iStent Inject Research Articles

Second-Generation Trabecular Micro-Bypass (iStent inject) with Cataract Surgery in Eyes with Normal-Tension Glaucoma: One-Year Outcomes of aMulti-Centre Study.

PurposeThe efficacy and safety of the trabecular micro-bypass stents (iStent and iStent inject) have been well documented in various open-angle glaucoma subtypes. However, their outcomes remain understudied in normal-tension glaucoma (NTG). The present study aimed to assess the 1-year outcomes related to the implantation of two second-generation trabecular micro-bypass stents (iStent inject) concomitant with cataract surgery (CE-TMS), exclusively in eyes with NTG.MethodsThis multi-center, consecutive case series included eyes with cataract and normal-tension glaucoma that underwent CE-TMS to reduce intraocular pressure or glaucoma medication use. The 12-month efficacy measures included change in average intraocular pressure (IOP) and medication burden. Safety included change in best-corrected visual acuity, cup-to-disc ratio, visual field mean-deviation and retinal nerve fiber layer thickness. Intra- or postoperative adverse events were noted.ResultsA total of 62 eyes with mild-to-severe NTG and average preoperative IOP of 15.82 ± 2.94 mmHg on 1.50 ± 1.28 glaucoma medications were included. Postoperatively, IOP declined by 22% from 15.82 ± 2.94 mmHg to 12.32 ± 2.58 (p < 0.001), all eyes had IOP ≤ 18 mmHg (versus 74% preoperatively), and half had IOP ≤ 12 mmHg (versus 15% preoperatively). Medication burden decreased by 70% from 1.50 ± 1.28 to 0.45 ± 0.86 (p < 0.001), and 73% of the eyes were medication-free (versus 23% preoperatively). Safety was favorable, with no evidence of sight-threatening adverse events.ConclusionImplantation of iStent inject (two second-generation trabecular micro-bypass stents) combined with cataract surgery is efficacious in reducing IOP and medication burden with a favorable safety profile in eyes with mild-to-severe NTG.

IStent inject trabecular microbypass stent implantation with cataract extraction in open-angle glaucoma: early clinical experience

BackgroundRetrospective, consecutive case series to evaluate the implantation of two second-generation trabecular microbypass stents in combination with cataract surgery in a real-world, clinical setting.MethodsThe series included 56 eyes implanted with the iStent inject device with phacoemulsification. The series consisted of eyes with primary open-angle glaucoma (n = 52) and pseudoexfoliative glaucoma (n = 4). Primary outcome measures included intraocular pressure (IOP) and number of glaucoma medications. Safety outcomes included the need for secondary surgical intervention and the incidence of IOP spikes ≥10 mmHg and ≥ 15 mmHg.ResultsIOP was reduced by 21% to 14.7 ± 2.9 mmHg (p < 0.01) at 6 months postoperative from 18.7 ± 5.8 mmHg at baseline. Preoperatively, the mean number of glaucoma medications was 1.5 ± 0.9 and reduced by 39% to 0.9 ± 1.2 (p < 0.01) at 6 months. At 6 months, 68% of eyes had an IOP ≤15 mmHg, increased from 30% at baseline. 55% of eyes were medication-free at 6 months, up from 18% at baseline. There were no severe postoperative complications. No eyes underwent an additional glaucoma procedure.ConclusionsImplantation of the iStent inject device with concomitant cataract surgery effectively provides a sustained reduction in IOP with a markedly improved medication burden out to 6 months postoperative. The safety profile is excellent.

A Prospective Analysis of iStent Inject Microstent Implantation: Surgical Outcomes, Endothelial Cell Density, and Device Position at 12 Months.

