Introduction In this real-world, retrospective, comparative study we evaluated 6-month performance and safety in consecutive eyes following implantation of the iStent® or iStent inject ® trabecular micro-bypass device with concomitant cataract surgery. Methods Performance outcomes included intraocular pressure (IOP) reduction; glaucoma medication reduction; proportions of eyes achieving an IOP of < 18, < 16, < 14, or < 12 mmHg; and proportions of eyes on 0, 1, 2, or ≥ 3 medications. Safety outcomes included adverse events, secondary surgeries, and best-corrected visual acuity (BCVA). Results A total of 73 eyes with open-angle glaucoma and cataract were included in the study; of these, 38 eyes were implanted with the iStent device and 35 were implanted with the iStent inject device. The two groups of patients had similar baseline characteristics, with the exception of mean age and medication burden (both higher in patients receiving the iStent inject device); over 90% of eyes in both groups had early glaucoma. At 6 months after surgery, mean IOP had fallen from 16.5 ± 3.9 to 13.9 ± 2.3 mmHg in eyes with the iStent implant ( p < 0.001), and from 17.3 ± 3.0 to 12.7 ± 1.8 mmHg in those with the iStent inject implant ( p < 0.001). This reduction was significantly greater in the iStent inject eyes than in the iStent eyes (26.6 vs. 15.8%) ( p = 0.005). Significantly more eyes receiving the iStent inject device compared to the iStent device achieved an IOP of < 18 mmHg at 6 months post surgery (100 vs. 86.8%) ( p = 0.033). Average medication usage was reduced from 1.8 to 0.4 medications in iStent eyes ( p < 0.001) and from 2.3 to 0.4 medications in iStent inject eyes ( p < 0.001). Over 70% of eyes in both groups became medication-free by 6 months post implantation. Adverse events in iStent eyes were mild and resulted in no sequelae; two iStent eyes underwent non-penetrating deep sclerectomy during follow-up. No complications or secondary surgeries were noted in iStent inject eyes. All eyes in both groups maintained or showed improved BCVA versus baseline. Conclusion Significant and safe IOP and medication reductions were observed after iStent or iStent inject implantation with concomitant cataract surgery. Trends toward greater effectiveness and fewer adverse events were observed with the iStent inject device compared with the iStent device. Funding Article processing charges were provided by Glaukos Corporation.
IntroductionThis retrospective consecutive case series assessed 12-month effectiveness and safety of iStent® or iStent inject® trabecular micro-bypass implants with cataract surgery in patients with open-angle glaucoma (OAG) in a real-world clinical setting.MethodsEffectiveness outcomes consisted of intraocular pressure (IOP) reduction; glaucoma medication reduction; proportions of eyes achieving IOP < 18, < 15, or < 12 mmHg; and proportional analysis of medication usage. Safety outcomes included adverse events, secondary surgeries, and best-corrected visual acuity (BCVA).ResultsThis evaluation included 58 eyes with OAG (35 iStent, 23 iStent inject), with 96.6% of eyes having mild or moderate glaucoma. Diagnoses included primary open-angle glaucoma (the majority; 72.4%), pseudoexfoliative glaucoma, and pigmentary glaucoma. Baseline mean IOP and medications were statistically comparable between groups: 16.1 ± 3.6 mmHg on a mean of 1.8 ± 0.8 medications in the iStent group, and 16.2 ± 3.1 mmHg on a mean of 1.7 ± 0.8 medications in the iStent inject group. Twelve months after stent-cataract surgery, mean IOP was significantly lower in the iStent inject group than in the iStent group (13.1 mmHg vs. 15.4 mmHg, respectively; p < 0.001), and the percent reduction in IOP from baseline was significantly greater in iStent inject eyes than in iStent eyes (19.1% vs. 4.3% reduction, respectively; p < 0.001). At 12 months postoperative, significantly greater proportions of iStent inject eyes than iStent eyes achieved IOP < 18 mmHg (100% vs. 80.0% of eyes, respectively; p = 0.035), IOP < 15 mmHg (73.9% vs. 34.3% of eyes, respectively; p = 0.003), and IOP < 12 mmHg (26.1% vs. 0% of eyes, respectively; p = 0.002). Meanwhile, both groups achieved significant medication reductions at 12 months vs. baseline (94.1% reduction in iStent inject eyes, p < 0.0001; and 72.2% reduction in iStent eyes, p < 0.0001), with the percent reduction being significantly greater in iStent inject eyes than in iStent eyes (p = 0.023). At 12 months, mean number of medications was significantly lower in iStent inject eyes than iStent eyes (0.1 vs. 0.5 medications, respectively; p = 0.021), and significantly more iStent inject eyes (95.7%) than iStent eyes (71.4%) were off medications entirely (p = 0.021). A similarly high safety profile was observed in both groups.ConclusioniStent or iStent inject implantation with cataract surgery resulted in substantial and safe reductions in IOP and medications through 12 months postoperative. Consistent with prior observations, greater efficacy was observed with iStent inject than with iStent.FundingThe Rapid Service Fees were funded by Glaukos Corporation.
