<p>iStent Trabecular Micro-Bypass Stent Implantation with Cataract Surgery in a Japanese Glaucoma Population</p>

Abstract

Introduction: This study assesses two-year efficacy and safety following implantation of a single trabecular micro-bypass stent (iStent ®) with concomitant phacoemulsification cataract surgery in Japanese patients with open-angle glaucoma (OAG). Materials and Methods: This retrospective, consecutive case series included eyes that underwent iStent implantation with phacoemulsification and were followed for 24 months postoperative. Efficacy and safety measures included intraocular pressure (IOP), number of glaucoma medications, adverse events, secondary surgeries, visual fields, and endothelial cell counts. Results: Of 73 operated eyes, 53 eyes had 24 months of follow-up and are analyzed. Diagnoses included primary open-angle glaucoma (POAG, n=25), normal-tension glaucoma (NTG, n=16), and pseudoexfoliative glaucoma (PXG, n=12). At 24 months, mean IOP reduced by 18% to 13.6 ±3.0 mmHg versus 16.5±3.4 mmHg preoperatively (p<0.0001), and mean medication number reduced by 81% to 0.37±0.74 versus 1.96±0.98 preoperatively (p<0.0001). The percentage of medication-free eyes was 77% versus 0% preoperatively, and 81% of eyes had IOP ≤15 mmHg versus 42% preoperatively. Results were similarly favorable across glaucoma subtypes (POAG, NTG, PXG). Notably, mean IOP in NTG eyes decreased to 12.8±1.4 mmHg from 14.4±3.0 mmHg preoperatively (p=0.03), and medications decreased by 87% to 0.31±0.70 versus 2.38 ±0.72 preoperatively (p<0.0001). At 24 months, 81% of NTG eyes were medication-free (versus 0% preoperatively); 2 NTG eyes (13%) were on ≥2 medications (versus 100% preoperatively). Throughout the follow-up, visual fields and endothelial cell counts remained stable; 1 eye (1.9%) underwent filtration surgery. Discussion: Favorable safety and significant IOP and mediation reductions were achieved through two years following iStent implantation with phacoemulsification in a Japanese population. These gains were achieved across all glaucoma subtypes (including POAG, NTG, PXG). Conclusion: This real-world study supports the viability of iStent implantation to treat Japanese patients with glaucoma and shows that the benefits extend to those with NTG or PXG in addition to POAG.

Treatment of Open-Angle Glaucoma with iStent Implantation Combined with Phacoemulsification in Polish Caucasian Population

“…A substantial number of studies have demonstrated significant long-term IOP reduction and medication reduction following the implantation of the iStent. [11][12][13][14][15][16] Our previous study 13 was focused on physiology of aqueous outflow and was intended to confirm the conclusions of work of Batista et al 17 Current manuscript is a typical clinic research, and similar to recent population studies [18][19][20] its aim is to confirm the results of iStent implantation combined with a cataract surgery taking into consideration a Caucasian Polish population.…”

“…The mean age of the population at the time of surgery was 73.7 ± 4.5 years. Another study evaluating the iStent effectiveness on the Asian population was the one conducted by Nitta et al 20 carried on a Japanese glaucoma population, which has a significantly greater incidence of NTG than most other populations. They enrolled 74 patients with a mean age of 73 years for implantation of the iStent combined with phacoemulsification.…”

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

“…With up to 7 years of postoperative follow-up, iStent studies have often focused on patients with mild to moderate POAG undergoing cataract surgery, but an increasing number of studies have assessed iStent for different glaucoma types (eg, pseudoexfoliative, angle-closure, pigmentary), more advanced severity, standalone cases, and in combination with other procedures or stents. [11][12][13][14][15][16][17][18][19][20][21][22][23] The more recent iStent inject ® Trabecular Micro-Bypass (CE Mark 2010, FDA approval 2018) contains two stents that create two patent bypasses through the diseased trabecular meshwork. This device has been studied both with and without concomitant cataract extraction, and in studies with up to 5 years of follow-up.…”

Endothelial cell loss associated with minimally invasive glaucoma surgery

“…Another retrospective study involving 64 eyes observed a 7.2% CEC loss over 12 months [26]. The longest retrospective study to date of 53 eyes also reported a CEC loss of 3.6% over 24 months in a Japanese population [27]. In another study, no significant CEC loss was noted 6 months after two iStent devices were implanted in 10 eyes [28].…”