Evaluation of a Trabecular Microbypass Stent With Cataract Extraction in Severe Primary Open-angle Glaucoma

Ferguson, Tanner J.; Swan, Russell; Ibach, Mitch; Schweitzer, Justin; Sudhagoni, Ramu; Berdahl, John P.

doi:10.1097/ijg.0000000000000825

Cited by 39 publications

(27 citation statements)

References 14 publications

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“…In addition, the proportion of eyes with IOP ≤15 mmHg nearly doubled versus preoperative (81% at 24 months versus 42% preoperatively). Consistent with prior studies evaluating IOP-lowering treatments, 10,[15][16][17]46,47 eyes with higher baseline IOP achieved a more robust postoperative IOP reduction than eyes with lower baseline IOP. Also consistent with prior MIGS studies, 16,17,48 our data suggested a slight diminution of IOP-and medication-reducing effects after the first year postoperative.…”

Section: Discussionsupporting

confidence: 82%

“…To date, the safety and performance of iStent trabecular micro-bypass have been established by a breadth of studies evaluating the device, including in standalone implantation or in combination with cataract surgery or other MIGS procedures, in both single-and multiple-stent usage, in populations with various levels of disease severity, and in various subtypes of glaucoma and ocular hypertension. [7][8][9][10][11][12][13][14][15][16][17][18][19][20][21][22][23] The stent has been widely adopted and studied by surgeons around the world. 43 However, iStent outcomes have not been as closely examined in Japanese populations.…”

Section: Discussionmentioning

confidence: 99%

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iStent Trabecular Micro-Bypass Stent Implantation with Cataract Surgery in a Japanese Glaucoma Population

Nitta¹,

Yamada²,

Morokado³

et al. 2020

OPTH

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Introduction: This study assesses two-year efficacy and safety following implantation of a single trabecular micro-bypass stent (iStent ®) with concomitant phacoemulsification cataract surgery in Japanese patients with open-angle glaucoma (OAG). Materials and Methods: This retrospective, consecutive case series included eyes that underwent iStent implantation with phacoemulsification and were followed for 24 months postoperative. Efficacy and safety measures included intraocular pressure (IOP), number of glaucoma medications, adverse events, secondary surgeries, visual fields, and endothelial cell counts. Results: Of 73 operated eyes, 53 eyes had 24 months of follow-up and are analyzed. Diagnoses included primary open-angle glaucoma (POAG, n=25), normal-tension glaucoma (NTG, n=16), and pseudoexfoliative glaucoma (PXG, n=12). At 24 months, mean IOP reduced by 18% to 13.6 ±3.0 mmHg versus 16.5±3.4 mmHg preoperatively (p<0.0001), and mean medication number reduced by 81% to 0.37±0.74 versus 1.96±0.98 preoperatively (p<0.0001). The percentage of medication-free eyes was 77% versus 0% preoperatively, and 81% of eyes had IOP ≤15 mmHg versus 42% preoperatively. Results were similarly favorable across glaucoma subtypes (POAG, NTG, PXG). Notably, mean IOP in NTG eyes decreased to 12.8±1.4 mmHg from 14.4±3.0 mmHg preoperatively (p=0.03), and medications decreased by 87% to 0.31±0.70 versus 2.38 ±0.72 preoperatively (p<0.0001). At 24 months, 81% of NTG eyes were medication-free (versus 0% preoperatively); 2 NTG eyes (13%) were on ≥2 medications (versus 100% preoperatively). Throughout the follow-up, visual fields and endothelial cell counts remained stable; 1 eye (1.9%) underwent filtration surgery. Discussion: Favorable safety and significant IOP and mediation reductions were achieved through two years following iStent implantation with phacoemulsification in a Japanese population. These gains were achieved across all glaucoma subtypes (including POAG, NTG, PXG). Conclusion: This real-world study supports the viability of iStent implantation to treat Japanese patients with glaucoma and shows that the benefits extend to those with NTG or PXG in addition to POAG.

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Section: Discussionsupporting

confidence: 82%

Section: Discussionmentioning

confidence: 99%

iStent Trabecular Micro-Bypass Stent Implantation with Cataract Surgery in a Japanese Glaucoma Population

Nitta¹,

Yamada²,

Morokado³

et al. 2020

OPTH

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“…The observed 2.7 mmHg IOP reduction should be appreciated in the context of the cohort’s relatively low mean starting IOP, given that lower starting IOP usually results in smaller postoperative IOP reductions. 16 , 17 , 29 , 42 , 43 The IOP target of ≤15 mmHg was achieved in half-again more eyes at two years versus preoperative (77% vs 49%, p<0.001). Coinciding with this IOP reduction, there was a threefold decrease in mean medication burden (0.49 versus 1.49 medications, p<0.001).…”

Section: Discussionmentioning

confidence: 91%

Two-Year Multicenter Outcomes of iStent inject Trabecular Micro-Bypass Stents Combined with Phacoemulsification in Various Types of Glaucoma and Ocular Hypertension