The surgical outcome of iStent inject devices is associated with device protrusion within the anterior chamber. Schlemm canal (SC) dilatation has a prognostic value. iStent inject devices do not move within the first year after implantation. The iStent inject is a device designed to be implanted ab-interno through the trabecular meshwork. The present study follows up on our preliminary report, using successive in vivo anterior segment optical coherence tomography (AS-OCT) imaging to analyze the associations between stent positioning, iridocorneal angle structures, and surgical outcomes. In total, 54 eyes of 42 patients (73.3±7.4 y) with cataract and mild-to-moderate open-angle glaucoma were examined in this prospective study. All patients underwent implantation of 2 iStent inject devices combined with phacoemulsification. Patients were followed up over a 12-month period. AS-OCT was performed after 3 and 12 months. Thirty unoperated fellow eyes served as control eyes. Intraocular pressure (IOP) decreased from 16.5±4.2 mm Hg at baseline to 15.1±3.7 mm Hg at 12 months (-8.7%; P=0.004), while medications decreased from 1.8±1.0 to 0.5±0.9 (-72.2%; P<0.001). Unmedicated IOP≤18 mm Hg was achieved in 58.8% of operated eyes. No sight-threatening complications were reported. On AS-OCT, 44.9% of devices were buried within the trabeculum. Device position was unchanged between scans. Regression analysis elicited significant predictors: SC dilatation effect [risk ratio (RR)=0.230; P=0.003], greatest SC diameter (RR=0.991; P=0.049), extrusion of the most anterior device (RR=0.993; P=0.012), gonioscopically visible devices (RR=0.406; P=0.040), baseline treatments (RR=2.214; P=0.001), and baseline IOP (RR=0.184; P=0.006). Endothelial cell density decreased by 14.6% at 12 months (P<0.001). This study demonstrates the IOP-lowering and medication-lowering potential of iStent inject surgery in primary open-angle and pseudoexfoliative glaucoma. It confirms that surgical outcomes are positively associated with device protrusion within the anterior chamber, and suggests SC dilatation effect as a favorable prognostic indicator. It shows that stents are stable in time, highlighting the importance of the initial implantation location.

IStent inject trabecular micro-bypass stents with topical prostaglandin as standalone treatment for open-angle glaucoma: 4-year outcomes.

Long-term data are needed regarding effective and safe glaucoma treatment modalities. This study evaluated 4-year outcomes of second-generation trabecular micro-bypass stent implantation (iStent inject) combined with topical travoprost in open-angle glaucoma (OAG). Prospective, non-randomized, multi-surgeon study at a tertiary care ophthalmology centre. OAG subjects with preoperative intraocular pressure (IOP) 18 to 30 mmHg on two medications and 22 to 38 mmHg post-washout. Subjects (n = 53) underwent standalone iStent inject implantation and started travoprost on postoperative Day 1. Measures included IOP, medications, comprehensive ophthalmic examinations and testing, and adverse events (AEs). Annual medication washouts were performed. Mean medicated and unmedicated IOP; and proportions of eyes with IOP ≤18mmHg, ≤15 mmHg, or ≥20% reduced while on travoprost vs screening IOP on two medications. At 48 months postoperative, 85% of eyes reduced IOP ≥20% on travoprost vs screening IOP on 2 medications; 92% of eyes had IOP ≤18 mmHg on travoprost; and 83% had IOP ≤15 mmHg on travoprost. At Month 49 (post-washout), 90% of eyes reduced IOP ≥20% vs preoperative washout IOP. Throughout follow-up, mean IOP on travoprost was 11.9 to 13.0 mmHg (34%-40% reduced vs 19.7 mmHg on 2 medications preoperatively; P < .0001 throughout), and post-washout IOP was 16.5 to 17.7 mmHg (28%-34% reduced vs 24.9 mmHg preoperatively; P < .0001 throughout). Favourable safety included minimal AEs; stable visual acuity, cup-to-disc ratio and visual fields; and no secondary surgeries. Combining iStent inject implantation with topical prostaglandin produced significant and safe 4-year IOP and medication reductions in OAG.

Minimally Invasive Glaucoma Surgery: Where Is the Evidence?

Purpose:The last decade has witnessed an unprecedented growth in glaucoma treatment options through the introduction of minimally invasive glaucoma surgeries (MIGS). The aim of the present review is to provide an understanding of the currently available MIGS and to examine what data are currently available to guide treatment choice.Design:Meta-analysis and systematic review of randomized and non-randomized control trials.Methods:Out of 2567 articles identified, a total of 77 articles were retained for analysis, including 28 comparative studies and 12 randomized control trials. Overall, 7570 eyes were included. When data permitted, the weighted mean difference in intraocular pressure reduction was calculated for comparison purposes.Results:Weighted mean intraocular pressure reductions from all analyzed studies were: 15.3% (iStent), 29.1% (iStent inject), 36.2% (ab interno canaloplasty), 34.4% (Hydrus), 36.5% (gonioscopically-assisted transluminal trabeculotomy), 24.0% (trabectome), 25.1% (Kahook dual blade), 30.2% (Cypass), 38.8% (XEN), and 50.0% (Preserflo).Conclusions:One of the advantages of the heterogenous range of available MIGS options is the chance to tailor therapy in an individualized manner. However, high-quality data are required to make this choice more than an educated guess. Overall, this review confirms the efficiency of assessed MIGS compared with standalone phacoemulsification, but it highlights that only few studies compare different MIGS techniques and even fewer assess MIGS against criterion standard treatments. Current evidence, while non-negligible, is mostly limited to heterogenous nonrandomized studies and uncontrolled retrospective comparisons, with few quality randomized control trials. We suggest that future research should be comparative and include relevant comparators, standardized to report key outcome features, long-term to assess sustainability and late complications, and ideally randomized.

