<p>Two-Year Multicenter Outcomes of iStent <em>inject</em> Trabecular Micro-Bypass Stents Combined with Phacoemulsification in Various Types of Glaucoma and Ocular Hypertension</p>

Abstract

Purpose This multicenter study evaluated 2-year effectiveness and safety following implantation of two second-generation trabecular micro-bypass stents (iStent inject ® ) with phacoemulsification. Materials and Methods This was a retrospective study of iStent inject implantation with phacoemulsification by nine surgeons across Australia. Eyes had mild to advanced glaucoma (predominantly primary open-angle/POAG, appositional angle-closure/ACG, or normal-tension/NTG) or ocular hypertension (OHT), and cataract. Evaluations included intraocular pressure (IOP); medications; proportions of eyes with 0 or ≥2 medications, reduced/stable medications versus preoperative, and IOP ≤15 mmHg; visual acuity; cup-to-disc ratio (CDR); visual fields (VF); adverse events; and secondary surgery. Results A total of 340 eyes underwent surgery and had 24-month follow-up data. At 24 months, mean IOP decreased by 16% from 16.4±4.7 mmHg preoperatively to 13.7±3.1 mmHg (p<0.001), and 77% of eyes achieved IOP of ≤15 mmHg versus 49% preoperatively (p<0.001). Mean number of medications decreased by 67% to 0.49±0.95 versus 1.49±1.20 preoperatively (p<0.001), with 74% of eyes medication-free versus 25% preoperatively (p<0.001), and 14% of eyes on ≥2 medications versus 46% preoperatively (p<0.001). Medication burden was reduced or stable in 98% of eyes versus preoperative. Stratified analyses showed significant IOP and medication reductions across glaucoma subtypes (POAG, ACG, NTG, OHT): 13–22% for IOP (p<0.01 for all) and 62–100% for medication (p<0.001 for all). Favorable safety included few adverse events; stable CDR, VF, and visual acuity; and filtering surgery in only 8 eyes (2.4%) over 2 years. Conclusion This 340-eye multicenter dataset provides robust evidence of the safety and efficacy of iStent inject implantation with phacoemulsification, with significant and sustained IOP and medication reductions through 2 years. Results were similarly favorable across glaucoma subtypes (including POAG, ACG, NTG, OHT) and were attained across various glaucoma severities, clinical sites, and surgeons, highlighting the real-world versatility and utility of this treatment modality.

Treatment Success Across Different Levels of Preoperative Disease Burden: Stratified Two-Year Outcomes from the Pivotal Trial of iStent inject® Trabecular Micro-Bypass in Primary Open-Angle Glaucoma and Cataract

“…This device has been studied both with and without concomitant cataract extraction, and in studies with up to 5 years of follow-up. [24][25][26][27][28][29][30][31][32][33][34][35][36][37][38][39] Both iStent and iStent inject are implanted ab internally and enhance the physiologic trabecular outflow pathway of aqueous humor, thereby decreasing IOP. Targeting the natural outflow pathway helps avoid the risks of suprachoroidal, bleb-forming, subconjunctival, and/or ab externo procedures.…”

iStent inject Trabecular Micro-Bypass with or Without Cataract Surgery Yields Sustained 5-Year Glaucoma Control

“…Among the publications on iStent inject , two in particular may be informative against which to compare our study. For the Combined subgroup, we can consider our findings in the context of the largest multicenter real-world study to-date on combined iStent inject implantation [ 15 ]. That study, by Clement et al, included 340 eyes from 9 surgeons across Australia.…”

“…That study, by Clement et al, included 340 eyes from 9 surgeons across Australia. They reported final IOP of 13.7 mmHg at 2 years postoperative (a 16% reduction vs. a relatively low baseline IOP of 16.4 mmHg), with 77% of eyes achieving IOP ≤ 15 mmHg and mean medication burden reducing by 67% (from 1.49 to 0.49 mean medications) [ 15 ]. In comparison, the Combined subgroup in our cohort experienced a final postoperative IOP of 13.8 mmHg (a 39% reduction vs. a baseline IOP of 22.6 mmHg), with 86% of eyes achieving IOP ≤ 15 mmHg and mean medication burden reducing by 69% (from 2.52 to 0.78 mean medications).…”

Normal‐tension glaucoma: Current concepts and approaches‐A review

“…Mean number of medications decreased by 67% to 0.49 ± 0.95 versus 1.49 ± 1.20 preoperatively, with an excellent safety profile. 123 In another study, XEN gel stent appeared to be as effective or more effective in IOP reduction as it is a bleb raising procedure (but less hypotony than trabeculectomy): the IOP for NTG group reduced from 16.6 ± 3.4 to 11.6 ± 2.2 mmHg. 124 Dataset with longer duration of follow-ups will be needed to see long term efficacy and safety of these MIGS devices.…”