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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 prospectively monitor intraocular pressure (IOP) and gonioscopy changes within the first month after a single 4-mg intravitreal injection of triamcinolone acetonide (IVK) (Kenalog, Briston-Meyers Squibb, New York)., Design: Prospective comparative interventional case series., Methods: A consecutive series of 28 eyes of 14 patients with no prior intravitreal injections or history of glaucoma were prospectively enrolled. After baseline evaluation in both eyes, including IOP, gonioscopy, and optic nerve evaluation, a single 4-mg IVK was given in a standard sterile fashion in the eye to be treated. Eyes received IVK for macular edema associated with retinal vein occlusions and in conjunction with photodynamic therapy for choroidal neovascularization secondary to age-related macular degeneration, ocular histoplasmosis, and high myopia. The fellow eye served as the control. After the injection, IOP and gonioscopy were repeated at 1, 2, and 4-week intervals in both eyes., Results: Of the 14 patients, the 5 women and 9 men had a mean age of 67.6 years. Mean baseline IOP of the treated and fellow control eyes were similar at 15.9 versus 16.6 mm Hg, respectively. The control eyes maintained a small IOP range (15.6 to 16.6 mm Hg) during the 1-month follow-up period. In the treated eyes, the mean maximum IOP was 54% above baseline during follow-up, compared with 11% for control eyes. Six of 14 (43%) treated eyes had IOP elevation to 24 mm Hg or higher with mean change of 8.6 mm Hg and a mean maximum IOP of 32.1 mm Hg. There was no correlation between IOP rise and age, sex, diagnosis, or optic nerve appearance. However, during the course of the study, 4 of 6 (67%) of the treated eyes that required topical drops for the IOP elevation had documented abnormal inferior angle changes characterized by pigmented particulate matter in the inferior angle not present at the baseline exam. The most frequent time point for an IOP elevation that required treatment was at 2-week postinjection. No eyes required surgical management of IOP during the course of this 4-week study., Conclusions: We observed a significant IOP rise in eyes after a single intravitreal injection of 4 mg of triamcinolone within 1 month of injection. In this study, the most frequent time point that required IOP treatment was at 2-week postinjection, suggesting that early and frequent monitoring of IOP should be considered. Two-thirds of eyes that required medical control of IOP developed gonioscopy changes, characterized by particulate matter in the inferior angle, not present at baseline. Eyes that developed gonioscopic changes were 5 times more likely to be treated for IOP elevation than those without gonioscopic findings.

Purpose: To report the occurrences of early rapid increases in intraocular (IOP) after intravitreal glucocorticoid injection., Design: Observational case series., Methods: We retrospectively reviewed the records of three patients seen and treated at Duke Eye Center., Results: In all three cases, a significant rise in IOP occurred within 1 week of intravitreal triamcinolone injection for refractory macular edema. In one patient, a white material was found in the angle on gonioscopy. All three cases required surgical intervention to reduce the IOP., Conclusions: Considering the early rapid rise in IOP in these three cases, we suggest that clinicians closely monitor patients after intravitreal triamcinolone injections for the development of acute glaucoma. Additionally, it may be advisable to perform gonioscopic examinations to look for any abnormal accumulation of material in the angle.

The glaucoma treatment paradigm is in evolution. The topical medications-first approach is limited by significant barriers such as high rates of nonadherence and side effects including ocular surface disease. The era of interventional glaucoma has seen the development of selective laser trabeculoplasty (SLT), procedural pharmaceuticals, and minimally invasive glaucoma surgeries (MIGS). New and emerging data support the use of these interventional treatment modalities early in the course of glaucoma rather than reserving them for advanced or treatment-recalcitrant cases. The various treatments available represent multiple mechanisms (e.g., trabecular outflow, uveoscleral outflow, aqueous suppression) and modalities (medications, laser, incisional surgery) by which intraocular pressure (IOP) is reduced. Many patients require more than one treatment to achieve adequate IOP reduction and glaucoma control. Comprehensive IOP control—reduction of both mean IOP and IOP fluctuation—can best be achieved by targeting multiple mechanisms of IOP reduction and taking advantage of the attributes of multiple treatment modalities. [ABSTRACT FROM AUTHOR]

