Trabecular Micro-bypass Stent Research Articles

Intraocular Pressure Fluctuation as Assessed by Water Drinking Test Following iStent inject Implantation in Open Angle Glaucoma Patients.

Introduction This study investigated the intraocular pressure (IOP) fluctuation as assessed by the water drinking test (WDT) in open-angle glaucoma (OAG) patients after combined cataract surgery with iStent implantation. Methods This was a prospective non-randomized comparative study. Eyes with OAG and cataracts that were planned for either combined phacoemulsification and iStent implantation (iStent+CS) or phacoemulsification alone (CS) were recruited. The iStent inject (Model G2-M-IS) or iStent injectW (Model G2-W) trabecular micro-bypass stent (Glaukos Corporation, San Clemente, CA, USA) was implanted in the iStent+CS group. Water drinking test (WDT) was performed before and 3 months after surgery. WDT-IOP parameters including peak IOP, IOP fluctuation, and area under curve (AUC) were compared between the two groups. Results There were 20 eyes in the iStent+CS group and 16 eyes in the CS group. Both groups had similar pre-operative baseline IOP (15.6 ± 3.7 mmHg vs 15.8 ± 1.8 mmHg in the iStent+CS and CS group, respectively, p = 0.883). The iStent+CS group experienced greater numerical reduction in peak IOP (2.6 ± 1.9 mmHg vs 1.9 ± 2.4 mmHg; p = 0.355), IOP fluctuation (1.7 ± 2.2 mmHg vs 0.8 ± 2.5 mmHg; p = 0.289), and AUC (54.8 ± 103.6 mmHg x minute vs 25.3 ± 79.0 mmHg x minute; p = 0.355) than the CS group. There was more reduction in the number of anti-glaucoma medications in the iStent+CS group (1.4 ± 1.2) than the CS group (0.3 ± 0.9; p = 0.005). Conclusion Both combined phacoemulsification with iStent inject implantation and phacoemulsification alone reduced peak IOP, IOP fluctuation, and AUC, and none of these parameters showed statistically significant difference. Greater reduction in anti-glaucoma medications was seen in the combined group.

Ten-Year Effectiveness and Safety of Trabecular Micro-BypassStentImplantation with Cataract Surgery in Patients with Glaucoma or Ocular Hypertension.

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. 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 10years postoperatively; examinations included intraocular pressure (IOP), medications, corrected-distance visual acuity (CDVA), and adverse events. A total of 63 eyes of 45 patients with OAG (n = 60 eyes) or ocular hypertension (n = 3 eyes) and data through 10years were analyzed. Mean preoperative IOP was 18.6 ± 4.4mmHg on 1.83 ± 1.03 mean medications. At study visits through 10years 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 10years postoperatively, 77.8% of eyes had IOP ≤ 18mmHg and 47.6% had IOP ≤ 15mmHg (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. Significant and safe IOP and medication reductions were observed through 10years after iStent implantation with cataract surgery in patients with OAG or ocular hypertension.

Outcomes of iStent inject combined with cataract surgery in Asian eyes: Australian data from the Fight Glaucoma Blindness international registry

PurposeTo analyse real-world outcomes in Asian eyes of iStent inject, a second-generation trabecular micro-bypass stent, combined with phacoemulsification.MethodsThis is a multi-centre, observational study of glaucomatous Asian eyes that have undergone iStent inject implantation combined with cataract surgery. Patient data were extracted from the Fight Glaucoma Blindness! Registry. Outcome measures included those of IOP reduction, glaucoma medication reduction, and adverse events including the need for secondary surgery.Results123 eyes of 86 patients with a mean age of 68.4 ± 9.3 years underwent iStent inject implantation with phacoemulsification. At baseline, the mean ± SD preoperative intraocular pressure (IOP) was 16.0 ± 4.4 mmHg, and the mean preoperative number of topical glaucoma medications was 1.9 ± 1.4. At 12 months 30.8% of eyes demonstrated a reduction in IOP greater than 20%, the mean IOP reduction was 12.5% with an additional reduction of 0.7 glaucoma medications. 40% of eyes were using no medications at 12 months compared to 16.3% preoperatively. 8.2% of eyes required a subsequent procedure within the 12-month follow-up window.ConclusioniStent inject implantation combined with phacoemulsification in Asian eyes showed a reduction of IOP and glaucoma medication use in a real-world clinical setting. The safety profile of the device is good with minimal adverse outcomes, however, a subset of patients required secondary procedures within the 12 month follow up.

