Trabecular Micro-bypass Stent Implantation Research Articles

Ten-Year Effectiveness and Safety of Trabecular Micro-BypassStentImplantation with Cataract Surgery in Patients with Glaucoma or Ocular Hypertension.

This study evaluated 10-year results of implanting one iStent trabecular micro-bypass stent during cataract surgery in eyes with open-angle glaucoma (OAG) or ocular hypertension. This retrospective, non-randomized study examined 10-year outcomes of iStent trabecular micro-bypass stent implantation with cataract surgery by one surgeon in eyes with OAG [including primary OAG (POAG) and pseudoexfoliative glaucoma (PXG)] or ocular hypertension at a multi-specialty German ophthalmology center. Study visits were conducted preoperatively and at 2.5, 3, 5, and 10years postoperatively; examinations included intraocular pressure (IOP), medications, corrected-distance visual acuity (CDVA), and adverse events. A total of 63 eyes of 45 patients with OAG (n = 60 eyes) or ocular hypertension (n = 3 eyes) and data through 10years were analyzed. Mean preoperative IOP was 18.6 ± 4.4mmHg on 1.83 ± 1.03 mean medications. At study visits through 10years postoperative, mean IOP reduced by 12.9-19.0% (p < 0.005 at all points), and mean medication burden reduced by 37.8-51.4% (p ≤ 0.006 at all points). At 10years postoperatively, 77.8% of eyes had IOP ≤ 18mmHg and 47.6% had IOP ≤ 15mmHg (vs. 50.8% and 25.4% preoperatively, respectively; p = 0.016). One-third (33.3%) of eyes were medication-free vs. 3.2% preoperatively (p < 0.001); 17.5% were on 2-5 medications (vs. 55.6% preoperatively, p = 0.005); and 93.7% of eyes were on the same or fewer medications vs. preoperative. Post-phacoemulsification CDVA improvement was maintained; no filtering surgeries were completed over 10-year follow-up. Significant and safe IOP and medication reductions were observed through 10years after iStent implantation with cataract surgery in patients with OAG or ocular hypertension.

Five-Year Outcomes of Single Trabecular Microbypass Stent (iStent®) Implantation with Phacoemulsification in Korean Patients.

This study reports the long-term intraocular pressure (IOP)-lowering efficacy and safety of a singletrabecular microbypass stent(iStent®; Glaukos Corp., San Clemente, CA, USA) for medically controlled open-angleglaucoma in Korean patients. This retrospective observational study included 42 eyes of 35 patients with primary open-angle glaucoma (POAG). All subjects underwent single first-generation iStent® implantation with phacoemulsification by a single surgeon with 5years follow-up. The primary outcomes were changes in IOP and the number of antiglaucoma medications compared to the preoperative values. The secondary outcome was the proportion of eyes with IOP ≤ 18mmHg without medication, ≤ 15mmHg without medication, and ≤ 18mmHg with or without medication. Adverse events and need for secondary glaucoma surgery were also recorded. The mean IOP decreased from 15.8 ± 2.8 to 13.8 ± 1.7mmHg and the mean number of medications was reduced from 2.24 ± 1.18 to 0.83 ± 1.12, respectively, at year5. At 3 and 5years, 80.6% and 78.6% of eyes, respectively, were receiving fewer medications than preoperative numbers. In contrast, only 50% of eyes on four preoperative medications showed medication reductions at 5years. At years3 and 5, 61.3% and 53.5% of eyes achieved IOP ≤ 18mmHg without medication, whereas 90.3% and 89.3% of eyes achieved ≤ 18mmHg regardless of medication use, respectively. Four eyes required additional glaucoma surgery (two Ahmed glaucoma valve implantations, one trabeculectomy, and one XEN45 Gel Stent implantation), and all were receiving four preoperative antiglaucoma medications. Transient IOP elevation (14.3%) was the most common complication, followed by five hyphema, one stent obstruction, one stent malposition, and one severe anterior chamber reaction. This study demonstrated a good safety profile and sustained IOP reduction after the implantation of a single trabecular microbypass stent (iStent®) with phacoemulsification in Korean patients. The majority of subjects with POAG showed a relatively good response; however, eyes receiving a higher number of medications preoperatively (especially four medications) had difficulty achieving a low target IOP.

