Trabecular microbypass stents as minimally invasive approach after conventional glaucoma filtration surgery

Macher, Thomas; Häberle, H; Wächter, J; Thannhäuser, C. L.; Aurich, H; Pham, Duy-Thoai

doi:10.1016/j.jcrs.2017.10.039

Cited by 13 publications

(6 citation statements)

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“…In the present cohort, IOP decreased by over 8 mmHg, a reduction of 37%; this reduction is approximately two to four times greater than the reduction expected with cataract surgery alone. This is consistent with clinical studies showing significantly greater reductions in IOP and medication use in patients with iStent and iStent inject implantation plus cataract surgery compared to cataract surgery alone [ 2 – 4 , 31 , 41 – 43 ]. It also aligns with the work of Fernandez-Barrientos et al [ 2 ], who demonstrated significant increases in trabecular outflow facility at 12 months in eyes implanted with iStent in combination with cataract surgery compared to eyes with cataract surgery alone.…”

Section: Discussionsupporting

confidence: 88%

“…iStent inject implantation was completed following standard phacoemulsification and intraocular lens (IOL) implantation. As described previously [ 23 – 31 ], the iStent inject implantation technique may be summarized as follows: after pupillary miosis with a cholinergic agent (carbachol), the anterior chamber is filled with a medium-viscosity ocular viscosurgical device (OVD) and the surgeon then guides a single-use stainless steel injector through a temporal clear corneal incision in order to deliver two pre-loaded titanium stents ab interno into the nasal Schlemm’s canal approximately two clock-hours apart. Each heparin-coated 360 µm × 230 µm stent has multiple lateral outlet lumens for fluid outflow and a symmetric design facilitating implantation in either the right or the left eye (Fig.…”

Section: Methodsmentioning

confidence: 99%

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Prospective, Non-randomized, 36-Month Study of Second-Generation Trabecular Micro-Bypass Stents with Phacoemulsification in Eyes with Various Types of Glaucoma

et al. 2018

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IntroductionThe aim of this study was to assess 36-month outcomes after cataract surgery and implantation of two second-generation trabecular micro-bypass stents (iStent inject, Glaukos Corporation, San Clemente, CA, USA) into eyes with predominantly primary open-angle glaucoma (POAG) or pseudoexfoliative glaucoma (PEX).MethodsThis prospective, non-randomized, consecutive cohort study included eyes with POAG (n = 60), PEX (n = 15), appositional narrow-angle (n = 4), pigmentary (n = 1), or neovascular (secondary) (n = 1) glaucoma and cataract requiring surgery. All eyes (n = 81) underwent ab interno iStent inject implantation following cataract surgery. Effectiveness endpoints through 36 months included intraocular pressure (IOP), number of medications, and proportion of eyes with ≥ 20% IOP reduction, IOP ≤ 18 mmHg, and IOP ≤ 15 mmHg. Safety measures included corrected distance visual acuity (CDVA), adverse events, and secondary surgeries. Outcomes were evaluated for the overall cohort, and for the POAG and PEX subgroups.ResultsPreoperatively, 32.1% of eyes had undergone prior glaucoma surgery, 56% were on 3–4 medications, and 1 eye (1%) was medication-free. At 36 months postoperatively, mean IOP reduced by 37% (14.3 ± 1.7 mmHg versus 22.6 ± 6.2 mmHg preoperatively), and mean medication burden decreased by 68% (0.8 ± 0.9 versus 2.5 ± 1.1 medications preoperatively). IOP reduced by ≥ 20% in 78% of eyes; 100% of eyes reached IOP ≤ 18 mmHg and 71% reached ≤ 15 mmHg. Medication burden reduced considerably: 22 eyes (54%) were medication-free compared to 1 eye (1%) preoperatively; 1 eye (2%) required ≥ 3 medications compared to 45 eyes (56%) preoperatively; and 92.7% of eyes required reduced medications postoperatively. From 3 through 36 months, mean IOP remained ≤ 15.0 mmHg, and mean number of medications remained ≤ 0.9. Outcomes in the POAG and PEX subgroups included 33% and 32% lower IOP, and 68% and 64% fewer medications, respectively. iStent inject showed a favorable safety profile, including no intraoperative complications, minimal adverse events, and a stable CDVA.ConclusionThis real-world cohort of eyes with various types of glaucoma and considerable disease burden exhibited durable and safe IOP and medication reductions through 36 months following iStent inject implantation with cataract surgery. Outcomes were similarly beneficial in eyes with POAG and PEX.FundingArticle processing charges were funded by Glaukos Corporation (San Clemente, CA, USA).