Three-Year Efficacy and Safety Outcomes of the Second-Generation Trabecular Micro-Bypass Stents in Conjunction with Cataract Surgery in Ocular Hypertension and Open-Angle Glaucoma

Purpose: To evaluate the efficacy and safety of the iStent Inject in conjunction with phacoemulsification in patients with open-angle glaucoma. Design: Prospective, non-randomized, single-center, consecutive case series Participants: Patients with primary and secondary open angle glaucoma undergoing cataract surgery and iStent Inject Main outcomes: The primary outcome of efficacy is postoperative reduction in mean Intraocular Pressure (IOP) and number of anti-glaucomatous drop classes. A primary endpoint is the achievement of =20% IOP reduction from baseline. Secondary outcome measures include visual acuity, visual field parameters, cup-to-disk ratio, and average retinal nerve fiber layer thickness. Results: 150 eyes were included with a mean follow-up of 2.28 years (standard deviation 1.18). IOP significantly decreased at nearly all timepoints and remains significantly reduced from baseline at 36 months. IOP reduction is modest and ranges between 5.6 to 11.7 %, with IOP being stably maintained lower than baseline throughout the observation period. IOP reduction is greatest in the mild glaucoma group. The primary endpoint of an over 20% IOP reduction being achieved in overall 32% of eyes. The burden of glaucoma drops was significantly reduced by 13% at 12 months post-op (p&lt;0.005). There was no statistically significant change in visual field parameters, although they improved after cataract surgery. The rate of additional glaucoma interventions needed were very low at &lt;1%. Conclusion: The combined cataract surgery and iStent Inject procedure is safe and effective at long-term with a low rate of serious complications. It offers good visual outcomes and reasonable glaucoma control long-term.

Five-Year Outcomes of Single Trabecular Microbypass Stent (iStent®) Implantation with Phacoemulsification in Korean Patients.

This study reports the long-term intraocular pressure (IOP)-lowering efficacy and safety of a singletrabecular microbypass stent(iStent®; Glaukos Corp., San Clemente, CA, USA) for medically controlled open-angleglaucoma in Korean patients. 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 5years 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 ≤ 18mmHg without medication, ≤ 15mmHg without medication, and ≤ 18mmHg with or without medication. Adverse events and need for secondary glaucoma surgery were also recorded. The mean IOP decreased from 15.8 ± 2.8 to 13.8 ± 1.7mmHg and the mean number of medications was reduced from 2.24 ± 1.18 to 0.83 ± 1.12, respectively, at year5. At 3 and 5years, 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 5years. At years3 and 5, 61.3% and 53.5% of eyes achieved IOP ≤ 18mmHg without medication, whereas 90.3% and 89.3% of eyes achieved ≤ 18mmHg regardless of medication use, respectively. Four eyes required additional glaucoma surgery (two Ahmed glaucoma valve implantations, one trabeculectomy, and one XEN45 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. 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.

Case report: Double implantation of the iStent inject in a high myope

The iStent inject is an ab-interno trabecular microbypass stent used in the treatment of primary open-angle glaucoma. Intraoperative complications are uncommon. However, we present the first reported case of simultaneous double-stent implantation, occurring in a 62-year-old Chinese male with high myopia and normal-tension glaucoma. Following an initial implantation failure, upon a single activation of the injector, simultaneous penetration of both stents into the trabecular meshwork occurred. Surgeons should be aware of the risk of double-implantation in myopic eyes with altered scleral rigidity, particularly when the first device is already located distally in the hub of the injector.

Efficacy and Safety of Pairing iStent Inject Trabecular Micro-Bypass and iAccess Precision Blade Goniotomy in Patients with Open-Angle Glaucoma.