Purpose: To report interim results of the VENICE study, a multi-center, randomized, controlled trial (RCT) comparing STREAMLINE Surgical System (STREAMLINE) canaloplasty with iStent inject W (iStent W) implantation in patients with mild-to-moderate primary open-angle glaucoma (POAG) undergoing phacoemulsification. Patients and Methods: Safety and efficacy analyses involving the first 72 randomized eyes are included in this report. Following pre- (Screening) and post-medication washout (Eligibility) visits, one eye per subject was randomized 1:1 to STREAMLINE or iStent W after undergoing uncomplicated phacoemulsification. Subjects were evaluated postoperatively at Day 1, Week 1, Month 1, 3, and 6. Intraocular pressure (IOP) measurements, number of IOP-lowering medications, and adverse events (AEs) were assessed at each follow-up visit. Results: Seventy-two eyes were randomized; 35 underwent STREAMLINE canaloplasty and 37 were implanted with the iStent W. Seventy eyes completed their 6-month follow-up. Both the mean morning post-washout Baseline IOP between STREAMLINE 24.86± 3.05 mmHg and iStent W 25.16± 3.41 mmHg and the mean IOP at 6 months between STREAMLINE eyes 16.52± 3.63 mmHg and iStent W eyes 16.08± 3.19 mmHg were not statistically significantly different (p=0.691 and 0.596, respectively). At 6 months, more eyes were on zero glaucoma medications in the STREAMLINE group (81.8%) compared to the iStent W group (78.4%). In medication-free eyes, the mean IOP was reduced from 24.80± 2.79 mmHg to 16.00± 3.40 mmHg and 24.60± 3.18 mmHg to 15.80± 2.21 mmHg in the STREAMLINE and iStent W groups, respectively (p=0.752). Both groups showed reduction in IOP-lowering medications at every visit, compared to pre-washout (Screening), with STREAMLINE resulting in numerically fewer medications 0.20± 0.48 compared to iStent W 0.40± 0.79 at 6 months (P=0.384). AEs were mild and self-limited. Conclusion: To our knowledge, the VENICE trial is the first RCT involving canaloplasty. These interim findings demonstrated comparable IOP and medication reduction between STREAMLINE canaloplasty and iStent W implantation, when combined with phacoemulsification. [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]

Purpose: To examine effectiveness outcomes stratified by preoperative disease burden in the pivotal trial of iStent inject® with cataract surgery (INJ) vs cataract surgery alone (CS). Materials and Methods: Prospective, 3:1 randomized, single-masked, concurrently-controlled, multicenter trial enrolling 505 subjects with cataract and mild-to-moderate primary open-angle glaucoma who underwent iStent inject implantation with phacoemulsification or phacoemulsification alone, and were followed for 2 years including annual medication washouts. Post hoc stratification was completed for baseline mean diurnal intraocular pressure (BL DIOP; Low-DIOP < 25mmHg, Mid-DIOP ≥ 25 to < 30 mmHg, High-DIOP ≥ 30mmHg) and preoperative medication burden (Low-Med 1 medication, Mid-Med 2 medications, High-Med ≥ 3 medications). Results: The 24-month primary and secondary effectiveness endpoints were met, with significant treatment-over-control differences in percent of eyes achieving ≥ 20% unmedicated DIOP reduction and in unmedicated DIOP reduction, respectively. In subgroup analyses, the proportions of INJ eyes achieving the primary endpoint remained steady across all BL DIOP (75.4%, 77.1%, 74.4% in Low/Mid/High-DIOP strata, respectively) and preoperative medication levels (76.8%, 70.8%, 79.7% in Low/Mid/High-Med strata, respectively); meanwhile, the proportions of CS eyes diminished with higher BL DIOP (64.5%, 63.6%, 33.3%, respectively) and more medications (69.0%, 63.3%, 29.4%, respectively). Regarding secondary effectiveness, postoperative DIOP reduction increased with higher BL DIOP in INJ eyes (6.2mmHg, 7.8mmHg, 9.8mmHg, respectively) but plateaued in CS eyes (5.2mmHg, 5.8mmHg, 5.4mmHg, respectively). INJ eyes also had consistent DIOP reduction regardless of preoperative medication burden (6.8mmHg, 6.7mmHg, 7.8mmHg, respectively), while DIOP reduction diminished with more medications in CS eyes (6.1mmHg, 5.0mmHg, 3.3mmHg, respectively). Safety was favorable, comparable to phacoemulsification alone. Conclusion: Significant IOP reductions occurred across all levels of BL DIOP and preoperative medication burden in iStent inject eyes. DIOP reductions increased with higher BL DIOP and remained stable across all levels of preoperative medication burden, suggesting the device's potential utility in more medically challenging cases. [ABSTRACT FROM AUTHOR]

