoma medications. The primary endpoint was the success rate. Results: Forty-eight eyes from 47 patients were included, with 28 eyes (58.3%) undergoing the standalone procedure and 20 eyes (41.7%) undergoing the combined procedure. Overall, there was a significant reduction in preoperative IOP from 19.7 ± 5.8 mmHg to 11.4 ± 2.6 mmHg at 18 months (P < 0.0001). In the standalone procedure group, preoperative IOP decreased from 21.5 ± 5.2 mmHg to 11.7 ± 2.5 mmHg (P < 0.0001), and in the combined procedure group, preoperative IOP decreased from 17.1 ± 5.8 mmHg to 10.9 ± 2.7 mmHg (P = 0.0002), with no significant difference between the two groups regarding final IOP. The mean number of antiglaucoma medications significantly decreased from 3.2 ± 1.1 to 0.3 ± 0.7 in the overall study population (P < 0.0001). At 18 months, 40 eyes (83.3%) were classified as successful. Regarding safety, out of the total number of eyes, two (4.2%) experienced choroidal detachment without visual impairment, two (4.2%) had transient hyphema, one (2.1%) showed reactivation of a corneal herpetic ulcer, one (2.1%) had diplopia, and one (2.1%) exhibited a shallow anterior chamber during the first week. Conclusion: The combination of Ologen™ and Preserflo™ MicroShunt, either alone or in conjunction with phacoemulsification, demonstrated a favorable profile in terms of IOP reduction and safety. [ABSTRACT FROM AUTHOR]

The XEN45 is a minimally invasive glaucoma surgery device commonly used in clinical practice. This retrospective study included consecutive patients with open-angle glaucoma who underwent a XEN45 implant with mitomycin C, either alone or in combination with phacoemulsification, between June 2015 and March 2021. The primary end point was the mean change in intraocular pressure (IOP) from the baseline to month 6. A total of 677 eyes, 395 (58.3%) in the XEN alone group and 282 (41.7%) in the XEN+Phaco group, were included in this study. The preoperative IOP was significantly lowered from 28.7 ± 8.6 mmHg and 25.4 ± 6.9 mmHg to 13.5 ± 5.0 mmHg and 13.5 ± 4.1 mmHg at month 6 in the XEN solo and XEN+Phaco groups, respectively, with p < 0.0001 each. The mean (95% confidence interval) number of ocular hypotensive medications was significantly reduced from 3.3 (3.2–3.4) to 0.2 (0.1–0.2) and from 3.1 (2.9–3.2) to 0.2 (0.1–0.2) in the XEN solo and XEN+Phaco groups, respectively, with p < 0.0001 each. Needling was performed in 228 (33.7%) eyes. Conclusions: the XEN implant significantly reduces both IOP and the number of ocular hypotensive medications. IOP lowering was higher in the XEN solo group than in the XEN+Phaco one, although such a difference was only evident during the first month after surgery. [ABSTRACT FROM AUTHOR]