Introduction: This retrospective consecutive study compared standalone implantation of multiple (2-3) trabecular micro-bypass stents (iStent inject ± iStent) (Multi-Stent group) vs trabeculectomy ? mitomycin C (Trab group) in moderate to severe open-angle glaucoma (OAG). Methods: Eligible patients underwent Multi-Stent or Trab surgery from 2018 to 2020 and had at least 3-month follow-up; visual field mean deviation (VF MD) -6 dB or worse; inadequate prior response to maximum medications ± laser procedures; and had trabeculectomy as their next planned intervention. Primary effectiveness, safety-adjusted treatment success, was defined as C 20% intraocular pressure (IOP) reduction on the same or fewer medications, without clinically significant safety events (severe complications, secondary surgeries, reinterventions). Secondary effectiveness included mean IOP and medications; qualified and complete attainment of target IOP (B 21/18/15/12 mmHg and [ 6 mmHg); health-
Precis: Both nonpenetrating deep sclerectomy (NPDS) and iStent inject are safe and effective when combined with phacoemulsification. The NPDS group presented lower final intraocular pressure (IOP); however, more postoperative intervention and longer recovery time was required. Aim: The aim of this study was to assess the 1-year efficacy and safety of second-generation trabecular microbypass stent implantation (iStent inject) versus NPDS in association with phacoemulsification (Phaco) for the concomitant surgical treatment of open-angle glaucoma and cataracts. Materials and Methods: This was a single-center longitudinal retrospective comparative study of eyes treated with Phaco-NPDS, with adjunctive use of collagen matrix implant and mitomycin C (group 1), or Phaco-iStent inject (group 2). The main outcome measures were success rates [absolute success: proportion of eyes with IOP<18 mm Hg without any glaucoma medication; relative success: proportion of eyes achieving different target IOPs (<18; <15; and <12 mm Hg) with or without medication]; mean reduction (%) in IOP and medication use; number of postoperative reinterventions (goniopuncture, needling, and reoperation); and number of complications. Results: The mean age (y) was 69.3 in group 1 and 72.7 in group 2. Groups 1 (n=51) and 2 (n=32) achieved absolute success rates of 74.5% and 81.3%, respectively (P=0.333). Concerning relative success rates, no significant difference was found for IOP<18 mm Hg or an IOP<15 mm Hg between the 2 groups. However, significantly more eyes achieved an IOP <12 mm Hg in the Phaco-NPDS group. The mean percentage of IOP reduction from baseline to the end of follow-up was also statistically higher in group 1 (39.9% vs. 24.5%). Both groups achieved similar results in the mean reduction of medications per eye. No significant complications were found in either group, but patients in group 1 required more postoperative intervention than group 2. Conclusions: Both techniques are safe and effective for the concomitant surgical treatment of open-angle glaucoma and cataracts and presented comparable relative success rates at different target IOP levels (<18 and <15 mm Hg). A larger proportion of patients in group 1 achieved a target IOP <12 mm Hg; however, more postoperative intervention was required.
scite is a Brooklyn-based organization that helps researchers better discover and understand research articles through Smart Citations–citations that display the context of the citation and describe whether the article provides supporting or contrasting evidence. scite is used by students and researchers from around the world and is funded in part by the National Science Foundation and the National Institute on Drug Abuse of the National Institutes of Health.
hi@scite.ai
10624 S. Eastern Ave., Ste. A-614
Henderson, NV 89052, USA
Copyright © 2024 scite LLC. All rights reserved.
Made with 💙 for researchers
Part of the Research Solutions Family.