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

Guedes, Ricardo Augusto Paletta; Gravina, Daniela Marcelo; Guedes, Vanessa Maria Paletta; Chaoubah, Alfredo

doi:10.1007/s40123-021-00424-4

Cited by 12 publications

(20 citation statements)

References 51 publications

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“…This favorable risk-benefit profile of trabecular bypass procedure was corroborated in a recent comparative study of 2–3 trabecular bypass stents versus trabeculectomy, which showed substantial reductions in IOP and medications for both procedures, but significantly higher percentage of safety-adjusted treatment success in the trabecular micro-bypass versus trabeculectomy group. 16 …”

Section: Discussionmentioning

confidence: 99%

“…35 , 36 Furthermore, the incremental benefits of additional stents (eg, 3 vs. 2 vs. 1 stent), such as additional IOP reduction and reduced medication burden, have been validated in both preclinical and clinical studies, with favorable safety in all treatment groups. 16 , 33 – 39 …”

Section: Discussionmentioning

confidence: 99%

“…This was a single-arm, open-label trial, consistent with FDA standards for a 510(k) device registration submission. Although the follow-up period of 12 months is of relatively short duration, the iStent infinite has the same mechanism of action and treatment approach as the first-generation iStent and second-generation iStent inject devices, which have shown consistent durability in maintaining IOP and medication reductions for up to 8 years postoperative 16–18,20–32,37–39. Hence, long-term studies with iStent infinite would be expected to demonstrate similarly consistent effectiveness and safety over time.…”

Section: Discussionmentioning

confidence: 99%

“… 14 , 15 A recent real-world head-to-head comparison of trabeculectomy versus MIGS with the placement of 2 or 3 trabecular micro-bypass stents highlighted this benefit-to-risk balance, with significantly higher safety-adjusted treatment success in multistent eyes than in trabeculectomy eyes. 16 …”

mentioning

confidence: 99%

“… 20 – 32 The evidence also demonstrates an incremental increase in IOP-reducing and medication-reducing effect with a higher number of iStents (1 vs. 2 vs. 3) 20 , 33 – 39 and suggests a specific incremental benefit of 3 over 2 stents. 16 …”

mentioning

confidence: 99%

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Effectiveness and Safety of iStent Infinite Trabecular Micro-Bypass for Uncontrolled Glaucoma

Sarkisian

Grover

Gallardo

et al. 2022

Journal of Glaucoma

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Précis: The iStent Infinite Trabecular Micro-Bypass System implanted in patients with open angle glaucoma (OAG) (uncontrolled by prior surgical or medical therapy) was effective in reducing mean diurnal intraocular pressure with a favorable safety profile. Purpose: The purpose of this study is to evaluate safety and effectiveness of the iStent infinite Trabecular Micro-Bypass System in patients with OAG uncontrolled by prior surgical or medical therapy. Design: Prospective, multicenter, single-arm, open-label clinical trial. Methods: Implantation of iStent infinite (3 iStent inject W stents) was performed as a stand-alone surgical procedure in eyes with OAG uncontrolled by prior incisional or cilioablative surgeries or maximum tolerated medical therapy (MTMT). Prospectively declared effectiveness endpoints were proportion of eyes achieving ≥20% mean diurnal intraocular pressure (MDIOP) reduction from baseline at month 12 on the same or fewer intraocular pressure (IOP)-lowering medication classes (responder endpoint) and mean change in MDIOP from baseline at month 12. Safety parameters included visual acuity, slit-lamp and fundus examinations, gonioscopy, perimetry, surgical complications, and adverse events. Results: Seventy-two eyes of 72 patients (mean age 71.9 y) with preoperative mean medicated MDIOP of 23.4±2.8 mm Hg on a mean of 3.1±0.9 IOP-lowering medication classes were enrolled: 61 eyes with failed prior surgery/ies (Failed-Surgery subgroup) and 11 eyes uncontrolled on MTMT (MTMT subgroup). A total of 76.1% of all enrolled patients met the responder endpoint (73.4% Failed-Surgery, 90.9% MTMT), with mean reduction (SE) in MDIOP at month 12 of 5.9(0.6) mm Hg [5.5(0.7) mm Hg Failed-Surgery subgroup, 8.1(0.9) mm Hg MTMT subgroup]. For patients on the same or fewer medication(s) as baseline, 53.0% achieved ≥30% MDIOP reduction without surgical interventions/other events. Safety was favorable, with no explants, infection, or device-related interventions or hypotony. Conclusions: iStent infinite stand-alone surgery achieved clinically significant IOP reduction and favorable safety in patients with OAG uncontrolled by prior therapy.