aime E Dickerson Jr5,6 On behalf of the GEMINI 2 STUDY GROUP1Vance Thompson Vision, West Fargo, ND, USA; 2Omni Eye Services, Atlanta, GA, USA; 3Ophthalmology Associates, Fort Worth, TX, USA; 4Oklahoma Eye Surgeons, Oklahoma City, OK, USA; 5Sight Sciences, Menlo Park, CA, USA; 6North Texas Eye Research Institute, University of North Texas Health Science Center, Fort Worth, TX, USACorrespondence: Jaime E Dickerson, Email [email protected] Purpose: To provide long-term intraocular pressure (IOP) and ocular hypotensive medication usage outcomes through 36 months for patients treated with canaloplasty and trabeculotomy (OMNI Surgical System) combined with cataract surgery as participants in the GEMINI study.Setting: Eleven ophthalmology practices in 10 US states.Design: Non-interventional 36-month extension of the 12-month, prospective, multicenter, GEMINI study.Methods: GEMINI patients had visually significant cataract, mild-to-moderate glaucoma (ICD-10 guidelines), medicated IOP < 33 mmHg, and unmedicated mean diurnal IOP (DIOP) (after washout) 21– 36 mmHg. Patients from GEMINI were eligible for inclusion. Outcome measures were reduction in mean unmedicated DIOP, reduction in mean IOP-lowering medications, percent of eyes with ≥ 20% reduction in unmedicated DIOP, and percent of eyes with unmedicated DIOP ≥ 6 and ≤ 18 mmHg.Results: A total of 66 patients provided consent and were enrolled. Mean (SD) unmedicated DIOP was 23.1 (2.7) mmHg at baseline, 16.7 (4.1), 16.3 (3.3) at 24 and 36 months; mean reductions of 6.2 (4.1) and 6.9 (3.4) mmHg. Twelve-month IOP at the end of GEMINI was 15.6 mmHg. The proportion of eyes with ≥ 20% reduction in IOP was 77% and 78% (months 24 and 36) compared to 87% at month 12 from GEMINI. About 68% of patients had an IOP between 6 and 18 mmHg at 24 months and 71% at 36 months. Mean IOP-lowering medications was 1.7 at baseline, which was reduced to 0.4 (24 months, − 1.3) and 0.3 (36 months, − 1.4). About 74% of patients (46 of 62) were medication free at 36 months.Conclusion: GEMINI demonstrated 12-month effectiveness of canaloplasty and trabeculotomy with OMNI combined with cataract surgery for IOP and medication reduction in mild-to-moderate glaucoma. However, longer-term data is key to the decision making in the selection of a surgical treatment. This GEMINI extension demonstrates that the 12-month outcomes from GEMINI were sustained through 36 months. [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: This study compared outcomes of the iStent inject trabecular micro-bypass system versus the Hydrus Microstent in patients with primary open-angle glaucoma (POAG). Methods: Forty subjects (80 eyes) with POAG were included in this single-center, retrospective, contralateral-eye analysis. All patients underwent phacoemulsification with either iStent inject or Hydrus implantation in one eye and the other device in the contralateral eye, with ≥ 3-month follow-up. In 58 eyes (27 iStent inject, 31 Hydrus) the surgery also included ab interno canaloplasty (ABiC). Twelve-month outcomes included intraocular pressure (IOP), medications, and adverse events. Subgroup analyses were completed for iStent inject versus Hydrus, and with versus without ABiC. Results: At 12 months versus baseline, mean IOP reduced from 16.8 ± 3.7 to 13.6 ± 2.9 (p = 0.003) in iStent inject eyes, and from 18.1 ± 4.5 to 14.9 ± 3.2 mmHg (p = 0.003) in Hydrus eyes (between-group IOP reduction p = 0.582). Mean number of glaucoma medications reduced from 1.23 ± 0.97 to 0.30 ± 0.76 (p < 0.001) in iStent inject eyes and from 1.20 ± 1.02 to 0.39 ± 0.72 (p = 0.001) in Hydrus eyes (between-group medication reduction p = 0.943). At 12 months, 82.6% of iStent inject eyes and 73.9% of Hydrus eyes were medication-free versus 20.0% preoperatively in both groups (p < 0.0001 both groups). There were no statistically significant IOP or medication differences between iStent inject and Hydrus pre- or postoperatively, both in the overall cohort and in the with/without ABiC subgroups. Outcomes also were similar between eyes with/without ABiC in the overall cohort and in the iStent inject/Hydrus subgroups. There were no adverse events in the iStent inject group; two eyes in the Hydrus group had device-related complications requiring five additional surgeries (one Hydrus repositioning, one Hydrus exchange, one Hydrus removal, two goniotomies). Conclusion: In this contralateral-eye comparison of iStent inject versus Hydrus, the groups had similar IOP and medication outcomes, regardless of stratification by ABiC completion. Eyes receiving Hydrus had more complications and subsequent surgeries. Plain Language Summary: The present study contributes some of the first real-world data comparing iStent inject versus Hydrus Microstent implantation in combination with cataract surgery in opposite eyes (right or left) of the same patient (i.e., contralateral-eye study). The report also includes subgroup analyses of eyes with versus without ab interno canaloplasty (ABiC). There were no significant between-group differences in mean intraocular pressure or medication burden preoperatively or postoperatively for iStent inject versus Hydrus. The intraocular pressure and medication reductions versus the groups' respective baselines were statistically similar as well. Finally, results remained similar for iStent inject versus Hydrus regardless of whether ABiC was completed, and were also similar when comparing eyes with ABiC versus without ABiC. In eyes receiving Hydrus, there was a greater incidence of complications and need for further surgery. [ABSTRACT FROM AUTHOR]

Purpose: To examine the potential risk factors affecting the long-term outcomes following a combination of phacoemulsification with ab interno trabeculotomy with the microhook (μLOT-Phaco) and goniotomy with the Kahook Dual Blade (KDB-Phaco).Methods: For 12 months, we retrospectively examined a total of 100 eyes of 100 patients with primary open-angle glaucoma (POAG) and exfoliation glaucoma (EG) who had previously undergone surgery between December 2016 and December 2020. Patients with a preoperative intraocular pressure (IOP) ˂12 mmHg were excluded. Probability of success was calculated using the Kaplan–Meier method, with surgical failure defined as an IOP > 18 mmHg, < 20% IOP reduction or additional glaucoma surgery. The Cox proportional hazards model was used to examine the potential risk factors for failure, which included age, gender, type of glaucoma, surgical techniques, preoperative IOP, number and type of preoperative IOP-lowering medications, preoperative visual field mean deviation (MD) value, and axial length.Results: For the 51 males and 49 females, mean preoperative age was 74.4 ± 9.0 years, with μLOT-Phaco performed in 44 and KDB-Phaco in 56 subjects. The type of glaucoma was POAG in 68 and EG in 32 eyes. Preoperative IOP was 20.5 ± 6.7 mmHg, while postoperative IOPs were 14.4 ± 4.2 mmHg, 13.7 ± 2.8 mmHg, and 14.6 ± 3.9 mmHg, respectively (P < 0.001). Significant decreases from the preoperative number of IOP-lowering medications (3.1 ± 1.2) were observed at 12, 24, and 36 months, respectively (1.2 ± 1.3, 1.6 ± 1.3, and 2.1 ± 1.4 (P < 0.001)). Probability of success at 12, 24, and 36 months postoperatively was 52.0%, 49.6%, and 47.7%, respectively. Lower preoperative IOP was shown to be a potential risk factor for surgical failure.Conclusion: Long-term follow-ups showed IOP decreased in μLOT-Phaco and KDB-Phaco patients. Results suggest that patients with higher preoperative IOP may have better postoperative outcomes. [ABSTRACT FROM AUTHOR]