Cessation of ocular hypertensive attacks following iStent trabecular micro-bypass stent implantation in a patient with Posner-Schlossman syndrome: a case report

Background: Posner-Schlossman syndrome (PSS) is an ocular condition with self-limiting recurrent episodes of markedly elevated intraocular pressure (IOP) and non-granulomatous anterior chamber inflammation. Surgical treatment is indicated if medical therapy fails to control IOP.&#x0D; Case presentation: A 58-year-old male presented with intermittent attacks of blurred vision and pain in the right eye for 6 months. Examination revealed keratic precipitates with IOP of 56 mmHg in the right eye. Gonioscopy revealed open angles in both eyes. Erythrocyte sedimentation rate was within normal limits, while aqueous tapfor viral PCR, rapid plasma reagent test, and Mantoux test were negative. IOP was in the high-teens (inappropriate) on 2 topical antiglaucoma medications and the patient developed ocular surface problems. iStent was implanted. IOP remained stable within the mid-teens with no further episodes of raised IOP in the following 6 months.&#x0D; Conclusion: This case showed cessation of ocular hypertensive attacks in PSS after iStent implantation.

12‐month outcomes of trabecular microbypass iStent inject W implantation combined with cataract surgery in open‐angle glaucoma eyes

AbstractPurpose: To evaluate the effectiveness (lowering medication) of a single trabecular microbypass stent (iStent Inject® W, Glaukos) implantation in combination with phacoemulsification in open‐angle glaucoma eyes over a 12‐month period.Methods: Non‐randomized, single‐centre, retrospective case series of glaucoma eyes undergoing iStent implantation with phacoemulsification. Patients with no prior glaucoma surgery and intolerant or non‐compliant with medications were eligible for inclusion. Primary outcome effectiveness measures include reduction number of glaucoma medications and stabilization of intraocular pressure (IOP).Results: 30 eyes of 24 patients (mean age 74.9 ± 8.4) were included in this study. Mean baseline IOP was 17.7 ± 3.5 mmHg and was reduced to 16.1 ± 2.6 and 15.7 ± 2.5 at 6‐ and 12 months respectively (p = 0.002). Mean number of medications was 2.3 ± 1 at baseline and was significantly reduced to 0.7 ± 0.9 at 12 months (p &lt; 0.001; −68%). No eye was medication free at baseline versus 50% (n = 15) at 12 months. In controlled glaucoma eyes (≤18 mmHG), mean IOP was stable (15.5 ± 2.1 at baseline; 15.3 ± 2.4 at 12‐month) while medications were reduced from 1.9 ± 0.7 at baseline to 0.5 ± 0.6, whereas in uncontrolled glaucoma eyes (&gt;18mmHG at baseline) both IOP and medications were reduced from 20.7 ± 2.5 and 2.7 ± 1.2 at baseline to 16.2 ± 2.6 and 1.1 ± 1.1 at 12‐month respectively. There was no statistically significant change in retinal nerve fibre layer (RNFL) thickness at 12 months (p = 0.32). No eyes have experienced adverse events such as postoperatively IOP spikes or hyphema.Conclusions: iStent Inject W implantation with phacoemulsification results in a significant reduction in mean glaucoma medications in glaucoma eyes. IOP was also reduced and there was no loss of visual acuity or RNFL. In uncontrolled IOP eyes, the stent implantation has brought IOP under control and reduced the number of medications, while in controlled IOP eyes, it has lowered the number of medications.

IStent Trabecular Micro-bypass Stent Implantation Combined with Phacoemulsification for Open-Angle Glaucoma: A 2-Year Post-marketing Surveillance Study in Japan.

