&lt;p&gt;Mid-Term Evaluation of iStent Inject&lt;sup&gt;®&lt;/sup&gt; Trabecular Micro-Bypass Stent Implantation with or without Phacoemulsification: A Retrospective Study&lt;/p&gt;

Seixas, Regina Cele Silveira; Balbino, Marcos; Neto, Alberto Basile; Costa, Amanda de Alcantara Almeida; Jordão, Marcelo Lopes da Silva; Russ, Heloisa Helena Abil

doi:10.2147/opth.s283587

Cited by 6 publications

(3 citation statements)

References 39 publications

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“…iStent, iStent Inject, and Hydrus Microstent all bypass the trabecular meshwork by means of stent implantation; all share two of their five most common aggregate complications sampled from all included studies in this literature review, namely IOP spike, and device obstruction or stent occlusion. For certain individuals, differences in rates of complications may influence a clinician's choice of device; for instance, IOP spikes are reported to affect between 1.8-22.2% of iStent patients [13,16,[18][19][20][21][22][23][24][25], and, similarly, 1.06-18.6% of iStent Inject cases [28][29][30][31][32][34][35][36], but were only seen in between 1.9 and 6.45% of Hydrus implantations [13,[38][39][40][41][42]. Notably, the number of Hydrus studies available for inclusion was smaller, and hence these data are possibly less reliable than for the two Glaukos devices, but in a patient with contra-indications to trabeculectomy or tube shunt surgery, this may nonetheless be a compelling consideration in Hydrus' favour.…”

Section: Discussionmentioning

confidence: 99%

“…Notably, the number of Hydrus studies available for inclusion was smaller, and hence these data are possibly less reliable than for the two Glaukos devices, but in a patient with contra-indications to trabeculectomy or tube shunt surgery, this may nonetheless be a compelling consideration in Hydrus' favour. Conversely, in a patient intolerant of mydriatic agents, the 0% rate of PAS formation following iStent and iStent Inject implantation may be valuable when compared against the 0-18.8% of Hydrus patients who developed this complication [13,16,[18][19][20][21][22][23][24][25][28][29][30][31][32][34][35][36][38][39][40][41][42].…”

Section: Discussionmentioning

confidence: 99%

“…There was no statistically significant difference between rates of IOP spike or CECL in treatment versus control groups [29]. Seixas et al found no rate of significant difference in adverse events between those undergoing cataract surgery with or without iStent inject implantation [30]. Other literature concurs that iStent inject implantation is a safe and well-tolerated procedure without sight-threatening sequelae [31][32][33][34][35][36]; where adverse events do arise, these are similar to those encountered with iStent insertion, namely IOP spikes, stent obstruction, and hyphaema, albeit at apparently lower rates [36].…”

Section: Istent Injectmentioning

confidence: 96%

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Minimally Invasive Glaucoma Surgery: Safety of Individual Devices

Rowson

Hogarty

Maher

et al. 2022

JCM

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Primary open-angle glaucoma progression in those already on maximal medical therapy has traditionally been treated with trabeculectomy, a surgical procedure that carries a high degree of morbidity. In the last few decades, significant advances have been made in the field of minimally invasive glaucoma surgery (MIGS) devices, which aim to defer or prevent trabeculectomy via less arduous surgical techniques in certain types of glaucoma. Although reviews have been published examining the efficacy of various MIGS techniques, no article synthesises the comparative safety of all available devices. We performed a literature review examining the safety of MIGS devices. Fifteen devices were included, variously attempting to increase aqueous outflow through the trabecular meshwork or the suprachoroidal space, shunting into the subconjunctival space, or reducing aqueous production through ciliary body ablation. Notably, the earliest product attempting to increase outflow to the suprachoroidal space, Alcon’s CyPass Micro-Stent, was withdrawn from the market due to concerns regarding increased corneal endothelial cell loss at five years post-implantation. All other devices were described as well-tolerated, with the most common adverse effects including hyphaema, intraocular pressure spikes, and device migration or obstruction. MIGS devices are purported to be uniformly safe, and many studies report no statistically significant increased complications beyond those associated with cataract surgery alone. It is important to note, however, the generally poor quality of current studies, with a dearth of randomised, or even prospective, data, and a large proportion of studies funded by device producers.

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Section: Discussionmentioning

confidence: 99%

Section: Discussionmentioning

confidence: 99%

Section: Istent Injectmentioning

confidence: 96%

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Minimally Invasive Glaucoma Surgery: Safety of Individual Devices

Rowson

Hogarty

Maher

et al. 2022

JCM

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iStent inject Trabecular Micro-Bypass with or Without Cataract Surgery Yields Sustained 5-Year Glaucoma Control

Hengerer

Conrad-Hengerer

2022

Adv Ther

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Introduction: This study evaluated the 5-year effectiveness and safety of iStent inject Ò trabecular micro-bypass with or without cataract surgery (Combined or Standalone, respectively) in patients with open-angle glaucoma (OAG). Methods: This prospective longitudinal case series included consecutive iStent inject cases from a single surgeon at a large German academic hospital. Intraocular pressure (IOP), medications, safety, and indicators of disease stability through 5 years were assessed in the Overall cohort and in subgroup analyses stratified by usage (Combined or Standalone). Results: Preoperative mean IOP in the Overall cohort (n = 125) was 23.5 ± 6.2 mmHg on 2.68 ± 1.02 mean medications, reducing to 14.1 ± 1.8 mmHg on 0.77 ± 0.82 medications at 5 years (40% and 71% reductions, respectively; both p\0.001). All but 1 eye ([99%) were on medication(s) preoperatively, but 46% were medication-free at 5 years (p\0.001). In Combined eyes (n = 81), mean IOP decreased by 39% (22.6 mmHg to 13.8 mmHg, p\0.001) and medications by 69% (2.52 to 0.78, p\0.001). In Standalone eyes, mean IOP reduced by 42% (25.3 mmHg to 14.6 mmHg, p\0.001) and medications by 75% (2.98 to 0.74, p\0.001). At final follow-up, 83% of eyes had achieved C 20% IOP reduction, and all but 1 eye ([99%) had the same or lower IOP versus preoperative; all eyes (100%) maintained or reduced their medication burden versus preoperative. Favorable safety included 0 intraoperative complications and 0 filtration surgeries through 5 years. Long-term indicators of disease stability (visual fields, retinal nerve-fiber layer thickness, and cup:disc ratio) were unchanged over the course of 5-year follow-up. Conclusions: iStent inject produced significant and durable 5-year reductions in IOP (nearly 10-mmHg reduction) and medications (nearly 2-medication reduction), with stable disease parameters over time. Combined and Standalone subgroups had similar outcomes.

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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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<p>Mid-Term Evaluation of iStent Inject<sup>®</sup> Trabecular Micro-Bypass Stent Implantation with or without Phacoemulsification: A Retrospective Study</p>

Cited by 6 publications

References 39 publications

Minimally Invasive Glaucoma Surgery: Safety of Individual Devices

Minimally Invasive Glaucoma Surgery: Safety of Individual Devices

iStent inject Trabecular Micro-Bypass with or Without Cataract Surgery Yields Sustained 5-Year Glaucoma Control

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

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