Purpose: To describe the outcomes of inferior hemisphere 180° gonioscopy-assisted transluminal trabeculotomy (hemi-GATT) in patients with moderate-severe stage primary open-angle glaucoma (POAG). Methods: This single center, retrospective study identified patients with POAG who had undergone combined inferior hemi-GATT with phacoemulsification. Patients with moderate-severe staged POAG were included in the study. Outcome measures included surgical success, intraocular pressure (IOP), number of topical IOP-lowering drops, best-corrected visual acuity (BCVA), visual field mean deviation (MD) and complications. Success was defined using two criteria: Criterion A (IOP <17 mmHg and >20% reduction) and Criterion B (IOP <12 mmHg and >20% reduction). Results: One hundred-twelve eyes of 112 patients were included in this study. Of these, 91 patients were followed for 24 months or greater to assess endpoint surgical success. Kaplan-Meier survival analysis for Criterion A demonstrated a 64.8% probability of success without topical IOP-lowering therapy (complete success) and a 93.4% probability of success with or without topical IOP-lowering therapy (qualified success). Probabilities of complete and qualified success using Criterion B were 26.4% and 30.8%, respectively. IOP reduction from baseline (21.9 ± 5.8 mmHg) to 24-month follow-up (13.6 ± 3.9 mmHg) was 37.9% for the overall cohort. The most common complication was transient hyphema, which occurred in 25.9% (29 of 112) of patients. All cases of hyphema resolved spontaneously. Conclusions: Combined hemi-GATT with phacoemulsification was associated with favorable outcomes and a low complication rate in this study of patients with moderate-severe POAG. Further studies are required comparing hemi-GATT to the 360° approach. [ABSTRACT FROM AUTHOR]

Introduction: This study evaluated efficacy and safety of implanting two second-generation trabecular micro-bypass stents (iStent inject/iStent inject W) with phacoemulsification, either with or without iAccess Precision Blade goniotomy, in patients with mild-to-moderate open-angle glaucoma (OAG). Methods: This retrospective, non-randomized, unmasked, dual-arm, single-site, multi-surgeon, consecutive case series evaluated all OAG eyes that underwent phacoemulsification and iStent inject implantation either as a dual procedure (group A) or paired with iAccess goniotomy (group B) from July 2020 to May 2022. Effectiveness outcomes analyzed from 1 month onward included intraocular pressure (IOP), proportions of eyes with IOP ≤ 12/≤ 15/≤ 18, proportion medication-free, and medication number. Safety outcomes at all timepoints included adverse events and secondary surgeries. Results: In group A, mean IOP reduced from 14.9 ± 3.2 mmHg on 1.22 ± 1.31 mean medications preoperatively (n = 63) to 13.5 ± 2.5 mmHg on 0.24 ± 0.61 medications at month 3 (n = 34; p = 0.048 IOP, p < 0.001 medications). In group B, mean IOP reduced from 16.0 ± 4.2 mmHg on 1.12 ± 1.07 medications preoperatively (n = 93) to 12.2 ± 2.3 mmHg on 0.57 ± 1.27 medications at month 3 (n = 23; p < 0.001 IOP, p = 0.003 medications). From preoperative to 3 months, the percent of eyes with IOP ≤ 12 mmHg remained at 32.4% in group A (p = 1.0) and rose from 21.7% to 60.9% in group B (p = 0.0177); eyes with IOP ≤ 15 mmHg rose from 52.9% to 76.5% in group A (p = 0.0963) and from 43.5% to 91.3% in group B (p = 0.0034). Adjusting for baseline between-group differences, group B had significantly greater postoperative IOP reduction than group A (p = 0.043); medication reductions were similar. Safety was favorable in both groups. Conclusions: Phacoemulsification and iStent inject with or without iAccess Precision Blade goniotomy produced clinically meaningful and safe IOP and medication reductions. The paired iStent inject + iAccess + phacoemulsification procedure enabled greater IOP reduction and lower IOP thresholds than iStent inject + phacoemulsification. The study provides some of the first data on this paired approach and on the novel iAccess Precision Blade. [ABSTRACT FROM AUTHOR]