IntroductionWe report 2-year outcomes after implantation of iStent trabecular micro-bypass stent with phacoemulsification, in Japanese patients with mild–moderate open-angle glaucoma (OAG).MethodsThis was a 24-month, prospective, longitudinal, observational, post-marketing study conducted between July 2017 and September 2020. Patients consisted of adults with OAG on antiglaucoma medications who had cataract surgery combined with one iStent implantation. Outcome measures included intraocular pressure (IOP), antiglaucoma medications, treatment success rates (defined as eyes having lower IOP with same or reduced number of medications from baseline, or same IOP with reduced number of medications from baseline, and not requiring secondary glaucoma surgeries postoperatively), and safety. Outcomes were analyzed in the overall cohort and in glaucoma subtypes: primary OAG, normal-tension glaucoma, and exfoliative glaucoma.ResultsOverall, 232 eyes were enrolled. At 24 months, mean ± standard deviation IOP decreased from 17.6 ± 4.0 mmHg preoperatively to 14.3 ± 3.0 mmHg (p < 0.05), and mean number of medications reduced from 2.2 ± 1.2 preoperatively to 0.7 ± 1.2 (p < 0.05). Similar trends were observed across glaucoma subtypes. In the overall cohort, 96.7%, 95.3%, and 93.7% of patients achieved treatment success at 6, 12, and 24 months, respectively. There were 67.6% medication-free eyes at 24 months compared to 3.2% medication-free eyes preoperatively (p < 0.0001). Safety profile was favorable over the 2-year period.ConclusionsFollowing iStent implantation with phacoemulsification, clinically relevant and statistically significant reductions in IOP and number of medications were observed in Japanese eyes with OAG over 2 years, with favorable safety profile. These reductions were observed across all glaucoma subtypes.Supplementary InformationThe online version contains supplementary material available at 10.1007/s12325-022-02207-0.

Direct Visualization of the Aqueous Outflow Pathway Using Indocyanine Green during Trabecular Microbypass Stent Implantation

Direct Visualization of the Aqueous Outflow Pathway Using Indocyanine Green during Trabecular Microbypass Stent Implantation

Surgical Outcomes of Combined 2nd-Generation Trabecular Microbypass (iStent Inject) and Cataract Surgery for the Treatment of Primary Open-Angle Glaucoma in the Saudi Population.

IntroductionTo investigate the 24-month efficacy and safety of iStent inject trabecular microbypass system implantation combined with phacoemulsification in subjects with primary open-angle glaucoma (POAG) and concomitant cataract.MethodsThis prospective, uncontrolled, interventional case series included 36 eyes (29 subjects) with POAG of mild to moderate severity and coexisting cataract that underwent combined phacoemulsification and implantation of a second-generation trabecular microbypass stent (iStent inject®). Main outcome measures involved mean intraocular pressure (IOP), number of antiglaucoma medications, and proportional analysis of eyes with IOP ≤ 18 mmHg or ≤ 15 mmHg, or with 0 or ≥ 2 glaucoma medications. Secondary outcome measures involved the cup-to-disc ratio, corrected distance visual acuity (CDVA), and adverse issues.ResultsIn 36 eyes, the mean IOP at baseline was 18.28 ± 2.87 mmHg, which decreased to 14.24 ± 1.36 (22.1%) and 14.46 ± 1.56 mmHg (20.9%) at 18 and 24 months, respectively (p < 0.001). At the last follow-up, 100% of eyes had an IOP ≤ 18 mmHg (vs. 50% preoperatively), and 75.7% of eyes had an IOP ≤ 15 mmHg (vs. 16.7% preoperatively); 58.3% of eyes achieved ≥ 20% IOP reduction from preoperative status. At baseline, eyes were treated with a mean of 2.35 ± 1.18 medications, which was reduced to 0.80 ± 1.04 (66% reduction) and 0.69 ± 0.95 medications (70.6% reduction) at 18 and 24 months, respectively (p < 0.001). At the last follow-up, 54.1% of eyes were medication-free (vs. 0% preoperatively) and 24.3% of eyes were treated with ≥ 2 medications (vs. 64.9% preoperatively). This combined procedure demonstrated an excellent safety profile with no reported intraoperative complications or adverse events; CDVA was maintained throughout the entire follow-up period.ConclusionsThis real-world series demonstrated that iStent inject device implantation at the time of phacoemulsification is a safe and effective method to decrease IOP and the necessity for antiglaucoma medications in patients with mild-to-moderate POAG and cataract; no associated vision-threatening complications were noted.