Purpose: To compare reduction in intraocular pressure (IOP) and IOP-lowering medication in eyes undergoing excisional goniotomy with Kahook Dual Blade (KDB) vs iStent microbypass implantation, both combined with phacoemulsification, in eyes with mild to moderate open-angle glaucoma (OAG). Setting: Nine practices in the United States. Design: Prospective, randomized, active-controlled, parallel-group clinical trial. Methods: Eyes were randomized to KDB-Phaco or iStent-Phaco group. Demographics, corrected distance visual acuity, IOP, IOP-lowering medications, and adverse events were collected at baseline and at day 1, week 1, and months 1, 3, 6, and 12 postoperatively. The primary outcome measure was the proportion of eyes at 12 months with IOP reduction of 20% or greater or IOP medication reduction of 1 or more compared with baseline. Results: For this study, 164 eyes of 164 patients were analyzed (82 in each group). Mean IOP was reduced at 12 months compared with baseline from 18.5 (standard of error 0.4) to 15.4 (0.4) mm Hg in the KDB-Phaco group and from 18.5 (0.3) to 16.1 (0.4) mm Hg in the iStent-Phaco group (P =.24). Mean IOP-lowering medications were reduced from 1.3 (0.1) to 0.3 (0.1) in the KDB-Phaco group and from 1.4 (0.1) to 0.4 (0.1) in the iStent-Phaco group (P =.17). Among study completers, the primary outcome was attained in 74 (93.7%) of 79 patients of KDB-Phaco eyes and 65 (83.3%) of 78 patients of iStent-Phaco eyes (P =.04). Both procedures had similar safety profiles. Conclusions: Both procedures lowered both IOP and the need for IOP-lowering medications effectively and safely in eyes with mild to moderate OAG and cataract. Significantly, more KDB-Phaco eyes than iStent-Phaco eyes met the primary outcome of 20% or greater IOP reduction or 1 or more medication reduction at 12 months. [ABSTRACT FROM AUTHOR]