Purpose: To evaluate the efficacy and safety of excisional goniotomy performed with the Kahook Dual Blade (KDB) combined with cataract surgery in patients with pimary open angle glaucoma (POAG) and Normal Tension Glaucoma (NTG) under topical therapy. Further sub-analysis was performed to compare between 90 and 120 degrees goniotomy. Methods: This was a prospective case series of 69 eyes from 69 adults (age 78 ± 5.9 years; male = 27, female = 42). Indications for surgery included insufficient IOP control with topical medication, glaucomatous damage progression under topical therapy and reduction of medication burden. Complete success was defined as IOP lowering below 21 mmHg without the need for topical medication. For NTG patients, complete success was defined as IOP lowering below 17 mmHg without the need for topical medication. Results: IOP was significantly lowered from 19.7 ± 4.7 to 15.1 ± 2.7 at 2 months, 15.8 ± 2.3 at 6 months and 16.1 ± 3.2 at 12 months (p < 0.05) for POAG and 15.1 ± 2.5 to 14.1 ± 2.4 at 2 months, 14.1 ± 3.1 at 6 months and 13.6 ± 1.8 at 12 months (p > 0.08) for NTG, respectively. Complete success was achieved in 64% of the patients. IOP lowering under 17 mmHg without the need for topical medication was achieved in 60% of the patients at 12 months. In NTG patients (14 eyes) IOP lowering under 17 mmHg without the need for topical medication was achieved in 71%. No significant difference was recorded in terms of IOP lowering at 12 months in-between 90° and 120° of treated trabecular meshwork (p > 0.7). No severe adverse reactions were recorded in this study. Conclusion: One-year results show that KDB combined with cataract surgery is an effective treatment option for glaucoma patients. IOP lowering was successfully achieved in NTG patients with complete success in 70% of the patients. In our study, no significant differences were recorded in-between 90° and 120° of treated trabecular meshwork. [ABSTRACT FROM AUTHOR]

This article discusses a study that aimed to evaluate the incidence of acute post-operative intraocular pressure (IOP) spikes in glaucoma patients who underwent a XEN45 implant in combination with phacoemulsification. The study found that the incidence rate of IOP spikes on the first day after surgery was very low, with no eye having an IOP greater than 20 mmHg. The spikes resolved without treatment and without any negative effects by the seventh day after surgery. The study suggests that the XEN45 implant may help prevent postoperative IOP spikes in glaucoma patients. [Extracted from the article]

Purpose: To assess the effectiveness of XEN45, either alone or in combination with phacoemulsification, in open-angle glaucoma (OAG) patients in clinical practice. Methods: Retrospective and single-center study conducted on OAG patients who underwent XEN45 implant, either alone or in combination with cataract surgery. We compared the clinical outcomes of the eyes of thosewho underwent XEN-solo versus those who underwent XEN+Phacoemulsification. The primary endpoint was the mean change in intraocular pressure (IOP) from baseline to the last follow-up visit. Results: A total of 154 eyes, 37 (24.0%) eyes that underwent XEN-solo and 117 (76.0%) eyes that underwent XEN+Phacoemulsification, were included. The mean preoperative IOP was significantly lowered from 19.1± 5.0 mmHg to 14.9± 3.8 mmHg at month-36, p< 0.0001. Preoperative IOP was significantly lowered from 21.2± 6.2 mmHg and 18.4± 4.3 mmHg to 14.3± 4.0 mm Hg and 15.2± 3.7 mmHg at month-36 in the XEN-solo and XEN+Phacoemulsification groups, p< 0.0004 and p=0.0009; with no significant differences between them. In the overall study population, the mean number of antiglaucoma medications was significantly reduced from 2.1± 0.8 to 0.2± 0.6, p< 0.0001. There were no significant differences in the proportion of eyes with a final IOP ≤ 14 mmHg and ≤ 16 mmHg between XEN-solo and XEN+Phaco groups (p=0.8406 and 0.04970, respectively). Thirty-six (23.4%) eyes required a needling procedure. Conclusion: XEN implant significantly lowered IOP and reduced the need of ocular hypotensive medication, while maintaining a good safety profile. Beyond week-1, there were no significant differences in IOP lowering between XEN-solo and XEN+Phacoemulsification groups. [ABSTRACT FROM AUTHOR]