Incidence of steroid response in microinvasive glaucoma surgery with trabecular microbypass stent and ab interno trabeculectomy

ObjectiveTo determine the incidence and risk factors for steroid response in patients undergoing combined phacoemulsification cataract extraction (PCE) and microinvasive glaucoma surgery with either trabecular microbypass stent implantation (iStent) or ab interno trabeculectomy (Trabectome). DesignRetrospective, noncomparative, single-institutional observational chart review. ParticipantsConsecutive patients with open-angle glaucoma who underwent PCE with iStent or Trabectome with 3 months of follow-up. MethodsData were collected from patient charts, including pre- and postoperative intraocular pressure (IOP) following application of topical corticosteroid on postoperative visits for at least 3 months. A steroid response was defined as an IOP rise of greater than 5 mm Hg beginning at least 3 days after surgery with no other obvious explanation and with IOP < 20 mm Hg following rapid tapering or withdrawal of the steroid. ResultsA total of 118 eyes from 89 patients, average age of 71.4 ±12.1 years, were included. Overall, a steroid response was seen in 12.7% of eyes (n = 15), and no difference was noted between Trabectome (11.8%) and iStent (13.6%, p = 0.782) eyes. Axial length (AL; p = 0.01), younger age (p = 0.009), traumatic glaucoma (p = 0.004), and normal-tension glaucoma (NTG; p = 0.0048) were significant predictors of steroid response in a multivariate analysis. In eyes with AL ≥ 25 mm, the steroid response rate was 40%, in contrast to eyes with AL < 25 mm, where it was 10.2%. ConclusionA steroid response develops in approximately 1 in 8 patients undergoing PCE with Trabectome or iStent. Young age, AL > 25 mm, traumatic glaucoma, and NTG were found to be significant predictors of steroid response.

Fellow-Eye Comparison between Phaco-Microhook Ab-Interno Trabeculotomy and Phaco-iStent Trabecular Micro-Bypass Stent.

The aim of this study is to compare the surgical efficacy and safety between microhook ab-interno trabeculotomy (µLOT) and iStent trabecular micro-bypass stent implantation when both were combined with cataract surgery in both eyes of patients. Sixty-four glaucomatous eyes (32 participants; mean age, 75.9 ± 7.6 years; 15 men, 17 women) were included retrospectively. Intraocular pressure (IOP), number of antiglaucoma medications, best-corrected visual acuity (BCVA), anterior chamber flare (ACF) and corneal endothelial cell density (CECD) were evaluated preoperatively, as well as 2, 3, 6, and 12 months postoperatively. Surgical complications and interventions were compared between the procedures. The preoperative IOP and medications with µLOT (18.8 ± 5.7 mmHg and 3.0 ± 1.2, respectively) were higher than with the iStent (15.5 ± 3.4 mmHg and 2.7 ± 1.2, respectively) (p = 0.0001 and p = 0.0437, respectively). At 12 months, the µLOT values (12.6 ± 2.3 mmHg and 2.3 ± 0.9, respectively) were identical to iStent (12.8 ± 2.5 mmHg and 2.3 ± 0.9, respectively) (p = 0.0934 and p = 0.3251, respectively). At 12 months, the IOP decreased more with µLOT (6.2 mmHg, 29.5%) than iStent (2.7 mmHg, 15.6%) (p = 0.0003). The decrease in medications was greater with µLOT (0.7) than iStent (0.4) (p = 0.0437). Survival rate of IOP control ≤15 mmHg and IOP reduction ≥20% was significantly higher after µLOT (40.6% at 12 months) than iStent (18.8%) (p = 0.0277). The frequency of layered hyphema was significantly greater with µLOT (8 eyes, 25%) than iStent (0 eyes, 0%) (p = 0.0048). The increase in the ACF at 2 weeks postoperatively was significantly greater with µLOT than iStent (p = 0.0156), while changes in the BCVA and CECD were identical between groups. The fellow-eye comparison showed that the IOP reduction was greater with µLOT than iStent when combined with cataract surgery.