&lt;p&gt;Refractive Outcomes After Trabecular Micro-Bypass Stents (iStent &lt;em&gt;Inject&lt;/em&gt;) with Cataract Extraction in Open-Angle Glaucoma&lt;/p&gt;

PurposeSimultaneous cataract and glaucoma surgery has traditionally been challenging for the anterior segment surgeon. The introduction of minimally invasive glaucoma surgery (MIGS) in conjunction with cataract surgery appears safe and effective in lowering intraocular pressure. Although a significant visual impact leading from the combined procedure is unexpected, we aim to describe the refractive outcomes in a cohort of patients undergoing simultaneous cataract removal and iStent inject and discuss the potential implications of combined surgery in patients with co-existent glaucoma.Patients and MethodsThis is a retrospective consecutive case series inclusive of patients undergoing combined femtosecond laser-assisted cataract surgery and the insertion of two trabecular micro-bypass stents (iStent inject). Visual acuity, refraction and astigmatic vector analysis were collated and analysed from the preoperative and 4 weeks postoperative visits.ResultsOne hundred and six eyes of 89 patients from 2 surgeons were included in the original cohort. The mean absolute difference from target refraction was 0.36 ± 0.25D. 73.9% of eyes were within ± 0.5D of the refractive target and 98.9% of eyes were within ± 1.00D. 73.8% of eyes had 0.5D or less residual refractive astigmatism following the procedure.ConclusionWe present a novel cohort of glaucoma patients undergoing combined trabecular micro-bypass stents (iStent inject) and cataract surgery achieving excellent refractive outcomes. The results of this study indicate that this second-generation device is refractively neutral.

Second-generation trabecular micro-bypass stent implantation: Retrospective analysis after 12- and 24-month follow-up

BackgroundThe study aimed to investigate the 24-month safety and efficacy of implantation of two second-generation iStent inject trabecular micro-bypass stents with concomitant cataract surgery.MethodsThis consecutive case series included 164 eyes of 109 patients implanted with the iStent inject® device with concomitant cataract surgery. The series was comprised of eyes with primary open-angle glaucoma (n = 84), pseudoexfoliation glaucoma (n = 42), normal-tension glaucoma (n = 18), and ocular hypertension (n = 20). All 164 eyes reached 9–14 months of follow-up (“12-month consistent cohort”), with a subset of 88 eyes reaching 21–26 months of follow-up (“24-month consistent cohort”). Performance outcome measures included intraocular pressure (IOP) and number of glaucoma medications. Safety outcomes included intra- or postoperative complications, the need for secondary procedures and corrected distance visual acuity. Comparisons of change in continuous (e.g., IOP) and categorical (e.g., proportions of eyes on zero medications) measures between baseline and postoperative times were made with the paired t-test and McNemar’s chi-squared test, respectively.ResultsAt 12 months postoperatively, IOP was reduced by 25.5% (from 20.0 ± 5.5 mmHg to 14.9 ± 2.0 mmHg; p < 0.001); at 24 months postoperatively, IOP was reduced by 26.6% (from 20.3 ± 6.1 mmHg to 14.9 ± 1.9 mmHg; p < 0.001). At 12 months postoperatively, mean number of glaucoma medications was reduced by 85.0% (from 2.0 ± 1.0 to 0.3 ± 0.8 medications; p < 0.001); at 24 months postoperatively, mean number of medications was reduced by 81.0% (from 2.1 ± 1.1 to 0.4 ± 0.8 medications; p < 0.001). After 12 months, 96.3% of eyes had an IOP ≤ 18 mmHg and 58.5% of eyes had an IOP ≤ 15 mmHg, with 81.1% of eyes free of any medication, compared to 1.8% of eyes medication-free in the 12-month cohort at baseline. After 24 months, 98.9% of eyes had an IOP ≤ 18 mmHg and 53.4% of eyes had an IOP ≤ 15 mmHg, with 72.7% free of medication compared to 1.1% of eyes medication-free in the 24-month cohort at baseline. Overall, a high safety profile was observed with no significant postoperative complications.ConclusionsThe insertion of iStent inject (comprised of two second-generation trabecular micro-bypass stents) with cataract surgery effectively provides a sustained reduction in IOP with a markedly improved medication burden up to 24 months postoperatively.

