Second-Generation Trabecular Micro-Bypass (iStent inject) with Cataract Surgery in Eyes with Normal-Tension Glaucoma: One-Year Outcomes of a Multi-Centre Study

Salimi, Ali; Clement, Colin I; Shiu, Michael; Harasymowycz, Paul

doi:10.1007/s40123-020-00266-6

Cited by 26 publications

(32 citation statements)

References 43 publications

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“…In this context, the number of micro-invasive glaucoma surgery (MIGS) procedures has increased because they offer safer interventional glaucoma treatment earlier in the course of the disease [6,[9][10][11]. In particular, canal-based MIGS provides advantages such as quicker visual recovery and sparing of conjunctival tissue for future glaucoma surgeries [10,[12][13][14].…”

Section: Introductionmentioning

confidence: 99%

“…The single trabecular microbypass stent with an internal diameter of 120 lm (iStentÒ) and the second-generation iStentÒ inject (containing two stents, each with an internal diameter of 80 lm) were designed to allow direct aqueous flow into Schlemm's canal, bypassing the trabecular meshwork [12,13]. Both devices have been studied in a variety of surgical treatment approaches, including stand-alone and cataract combination treatment; with single or multiple stents; and in the spectrum of glaucoma severities from mild to advanged stages, or even failed trabeculectomy [12,[15][16][17][18][19].…”

Section: Introductionmentioning

confidence: 99%

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Clinical Outcomes After Second-Generation Trabecular Microbypass Stents (iStent inject®) with Phacoemulsification in Korean Patients

Rho

Lim

2021

Ophthalmol Ther

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Introduction: To evaluate the intraocular pressure (IOP)-lowering effect of second-generation trabecular microbypass stents (iStentÒ inject) with cataract extraction (combination group) and compare refractive changes in the combination group and the control (phacoemulsification only) group. Methods: This retrospective case-control study included 36 eyes with cataract and medically controlled open-angle glaucoma with IOP \ 21 mmHg and 100 nonglaucomatous eyes with cataract. Data were collected preoperatively and for 6 months postoperatively. Data included IOP, number of glaucoma medications, corrected distance visual acuity, and mean absolute error (MAE) from target refraction, and astigmatic vector analysis. Surgical success for the combination group was defined according to three criteria: (A) IOP \ 15 mmHg without medication, (B) IOP \ 18 mmHg without medication, and (C) IOP \ 18 mmHg with or without medication. Results: In the combination group, mean IOP was reduced from 15.1 ± 2.9 mmHg to 12.5 ± 2.0 mmHg, and the mean number of medications decreased from 1.9 ± 1.0 to 0.4 ± 0.8 at postoperative 6 months (both P \ 0.001). Surgical success rates were 77.8%, 83.3%, and 97.2% at 6 months by criteria A, B, and C, respectively. Mean IOP was reduced from 14.3 ± 2.7 mmHg to 13.1 ± 2.1 mmHg at 1 month in the control group (P \ 0.001). The MAE was 0.33 ± 0.26 D, and 83.3% of eyes had spherical equivalent difference within 0.50 D in the combination group (0.38 ± 0.33 D and 76.0% in the control group; P = 0.309 and P = 0.363, respectively). Preoperative and postoperative centroid values were 0.51 D @ 1°and 0.66 D @ 178°, respectively (0.23 D @ 176°and 0.66 D @ 1°in the control group). There were no statistical differences between the two groups with respect to preoperative and postoperative mean absolute values (P = 0.154 and P = 0.322, respectively). Conclusions: On the basis of our results using Korean real-world interim experience, iStentÒ inject with cataract extraction has favorable IOP-lowering effects and minimally impacts refractive outcomes.