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). 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 1month 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. In group A, mean IOP reduced from 14.9 ± 3.2mmHg on 1.22 ± 1.31 mean medications preoperatively (n = 63) to 13.5 ± 2.5mmHg on 0.24 ± 0.61 medications at month3 (n = 34; p = 0.048 IOP, p < 0.001 medications). In group B, mean IOP reduced from 16.0 ± 4.2mmHg on 1.12 ± 1.07 medications preoperatively (n = 93) to 12.2 ± 2.3mmHg on 0.57 ± 1.27 medications at month3 (n = 23; p < 0.001 IOP, p = 0.003 medications). From preoperative to 3months, the percent of eyes with IOP ≤ 12mmHg 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 ≤ 15mmHg 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. 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.

Clinical Outcomes of Phacoemulsification in Japanese Patients Receiving First and Revised Second-Generation Trabecular Microbypass Stents.

This study evaluated the effectiveness and safety of first and revised second-generation trabecular microbypass stent insertion [iStent (IS) and iStent inject W (IW)] in cataract surgery. Single-center, retrospective, cohort study. The study included 176 eyes that received trabecular microbypass stents combined with cataract surgery at the Saitama Red Cross Hospital between September 2017 and September 2021. Patients were divided into IS and IW groups depending on the implant type. Demographic characteristics, intraocular pressure (IOP), and the number of antiglaucoma medications (Med) were analyzed preoperatively and 12 months postoperatively. In addition, postoperative complications were compared between the groups. IS and IW were implanted in 86 eyes and 90 eyes, respectively. IOP and Med at 1, 3, 6, 9, and 12 months decreased significantly from baseline in both groups ( P = 0.04, P < 0.001, P < 0.001, P < 0.001, and P < 0.001, respectively, for IOP in the IS group; P = 0.02, P < 0.001, P < 0.001, P < 0.001, and P < 0.001, respectively, for IOP in the IW group; P = 0.03, P = 0.002, P < 0.001, P < 0.001, and P < 0.001, respectively, for Med in the IS group; and P < 0.001 for all time points for Med in the IW group). IOP did not vary significantly between the groups at 1, 3, 6, 9, and 12 months postoperatively. Med was significantly lower in IW than IS at 1, 3, 6, 9, and 12 months postoperatively ( P < 0.001, P < 0.001, P = 0.002, P = 0.002, and P = 0.002, respectively). Hyphema and IOP >30 mm Hg (spike) occurred in 1.2% and 4.4%, and 1.2% and 3.3% of patients in the IS and IW groups, respectively. The probability of successful discontinuation of medications at 12 months postoperatively was 10.5% and 41.1%, respectively ( P < 0.001). Postoperative Med was significantly lower in the IW group. Simultaneous insertion of IW in patients with glaucoma requiring cataract surgery may be preferred to IS because it reduces the burden of Med.

Trabecular microbypass stent combined with phacoemulsification in patients with open-angle glaucoma, 1-year outcome in a Taiwanese population

Trabecular microbypass stent combined with phacoemulsification in patients with open-angle glaucoma, 1-year outcome in a Taiwanese population

12‐month outcomes of trabecular microbypass iStent inject W implantation combined with cataract surgery in open‐angle glaucoma eyes

AbstractPurpose: To evaluate the effectiveness (lowering medication) of a single trabecular microbypass stent (iStent Inject® W, Glaukos) implantation in combination with phacoemulsification in open‐angle glaucoma eyes over a 12‐month period.Methods: Non‐randomized, single‐centre, retrospective case series of glaucoma eyes undergoing iStent implantation with phacoemulsification. Patients with no prior glaucoma surgery and intolerant or non‐compliant with medications were eligible for inclusion. Primary outcome effectiveness measures include reduction number of glaucoma medications and stabilization of intraocular pressure (IOP).Results: 30 eyes of 24 patients (mean age 74.9 ± 8.4) were included in this study. Mean baseline IOP was 17.7 ± 3.5 mmHg and was reduced to 16.1 ± 2.6 and 15.7 ± 2.5 at 6‐ and 12 months respectively (p = 0.002). Mean number of medications was 2.3 ± 1 at baseline and was significantly reduced to 0.7 ± 0.9 at 12 months (p &lt; 0.001; −68%). No eye was medication free at baseline versus 50% (n = 15) at 12 months. In controlled glaucoma eyes (≤18 mmHG), mean IOP was stable (15.5 ± 2.1 at baseline; 15.3 ± 2.4 at 12‐month) while medications were reduced from 1.9 ± 0.7 at baseline to 0.5 ± 0.6, whereas in uncontrolled glaucoma eyes (&gt;18mmHG at baseline) both IOP and medications were reduced from 20.7 ± 2.5 and 2.7 ± 1.2 at baseline to 16.2 ± 2.6 and 1.1 ± 1.1 at 12‐month respectively. There was no statistically significant change in retinal nerve fibre layer (RNFL) thickness at 12 months (p = 0.32). No eyes have experienced adverse events such as postoperatively IOP spikes or hyphema.Conclusions: iStent Inject W implantation with phacoemulsification results in a significant reduction in mean glaucoma medications in glaucoma eyes. IOP was also reduced and there was no loss of visual acuity or RNFL. In uncontrolled IOP eyes, the stent implantation has brought IOP under control and reduced the number of medications, while in controlled IOP eyes, it has lowered the number of medications.