Four-Year Outcomes of Two Second-Generation Trabecular Micro-Bypass Stents in Patients with Open-Angle Glaucoma on One Medication.

IntroductionThis study evaluated long-term reductions in intraocular pressure (IOP) and medication following implantation of 2 second-generation trabecular micro-bypass stents (iStent inject®) in eyes with open-angle glaucoma (OAG) not controlled on 1 preoperative medication.Material and MethodsIn this prospective interventional multi-surgeon study, standalone implantation of 2 iStent inject stents was performed in 57 eyes of 57 subjects with OAG, preoperative IOP of 18–30 mmHg on 1 medication, and preoperative post-washout IOP of 22–38 mmHg. The main outcome measures included the proportions of eyes achieving medication-free IOP ≤18 mmHg, IOP ≤15 mmHg, or ≥20% IOP reduction versus preoperative unmedicated IOP. Assessments included IOP, medications, visual acuity, visual field, pachymetry, complications, and interventions. Subjects were followed for 48 months with follow-up continuing in all eyes.ResultsAt Month 48 (n=57), 95% of eyes achieved an IOP reduction of ≥20% without medication versus preoperative washout IOP; and although they had eliminated medication, 81% of eyes still had an IOP reduction of ≥20% versus preoperative IOP on 1 medication. Mean 48-month unmedicated IOP decreased by 46% to 13.2±1.6 mmHg vs 24.4±1.3 mmHg preoperatively (p<0.0001), with 95% of medication-free eyes having IOP ≤18mmHg and 82% having IOP ≤15mmHg. Over the course of follow-up, 3 eyes had medication added and 1 eye underwent a secondary glaucoma surgery, and safety parameters were favorable.DiscussionStandalone iStent inject implantation in OAG patients on 1 preoperative medication resulted in average IOP reduction to ≤15 mmHg with the elimination of medication and favorable safety through 48 months.Trial RegistrationClinicalTrials.gov identifier, NCT02868190.

Simultaneous bilateral combined micro invasive glaucoma surgery (migs) with istent inject® and femtosecond laser-assisted cataract surgery with premium iols

Simultaneous bilateral combined micro invasive glaucoma surgery (migs) with istent inject® and femtosecond laser-assisted cataract surgery with premium iols

Micro-Invasive Glaucoma Surgery with the iStent inject: Impact on IOP and Medication Burden in a Real-World Setting

Background: The iStent inject is a Micro-Invasive Glaucoma Surgical (MIGS) device that has shown to reduce IOP and to be safe for glaucoma patients with fewer complications than regular surgery. Objective: To investigate, up to 15 - 20 months, the efficacy and safety of implantation of two second-generation trabecular microbypass stents in patients with or without prior glaucoma surgery. Methods: Fifty-seven eyes were implanted with the iStent inject. The population was comprised of eyes with primary open-angle glaucoma (n = 51), pseudoexfoliation glaucoma (n = 5) and ocular hypertension (n = 1). Major outcome parameters included IOP, medication needs and corrected distance visual acuity (CDVA). Follow-up time points were one day, 2 - 4 months, 9 - 14 months and 15 - 20 months. Results: The main reason to perform MIGS was IOP reduction in 68.4%, reduced number of medications due to drug intolerance in 24.6% and reduced medication due to compliance issues in 7.0% of the eyes. IOP decreased by 22.47%, from 19.40 ± 3.83 mmHg preoperatively (preop) to 15.04 ± 1.67 mmHg at 15-20 months postoperatively. IOP reduction was achieved at all follow-up time points (p < 0.001). A decrease in the number of medications was achieved in 32.1% of the patients after 15 - 20 months. Conclusions: Insertion of the iStent inject in patients with or without prior glaucoma surgery shows effective and sustained improvements in IOP with no safety concerns.