Matched Cohort Study of Cataract Surgery With and Without Trabecular Microbypass Stent Implantation in Primary Angle-Closure Glaucoma

To compare 1-year outcomes of phacoemulsification alone (phaco-only) vs phacoemulsification with implantation of 2 trabecular microbypass stents (iStent or iStent inject; phaco-stent) in eyes with primary angle-closure glaucoma (PACG). Retrospective matched clinical cohort study. PACG eyes that underwent phaco-only vs phaco-stent at a single ophthalmology center. Groups were matched for baseline intraocular pressure (IOP) and medication use with a tolerance of ±2mm Hg and ±1 medication, respectively. Primary outcomes included postoperative change in the mean IOP and medications. One-year outcomes were assessed using generalized estimating equations corrected for baseline intergroup differences. One hundred fifty-eight eyes (79 per group) were included. At 1 year, IOP decreased by 13% (from 16.8 ± 3.1mm Hg preoperatively) in the phaco-only group (P < .001) and by 27% (from 17.6 ± 3.2mm Hg) in the phaco-stent group (P < .001). Medication use decreased by 11% (from 1.8 ± 1.3 medications preoperatively) in the phaco-only group (P < .001) and by 46% (from 2.2 ± 1.2 medications) in the phaco-stent group (P < .001). The phaco-stent group experienced significantly larger reductions in IOP and medications compared with the phaco-only group (P < .001). The incidence of IOP spikes was significantly greater in the phaco-only group (18%) compared with the phaco-stent group (4%; P= .005). Safety was favorable with few transient postoperative adverse events. The results of this study highlight that phacoemulsification with implantation of 2 trabecular microbypass stents is more effective and possibly more protective than phaco-only in PACG eyes, as evidenced by significantly larger IOP and medication reductions and smaller incidences of IOP spikes among the phaco-stent eyes.

Clinical outcomes of trabecular microbypass stent (iStent®) implantation in medically controlled open‐angle glaucoma in the Korean population

PurposeTo evaluate the safety and efficacy [intraocular pressure (IOP)‐lowering effect and medication use] of a single trabecular microbypass stent (iStent®; Glaukos Corp., San Clemente, CA, USA) for medically controlled open‐angle glaucoma.MethodsThis retrospective case‐series included 42 eyes of 34 patients with medically controlled open‐angle glaucoma with IOP less than 21 mmHg. Clinical outcomes analyzed were IOP, medication use, corrected distance visual acuity (CDVA), and surgical complications. Surgical success was defined according to three criteria: (A) IOP &lt;21 mmHg without medication; (B) IOP &lt;18 mmHg without medication; and (C) IOP &lt;18 mmHg with or without medication. Patients were followed for a minimum of six months postoperatively.ResultsMean IOP was reduced from 15.8 ± 2.8 mmHg to 14.5 ± 2.8 mmHg (p &lt; 0.001), while mean number of medications decreased from 2.2 ± 1.2 to 0.8 ± 1.1 at final visit (p &lt; 0.001). Surgical success rates were 78.6%, 61.9%, and 97.6% at six months and 78.6%, 59.5%, and 95.2% at final visits according to criteria A, B, and C. Meanwhile, 59.5% of patients were medication‐free at their final visit. The relative risk of surgical failure by Criterion B was 4.337 (95% confidence interval:1.799–10.454) times greater in the higher‐medication group (three or more preoperative medications). CDVA was significantly improved from 0.41 ± 0.10 to 0.09 ± 0.07 LogMAR in the combined phacoemulsification and iStent® implantation group (p &lt; 0.001). There was no case whose vision was threatened (vision loss of two or more lines) or who showed severe complications after surgery.ConclusionsSingle trabecular microbypass stent implantation was effective in reducing IOP and medication usage in patients with open‐angle glaucoma with a low preoperative IOP. Our results imply that it is more difficult to achieve low target IOP control in eyes with higher numbers of preoperative medications.