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Section: Discussionsupporting

confidence: 88%

Section: Methodsmentioning

confidence: 99%

Prospective, Non-randomized, 36-Month Study of Second-Generation Trabecular Micro-Bypass Stents with Phacoemulsification in Eyes with Various Types of Glaucoma

et al. 2018

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“…Previous studies have highlighted the efficacy of the iStent Inject with and without concomitant cataract surgery in reducing the IOP and medication burden [18][19][20][21][22][23][24][25][26][27]. In this study, we present a large consecutive case series of eyes undergoing iStent Inject implantation with concomitant cataract surgery by a single surgeon at an academic ophthalmology center in Montreal, Canada.…”

Section: Introductionmentioning

confidence: 99%

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

2019

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Purpose: To assess the 1-year efficacy and safety of the implantation of two second-generation trabecular micro-bypass stents (iStent Inject Ò) with concomitant cataract surgery in various subtypes and severities of glaucoma. Methods: This 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 B 18, B 15, and B 12 mmHg compared to baseline. Other measures included corrected distance visual acuity (CDVA), cup-todisc ratio (CDR), visual field mean deviation (VF MD), retinal nerve fiber layer (RNFL) thickness, ganglion cell inner plexiform layer (GCIPL) thickness, and adverse events. Results: In 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 B 18 mmHg (versus 69% preoperatively), 70% of eyes achieved IOP B 15 mmHg (versus 42% preoperatively), and 29% of eyes achieved IOP B 12 mmHg (versus 7% preoperatively). For all eyes, topical medications were either maintained or decreased from baseline, with C 1 medication eliminated from the preoperative regimen for 83% of eyes and C 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. Conclusion: iStent Inject implantation with cataract surgery safely reduced IOP and medication burden in a real-world clinical population with mild to severe glaucoma, and Enhanced Digital Features To view enhanced digital features for this article go to https://doi.org/10.6084/ m9.figshare.9762590.

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“…These outcomes support existing literature showing substantial reductions in medication after iStent and iStent inject implantation. [44][45][46] The iStent inject device is designed to have three general advantages over the iStent, as highlighted in a recent comparative study by Guedes et al 30 First, the iStent inject injector is pre-loaded with two stents (rather than one) in order to bypass two separate areas of the trabecular meshwork. Each stent is precisely designed to facilitate the needed flow of aqueous through the trabecular meshwork, which in a normal healthy eye averages 2.5 µL/ min.…”

Section: Discussionmentioning

confidence: 99%

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

Lindstrom¹,

Sarkisian²,

Lewis³

et al. 2020

OPTH

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Introduction: This 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 Methods: In 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. Results: At 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. Discussion: Standalone 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 Registration: ClinicalTrials.gov identifier, NCT02868190.

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Trabecular microbypass stents as minimally invasive approach after conventional glaucoma filtration surgery

Abstract: For eyes with previous filtration surgery and medically uncontrolled IOP, the implantation of 2 stents provided a minimally invasive and safe reduction of mean IOP to less than 18 mm Hg at 12 months. The number of medications was also reduced.

Cited by 13 publications

References 9 publications

Prospective, Non-randomized, 36-Month Study of Second-Generation Trabecular Micro-Bypass Stents with Phacoemulsification in Eyes with Various Types of Glaucoma

Prospective, Non-randomized, 36-Month Study of Second-Generation Trabecular Micro-Bypass Stents with Phacoemulsification in Eyes with Various Types of Glaucoma

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

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

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