Outflow Facility Effects of 3 Schlemm’s Canal Microinvasive Glaucoma Surgery Devices

To study the effect of 3 Schlemm's canal (SC) microinvasive glaucoma surgery (MIGS) devices on outflow facility. Paired comparisons, randomized design, baseline-controlled study. Thirty-six pairs of dissected anterior segments from donated human eye bank eyes without glaucoma were studied. A baseline measurement was collected from each eye to serve as its control. Using a constant pressure perfusion method, outflow facility was measured in paired eyes from human donors. Measurements were made at perfusion pressures of 10 mmHg, 20 mmHg, 30 mmHg, and 40 mmHg. Outflow facility was measured before (baseline control) and after the implantation of an SC glaucoma drainage device or sham procedure. Three sets of experiments were carried out comparing 1 and 2 iStent Trabecular Micro-Bypass Stents and 2 iStent Inject implants with the Hydrus Microstent. Change in outflow facility from baseline or contralateral eye. After Hydrus placement, the outflow facility increased from 0.23±0.03 μl/minute per millimeter of mercury at baseline to 0.38±0.03 μl/minute per millimeter of mercury (P < 0.001). The percent increase in outflow facility was 79±21% for the Hydrus and 11±16% for the 2 iStent Inject devices, a difference that was significant (P= 0.018). Outflow facility with 1 iStent (0.38±0.07 μl/minute per millimeter of mercury) was greater than baseline (0.28±0.03 μl/minute per millimeter of mercury; P= 0.031). The 1 iStent showed a greater increase in outflow facility from baseline (0.10±0.04 μl/minute per millimeter of mercury) compared with the sham procedure (-0.08±0.05 μl/minute per millimeter of mercury; P= 0.042). No other significant differences were found. The longer the MIGS device, and thus the more SC that it dilates, the greater the outflow facility.

A Canadian Cost-Utility Analysis of 2 Trabecular Microbypass Stents at Time of Cataract Surgery in Patients with Mild to Moderate Open-Angle Glaucoma

To assess, from the Canadian public payer perspective, the cost-utility of implanting iStent Inject trabecular bypass stent (TBS) devices in conjunction with cataract surgery versus cataract surgery alone in patients with open-angle glaucoma (OAG) and visually significant cataract. Cost-utility analysis using efficacy and safety results of pivotal randomized clinical trial. Modeled cohort of patients with OAG (83.1% with mild disease, 16.9% with moderate disease) and visually significant cataract. Open-angle glaucoma treatment costs and effects were projected over a 15-year time horizon using a Markov model with Hodapp-Parrish-Anderson glaucoma stages (mild, moderate, advanced, severe or blind) and death as health states. Patients in the mild or moderate OAG health states received implantation of iStent Inject during cataract surgery versus cataract surgery alone. On worsening of visual field defect and optic disc damage, patients could receive selective laser trabeculoplasty and trabeculectomy. We measured treatment effect as reduction in intraocular pressure (IOP) and mean medication use and estimated transition probabilities based on efficacy-adjusted visual field mean deviation decline per month. Healthcare resource utilization and utility scores were obtained from the literature. Cost inputs (2017 Canadian dollars [C$]) were derived using the Ontario Health Insurance Plan, expert opinion, medication claims datasets, and Ontario Drug Benefit Formulary medication consumption costs. We conducted deterministic and probabilistic sensitivity analyses to examine the impact of alternative model input values on results. Incremental cost per quality-adjusted life year (QALY) gained. Compared with cataract surgery alone, TBS plus cataract surgery showed a 99% probability of being more effective (+0.023 QALYs; 95% confidence interval [CI], 0.004 to 0.044) and a 73.7% probability of being cost-saving (net cost, -C$389.00; 95% CI, -C$1712.00 to C$850.70). In 95% of all simulations, TBS plus cataract surgery showed a cost per QALY of C$62 366 or less. Results were robust in additional sensitivity and scenario analyses. iStent Inject TBS implantation during cataract surgery seems to be cost effective for reducing IOP in patients with mild to moderate OAG versus cataract surgery alone.

PSS21 EFFECT OF ISTENT INJECT TRABECULAR MICRO-BYPASS ON PATIENT-REPORTED OUTCOMES FOR THOSE WITH OPEN-ANGLE GLAUCOMA AND COEXISTING CATARACTS

