Safety and Efficacy of Two Trabecular Micro-Bypass Stents as the Sole Procedure in Japanese Patients with Medically Uncontrolled Primary Open-Angle Glaucoma: A Pilot Case Series

Shiba, Daisuke; Hosoda, Shigeki; Yaguchi, Shigeo; Ozeki, Naoki; Yuki, Kenya; Ohta, Michio

doi:10.1155/2017/9605461

Cited by 30 publications

(22 citation statements)

References 27 publications

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“…The only published report of double iStent standalone surgery performed outside of the MIGS Study Group was a 10-patient pilot study conducted at a single center in Japan. 39 In that study, the mean preoperative IOP was 22.2AE3.0 mmHg and each patient was on 3 medications (prostaglandin analogues, b-blockers, and carbonic anhydrase inhibitors) per protocol throughout the 6-month course of the study. At 6 months follow-up, mean IOP was 16.9AE3.6 mmHg on 3 medications, and the response rate, defined as the percentage of eyes reaching 18 mmHg, was 44%.…”

Section: Discussionmentioning

confidence: 99%

A Prospective Randomized Trial Comparing Hydrus and iStent Microinvasive Glaucoma Surgery Implants for Standalone Treatment of Open-Angle Glaucoma

et al. 2020

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Section: Discussionmentioning

confidence: 99%

A Prospective Randomized Trial Comparing Hydrus and iStent Microinvasive Glaucoma Surgery Implants for Standalone Treatment of Open-Angle Glaucoma

et al. 2020

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“…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%

“…They have been studied extensively and are established as a safe and effective option in various types of OAG with and without concomitant cataract surgery. However, relatively few studies have been completed in Japanese patients 11,23 or in NTG. 24,25 Japanese populations have a significantly higher prevalence of NTG than most other populations, accounting for >90% of OAG cases in Japan.…”

Section: Introductionmentioning

confidence: 99%

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

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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“…This stent allows circumvention of the damaged trabecular meshwork by creating a direct route from the anterior chamber to Schlemm's canal. Considerable evidence has shown the stents' ability to provide meaningful postoperative reductions in IOP and medication burden for up to 5 years with or without concomitant cataract surgery, and in various subtypes and severities of glaucoma [11][12][13][14][15][16][17]. Moreover, these benefits have occurred with favorable safety and minimal disruption to ocular structures.…”

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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Safety and Efficacy of Two Trabecular Micro-Bypass Stents as the Sole Procedure in Japanese Patients with Medically Uncontrolled Primary Open-Angle Glaucoma: A Pilot Case Series

Cited by 30 publications

References 27 publications

A Prospective Randomized Trial Comparing Hydrus and iStent Microinvasive Glaucoma Surgery Implants for Standalone Treatment of Open-Angle Glaucoma

A Prospective Randomized Trial Comparing Hydrus and iStent Microinvasive Glaucoma Surgery Implants for Standalone Treatment of Open-Angle Glaucoma

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

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

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