Canaloplasty and trabeculotomy with the OMNI® surgical system in OAG with prior trabecular microbypass stenting

PurposeEvaluate effectiveness and safety outcomes for patients treated with canaloplasty and trabeculotomy previously treated with a trabecular microbypass stent (TBS).MethodsRetrospective, multicenter, IRB approved study. Patients treated with TBS (iStent/iStent inject, Glaukos) and subsequently with OMNI surgical system (OSS) (Sight Sciences). From 5 practices in 5 US states. Open-angle glaucoma (OAG), minimum 3 months follow-up after OSS surgery, Pre-OSS IOP ≥ 17 mmHg on ≥ 1 medication. No glaucoma procedures between TBS and OSS. Endpoints: proportion with ≥ 20% reduction in IOP, IOP between 6 and 18 mmHg, mean IOP, change in IOP, mean number of medications. Adverse events and secondary surgical interventions (SSI). Mann–Whitney rank sum test compared pre-OSS IOP and medications with follow-up.ResultsTwenty seven patients. Average age (SD) 72.2 (10.8), 22/27 primary OAG (82%), mean MD − 6.2 (7.0) dB. Mean IOP before OSS 22.3 (4.3) mmHg on 2.2 (1.3) medications. At last follow-up (mean 11 months) IOP was 17.2 mmHg on 1.8 medications, − 5.1 mmHg (− 23%, p < .001), − 0.4 meds (− 18%, p = .193); ≥ 20% IOP reduction (41%), IOP ≤ 18 (56%). Adverse events were non-serious. Hyphema > 1 mm (3, 11%), BCVA decrease (4, 15%), IOP spike (2, 7%). SSI (4, 15%) had higher pre-OSS IOP (23.4 mmHg) and worse MD (− 9.6 dB).ConclusionPatients uncontrolled by medication and a prior TBS would once have been candidates for trabeculectomy and tube shunts. OSS offered a minimally invasive option that provided IOP control and avoidance of traditional surgery for the majority over follow-up averaging 11 months and up to 42 months.

Multicenter Effectiveness and Disease Stability Through 3 Years After iStentTrabecular Micro-Bypass with Phacoemulsification in Glaucoma and Ocular Hypertension.

PurposeTo evaluate 3-year safety and efficacy of two second-generation trabecular micro-bypass stents. (iStent inject®) with phacoemulsification.Materials and MethodsThis 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.ResultsA 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.ConclusionIn 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.

Comparison of minimally invasive glaucoma surgery with trabecular micro-bypass stent and microhook ab interno trabeculotomy performed in conjunction with cataract surgery.

To evaluate the effectuality and safety of cataract surgery combined with either ab interno trabeculotomy by the microhook (µLOT) or a single iStent® trabecular bypass implantation (iStent) in eyes with cataract and mild-to-moderate glaucoma. This study enrolled subjects with mild-to-moderate open angle glaucoma with visually significant cataract who used two or more ophthalmic antiglaucoma agents between 60 and 90y of age. Patients underwent cataract surgery cooperated with either implantation of an iStent (iStent-phaco) or excisional goniotomy with the µLOT (µLOT-phaco). Patients underwent µLOT-phaco in the eye with lower the mean deviation, according to the Humphrey field analyzer, while iStent-phaco was carried out on the other eye. Intraocular pressure (IOP) pre- and post-surgery, alterations in anterior chamber flare (ACF), and corneal endothelial cell density (ECD) were estimated. Twenty subjects were enrolled (mean age: 73.6±7.3y). The mean medicated preoperative IOP was 16.7 mm Hg in the µLOT and 16.2 mm Hg in the iStent eyes. The mean final IOP at 12mo was 13.6 mm Hg in the µLOT eyes and 13.6 mm Hg in the iStent eyes, representing a 17.8% and 17.2% reduction, respectively. The preoperative ACF in the µLOT eyes was 9.5 pc/ms and it returned to normal in 30d postoperatively, with a value of 11.4 pc/ms. In the iStent eyes, ACF was 9.6 pc/ms preoperatively and it returned to normal by 7d postoperatively (11.2 pc/ms at day 7), demonstrating that postoperative inflammation was less in the iStent eyes. The corneal ECD in both groups was not significantly decreased. In this study, iStent and µLOT are both effective through 12mo of follow-up. Safety is more favorable in the iStent eyes, based on early anterior chamber inflammation.

