Evaluating the Trabecular Micro-Bypass Stent Combined with Phacoemulsification Compared to Phacoemulsification Alone

Wardani, Mohamad El; Bergin, Ciara; Achache, Farid; Sharkawi, Eamon

doi:10.1055/s-0035-1545798

Cited by 33 publications

(25 citation statements)

References 4 publications

Supporting

Mentioning

Contrasting

Order By: Relevance

“…Within a whole eye perfusion model, IOP decreased by 6.0 mmHg from baseline with a single iStent and decreased by an additional 2.9 mmHg with a second iStent, for a total IOP reduction of 8.9 mmHg from baseline [47]. Echoing these preclinical findings, a prospective clinical trial compared 3.5-year results of one, two, or three iStents implanted in a sole procedure [30], while two other studies analyzed two or three iStents with concomitant cataract surgery [48,49]. These three studies confirmed that while the first stent produces the majority of IOP reduction, additional stents enable further reduction.…”

Section: Discussionmentioning

confidence: 99%

Second-generation trabecular micro-bypass stent implantation: Retrospective analysis after 12- and 24-month follow-up

Neuhann¹,

Neuhann²

2020

Eye and Vis

View full text Add to dashboard Cite

Background: The study aimed to investigate the 24-month safety and efficacy of implantation of two secondgeneration iStent inject trabecular micro-bypass stents with concomitant cataract surgery. Methods: This consecutive case series included 164 eyes of 109 patients implanted with the iStent inject® device with concomitant cataract surgery. The series was comprised of eyes with primary open-angle glaucoma (n = 84), pseudoexfoliation glaucoma (n = 42), normal-tension glaucoma (n = 18), and ocular hypertension (n = 20). All 164 eyes reached 9-14 months of follow-up ("12-month consistent cohort"), with a subset of 88 eyes reaching 21-26 months of follow-up ("24-month consistent cohort"). Performance outcome measures included intraocular pressure (IOP) and number of glaucoma medications. Safety outcomes included intra-or postoperative complications, the need for secondary procedures and corrected distance visual acuity. Comparisons of change in continuous (e.g., IOP) and categorical (e.g., proportions of eyes on zero medications) measures between baseline and postoperative times were made with the paired t-test and McNemar's chi-squared test, respectively. Results: At 12 months postoperatively, IOP was reduced by 25.5% (from 20.0 ± 5.5 mmHg to 14.9 ± 2.0 mmHg; p < 0.001); at 24 months postoperatively, IOP was reduced by 26.6% (from 20.3 ± 6.1 mmHg to 14.9 ± 1.9 mmHg; p < 0.001). At 12 months postoperatively, mean number of glaucoma medications was reduced by 85.0% (from 2.0 ± 1.0 to 0.3 ± 0.8 medications; p < 0.001); at 24 months postoperatively, mean number of medications was reduced by 81.0% (from 2.1 ± 1.1 to 0.4 ± 0.8 medications; p < 0.001). After 12 months, 96.3% of eyes had an IOP ≤ 18 mmHg and 58.5% of eyes had an IOP ≤ 15 mmHg, with 81.1% of eyes free of any medication, compared to 1.8% of eyes medication-free in the 12-month cohort at baseline. After 24 months, 98.9% of eyes had an IOP ≤ 18 mmHg and 53.4% of eyes had an IOP ≤ 15 mmHg, with 72.7% free of medication compared to 1.1% of eyes medication-free in the 24-month cohort at baseline. Overall, a high safety profile was observed with no significant postoperative complications. Conclusions: The insertion of iStent inject (comprised of two second-generation trabecular micro-bypass stents) with cataract surgery effectively provides a sustained reduction in IOP with a markedly improved medication burden up to 24 months postoperatively.

show abstract

Section: Discussionmentioning

confidence: 99%

Second-generation trabecular micro-bypass stent implantation: Retrospective analysis after 12- and 24-month follow-up

Neuhann¹,

Neuhann²

2020

Eye and Vis

View full text Add to dashboard Cite

show abstract

“…On the clinical side, a prospective randomized trial by Katz et al compared long-term outcomes following implantation of one, two, and three iStents in a standalone procedure, and Belovay et al and El Wardani et al evaluated two or three iStents combined with cataract surgery [33,56,57]. All three clinical studies demonstrated that the majority of IOP reduction occurs after the first stent and that additional stents produce further IOP reduction, likely due to access to more regions of the distal outflow network and increased probability of stenting areas of Schlemm's canal that are still patent and functional.…”

Section: Discussionmentioning

confidence: 99%

Real-world Case Series of iStent or iStent inject Trabecular Micro-Bypass Stents Combined with Cataract Surgery