&lt;p&gt;Mid-Term Evaluation of iStent Inject&lt;sup&gt;®&lt;/sup&gt; Trabecular Micro-Bypass Stent Implantation with or without Phacoemulsification: A Retrospective Study&lt;/p&gt;

IntroductionThis study evaluated the 6-month performance and safety of micro-invasive glaucoma surgery (MIGS) with iStent inject either with or without cataract surgery.Material and MethodsLongitudinal retrospective study of 86 surgeries in 49 patients with inadequately controlled open-angle glaucoma (OAG) or ocular hypertension who underwent iStent inject trabecular micro-bypass implantation either alone (isolated group) or combined with cataract surgery (combined group). The two primary outcomes included an intraocular pressure (IOP) drop of ≥20% versus preoperative values (adequate drop) and IOP maintenance between 6 and 18 mmHg (adequate Range). For both outcomes, we determined “complete” and “qualified” success if patients did not require or did require glaucoma medications, respectively, at the end of follow-up. Safety outcomes included best-corrected visual acuity, adverse events, and secondary surgeries.ResultsIn the adequate drop analysis, 30.2% achieved “complete success,” and 37.2% achieved “qualified success.” For adequate range, 40.7% achieved “complete success” and 39.5% achieved “qualified success.” There was no difference in medication decrease (p=0.77) nor IOP reduction (p=0.46) between the isolated and combined groups. Safety was generally favorable and similar between groups, with mild transient adverse events that resulted in no sequelae.Discussion/ConclusioniStent inject implantation either with or without cataract surgery was able to safely decrease IOP and medication requirements through 6 months after surgery.

Three-Year Outcomes of Second-generation Trabecular Micro-bypass Stents (iStent inject) With Phacoemulsification in Various Glaucoma Subtypes and Severities.

This longitudinal case series provides valuable long-term data on the safety and efficacy of iStent inject with concomitant cataract surgery. Patients experienced significant and durable reductions in both intraocular pressure (IOP) and medication burden through 3 years postoperative. The purpose of this study was to examine the 3-year effectiveness and safety of iStent inject second-generation trabecular micro-bypass stent implantation with concomitant phacoemulsification cataract surgery in eyes with various glaucoma subtypes and severities. This was a single-center consecutive case series. Three-year outcomes included mean IOP and medications, the proportions of eyes with IOP ≤18, ≤15, and ≤12 mm Hg, and success (absence of secondary glaucoma interventions). Safety included best-corrected visual acuity (BCVA), cup-to-disc ratio, visual field (VF) mean deviation, retinal nerve fiber layer (RNFL), and ganglion cell-inner plexiform layer (GCIPL) thickness, and adverse events. A total of 124 eyes with different glaucoma subtypes and severities were included. At 3 years postoperative, mean IOP reduced from 16.90±3.85 mm Hg preoperatively to 13.17±2.83 mm Hg (22% reduction, P<0.001) and mean medication burden decreased from 2.38±1.29 medications preoperatively to 1.16±1.22 medications (51% reduction, P<0.001). At 3 years, 96% of eyes achieved IOP ≤18 mm Hg (vs. 69% preoperatively), 80% of eyes achieved IOP ≤15 mm Hg (vs. 40% preoperatively), and 42% of eyes achieved IOP ≤12 mm Hg (vs. 7% preoperatively) with 76% of eyes eliminating ≥1 medication and 37% of eyes eliminating ≥2 medications versus preoperative medication burden. The 3-year cumulative survival rate was 74%. Postphacoemulsification BCVA improvement was preserved, and cup-to-disc ratio, VF mean deviation, and RNFL and GCIPL thickness remained stable. A favorable safety profile included no intraoperative complications and few, transient, postoperative adverse events. Significant and sustained IOP and medication reductions were achieved through 3 years after iStent inject implantation with cataract surgery in a real-world clinical population with mild-to-severe glaucoma, along with favorable safety including stable BCVA, VF, and RNFL and GCIPL thickness.

IStent Trabecular Micro-Bypass Stent Implantation with Cataract Surgery in a Japanese Glaucoma Population.

IntroductionThis 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 MethodsThis 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.ResultsOf 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.DiscussionFavorable 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).ConclusionThis 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.