IStent Trabecular Micro-bypass Stent Implantation Combined with Phacoemulsification for Open-Angle Glaucoma: A 2-Year Post-marketing Surveillance Study in Japan.

IntroductionWe report 2-year outcomes after implantation of iStent trabecular micro-bypass stent with phacoemulsification, in Japanese patients with mild–moderate open-angle glaucoma (OAG).MethodsThis was a 24-month, prospective, longitudinal, observational, post-marketing study conducted between July 2017 and September 2020. Patients consisted of adults with OAG on antiglaucoma medications who had cataract surgery combined with one iStent implantation. Outcome measures included intraocular pressure (IOP), antiglaucoma medications, treatment success rates (defined as eyes having lower IOP with same or reduced number of medications from baseline, or same IOP with reduced number of medications from baseline, and not requiring secondary glaucoma surgeries postoperatively), and safety. Outcomes were analyzed in the overall cohort and in glaucoma subtypes: primary OAG, normal-tension glaucoma, and exfoliative glaucoma.ResultsOverall, 232 eyes were enrolled. At 24 months, mean ± standard deviation IOP decreased from 17.6 ± 4.0 mmHg preoperatively to 14.3 ± 3.0 mmHg (p < 0.05), and mean number of medications reduced from 2.2 ± 1.2 preoperatively to 0.7 ± 1.2 (p < 0.05). Similar trends were observed across glaucoma subtypes. In the overall cohort, 96.7%, 95.3%, and 93.7% of patients achieved treatment success at 6, 12, and 24 months, respectively. There were 67.6% medication-free eyes at 24 months compared to 3.2% medication-free eyes preoperatively (p < 0.0001). Safety profile was favorable over the 2-year period.ConclusionsFollowing iStent implantation with phacoemulsification, clinically relevant and statistically significant reductions in IOP and number of medications were observed in Japanese eyes with OAG over 2 years, with favorable safety profile. These reductions were observed across all glaucoma subtypes.Supplementary InformationThe online version contains supplementary material available at 10.1007/s12325-022-02207-0.

Standalone Implantation of 2-3 Trabecular Micro-Bypass Stents (iStent inject ± iStent) as an Alternative to Trabeculectomy for Moderate-to-Severe Glaucoma.