Clement¹,

Howes²,

Ioannidis³

et al. 2020

OPTH

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Purpose This multicenter study evaluated 2-year effectiveness and safety following implantation of two second-generation trabecular micro-bypass stents (iStent inject ® ) with phacoemulsification. Materials and Methods This was a retrospective study of iStent inject implantation with phacoemulsification by nine surgeons across Australia. Eyes had mild to advanced glaucoma (predominantly primary open-angle/POAG, appositional angle-closure/ACG, or normal-tension/NTG) or ocular hypertension (OHT), and cataract. Evaluations included intraocular pressure (IOP); medications; proportions of eyes with 0 or ≥2 medications, reduced/stable medications versus preoperative, and IOP ≤15 mmHg; visual acuity; cup-to-disc ratio (CDR); visual fields (VF); adverse events; and secondary surgery. Results A total of 340 eyes underwent surgery and had 24-month follow-up data. At 24 months, mean IOP decreased by 16% from 16.4±4.7 mmHg preoperatively to 13.7±3.1 mmHg (p<0.001), and 77% of eyes achieved IOP of ≤15 mmHg versus 49% preoperatively (p<0.001). Mean number of medications decreased by 67% to 0.49±0.95 versus 1.49±1.20 preoperatively (p<0.001), with 74% of eyes medication-free versus 25% preoperatively (p<0.001), and 14% of eyes on ≥2 medications versus 46% preoperatively (p<0.001). Medication burden was reduced or stable in 98% of eyes versus preoperative. Stratified analyses showed significant IOP and medication reductions across glaucoma subtypes (POAG, ACG, NTG, OHT): 13–22% for IOP (p<0.01 for all) and 62–100% for medication (p<0.001 for all). Favorable safety included few adverse events; stable CDR, VF, and visual acuity; and filtering surgery in only 8 eyes (2.4%) over 2 years. Conclusion This 340-eye multicenter dataset provides robust evidence of the safety and efficacy of iStent inject implantation with phacoemulsification, with significant and sustained IOP and medication reductions through 2 years. Results were similarly favorable across glaucoma subtypes (including POAG, ACG, NTG, OHT) and were attained across various glaucoma severities, clinical sites, and surgeons, highlighting the real-world versatility and utility of this treatment modality.

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“…Compared with the previously published outcomes of the surgeon's stent-cataract experience, in which IOP was reduced by 37% and medications were reduced by 68% [46], the IOP and medication reductions in this stand-alone cohort were slightly higher (42% and 82% reductions, respectively). Possible reasons for this difference include the higher preoperative IOP in the stand-alone cohort, as this is known to produce greater postoperative IOP reductions [27,29]. The preoperative medication burden also was higher in the stand-alone cohort, which may predispose to greater reductions in medication number if the end goal is the same for a given patient (0 or 1 medication, for example).…”

Section: Discussionmentioning

confidence: 99%

“…To date, this device has amassed a sizable longterm evidence base regarding its safety and performance in eyes with open-angle glaucoma, in settings both with and without cataract surgery. Most studies of the device have assessed outcomes in mild to moderate glaucoma [17][18][19][20][21][22][23][24][25][26][27], but other patient populations increasingly have been the subject of evaluation, such as pseudoexfoliative glaucoma, severe or refractory glaucoma, or newly diagnosed, treatment-naïve glaucoma [28][29][30][31][32][33]. Another growing and relevant area of investigation has been economics outcomes research [34][35][36][37][38][39], which consistently has shown favorable cost-effectiveness of the iStent in various healthcare models around the world.…”

Section: Introductionmentioning

confidence: 99%

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

2019

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Introduction: To evaluate long-term outcomes following stand-alone implantation of two second-generation trabecular micro-bypass stents (iStent inject Ò , Glaukos Corp., San Clemente, CA, USA) in eyes with predominantly primary open-angle glaucoma (POAG) and considerable preoperative disease burden. Methods: Eyes 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. Results: Two 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 C 20% versus preoperatively. In addition, 97% of eyes reached IOP B 18 mmHg (vs. 9.1% preoperatively; p \ 0.0001) and 70.0% of eyes reached IOP B 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. Conclusion: This 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. Funding: Article processing charges and writing assistance were provided by Glaukos Corp.

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Evaluation of a Trabecular Microbypass Stent With Cataract Extraction in Severe Primary Open-angle Glaucoma

Abstract: Trabecular microbypass stent implantation during cataract surgery safely and effectively lowers IOP and medication use in patients with severe primary open-angle glaucoma.

Cited by 39 publications

References 14 publications

<p>iStent Trabecular Micro-Bypass Stent Implantation with Cataract Surgery in a Japanese Glaucoma Population</p>

<p>iStent Trabecular Micro-Bypass Stent Implantation with Cataract Surgery in a Japanese Glaucoma Population</p>

<p>Two-Year Multicenter Outcomes of iStent <em>inject</em> Trabecular Micro-Bypass Stents Combined with Phacoemulsification in Various Types of Glaucoma and Ocular Hypertension</p>

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

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