Purpose: To evaluate the therapeutic success, and risk factors for combined phacoemulsification and Kahook Dual Blade excisional goniotomy (Phaco/KDB) in primary angle-closure glaucoma (PACG). Methods: A retrospective review was conducted on glaucoma patients who underwent Phaco/KDB between September 2019 and August 2021 at 2 ophthalmology centers. Complete success was defined as unmedicated intraocular pressure (IOP) ≤ 18 mmHg with no further glaucoma surgery, while the medicated IOP ≤ 18 mmHg was defined as qualified success with lesser medications than at baseline. Results: Seventy-two eyes (64 patients) with a mean age of 67.1 ± 8.1 years were included in this study, and 70.2% were female. The mean medicated baseline IOP decreased from 23.4 ± 8.1 to 16.6 ± 3.9 mmHg at an average of 11.6 ± 3.7 months of follow-up (− 29.1%; P < 0.00). Medications decreased from 2.6 ± 1.3 to 0.4 ± 0.9 (− 82.6%; P < 0.001). Complete success and qualified success were achieved in 65.3% and 79.2% of eyes, respectively. Male gender [hazard ratio (HR): 6.00 (1.57–22.9); P = 0.009] was observed a risk factor for surgical failure, whereas higher axial length (HR:0.37 (0.16–0.86); P = 0.021), and a combined circumferential goniosynechialysis procedure (HR: 0.13 (0.02–0.74); P = 0.022) lowered the risk of surgical failure. Hyphema, postoperative shallowing anterior chamber, and IOP spike were the most common complications. The cumulative survival proportion for qualified success at 12 months was 82.5% ± 0.05 (95% CI, 0.70–0.90). Conclusion: Phaco/KDB provided acceptable therapeutic success rate and may, therefore, be recommended in patients with coexisting cataract and PACG. Identifying patients with risk factors preoperatively may help clinicians predict surgical success. [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]

Background: A single-center prospective randomized observational study to compare three types of canaloplasty, i.e., ab externo (ABeC), minicanaloplasty (miniABeC) and ab interno, (ABiC) combined with cataract surgery in primary open-angle glaucoma (POAG) patients over 12 months. Methods: 48 POAG patients underwent one of three canaloplasty procedures: ABeC (16 eyes), miniABeC (16 eyes) or ABiC (16 eyes) or combined with phacoemulsification. Patients were assessed at baseline, at day 0–1–7 and at month 1–3–6–12. Successful treatment was defined as unmedicated IOP reduction ≥20%. Complete surgical success was defined as an IOP ≤ 15 mmHg without medications, and a qualified surgical success as IOP ≤ 15 mmHg with or without medications. Results: Pre-washout IOP median values (mmHg) were 17 (ABeC), 18 (miniABeC) and 17 (AbiC) and decreased at 12-month follow up postoperatively to 13 (p = 0.005), 13 (p = 0.004) and 14 (p = 0.008), respectively—successful treatment was achieved in approximately 100% of patients for ABeC and in 93.8% for both miniABeC and AbiC groups. Preoperatively, the median number of medications was 2.0 (range 1–3) (ABeC), 2.0 (1–3) (miniABeC) and 2.0 (0–4) (ABiC); 12-month post-operatively, all medications were withdrawn except in two patients (followed miniABeC and AbiC). Conclusions: The three variants of canaloplasty significantly reduced IOP and the number of medications in patients with mild to moderate POAG and gave no significant complications. [ABSTRACT FROM AUTHOR]

Purpose: To evaluate 3-year safety and efficacy of two second-generation trabecular micro-bypass stents. (iStent inject®) with phacoemulsification. Materials and Methods: This multicenter retrospective study of iStent inject implantation with phacoemulsification included data from eight surgeons across Australia. Eyes with cataract and mild to advanced glaucoma [predominantly primary open-angle (POAG), primary angle closure (PAC), or normal-tension (NTG) glaucoma] or ocular hypertension (OHT) were included. Study assessments included intraocular pressure (IOP); number of ocular hypotensive medications; proportions of eyes with 0, 1, 2, or ≥ 3 IOP-lowering medications; IOP ≤ 15 mmHg or ≤ 18 mmHg; visual fields (VF); retinal nerve fiber layer thickness (RNFL); central corneal thickness (CCT); intraoperative complications; adverse events; and secondary surgeries. Results: A total of 273 eyes underwent surgery and had 36-month follow-up. At 36 months versus preoperative, mean IOP decreased by 15.5% (16.4± 4.6 mmHg to 13.9± 3.5 mmHg; p< 0.001), and 70.3% of eyes achieved IOP of ≤ 15 mmHg (versus 49.1% preoperatively; p< 0.001). The mean medication burden decreased by 68.5% (from 1.51± 1.17 to 0.48± 0.89 medications; p< 0.001); 71.4% of eyes were medication-free (versus 21.6% preoperatively; p< 0.001), while 6.2% of eyes were on ≥ 3 medications (versus 22.3% preoperatively; p< 0.001); 96.3% of eyes maintained or reduced medications vs preoperative. Significant IOP and medication reductions occurred across glaucoma subtypes (POAG, PAC, NTG, OHT): 13– 22% for IOP (p< 0.05 for all) and 42– 94% for medication (p< 0.05 for all). Favorable safety included few adverse events; stable VF, RNFL, and CCT; and filtering surgery in only 8 eyes (2.9%) over 3 years. Conclusion: In this multicenter cohort from 8 surgeons across Australia, significant IOP and medication reductions were sustained through 3 years after iStent inject implantation with phacoemulsification. Results were favorable across different glaucoma subtypes (including POAG, PAC, NTG, OHT), severities, and surgeons, thereby underscoring the real-world relevance and efficacy of iStent inject implantation for glaucoma treatment. [ABSTRACT FROM AUTHOR]