IntroductionThis retrospective consecutive study compared standalone implantation of multiple (2–3) trabecular micro-bypass stents (iStent inject ± iStent) (Multi-Stent group) vs trabeculectomy + mitomycin C (Trab group) in moderate to severe open-angle glaucoma (OAG).MethodsEligible patients underwent Multi-Stent or Trab surgery from 2018 to 2020 and had at least 3-month follow-up; visual field mean deviation (VF MD) − 6 dB or worse; inadequate prior response to maximum medications ± laser procedures; and had trabeculectomy as their next planned intervention. Primary effectiveness, safety-adjusted treatment success, was defined as ≥ 20% intraocular pressure (IOP) reduction on the same or fewer medications, without clinically significant safety events (severe complications, secondary surgeries, reinterventions). Secondary effectiveness included mean IOP and medications; qualified and complete attainment of target IOP (≤ 21/18/15/12 mmHg and > 6 mmHg); health-economic and quality-of-life (QoL) measures; and 2-vs-3-stent subgroup analysis.ResultsThe baseline groups (n = 70 Multi-Stent/40 Trab) were similar: mean IOP (21.1 mmHg/22.3 mmHg); medications (2.87/3.10 medications); disease stage (30%/35% severe); VF MD (− 10.1 dB/− 10.4 dB); and mean last follow-up (LFU, 13.1 months/15.7 months) (all differences non-significant). Primary effectiveness: treatment success at LFU was 62.9% vs 30.0% in Multi-Stent vs Trab eyes, respectively (p = 0.001). Secondary effectiveness: At LFU in Multi-Stent vs Trab groups, respectively: mean IOP decreased by 31% to 14.2 mmHg (p < 0.001) vs by 43% to 12.5 mmHg (p < 0.001); mean medications decreased by 51% to 1.31 medications (p < 0.001) vs by 84% to 0.43 medications (p < 0.001). Multi-Stent eyes, compared to Trab eyes, had fewer visits ± reinterventions within 3 months (3.6 vs 6.1, p < 0.001); longer time to first reintervention (12.2 months vs 4.5 months, p = 0.01); fewer total reinterventions (0.26 vs 0.75, p = 0.006); and earlier lifting of postoperative restrictions (12.6 vs 32.1 days, p < 0.001). In 2-vs-3-stent analysis, there was a trend toward more 3-stent eyes achieving target IOP than 2-stent eyes. Visual fields remained stable in both Multi-Stent and Trab eyes.ConclusionImplanting 2–3 trabecular micro-bypass stents was a viable alternative to trabeculectomy for moderate-to-severe OAG, with clinically appropriate IOP/medication reductions and higher safety-adjusted treatment success vs trabeculectomy.

Long-term outcomes of two first-generation trabecular micro-bypass stents (iStent) with phacoemulsification in primary open-angle glaucoma: eight-year results

BackgroundThe short- and medium-term outcomes of iStent have been extensively studied; however, only few studies have investigated its long-term outcomes. Here, we assessed the long-term efficacy and safety of two iStents with concomitant cataract surgery in glaucomatous eyes while also evaluating measures of disease stability using visual field and optical coherence tomography (OCT) of the optic nerve and the macula throughout 8 years of follow-up.MethodsThis longitudinal, single-center consecutive case series included glaucomatous eyes that underwent implantation of two first-generation trabecular micro-bypass stents (iStent) with concomitant cataract surgery. Eight-year efficacy outcomes included mean intraocular pressure (IOP) and medications, as well as surgical success. Eight-year safety outcomes included best-corrected visual acuity (BCVA), visual field mean deviation (VF-MD), cup-to-disc ratio (CDR), retinal nerve fiber layer (RNFL) thickness, ganglion cell-inner plexiform layer (GC-IPL) thickness, and adverse events.ResultsA total of 62 eyes with primary open-angle glaucoma (POAG) were included. At 8 years postoperative, IOP reduced by 26% from 19.2 ± 3.9 mmHg preoperatively to 14.2 ± 2.4 mmHg (P < 0.001), 91.1% of eyes achieved IOP ≤ 18 mmHg (vs. 51.6% preoperatively), 69.6% of eyes achieved IOP ≤ 15 mmHg (vs. 14.5% preoperatively), and 25% of eyes achieved IOP ≤ 12 mmHg (vs. 1.6% preoperatively). Medication use decreased by 17.9% from 2.8 ± 1.1 preoperatively to 2.3 ± 1.2 (P = 0.018). Surgical success was 90%, as six eyes underwent subsequent glaucoma surgeries. Safety measures of BCVA, CDR, RNFL thickness and GC-IPL thickness remained stable through 8 years postoperative. VF-MD remained stable until postoperative year 5 and subsequently progressed according to the natural history of glaucomatous disease.ConclusionsImplantation of two iStents with concomitant cataract surgery is an effective and safe treatment option for surgery-naïve POAG eyes, evidenced by significant IOP and medication reductions, reasonable surgical success, and favorable safety outcomes, throughout the 8-year follow-up. Our data additionally supports the efficacy of this combined procedure in stabilizing or slowing disease progression.

Clinical Outcomes After Second-Generation Trabecular Microbypass Stents (iStent inject®) with Phacoemulsification in Korean Patients.