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Section: Introductionmentioning

confidence: 99%

Section: Introductionmentioning

confidence: 99%

Clinical Outcomes After Second-Generation Trabecular Microbypass Stents (iStent inject®) with Phacoemulsification in Korean Patients

Rho

Lim

2021

Ophthalmol Ther

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“…This device has been studied both with and without concomitant cataract extraction, and in studies with up to 5 years of follow-up. [24][25][26][27][28][29][30][31][32][33][34][35][36][37][38][39] Both iStent and iStent inject are implanted ab internally and enhance the physiologic trabecular outflow pathway of aqueous humor, thereby decreasing IOP. Targeting the natural outflow pathway helps avoid the risks of suprachoroidal, bleb-forming, subconjunctival, and/or ab externo procedures.…”

Section: Introductionmentioning

confidence: 99%

Treatment Success Across Different Levels of Preoperative Disease Burden: Stratified Two-Year Outcomes from the Pivotal Trial of iStent inject® Trabecular Micro-Bypass in Primary Open-Angle Glaucoma and Cataract

Singh¹,

Sarkisian²,

Hornbeak³

et al. 2021

OPTH

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Purpose: To examine effectiveness outcomes stratified by preoperative disease burden in the pivotal trial of iStent inject ® with cataract surgery (INJ) vs cataract surgery alone (CS). Materials and Methods: Prospective, 3:1 randomized, single-masked, concurrentlycontrolled, multicenter trial enrolling 505 subjects with cataract and mild-to-moderate primary open-angle glaucoma who underwent iStent inject implantation with phacoemulsification or phacoemulsification alone, and were followed for 2 years including annual medication washouts. Post hoc stratification was completed for baseline mean diurnal intraocular pressure (BL DIOP; Low-DIOP <25mmHg, Mid-DIOP ≥25 to <30 mmHg, High-DIOP ≥30mmHg) and preoperative medication burden (Low-Med 1 medication, Mid-Med 2 medications, High-Med ≥3 medications). Results: The 24-month primary and secondary effectiveness endpoints were met, with significant treatment-over-control differences in percent of eyes achieving ≥20% unmedicated DIOP reduction and in unmedicated DIOP reduction, respectively. In subgroup analyses, the proportions of INJ eyes achieving the primary endpoint remained steady across all BL DIOP (75.4%, 77.1%, 74.4% in Low/Mid/High-DIOP strata, respectively) and preoperative medication levels (76.8%, 70.8%, 79.7% in Low/Mid/High-Med strata, respectively); meanwhile, the proportions of CS eyes diminished with higher BL DIOP (64.5%, 63.6%, 33.3%, respectively) and more medications (69.0%, 63.3%, 29.4%, respectively). Regarding secondary effectiveness, postoperative DIOP reduction increased with higher BL DIOP in INJ eyes (6.2mmHg, 7.8mmHg, 9.8mmHg, respectively) but plateaued in CS eyes (5.2mmHg, 5.8mmHg, 5.4mmHg, respectively). INJ eyes also had consistent DIOP reduction regardless of preoperative medication burden (6.8mmHg, 6.7mmHg, 7.8mmHg, respectively), while DIOP reduction diminished with more medications in CS eyes (6.1mmHg, 5.0mmHg, 3.3mmHg, respectively). Safety was favorable, comparable to phacoemulsification alone. Conclusion: Significant IOP reductions occurred across all levels of BL DIOP and preoperative medication burden in iStent inject eyes. DIOP reductions increased with higher BL DIOP and remained stable across all levels of preoperative medication burden, suggesting the device's potential utility in more medically challenging cases.

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“…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. 41 NTG presents a challenge for glaucoma treatment, particularly with respect to MIGS devices, because it can be difficult to lower IOP below episcleral venous pressure (EVP) with current MIGS procedures involving the physiologic trabecular outflow pathway.…”

Section: Introductionmentioning

confidence: 99%

“… 7 – 40 However, relatively few studies have been completed in Japanese patients 11 , 23 or in NTG. 24 , 25 …”

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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Second-Generation Trabecular Micro-Bypass (iStent inject) with Cataract Surgery in Eyes with Normal-Tension Glaucoma: One-Year Outcomes of a Multi-Centre Study

Cited by 26 publications

References 43 publications

Clinical Outcomes After Second-Generation Trabecular Microbypass Stents (iStent inject®) with Phacoemulsification in Korean Patients

Clinical Outcomes After Second-Generation Trabecular Microbypass Stents (iStent inject®) with Phacoemulsification in Korean Patients

Treatment Success Across Different Levels of Preoperative Disease Burden: Stratified Two-Year Outcomes from the Pivotal Trial of iStent inject® Trabecular Micro-Bypass in Primary Open-Angle Glaucoma and Cataract

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

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