Manning

2019

Ophthalmol Ther

View full text Add to dashboard Cite

Introduction: This real-world retrospective case series assessed 12-month effectiveness and safety following implantation of iStent Ò or iStent inject Ò trabecular micro-bypass with cataract surgery. Methods: Consecutive patients were implanted with either iStent (comprising 1 stent) or iStent inject (comprising 2 stents), together with cataract surgery. Most patients had primary openangle glaucoma. Effectiveness outcomes through 12 months included intraocular pressure (IOP) and glaucoma medications. Proportional analyses were completed for eyes achieving IOP B 18 mmHg, IOP B 15 mmHg, or IOP reduction C 20% from preoperative; and eyes on 0 medications or C 2 medications. Safety outcomes included adverse events, secondary surgeries, visual acuity, and visual fields. Results: This analysis included 137 eyes (67 iStent, 70 iStent inject) with cataract and mild to moderate glaucoma or ocular hypertension. Over 73% of eyes in both groups had early disease, and * 22% had prior glaucoma surgery. At 12 months postoperatively, mean IOP decreased from 18.4 ± 4.2 mmHg to 14.2 ± 2.5 mmHg in iStent eyes (p \ 0.0001), and from 20.4 ± 5.6 mmHg to 14.4 ± 2.1 mmHg in iStent inject eyes (p \ 0.0001). The IOP reduction was significantly greater for iStent inject eyes than iStent eyes (6.0 mmHg versus 4.2 mmHg reduction, p = 0.034). Both groups had high proportions of patients achieving the 12-month IOP endpoints, although consistently greater proportions reached these endpoints after iStent inject than iStent: 95.7% versus 92.5% had IOP B 18 mmHg, respectively; 74.3% versus 71.6% had IOP B 15 mmHg, respectively; and 68.6% versus 62.7% had IOP reduction C 20% from baseline, respectively. Mean medication burden at 12 months decreased from 1.8 ± 0.7 to 0.3 ± 0.5 medications in iStent eyes (84.0% reduction, p \ 0.0001), and from 1.3 ± 0.9 to 0.1 ± 0.3 medications in iStent inject eyes (94.7% reduction, p \ 0.0001). Significantly more iStent inject eyes were medication-free at 12 months than iStent eyes (92.9% versus 76.1% medication-free, respectively; p = 0.0068). Favorable safety included few adverse events, no secondary glaucoma surgeries, and stable visual acuity and visual fields in both groups. Conclusion: Significant and safe IOP and medication reductions were achieved through 12 months after iStent or iStent inject implantation with cataract surgery. iStent inject eyes Enhanced digital features To view enhanced digital features for this article go to

show abstract

“…In terms of IOP reduction, the patient outcomes were comparable to published results of surgeons' early cases of combined phacoemulsification and iStent insertion. [6][7][8][9][10] This suggests that our residents' performance was not inferior to that of other surgeons new to the procedure. While the focus of this article is not the efficacy of the iStent, these patient outcomes support the promising results of our curriculum.…”

Section: Discussionmentioning

confidence: 77%

Institution of a Surgical Curriculum for Trabecular Microbypass Stent Placement

et al. 2018

View full text Add to dashboard Cite

Purpose This article evaluates whether a targeted, stepwise curriculum for microbypass stent placement leads to successful insertion of the iStent (Glaukos, Laguna Hills, CA) by resident surgeons. Participants Senior (postgraduate year 4) ophthalmology residents (9 residents) from three classes during the 2015 to 2016, 2016 to 2017, and 2017 to 2018 academic years. Design Residents participated in a three-stage surgical curriculum. First, a wet laboratory was held for residents to gain familiarity with the device and develop bimanual surgical proficiency. The wet laboratory involved several stations, with each station requiring increased dexterity for successful completion. Next, residents practiced bimanual intraoperative gonioscopy after routine phacoemulsification procedures. Finally, residents performed combined phacoemulsification and iStent insertion under the supervision of an experienced attending surgeon. Primary success was determined by correct anatomical placement of the device confirmed via subsequent intraoperative gonioscopy by the supervising surgeon. Secondary success was measured by change in intraocular pressure (IOP) and number of topical hypotensive medications used after surgery. Residents provided feedback about the effectiveness of the curriculum via an online survey. Results There were a total of 43 cases. There were no significant intraoperative complications, including hyphema. The iStent location was confirmed during both intraoperative and postoperative gonioscopy and was noted to be in appropriate position for the duration of the follow-up period (6–12 months) for all patients. Average preoperative IOP in our subjects was 17.5 ± 4.0 mm Hg and mean number of preoperative medications was 1.4 ± 1.0. At 6 months' postoperative, average IOP was 14.5 ± 2.2 mm Hg (13% reduction from baseline [±15%]). At 12 months' postoperative, average IOP was 14.4 ± 3.5 mm Hg, with a reduction of 14% (±18%). The mean number of medications at follow-up was 1.2 ± 1.1. Mean postoperative IOP at 6 and 12 months was significantly lower compared with baseline (p = 0.0002, p = 0.0001). Residents agreed that the curriculum prepared them to perform iStent insertion during residency and most residents felt prepared after residency. Conclusion This stepwise surgical curriculum for trabecular microbypass stent placement leads to successful performance of the procedure by residents and is a useful model for other residency programs.

show abstract

Evaluating the Trabecular Micro-Bypass Stent Combined with Phacoemulsification Compared to Phacoemulsification Alone

Abstract: iStent implantation resulted in similar IOP reduction to phacoemulsification alone but achieved a significantly greater reduction in glaucoma medications. This may improve compliance and quality of life, and reduce health care costs in patients with early to moderate glaucoma.

Cited by 33 publications

References 4 publications

Second-generation trabecular micro-bypass stent implantation: Retrospective analysis after 12- and 24-month follow-up

Second-generation trabecular micro-bypass stent implantation: Retrospective analysis after 12- and 24-month follow-up

Real-world Case Series of iStent or iStent inject Trabecular Micro-Bypass Stents Combined with Cataract Surgery

Institution of a Surgical Curriculum for Trabecular Microbypass Stent Placement

Contact Info

Product

Resources

About