IntroductionTo evaluate the intraocular pressure (IOP)-lowering effect of second-generation trabecular microbypass stents (iStent® inject) with cataract extraction (combination group) and compare refractive changes in the combination group and the control (phacoemulsification only) group.MethodsThis retrospective case–control study included 36 eyes with cataract and medically controlled open-angle glaucoma with IOP < 21 mmHg and 100 nonglaucomatous eyes with cataract. Data were collected preoperatively and for 6 months postoperatively. Data included IOP, number of glaucoma medications, corrected distance visual acuity, and mean absolute error (MAE) from target refraction, and astigmatic vector analysis. Surgical success for the combination group was defined according to three criteria: (A) IOP < 15 mmHg without medication, (B) IOP < 18 mmHg without medication, and (C) IOP < 18 mmHg with or without medication.ResultsIn the combination group, mean IOP was reduced from 15.1 ± 2.9 mmHg to 12.5 ± 2.0 mmHg, and the mean number of medications decreased from 1.9 ± 1.0 to 0.4 ± 0.8 at postoperative 6 months (both P < 0.001). Surgical success rates were 77.8%, 83.3%, and 97.2% at 6 months by criteria A, B, and C, respectively. Mean IOP was reduced from 14.3 ± 2.7 mmHg to 13.1 ± 2.1 mmHg at 1 month in the control group (P < 0.001). The MAE was 0.33 ± 0.26 D, and 83.3% of eyes had spherical equivalent difference within 0.50 D in the combination group (0.38 ± 0.33 D and 76.0% in the control group; P = 0.309 and P = 0.363, respectively). Preoperative and postoperative centroid values were 0.51 D @ 1° and 0.66 D @ 178°, respectively (0.23 D @ 176° and 0.66 D @ 1° in the control group). There were no statistical differences between the two groups with respect to preoperative and postoperative mean absolute values (P = 0.154 and P = 0.322, respectively).ConclusionsOn the basis of our results using Korean real-world interim experience, iStent® inject with cataract extraction has favorable IOP-lowering effects and minimally impacts refractive outcomes.

Cost-utility analysis of trabecular micro-bypass stents (TBS) in patients with mild-to-moderate open-angle Glaucoma in Italy

BackgroundGlaucoma is a disease characterized by progressive damage of the optic nerve. Several therapeutic options are available to lower intraocular pressure (IOP). In primary open-angle glaucoma (POAG) patients with inadequate IOP control (or controlled with multiple medical therapies or for whom medical therapy is contraindicated), the implantation of micro-invasive glaucoma surgery devices (MIGS) and concomitant cataract surgery has proved to be more effective in reducing intraocular pressure (IOP), as compared to cataract surgery alone. The objective of this study was to assess the cost-effectiveness of iStent inject® device with concurrent cataract surgery vs. cataract surgery alone, in patients with mild-to-moderate POAG, adopting the Italian National Health Service (NHS) perspective.MethodsSimulation of outcomes and costs was undertaken using a Markov model with 4 health states and one-month cycles, that is used to simulate the prognosis of these patients. Efficacy data were obtained from the randomized clinical trial (RCT). A lifetime horizon was adopted in the analysis. A discount rate of 3.5% was applied to both costs and effects. The Italian National Healthcare Service (NHS) perspective was considered, therefore only healthcare direct costs (acquisition of main interventions and subsequent procedures; medications; monitoring and follow-up; adverse events). Model robustness was tested through sensitivity analyses.ResultsResults of the base-case analysis showed that the total lifetime costs were higher in the iStent inject® + concurrent cataract surgery, compared with the cataract surgery alone group (€8368.51 vs. €7134.71 respectively). iStent inject® + concurrent cataract surgery was cost-effective vs. cataract surgery alone, with an incremental cost-effectiveness ratio of €13,037.01 per quality-adjusted life year (QALY) gained. Both one-way deterministic and probabilistic sensitivity analyses confirmed robustness of base-case results. The cost-effectiveness accessibility curve (CEAC) showed that iStent inject® + cataract surgery would have a 98% probability of being cost-effective, compared to cataract surgery alone, when the willingness to pay (WTP) is equal to €50,000 per QALY gained.ConclusionsThe results of the cost-utility analysis confirm that iStent inject® + cataract surgery is a cost-effective option for the treatment of patients affected by mild-to-moderate POAG, compared with cataract surgery alone, when evaluated from the Italian NHS perspective.