To conduct an exploratory analysis comparing cataract surgery plus implantation of the trabecular micro-bypass stent (iStent inject) versus cataract surgery alone in patient-reported outcome (PRO) scores from the Vision Function Questionnaire (VFQ-25) and the Ocular Surface Disease Index (OSDI) by key baseline characteristics. In a pivotal trial of cataract surgery plus iStent inject for the reduction of intraocular pressure (IOP) in subjects with glaucoma and cataracts, the VFQ-25 and OSDI questionnaires were administered to subjects at baseline and months 1, 6, 12, and 24. The percentage of subjects reaching an improvement based on minimally important differences (MID) in PRO scores was derived using half the standard deviation of baseline values. PRO responders were subjects with change from baseline (1) greater than or equal to the MID threshold for the VFQ composite and (2) less than or equal to the MID threshold for OSDI composite. The percentage of PRO responders was compared using a logistic generalized linear mixed model for repeated measures with stratification by (1) baseline IOP (< 25 mmHg and ≥ 25 mmHg) and (2) prostaglandin use (yes/no). A total of 382 subjects were randomized (N = 237 surgery plus iStent, N = 145 surgery alone) and had baseline and at least one postbaseline score. For composite scores, a greater percentage of responders was observed at all follow-up visits in the iStent inject group compared with the cataract surgery-alone group for the ≥ 25 mmHg IOP and for no prostaglandin use strata, with treatment differences ranging from 10.8% to 21.7% and 13.7% to 28.8%, respectively. In a post hoc exploratory analysis of the VFQ-25 and OSDI, cataract surgery plus iStent inject in subjects with high IOP (≥ 25 mmHg) or no prostaglandin use at baseline improved overall ocular symptoms and visual functioning compared with cataract surgery alone.

Which Patients Would Most Likely to Benefit: MIGS or MEGS, Which One Is It?

The availability of ab interno minimally invasive glaucoma surgery (MIGS) has promoted an international interest in this procedure. Our purpose is to define the role of MIGS in the constant evolving glaucoma treatment algorithm. Current MIGS approaches to lowering intraocular pressure (IOP) include increasing trabecular outflow (iStent trabecular microbypass stent, iStent inject, Hydrus Microstent, Kahook Dual Blade goniotomy, Trabectome ab interno trabeculectomy, Excimer laser trabeculotomy, and goniotomy-assisted transluminal trabeculotomy), increasing uveoscleral outflow with suprachoroidal shunts (Cypass microstent), and developing subconjunctival filtration (XEN gel stent and InnFocus microshunt). The efficacy of each depends on the achievement of desired target IOP reduction in a specific patient. The determination of whether a procedure is either a MIGS or minimally effective glaucoma surgery (MEGS) procedure is based on their efficacy and complications. Aqueous humor angiography suggests that success of trabecular bypass MIGS may not be patient-dependent only, but it may be affected by the location and flow of aqueous through collector channels. The future use of aqueous angiography may permit customized treatment of trabecular meshwork dependent MIGS procedures.

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

PurposeTo assess the 1-year efficacy and safety of the implantation of two second-generation trabecular micro-bypass stents (iStent Inject®) with concomitant cataract surgery in various subtypes and severities of glaucoma.MethodsThis single-surgeon, consecutive case series from a Canadian academic ophthalmology center included subjects with cataract, glaucoma, and the need to reduce intraocular pressure (IOP) and/or medications. The 12-month outcomes included mean IOP and medication burden as well as the proportions of eyes with IOP ≤ 18, ≤ 15, and ≤ 12 mmHg compared to baseline. Other measures included corrected distance visual acuity (CDVA), cup-to-disc ratio (CDR), visual field mean deviation (VF MD), retinal nerve fiber layer (RNFL) thickness, ganglion cell inner plexiform layer (GCIPL) thickness, and adverse events.ResultsIn 118 eyes, mean IOP reduced from 17.00 ± 3.82 mmHg preoperatively to 13.97 ± 2.65 mmHg at the 12-month follow-up mark (17.8% reduction, p < 0.001), and mean medication burden decreased from 2.31 ± 1.33 preoperatively to 1.03 ± 1.10 medications (56% reduction, p < 0.001). After 12 months, 93% of eyes achieved IOP ≤ 18 mmHg (versus 69% preoperatively), 70% of eyes achieved IOP ≤ 15 mmHg (versus 42% preoperatively), and 29% of eyes achieved IOP ≤ 12 mmHg (versus 7% preoperatively). For all eyes, topical medications were either maintained or decreased from baseline, with ≥ 1 medication eliminated from the preoperative regimen for 83% of eyes and ≥ 2 medications eliminated for 36% of eyes. Visual acuity improved significantly, consistent with expectations for cataract surgery, while CDR, VF MD, and RNFL and GCIPL thicknesses remained stable. Safety was favorable, with no intraoperative complications and few transient adverse events postoperatively.ConclusioniStent Inject implantation with cataract surgery safely reduced IOP and medication burden in a real-world clinical population with mild to severe glaucoma, and stabilized visual field, as well as RNFL and GCIPL thicknesses on OCT.FundingThe Rapid Service Fees were funded by Glaukos Corporation.

Real-world Case Series of iStent or iStent inject Trabecular Micro-Bypass Stents Combined with Cataract Surgery.

