Micro-Bypass Implantation for Primary Open-Angle Glaucoma Combined with Phacoemulsification: 4-Year Follow-Up

Fea, Antonio Maria; Consolandi, Giulia; Zola, Marta; Pignata, Giulia; Cannizzo, Paola Maria Loredana; Lavia, Carlo; Rolle, Teresa; Grignolo, Federico

doi:10.1155/2015/795357

Cited by 76 publications

(72 citation statements)

References 10 publications

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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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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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“…A large RCT performed by Craven et al demonstrated modest IOP reduction of 1.5 mmHg from preoperative medicated IOP levels with a corresponding decrease in medications from 1.6 ± 0.8 to 0.3 ± 0.6 [17], while another large RCT by Samuelson found an equally modest IOP reduction of 1.5 mmHg after 1 year with a decrease in medication from 1.5 ± 0.6 to 0.2 ± 0.6 [18]. Two other smaller RCTs by Fea et al found similar IOP reductions and medication reduction to 0.5 medication or less [19, 20] (Table 2). In some RCTs, there was a specified medication washout period postoperatively and the authors found postoperative IOP to be around 17 mmHg [10, 16].…”

Section: Resultsmentioning

confidence: 99%

Safety and Efficacy of Microinvasive Glaucoma Surgery

Chen

Sng

2017

Journal of Ophthalmology

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Microinvasive glaucoma surgery (MIGS) is emerging as a new therapeutic option for glaucoma patients who wish to reduce their medication burden and avoid the postoperative complications of conventional glaucoma filtration surgery. These devices differ in terms of their efficacy and safety profile. Schlemm's canal devices have the most favorable safety profile at the compromise of modest efficacy, while subconjunctival and suprachoroidal devices are potentially more effective at lowering the intraocular pressure at the expense of a higher rate of complications. This review consolidates the latest evidence on the efficacy and safety of the MIGS devices in clinical use and provides an overview on upcoming devices which would likely also become viable treatment options in the near future. These clinical data would assist a glaucoma surgeon in selecting the most appropriate MIGS device for each patient based on the glaucoma severity and patient expectations.

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“…The common control arm of cataract surgery as a single procedure allowed for indirect comparison of alternative MIGS. The widely used ITC method described by Bucher and collaborators was used, which allows for an adjusted estimation of the effects without compromising the original trial randomization [17]. In alignment with the evidence found, a total of three ITCs were feasible, as outlined in Fig.…”

Section: Indirect Treatment Comparison and Combined Treatment Effectsmentioning

confidence: 99%

Comparative efficacy and cost–utility of combined cataract and minimally invasive glaucoma surgery in primary open-angle glaucoma

Bartelt-Hofer

Fleßa

2020

Int Ophthalmol

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Purpose To assess the comparative efficacy and the long-term cost-utility of alternative minimally invasive glaucoma surgeries (MIGSs) when combined with cataract surgery in patients with primary openangle glaucoma (POAG). Methods Treatment effects, as measured by the 1-year reduction in intraocular pressure (IOP), were estimated with an adjusted indirect treatment comparison. Evidence from randomized clinical trials was identified for four different MIGS methods. A diseasetransition model was developed by capturing clinically relevant POAG stages and the expected natural disease evolution. Outcomes of the disease-transition model were the comparative utility [quality-adjusted life years (QALYs)], cost and cost-utility of included strategies in a lifetime horizon. Results Estimated 1-year IOP reductions were: cataract surgery-2.05 mmHg (95% CI-3.38;-0.72), one trabecular micro-bypass stent-3.15 mmHg (95% CI-5.66;-0.64), two trabecular micro-bypass stents-4.85 mmHg (95% CI-7.71;-1.99) and intracanalicular scaffold-2.25 mmHg (95% CI-4.87; 0.37). Discounted outcomes from the disease-transition model appraised the strategy of two trabecular micro-bypass stents with cataract surgery in the moderate POAG stage as the one providing the greatest added value, with 10,955€ per additional QALY. Improved outcomes were seen when assessing MIGS in the moderate POAG stage. Conclusions When indirectly comparing alternative MIGS methods combined with cataract surgery, the option of two trabecular micro-bypass stents showed both a superior efficacy and long-term cost-utility from a German perspective. Moreover, outcomes of the disease-transition model suggest POAG patients to beneficiate the most from an earlier intervention in the moderate stage contrary to waiting until an advanced disease is present. Keywords Primary open-angle glaucoma Á POAG Á Minimally invasive glaucoma surgery Á MIGS Á Costutility Á Cost-effectiveness

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Micro-Bypass Implantation for Primary Open-Angle Glaucoma Combined with Phacoemulsification: 4-Year Follow-Up

Cited by 76 publications

References 10 publications

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

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

Safety and Efficacy of Microinvasive Glaucoma Surgery

Comparative efficacy and cost–utility of combined cataract and minimally invasive glaucoma surgery in primary open-angle glaucoma

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