Surgical Outcomes of Combined 2nd-Generation Trabecular Microbypass (iStent Inject) and Cataract Surgery for the Treatment of Primary Open-Angle Glaucoma in the Saudi Population.

IntroductionTo investigate the 24-month efficacy and safety of iStent inject trabecular microbypass system implantation combined with phacoemulsification in subjects with primary open-angle glaucoma (POAG) and concomitant cataract.MethodsThis prospective, uncontrolled, interventional case series included 36 eyes (29 subjects) with POAG of mild to moderate severity and coexisting cataract that underwent combined phacoemulsification and implantation of a second-generation trabecular microbypass stent (iStent inject®). Main outcome measures involved mean intraocular pressure (IOP), number of antiglaucoma medications, and proportional analysis of eyes with IOP ≤ 18 mmHg or ≤ 15 mmHg, or with 0 or ≥ 2 glaucoma medications. Secondary outcome measures involved the cup-to-disc ratio, corrected distance visual acuity (CDVA), and adverse issues.ResultsIn 36 eyes, the mean IOP at baseline was 18.28 ± 2.87 mmHg, which decreased to 14.24 ± 1.36 (22.1%) and 14.46 ± 1.56 mmHg (20.9%) at 18 and 24 months, respectively (p < 0.001). At the last follow-up, 100% of eyes had an IOP ≤ 18 mmHg (vs. 50% preoperatively), and 75.7% of eyes had an IOP ≤ 15 mmHg (vs. 16.7% preoperatively); 58.3% of eyes achieved ≥ 20% IOP reduction from preoperative status. At baseline, eyes were treated with a mean of 2.35 ± 1.18 medications, which was reduced to 0.80 ± 1.04 (66% reduction) and 0.69 ± 0.95 medications (70.6% reduction) at 18 and 24 months, respectively (p < 0.001). At the last follow-up, 54.1% of eyes were medication-free (vs. 0% preoperatively) and 24.3% of eyes were treated with ≥ 2 medications (vs. 64.9% preoperatively). This combined procedure demonstrated an excellent safety profile with no reported intraoperative complications or adverse events; CDVA was maintained throughout the entire follow-up period.ConclusionsThis real-world series demonstrated that iStent inject device implantation at the time of phacoemulsification is a safe and effective method to decrease IOP and the necessity for antiglaucoma medications in patients with mild-to-moderate POAG and cataract; no associated vision-threatening complications were noted.

Reoperation for complications within 90 days of minimally invasive glaucoma surgery.

To describe reoperations that occurred within 90 days of minimally invasive glaucoma surgery (MIGS) at a single institution over a 30-month period. Tertiary care hospital. Retrospective case series. Charts of adult patients who underwent trabecular microbypass stents, gel microstents, and goniotomy procedures (including gonioscopy-assisted transluminal trabeculotomy) from October 1, 2017, to March 15, 2020, at Wills Eye Hospital were examined. Outcome measures were unanticipated reoperations within the first 90 days after MIGS procedures and the complications that led to these reoperations. A total of 448 MIGS procedures were performed on 436 eyes of 348 patients over a 30-month period by 6 glaucoma surgeons. Of these, 206 (46.0%) were trabecular microbypass stents (198 iStent/iStent inject and 8 Hydrus), 152 (33.9%) were gel microstents, and 90 (20.1%) were goniotomy procedures. Combined phacoemulsification took place in 256 eyes (58.7%). Reoperation within 90 days took place in 23 (5.3%) of 436 eyes, including 16 (10.5%) of 152 eyes in the gel microstent group, 4 (2.0%) of 198 eyes in iStent/iStent inject group, and 3 (3.3%) of 90 eyes in the goniotomy group. Indications for reoperation were elevated intraocular pressure (IOP) in 16 (69.6%) of 23 eyes, gel microstent tip exposure with wound leakage in 3 (13.0%) of 23 eyes, and early gel microstent encapsulation without elevated IOP in 1 (4.3%) of 23 eyes. Two (8.7%) of 23 eyes required reoperation for intraocular lens complications, whereas 1 (4.3%) of 23 eyes had elevated IOP and aphakia requiring reoperation. The rate of reoperation within the first 90 days after MIGS was low. Elevated IOP and complications associated with gel microstents were the main indications for reoperation.