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

Second-Generation Trabecular Micro-Bypass Stents as Standalone Treatment for Glaucoma: A 36-Month Prospective Study.

IntroductionTo evaluate long-term outcomes following stand-alone implantation of two second-generation trabecular micro-bypass stents (iStent inject®, Glaukos Corp., San Clemente, CA, USA) in eyes with predominantly primary open-angle glaucoma (POAG) and considerable preoperative disease burden.MethodsEyes with POAG, pseudoexfoliative glaucoma (PXG), appositional narrow-angle glaucoma (NAG, with open-angle configuration in the area of implantation), or secondary glaucoma were included in this prospective, non-randomized, consecutive case series. All eyes underwent ab interno iStent inject implantation as a sole procedure. Assessments through 36 months included IOP, medications, corrected distance visual acuity (CDVA), secondary glaucoma surgeries, and complications and adverse events.ResultsTwo iStent inject stents were implanted in 44 consecutive eyes (POAG = 38, PXG = 4, appositional NAG = 1, secondary neovascular glaucoma = 1) of 31 patients, and 33 eyes had 36-month follow-up data. Preoperative mean IOP was 25.3 ± 6.0 mmHg on a mean of 2.98 ± 0.88 medications, with 75% of eyes on 3–5 medications, no eyes medication-free, and 50% of eyes with history of prior glaucoma surgery. At 36 months postoperatively, mean IOP reduced by 42% to 14.6 ± 2.0 mmHg (p < 0.0001) and 87.9% of eyes achieved an IOP reduction of ≥ 20% versus preoperatively. In addition, 97% of eyes reached IOP ≤ 18 mmHg (vs. 9.1% preoperatively; p < 0.0001) and 70.0% of eyes reached IOP ≤ 15 mmHg (vs. 2.3% preoperatively; p < 0.0001). Mean medication burden decreased by 82% to 0.55 ± 0.79 (p < 0.0001), and 61% of eyes became medication-free. All eyes maintained or decreased their 36-month medication burden versus preoperatively. Safety was favorable, including minimal adverse events and stable CDVA through 36 months postoperatively.ConclusionThis real-world cohort of glaucomatous eyes with substantial preoperative disease burden experienced significant, sustained, safe IOP and medication reductions through 36 months following stand-alone iStent inject implantation.FundingArticle processing charges and writing assistance were provided by Glaukos Corp. (San Clemente, CA, USA).

Prospective, Randomized, Controlled Pivotal Trial of an Ab Interno Implanted Trabecular Micro-Bypass in Primary Open-Angle Glaucoma and Cataract: Two-Year Results

Evaluate the safety and effectiveness of an ab interno implanted (iStent inject) Trabecular Micro-Bypass System (Glaukos Corporation, San Clemente, CA) in combination with cataract surgery in subjects with mild to moderate primary open-angle glaucoma (POAG). Prospective, randomized, single-masked, concurrently controlled, multicenter clinical trial. Eyes with mild to moderate POAG and preoperative intraocular pressure (IOP) ≤24 mmHg on 1 to 3 medications, unmedicated diurnal IOP (DIOP) 21 to 36 mmHg, and cataract requiring surgery. After uncomplicated cataract surgery, eyes were randomized 3:1 intraoperatively to ab interno implantation of iStent inject (Model G2-M-IS; treatment group, n= 387) or no stent implantation (control group, n= 118). Subjects were followed through 2 years postoperatively. Annual washout of ocular hypotensive medication was performed. Effectiveness end points were ≥20% reduction from baseline in month 24 unmedicated DIOP and change in unmedicated month 24 DIOP from baseline. Safety measures included best spectacle-corrected visual acuity (BSCVA), slit-lamp and fundus examinations, gonioscopy, pachymetry, specular microscopy, visual fields, complications, and adverse events. The groups were well balanced preoperatively, including medicated IOP (17.5 mmHg in both groups) and unmedicated DIOP (24.8±3.3 mmHg vs. 24.5±3.1 mmHg in the treatment and control groups, respectively, P= 0.33). At 24 months, 75.8% of treatment eyes versus 61.9% of control eyes experienced ≥20% reduction from baseline in unmedicated DIOP (P= 0.005), and mean reduction in unmedicated DIOP from baseline was greater in treatment eyes (7.0±4.0 mmHg) than in control eyes (5.4±3.7 mmHg; P < 0.001). Of the responders, 84% of treatment eyes and 67% of control eyes were not receiving ocular hypotensive medication at 23 months. Furthermore, 63.2% of treatment eyes versus 50.0% of control eyes had month 24 medication-free DIOP ≤18 mmHg (difference 13.2%; 95% confidence interval, 2.9-23.4). The overall safety profile of the treatment group was favorable and similar to that in the control group throughout the 2-year follow-up. Clinically and statistically greater reductions in IOP without medication were achieved after iStent inject implantation with cataract surgery versus cataract surgery alone, with excellent safety through 2 years.

