Clinical evaluation of a trabecular microbypass stent with phacoemulsification in patients with open-angle glaucoma and cataract

Ferguson, Tanner J.; Berdahl, John P.; Schweitzer, Justin; Sudhagoni, Ramu

doi:10.2147/opth.s114306

Cited by 53 publications

(47 citation statements)

References 17 publications

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“…The IOP reduction at M36 approached 5 mmHg (4.82) with 68% (n = 15) of eyes achieving an IOP ≤15 mmHg compared to 25% (n = 6) of eyes at baseline. Consistent with prior studies, this study also demonstrated a relationship between baseline IOP and reduction of pressure, which has been demonstrated both with phacoemulsification alone as well as prior MIGS studies. Eyes with baseline IOP ≥22 mmHg achieved a robust reduction in pressure at their last follow‐up with a mean of 9.3 mmHg, significantly greater than the IOP reduction observed in eyes with baseline pressure <18 mmHg.…”

Section: Discussionsupporting

confidence: 90%

“…Although this is not a true “off label” use of the device, the clinical trials leading to its approval did not include eyes with pigmentary or pseudoexfoliative glaucoma. In addition, while not directly comparable, the results of this study are comparable or superior to our published data in eyes with POAG and PXG . At M24 postoperative in those studies, the mean IOP reduction in the POAG and PXG eyes was 3.96 and 5.49 mmHg, respectively.…”

Section: Discussionsupporting

confidence: 73%

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Trabecular micro‐bypass stent implantation with cataract extraction in pigmentary glaucoma

Ferguson

Ibach

Schweitzer

et al. 2019

Clinical Exper Ophthalmology

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Importance: Use of the trabecular micro-bypass stent with cataract surgery is well established to be safe and effective in primary open-angle glaucoma. This is the first study to exclusively evaluate use of the device in pigmentary glaucoma. Background: This study aimed to investigate the safety and efficacy of a trabecular micro-bypass stent in combination with cataract surgery in pigmentary glaucoma. Design: Retrospective, consecutive case series. Participants: Twenty-four eyes of 12 patients with pigmentary glaucoma implanted with one trabecular micro-bypass stent with concomitant cataract surgery. Methods: Baseline data was collected and compared to the following postoperative time points: 1 day, 1 week, 1 month out to 36 months (M36) after the procedure. Main Outcome Measures: These included intraocular pressure (IOP), number of glaucoma medications and need for additional surgery. Results: At M36 there was a 25% reduction in IOP to 14.68 ± 3.0 (P < .01) from 19.50 ± 6.7 mmHg at baseline. The mean number of glaucoma medications was 0.75 ± 1.0 prior to the surgery and 0.59 ± 0.6 (P > .05) at 36 M. At the 36 M time-point, 95% of eyes had IOP ≤ 18 mmHg and 68% of eyes were ≤ 15 mmHg. No eyes underwent a secondary glaucoma procedure. Conclusions and Relevance: The insertion of a single trabecular micro-bypass stent in combination with cataract surgery effectively provides a sustained reduction in IOP up to 3 years after surgery in patients with pigmentary glaucoma. The safety profile is favourable with low rate of IOP spikes and no patients requiring additional surgery. K E Y W O R D S iStent, MIGS, pigmentary glaucoma, secondary open-angle glaucoma, trabecular micro-bypass stent

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Section: Discussionsupporting

confidence: 90%

Section: Discussionsupporting

confidence: 73%

Trabecular micro‐bypass stent implantation with cataract extraction in pigmentary glaucoma

Ferguson

Ibach

Schweitzer

et al. 2019

Clinical Exper Ophthalmology

Self Cite

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“…Studies also demonstrate that MIGS procedures are more effective in patients with higher baseline IOP. Accordingly, patients with lower baseline IOP, as in normal-tension glaucoma, are predisposed to smaller IOP reductions following MIGS procedures, with these results potentially insufficient to mitigate disease progression [52,53]. Although many therapeutic options for OAG exist, even patients with access to excellent care and cutting-edge treatments still progress to blindness.…”

Section: Treatment Optionsmentioning

confidence: 99%

Open-Angle Glaucoma: Burden of Illness, Current Therapies, and the Management of Nocturnal IOP Variation

et al. 2019

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Glaucoma is a chronic, debilitating disease and a leading cause of global blindness. Despite treatment efforts, 10% of patients demonstrate loss of vision. In the US, [ 80% of glaucoma cases are classified as open-angle glaucoma (OAG), with primary open-angle (POAG) being the most common. Although there has been tremendous innovation in the surgical treatment of glaucoma as of late, two clinical variants of OAG, normaltension glaucoma (NTG) and severe POAG, are especially challenging for providers because patients with access to care and excellent treatment options may progress despite achieving a ''target'' intraocular pressure value. Additionally, recent research has highlighted the importance of nocturnal IOP control in avoiding glaucomatous disease progression. There remains an unmet need for new treatment options that can effectively treat NTG and severe POAG patients, irrespective of baseline IOP, while overcoming adherence limitations of current pharmacotherapies, demonstrating a robust safety profile, and more effectively controlling nocturnal IOP.

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“…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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Clinical evaluation of a trabecular microbypass stent with phacoemulsification in patients with open-angle glaucoma and cataract

Cited by 53 publications

References 17 publications

Trabecular micro‐bypass stent implantation with cataract extraction in pigmentary glaucoma

Trabecular micro‐bypass stent implantation with cataract extraction in pigmentary glaucoma

Open-Angle Glaucoma: Burden of Illness, Current Therapies, and the Management of Nocturnal IOP Variation

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

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