aime E Dickerson Jr4,6 On behalf of the ROMEO Study Group1Ophthalmology, Yale New Haven Hospital, New Haven, CT, USA; 2Vance Thompson Vision, Sioux Falls, SD, USA; 3Morris Eye Group, Encinitas, CA, USA; 4Clinical Research, Sight Sciences, Menlo Park, CA, USA; 5Mahatma Gandhi Medical College and Research Center, Wardha, India; 6North Texas Eye Research Institute, University of North Texas Health Science Center, Fort Worth, TX, USACorrespondence: Jaime E Dickerson Jr, Email [email protected] Purpose: Twelve-month safety and effectiveness results for canaloplasty combined with trabeculotomy using the OMNI surgical system in pseudophakic eyes or combined with cataract surgery in mild-to-moderate open-angle glaucoma (OAG). Setting: Sixteen centers in 11 US states (AL, AR, CA, CT, KS, LA, MO, NY, SD, TN, TX). Design: Retrospective, case series, open-label. Methods: A total of 136 eligible patients from 20 surgeons: mild-to-moderate OAG (visual field mean deviation (MD) not worse than − 12 dB), 12-month follow-up, preoperative medicated IOP > 18 mmHg and ≤ 36 mmHg on ≤ 5 medications. One eye per patient enrolled. Endpoints included proportion with ≥ 20% reduction in IOP or IOP between 6 and 18 mmHg (inclusive) and on the same or fewer medications without secondary surgical intervention (SSI) (primary success), mean IOP, change in IOP, ocular hypotensive medication use, and proportion of patients with a 20% or greater reduction in IOP at 12 months. Safety: adverse events (AE) and best corrected visual acuity (BCVA). Results: Primary success was met by 71%. Mean IOP was reduced (22.3– 15.9 mmHg, p < 0.0001). Medications went from 1.9 ± 1.3 to 1.3 ± 1.2 (p < 0.001). AE were mild and as expected for angle surgery. The most frequent AE were BCVA loss (6%), mild inflammation (4%), IOP elevation (3%), and clinically significant hyphema (3%). There were 4 (3%) SSI. Conclusion: The OMNI system provides effective IOP reduction, sustained IOP control, and meaningful medication reduction for up to 12 months postoperative. The present study confirms and extends the results from ROMEO. [ABSTRACT FROM AUTHOR]

Background: Glaucoma surgery has significantly evolved over the last years. This paper aims to evaluate the midterm clinical outcomes of the XEN63 device in a real-world scenario. Methods: A retrospective clinical study was conducted on consecutive patients who underwent an XEN63 implant insertion, either alone or in combination with phacoemulsification. The primary endpoint was the mean intraocular pressure (IOP) at the month 18 visit. Results: Twenty-three eyes (23 patients) were included in the analysis. The preoperative IOP was significantly lowered from 27.0 ± 7.8 mmHg to 14.1 ± 3.4 mmHg at month 18 (p < 0.0001). At month 18, 14 (77.8%) and 11 (61.1%) eyes had an IOP ≤ 16 mmHg and ≤ 14 mmHg, respectively, without ocular hypotensive medication. The mean number of ocular hypotensive medication taken was significantly reduced from 2.3 ± 0.9 drugs at baseline to 1.0 ± 1.4 drugs at month 18 (p = 0.0020). Four (17.4%) eyes had hypotony at postoperative day 1, which was successfully resolved without sequelae. Four (17.4%) eyes underwent a needling procedure and four (17.4%) eyes underwent additional surgeries. Conclusions: The XEN63, either alone or in combination with cataract surgery, significantly lowered the IOP and reduced the need for ocular hypotensive drugs over a period of 18 months. [ABSTRACT FROM AUTHOR]

Primary open-angle glaucoma (POAG) is currently treated with a variety of surgical and non-surgical approaches. Minimally invasive glaucoma surgery (MIGS) involves several devices and procedures that lower intraocular pressure (IOP) by increasing aqueous outflow. The first laser-based MIGS procedure, Excimer Laser Trabeculostomy (ELT), has emerged as a safe and effective treatment option. This article reviews ELT within the context of alternative MIGS procedures and focuses on the historical development of ELT, principles and techniques of the ELT procedure, safety and efficacy data, comparison to other outflow procedures, and future augmentations to expand the use of ELT. Performed alone or as an adjunct to cataract surgery, ELT has minimal complications and has shown long-term effectiveness in lowering intraocular pressure in thousands of patients. The non-thermal laser-tissue interactions of excimer lasers minimize peripheral tissue damage and ensure outflow channel patency without requiring foreign body implants or creating blebs. The development of 2D optical and 3D optical coherence tomography (OCT) guidance systems will eliminate the need for a goniolens to visualize angle structures and enable thousands more surgeons to perform ELT in the future. [ABSTRACT FROM AUTHOR]