Intermediate Results of iStent or iStent inject Implantation Combined with Cataract Surgery in a Real-World Setting: A Longitudinal Retrospective Study.

IntroductionIn this real-world, retrospective, comparative study we evaluated 6-month performance and safety in consecutive eyes following implantation of the iStent® or iStent inject® trabecular micro-bypass device with concomitant cataract surgery.MethodsPerformance outcomes included intraocular pressure (IOP) reduction; glaucoma medication reduction; proportions of eyes achieving an IOP of < 18, < 16, < 14, or < 12 mmHg; and proportions of eyes on 0, 1, 2, or ≥ 3 medications. Safety outcomes included adverse events, secondary surgeries, and best-corrected visual acuity (BCVA).ResultsA total of 73 eyes with open-angle glaucoma and cataract were included in the study; of these, 38 eyes were implanted with the iStent device and 35 were implanted with the iStent inject device. The two groups of patients had similar baseline characteristics, with the exception of mean age and medication burden (both higher in patients receiving the iStent inject device); over 90% of eyes in both groups had early glaucoma. At 6 months after surgery, mean IOP had fallen from 16.5 ± 3.9 to 13.9 ± 2.3 mmHg in eyes with the iStent implant (p < 0.001), and from 17.3 ± 3.0 to 12.7 ± 1.8 mmHg in those with the iStent inject implant (p < 0.001). This reduction was significantly greater in the iStent inject eyes than in the iStent eyes (26.6 vs. 15.8%) (p = 0.005). Significantly more eyes receiving the iStent inject device compared to the iStent device achieved an IOP of < 18 mmHg at 6 months post surgery (100 vs. 86.8%) (p = 0.033). Average medication usage was reduced from 1.8 to 0.4 medications in iStent eyes (p < 0.001) and from 2.3 to 0.4 medications in iStent inject eyes (p < 0.001). Over 70% of eyes in both groups became medication-free by 6 months post implantation. Adverse events in iStent eyes were mild and resulted in no sequelae; two iStent eyes underwent non-penetrating deep sclerectomy during follow-up. No complications or secondary surgeries were noted in iStent inject eyes. All eyes in both groups maintained or showed improved BCVA versus baseline.ConclusionSignificant and safe IOP and medication reductions were observed after iStent or iStent inject implantation with concomitant cataract surgery. Trends toward greater effectiveness and fewer adverse events were observed with the iStent inject device compared with the iStent device.FundingArticle processing charges were provided by Glaukos Corporation.

Aqueous Angiographic Outflow Improvement after Trabecular Microbypass in Glaucoma Patients

To study changes in aqueous humor outflow (AHO) patterns after trabecular micro-bypass (TMB) in glaucoma patients using intraoperative sequential aqueous angiography. Prospective comparative case series. Fifteen subjects (14 with glaucoma and 1 normal). Sequential aqueous angiography (Spectralis HRA+OCT; Heidelberg Engineering) was performed on fourteen glaucoma patients undergoing routine TMB (iStent Inject; Glaukos Corporation) and cataract surgery and one normal patient undergoing cataract surgery alone. Indocyanine green (ICG) aqueous angiography established initial baseline nasal angiographic AHO patterns. Two TMB stents were placed in regions of baseline low or high angiographic AHO in each eye (n = 2 eyes with enough space to place two stents in both low angiographic regions; n = 8 eyes with two stents both placed in high angiographic regions; n = 4 eyes with enough space to place one stent in a low angiographic region and the other stent in a high angiographic region). Subsequent fluorescein aqueous angiography was utilized to query alterations to angiographic AHO patterns. Angiographic signal and patterns before and after TMB. At baseline, all eyes showed segmental angiographic AHO patterns. Focused on the nasal hemisphere of each eye, for each stent TMB in initially low ICG angiographic signal regions showed transient or persistently improved fluorescein angiographic signal (11.2-fold; p = 0.014). TMB in initially high ICG signal regions led to faster development of fluorescein angiographic patterns (3.1-fold; p = 0.02). TMB resulted in different patterns of aqueous angiographic AHO improvement whose further understanding may advance basic knowledge of AHO and possibly enhance intraocular pressure reduction after glaucoma surgery in the future.