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Section: Discussionmentioning

confidence: 99%

Section: Discussionmentioning

confidence: 99%

Section: Discussionmentioning

confidence: 99%

mentioning

confidence: 99%

mentioning

confidence: 99%

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Effectiveness and Safety of iStent Infinite Trabecular Micro-Bypass for Uncontrolled Glaucoma

Sarkisian

Grover

Gallardo

et al. 2022

Journal of Glaucoma

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Aqueous Humor Circulation in the Era of Minimally Invasive Surgery for Glaucoma

Coroneo,

Graterol-Nisi,

Maver

et al. 2023

Ann Biomed Eng

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7-Year Efficacy and Safety of iStent inject Trabecular Micro-Bypass in Combined and Standalone Usage

Hengerer,

Auffarth,

Conrad-Hengerer

2024

Adv Ther

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Introduction This study evaluated 7-year effectiveness and safety of second-generation trabecular micro-bypass implantation (iStent inject ) either in combination with cataract surgery or as a standalone procedure (Combined or Standalone subgroups, respectively) in eyes with open-angle glaucoma. Methods This prospective, non-randomized, unmasked, longitudinal study included 125 consecutive iStent inject cases of a single surgeon at a large German academic hospital. Patients had considerable preoperative disease burden, with mean intraocular pressure (IOP) of 23.5 mmHg, 84.8% of eyes on ≥ 2 medications, and 38.4% of eyes with prior glaucoma surgery. IOP, medications, adverse events, and secondary surgeries were assessed through 7 years in the Overall cohort and in Combined ( n = 81) and Standalone ( n = 44) subgroups. Results Over 7-year follow-up, mean IOP decreased by 36.2–40.0% in Overall eyes, 34.1–38.9% in Combined eyes, and 39.5–43.5% in Standalone eyes ( p < 0.001 at all timepoints for all groups). Meanwhile, mean medications decreased by 59.3–71.3% in Overall eyes, 57.9–69.0% in Combined eyes, and 62.1–76.2% in Standalone eyes ( p < 0.001 at all timepoints in all groups). At last follow-up (mean 77.4 months; 92.8% of patients with last visit at 6 or 7 years), 83.7% of Overall eyes, 82.3% of Combined eyes, and 86.4% of Standalone eyes had achieved ≥ 20% IOP reduction vs preoperative. At last follow-up vs preoperative, 100% of eyes in all groups had the same or lower IOP and 100% had the same or lower medication regimen. Safety outcomes were favorable, with no filtration surgeries and only 4.84% of eyes experiencing clinically significant visual field loss over 7 years of follow-up. Conclusion iStent inject implantation with or without phacoemulsification produced significant and durable 7-year reductions in IOP (~ 34–44% reduction) and medications (~ 58–76% reduction) while preventing filtering surgery in this cohort of patients with relatively high preoperative disease burden. Combined and Standalone cases had similarly favorable effectiveness and safety.

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

Cited by 12 publications

References 51 publications

Effectiveness and Safety of iStent Infinite Trabecular Micro-Bypass for Uncontrolled Glaucoma

Effectiveness and Safety of iStent Infinite Trabecular Micro-Bypass for Uncontrolled Glaucoma

Aqueous Humor Circulation in the Era of Minimally Invasive Surgery for Glaucoma

7-Year Efficacy and Safety of iStent inject Trabecular Micro-Bypass in Combined and Standalone Usage

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