Purpose: Combined phacoemulsification plus excimer laser trabeculostomy (phaco-ELT) is a minimally invasive surgery that effectively reduces intraocular pressure (IOP) in patients with glaucoma and a concomitant diagnosis of cataract. The aim of this study was to evaluate the long-term treatment success as well as safety of phaco-ELT over an 8-year follow-up period. Methods: Patients with a diagnosis of primary or secondary glaucoma or ocular hypertension and a visually significant cataract who underwent a combined phaco-ELT between January 1, 2008, and December 31, 2010, were included. Data for IOP, the number of IOP-lowering medications (meds), best-corrected visual acuity, complications, and subsequent surgeries to lower IOP were collected preoperatively (baseline) and intraoperatively as well as at 1 day, 1 week, 1 month, 3 months, 6 months, 9 months, 1 year, and every 6 months thereafter to 8 years postoperatively. Results: One hundred sixty-one eyes of 128 patients were included. After 8 years of follow-up, the long-term treatment success rate with IOP ≤ 21 mmHg was 50.2%. No serious intra- or postoperative complications occurred. The mean IOP decreased significantly from 19.3 (±4.8) mmHg at baseline to 15.4 (±3.2, p =0.0040) mmHg at 8 years. Additionally, meds remained below baseline after 8 years of follow-up and were reduced significantly for up to 4 years. Only 25.5% of the eyes required a subsequent surgery to lower IOP during the follow-up period. Conclusion: Combined phaco-ELT is a safe procedure without serious intra- or postoperative complications, which has a positive long-term effect regarding IOP and meds. Remarkably, the mean IOP-lowering effect remained stable and was reduced ≥ 20% from baseline after 3 months for the remainder of the follow-up duration, whereas the number of meds was reduced significantly for up to 4 years. Furthermore, only 25.5% of the eyes required a subsequent surgery to control IOP throughout the whole follow-up of 8 years. [ABSTRACT FROM AUTHOR]

Purpose: To characterize the clinical outcomes of a novel ab interno minimally invasive procedure with the STREAMLINE® Surgical System for creation of incisional goniotomies and canal of Schlemm viscodilation in eyes with mild to severe primary open-angle glaucoma (POAG). Methods: In a prospective, single-arm, first-in-human case series, 20 eyes of 20 subjects with mild to severe POAG underwent creation of incisional goniotomies and canal of Schlemm viscodilation following phacoemulsification cataract extraction after washout of all intraocular pressure (IOP)-lowering medications. The angle surgery portion was performed with a single-use handpiece tipped with a microcannula that creates precise goniotomies through the trabecular meshwork into the canal of Schlemm and delivers a small volume of ophthalmic viscosurgical device directly into the canal via precise catheterization. Outcomes in this interim analysis included mean reduction in IOP and medications through 6 months of follow-up, as well as the proportion of eyes achieving IOP reduction ≥ 20% from baseline. Results: At month 6, mean IOP reduction of ≥ 20% from baseline was achieved in 89.5% of eyes (17/19). Mean (standard deviation) medicated IOP at screening was 16.3 (3.6) mmHg and unmedicated baseline IOP (after washout) was 23.5 (2.5) mmHg. Mean IOP was significantly reduced from baseline through 6 months of follow-up to 14.7 (2.4) mmHg (p< 0.001), representing an IOP reduction of 8.8 mmHg (36.9%). Overall, 57.9% (11/19) of eyes decreased dependence on IOP-lowering medications by at least one medication, and 42.1% (8/19) were medication free. Mean medication use was reduced from 2.0 (0.8) at screening to 1.1 (1.1) at 6 months (p< 0.001). Three eyes had transient IOP spikes treated with topical medications. Conclusion: The creation of incisional goniotomies and canal of Schlemm viscodilation safely and effectively reduced IOP and the need for IOP-lowering medications by both clinically and statistically significant magnitudes in eyes with mild to severe POAG undergoing concomitant phacoemulsification cataract extraction through the first 6 months of follow-up. [ABSTRACT FROM AUTHOR]

