Implantation of two second‐generation trabecular micro‐bypass stents and topical travoprost in open‐angle glaucoma not controlled on two preoperative medications: 18‐month follow‐up

Berdahl, John P.; Voskanyan, Lilit; Myers, Jonathan S.; Hornbeak, Dana M.; Giamporcaro, Jane Ellen; Katz, L. Jay; Samuelson, Thomas W.

doi:10.1111/ceo.12958

Cited by 45 publications

(42 citation statements)

References 21 publications

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“…Both groups exhibited nearly 15% medication reduction compared with preoperative medication use. While our study describes a modest IOP and medication reduction following iStent surgery, the extent of IOP and medication changes was not as great as those reported by Lindstrom et al and Berdahl et al, who report a 30%-40% IOP reduction [10,11]. Compared with their studies, our groups had a lower 3 BioMed Research International baseline IOP; it is reasonable that their studies had a higher percent of IOP reduction due to a higher baseline.…”

Section: Discussioncontrasting

confidence: 50%

“…Prior studies have evaluated single [3][4][5][6][7][8] and multiple [9][10][11] iStent implantation during cataract surgery in open-angle glaucoma patients. Prospective randomized studies of single stent placement, including those of Samuelson et al [3] (240 eyes), Fea [4] (33 eyes), and Craven et al [5] (240 eyes), found better pressure reduction for patients who underwent cataract surgery with stent implantation, rather than cataract surgery alone, on fewer medications.…”

Section: Discussionmentioning

confidence: 99%

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Comparison of Using One Trabecular Microbypass Stent versus Two during Cataract Surgery at Two Sites: One-Year Follow-Up

Yang

Ittarat

Tran

et al. 2020

BioMed Research International

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Purpose. To compare IOP and ocular hypotensive medication reduction of using one trabecular microbypass stent versus two in patients with open-angle glaucoma. Setting. Palo Alto Veterans Affairs (VA) Hospital and the Byers Eye Institute at Stanford University, Palo Alto, California, USA. Design. Retrospective case series. Methods. A chart review included patients who underwent trabecular microbypass implantation with cataract surgery in 2015-2017, with at least one-year follow-up. Subjects were divided into two groups by location (always one stent at Stanford versus two stents at the VA). Primary outcome measures included IOP and medication reduction at baseline and 12-month follow-up. Results. 132 subjects (166 eyes) were included. The preoperative IOP was 16.3±3.4 mmHg on 2.6±1.1 medications in the one-stent group (N=85) and 17.5±3.1 mmHg on 2.7±0.6 medications in the two-stent group (N=81). There was no significant difference between the two groups (p=0.06). At the 12-month visit, there was a 13.37%±2.93 reduction in IOP in the 1-stent group (p≤0.001) and 13.49%±2.69 in the 2-stent group (p≤0.001); both were not significantly different from each other (p=0.074). At 12 months, there was also a 14.5% reduction in medication use for the 1-stent group and 15.3% reduction in the 2-stent group, both statistically significant from baseline, (p=0.022 and p=0.037, respectively). Conclusions. Implantation with either one or two stents during cataract surgery in patients with glaucoma demonstrated similar IOP and med reduction in both groups between the two sites.

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Section: Discussioncontrasting

confidence: 50%

Section: Discussionmentioning

confidence: 99%

Comparison of Using One Trabecular Microbypass Stent versus Two during Cataract Surgery at Two Sites: One-Year Follow-Up

Yang

Ittarat

Tran

et al. 2020

BioMed Research International

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“…The impact on IOP increase of medication washout in eyes with 2 stents has been reported as approximately 4 mmHg. 15,37 Furthermore, a prior report of single versus multiple stent implantation as a stand-alone treatment showed incremental benefit with multiple stents. 23 Neither a comparison of single versus multiple stents nor the stand-alone surgical procedure was in the current study design.…”

Section: Discussionmentioning

confidence: 99%

Prospective, Randomized, Controlled Pivotal Trial of an Ab Interno Implanted Trabecular Micro-Bypass in Primary Open-Angle Glaucoma and Cataract

Duh¹,

et al. 2019

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8 for the iStent inject Study Group* Purpose: Evaluate the safety and effectiveness of an ab interno implanted (iStent inject) Trabecular Micro-Bypass System (Glaukos Corporation, San Clemente, CA) in combination with cataract surgery in subjects with mild to moderate primary open-angle glaucoma (POAG). Design: Prospective, randomized, single-masked, concurrently controlled, multicenter clinical trial. Participants: Eyes with mild to moderate POAG and preoperative intraocular pressure (IOP) 24 mmHg on 1 to 3 medications, unmedicated diurnal IOP (DIOP) 21 to 36 mmHg, and cataract requiring surgery. Methods: After uncomplicated cataract surgery, eyes were randomized 3:1 intraoperatively to ab interno implantation of iStent inject (Model G2-M-IS; treatment group, n ¼ 387) or no stent implantation (control group, n ¼ 118). Subjects were followed through 2 years postoperatively. Annual washout of ocular hypotensive medication was performed. Main Outcome Measures: Effectiveness end points were !20% reduction from baseline in month 24 unmedicated DIOP and change in unmedicated month 24 DIOP from baseline. Safety measures included best spectacle-corrected visual acuity (BSCVA), slit-lamp and fundus examinations, gonioscopy, pachymetry, specular microscopy, visual fields, complications, and adverse events. Results: The groups were well balanced preoperatively, including medicated IOP (17.5 mmHg in both groups) and unmedicated DIOP (24.8AE3.3 mmHg vs. 24.5AE3.1 mmHg in the treatment and control groups, respectively, P ¼ 0.33). At 24 months, 75.8% of treatment eyes versus 61.9% of control eyes experienced !20% reduction from baseline in unmedicated DIOP (P ¼ 0.005), and mean reduction in unmedicated DIOP from baseline was greater in treatment eyes (7.0AE4.0 mmHg) than in control eyes (5.4AE3.7 mmHg; P < 0.001). Of the responders, 84% of treatment eyes and 67% of control eyes were not receiving ocular hypotensive medication at 23 months. Furthermore, 63.2% of treatment eyes versus 50.0% of control eyes had month 24 medication-free DIOP 18 mmHg (difference 13.2%; 95% confidence interval, 2.9e23.4). The overall safety profile of the treatment group was favorable and similar to that in the control group throughout the 2-year follow-up. Conclusions: Clinically and statistically greater reductions in IOP without medication were achieved after iStent inject implantation with cataract surgery versus cataract surgery alone, with excellent safety through 2 years.

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“…1-2). In studies both with and without cataract surgery, and in both investigational and real-world settings, the ab interno-implanted iStent inject has demonstrated clinically significant reductions in IOP and medications over the long term [40][41][42][43][44][45][46][47][48][49][50][51]. These performance outcomes have been accompanied by favorable safety and a correspondingly advantageous benefit-to-risk profile.…”

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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Implantation of two second‐generation trabecular micro‐bypass stents and topical travoprost in open‐angle glaucoma not controlled on two preoperative medications: 18‐month follow‐up

Cited by 45 publications

References 21 publications

Comparison of Using One Trabecular Microbypass Stent versus Two during Cataract Surgery at Two Sites: One-Year Follow-Up

Comparison of Using One Trabecular Microbypass Stent versus Two during Cataract Surgery at Two Sites: One-Year Follow-Up

Prospective, Randomized, Controlled Pivotal Trial of an Ab Interno Implanted Trabecular Micro-Bypass in Primary Open-Angle Glaucoma and Cataract

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

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