Purpose: To compare the efficacy and safety of combined cataract extraction and either excisional goniotomy performed with the Kahook Dual Blade (KDB; phaco-KDB group) or single iStent trabecular bypass implantation (phaco-iStent group) in eyes with mild to moderate glaucoma and visually significant cataract.Methods: This was a retrospective analysis of 315 eyes from 230 adults with mild or moderate glaucoma treated with one or more intraocular pressure (IOP)-lowering medications (190 eyes of 134 subjects in the phaco-KDB group and 125 eyes of 96 subjects in the phaco-iStent group) that required no subsequent surgical intervention for IOP control through 12 months of follow-up. Data included best-corrected visual acuity (BCVA), IOP, and IOP-lowering medications, collected preoperatively and at 1 week and 1, 3, 6, and 12 months postoperatively as well as intraoperative and postoperative adverse events. The primary efficacy outcomes were the proportion of subjects in each group achieving ≥ 20% IOP reduction and ≥ 1 medication reduction at month 12. Subgroup analysis by baseline IOP (≤ 18 mmHg vs. > 18 mmHg) was also performed.Results: Mean (standard error) baseline IOP was 18.2 (0.3) mmHg in the phaco-KDB group and 16.7 (0.3) mmHg in the phaco-iStent group (p = 0.001). Statistically significant mean IOP and mean IOP medication reductions from baseline were achieved at all time points in both groups. Mean IOP reductions were significantly greater in the phaco-KDB group than in the phaco-iStent group at all time points including month 12 [- 5.0 (0.3) mmHg vs. - 2.3 (0.4) mmHg, p < 0.001], while mean medication reductions were similar between groups at all time points except week 1, when greater mean medication reduction was seen in the phaco-iStent group (- 1.23 vs. - 0.60 medications, p < 0.001). At month 12, IOP reductions ≥ 20% were achieved by 64.2% and 41.6% (p < 0.001) in the phaco-KDB and phaco-iStent groups, respectively, and IOP medication reductions of ≥ 1 medication were achieved by 80.4% and 77.4% (p = 0.522), respectively. Intraocular pressure subgroup analysis revealed significant reductions in IOP-lowering medications without compromise of IOP control in lower IOP subgroups and significant reductions in both IOP and IOP-lowering medications in the higher IOP subgroups. The most common adverse events were transient IOP elevations and transient anterior chamber inflammation, which occurred with similar frequency in both groups and resolved spontaneously.Conclusion: Goniotomy with the KDB lowered IOP significantly more than iStent implantation, with few adverse events in both groups. In eyes with mild to moderate glaucoma undergoing combined cataract extraction and glaucoma surgery, goniotomy with the KDB can safely deliver statistically significant and clinically meaningful reductions in both IOP and IOP medication burden through 12 months of follow-up.Funding: New World Medical, Inc., provided funding for the study, medical writing assistance, Rapid Service Fees, and the open access fee. [ABSTRACT FROM AUTHOR]

Purpose: The aim of this study was to compare intraocular pressure (IOP) outcomes in eyes with cataract and glaucoma undergoing phacoemulsification (phaco) in combination with goniotomy using the Kahook Dual Blade (KDB) or implantation of a single iStent trabecular bypass device. Methods: Retrospective analysis of IOP and IOP-lowering medication reduction in eyes undergoing phaco-goniotomy with KDB (n=237) or phaco-iStent (n=198). Preoperative, intraoperative, and postoperative data were collected through 6 months of follow-up. Outcome measures included mean IOP reduction, mean reduction in IOP-lowering medications, and the proportion of eyes achieving ≥20% IOP reduction or ≥1 medication reduction from baseline. Results: Mean IOP in the phaco-goniotomy with KDB group decreased from 17.9±4.4 mmHg at baseline to 13.6±2.7 mmHg at Month 6 (P,0.001), with mean medication use decreasing from 1.7±0.9 to 0.6±1.0 (P,0.001). In the phaco-iStent group, mean IOP decreased from 16.7±4.4 mmHg to 13.9±2.7 mmHg (P,0.001), with mean IOP-lowering medication use decreasing from 1.9±0.9 to 1.0±1.0 (P,0.001). Mean IOP reduction from baseline was significantly greater in the phaco-goniotomy with KDB group at Month 6 (phaco-goniotomy with KDB −4.2 mmHg [23.7%] vs phaco-iStent −2.7 mmHg [16.4%]; P,0.001). IOP-lowering medication reduction was greater in the phaco-goniotomy with KDB group compared to the phaco-iStent group (1.1 vs 0.9 medications, respectively; P=0.001). The most common adverse event was IOP spikes occurring in 12.6% of phaco-iStent eyes and 6.3% of phaco-goniotomy with KDB eyes (P=0.024). Conclusion: Goniotomy with the KDB combined with cataract surgery significantly lowers both IOP and the need for IOP-lowering medications compared to cataract extraction with iStent implantation in glaucomatous eyes through 6 months of postoperative follow-up. [ABSTRACT FROM AUTHOR]