Purpose: To report 12-month efficacy outcomes of 360° canaloplasty and 180° trabeculotomy using the OMNI surgical system in combination with phacoemulsification in patients with mild-moderate open-angle glaucoma (OAG) and visually significant cataract. Setting: Fifteen multi-subspecialty ophthalmology practices and surgery centers located in 14 US states. Design: Prospective, multicenter, IRB approved study of patients treated with canaloplasty (360°) and trabeculotomy (180°). Eligible patients had cataract and mild-moderate OAG with intraocular pressure (IOP) ≤ 33 mmHg on 1 to 4 hypotensive medications. Unmedicated post-washout mean diurnal IOP (DIOP) ≥ 21 and ≤ 36 mmHg. Methods: Medication washout preoperatively and prior to month 12 DIOP. Effectiveness outcomes were IOP and IOP lowering medication use. Safety outcomes included adverse events and secondary surgical interventions (SSIs). Evaluations at 1, 3, 6, and 12 months. Results: A total of 149 subjects underwent surgery and 120 were included in the final effectiveness analysis. Mean (standard deviation) unmedicated diurnal IOP was reduced from 23.8 (3.1) mmHg at baseline to 15.6 (4.0) at month 12 (− 35%) and medications (before washout) were reduced from 1.8 (0.9) at baseline to 0.4 (0.9) at month 12 (− 80%). At month 12, 84.2% of eyes achieved IOP reductions > 20% from baseline, 80% of eyes were medication-free, and 76% of eyes achieved IOP between 6– 18 mmHg inclusive. Adverse events were uncommon. Most were mild and self-limited including transient hyphema (9 of 149; 6%) and transient IOP elevations (3 of 149; 2.0%). No eyes required SSIs or experienced loss of VA that was attributable to the device or procedure. Conclusion: Canaloplasty and trabeculotomy performed with the OMNI surgical system at the time of phacoemulsification significantly reduces unmedicated mean diurnal IOP and medication use 12 months postoperatively, with an excellent safety profile. This procedure should be considered for eyes with mild-moderate OAG to reduce IOP, medication burden, or both. [ABSTRACT FROM AUTHOR]

Glaucoma continues to be a leading cause of blindness worldwide for the same reasons as in the past several decades, including the lack of early detection, improper treatment, and non-adherence to therapy. Medical therapy continues to be the first-line therapy even as surgical techniques are improving in their safety and efficacy. To turn the tide in preventing blindness from glaucoma, attention must be focused on targeted patient education, screening, effective treatment, and addressing health disparities. To achieve this, early safer cataract surgery and microinvasive glaucoma surgery must be considered as a first-line therapy in addition to medical therapy to best lower both intraocular pressure and the medication burden. [ABSTRACT FROM AUTHOR]

Purpose: To assess the effectiveness and safety of primary-needling in eyes who underwent a XEN45 implant. Methods: Retrospective and single center study. Consecutive patients with early-to-moderate open-angle glaucoma (OAG) or ocular hypertension, who underwent XEN45 surgery, either alone or combined with phacoemulsification, and had at least a valid 12-month post-operative visit, were included in the study. Primary needling was performed by using a 30-gauge needle without viscoelastic. Subjects were divided in two groups: Eyes who underwent XEN+primary-needling (needling) and those who underwent XEN without primary-needling (no-needling). The primary end-point was the mean change in IOP from baseline to the last follow-up visit. Results: Sixty-three eyes, 19 (30.2%) in the needling group and 44 (69.8%) in the no-needling one, were included in the study. There were not significant differences in mean IOP lowering between needling and no-needling groups at month-12 (mean difference − 2.5± 5.3 mm Hg, p=0.0926). No significant differences in mean reduction of ocular-hypotensive medications were observed between needling and no-needling groups, p=0.8690. At month-12, 50 (80.6%) had blebs considered as functioning, with no difference between groups, p = 0.5631. At month-12, 59 (93.7%) eyes were classified as success, with no significant differences between needling (17/19) and no-needling (42/44) groups, p=0.3754. Secondary needling was performed in 8 (12.7%) eyes, without differences between groups (p=0.6333). Conclusion: Primary needling, at the time of surgery, was a safe procedure in OAG patients who underwent a XEN implant, although it was not associated with a lower postoperative IOP or less ocular hypotensive medications. [ABSTRACT FROM AUTHOR]

Purpose: The purpose of this study is to determine whether ReSure hydrogel sealant is superior to standard suture for closure of clear corneal incisions in the setting of combined glaucoma procedures. Setting: Glaucoma Department, Duke University Eye Center. Design: This is a retrospective case series. Subjects studied were patients in a 6-year period undergoing combined phacoemulsification and glaucoma surgery. All cases were performed by the same surgeon. Wound closure methods correlated with discrete timeframes, as ReSure replaced suture midway through the study period, thereby establishing sutured closure as an analogous control group. Methods: All cases included a phacoemulsification procedure requiring a 2.4 mm clear corneal incision. Upon completion of the phacoemulsification portion of the case, the wound was closed with either ReSure hydrogel or standard 10– 0 suture closure. The researchers assessed the rate of Seidel-positive corneal wound leak on postoperative day one. Results: In all cases employing ReSure, no wound leak was observed at postoperative day one. Within the suture group, 3 cases showed Seidel positivity of the corneal incision. This equates to a statistically significant difference in wound leak frequency of 2.04% (P = 0.012); confidence interval, 0.21 to 5.82. Conclusion: ReSure was able to maintain closure 100% of the time over hundreds of combined cases. Suture, though the standard of practice, did not perform to this level, presenting with 3 cases of spontaneous wound leak. We conclude that ReSure is highly effective and superior to suture in closure of clear corneal incisions in combined glaucoma procedures. [ABSTRACT FROM AUTHOR]