Clinical outcomes of trabecular microbypass stent (iStent) implantation in medically controlled open-angle glaucoma in the Korean population

To evaluate the safety and efficacy [intraocular pressure (IOP)-lowering effect and medication use] of a single trabecular microbypass stent (iStent; Glaukos Corp, San Clemente, CA) for medically controlled open-angle glaucoma.This retrospective case series included 42 eyes of 34 patients with medically controlled open-angle glaucoma with IOP less than 21 mm Hg. Clinical outcomes analyzed were IOP, medication use, corrected distance visual acuity (CDVA), and surgical complications. Surgical success was defined according to 4 criteria: IOP < 21 mm Hg without medication; IOP < 18 mm Hg without medication; IOP < 15 mm Hg without medications; and IOP < 18 mm Hg with or without medication. Patients were followed for a minimum of 6 months postoperatively.Mean IOP was reduced from 15.8 ± 2.8 mm Hg to 14.5 ± 2.8 mm Hg (P < .001), while mean number of medications decreased from 2.2 ± 1.2 to 0.8 ± 1.1 at final visit (P < .001). Surgical success rates were 78.6%, 61.9%, 57.1%, and 97.6% at 6 months and 78.6%, 59.5%, 52.4%, and 95.2% at final visits according to criteria A, B, C, and D. Meanwhile, 59.5% of patients were medication-free at their final visit. The relative risk of surgical failure by Criteria B and C was 4.337 (95% confidence interval: 1.799–10.454) and 3.717 (95% confidence interval: 1.516–9.116) times greater in the higher-medication group (3 or more preoperative medications), respectively. CDVA was significantly improved from 0.41 ± 0.10 to 0.09 ± 0.07 LogMAR in the combined phacoemulsification and iStent implantation group (P < .001). There was no case whose vision was threatened (vision loss of 2 or more lines) or who showed severe complications after surgery.Single trabecular microbypass stent implantation was effective in reducing IOP and medication usage in patients with open-angle glaucoma with a low preoperative IOP. Our results imply that it is more difficult to achieve low target IOP control in eyes with higher numbers of preoperative medications.

Prospective Interventional Cohort Study of Ocular Surface Disease Changes in Eyes After Trabecular Micro-Bypass Stent(s) Implantation (iStent or iStent inject) with Phacoemulsification.

IntroductionThis study sought to assess ocular surface disease changes following cataract surgery combined with trabecular micro-bypass stent(s) implantation (iStent or iStent inject).MethodsThis prospective interventional single-arm clinical trial enrolled 47 eyes with mild-to-moderate open-angle glaucoma (OAG) on 1–4 glaucoma medications who underwent phacoemulsification and trabecular micro-bypass stent(s) implantation. Key glaucoma and ocular surface data through 3 months postoperatively included the Ocular Surface Disease Index score (OSDI), corneal/conjunctival staining (Oxford Schema), fluorescein tear break-up time (FTBUT), conjunctival hyperemia (Efron Scale), glaucoma medications, and intraocular pressure (IOP).ResultsMean OSDI scores improved from 40.1 ± 21.6 (severe) preoperatively to 17.5 ± 15.3 (mild) at 3 months (p < 0.0001). While 73% of eyes had moderate or severe OSDI scores preoperatively, 29% had such scores at 3 months, and the OSDI score was normal in 57% of eyes versus 9% preoperatively. Mean FTBUT increased from 4.3 ± 2.4 s preoperatively to 6.4 ± 2.5 s at 3 months (p < 0.0001); mean Oxford corneal/conjunctival staining reduced from 1.4 ± 1.0 preoperatively to 0.4 ± 0.6 at 3 months (p < 0.0001); mean Efron conjunctival hyperemia score reduced from 1.4 ± 0.7 preoperatively to 1.2 ± 0.6 at 3 months (p = 0.118). The number of glaucoma medications decreased from 1.5 ± 0.9 to 0.6 ± 0.8 mean medications (60% reduction, p < 0.0001), with all eyes maintaining or reducing medications versus preoperatively and 55% of eyes becoming medication-free (versus 0% preoperatively). Mean IOP reduced from 17.4 ± 4.2 mmHg to 14.5 ± 3.2 mmHg (p < 0.0001). The safety profile was excellent.ConclusionImplantation of trabecular micro-bypass stent(s) (iStent or iStent inject) with cataract surgery produced significant improvements in ocular surface health, alongside significant reductions in IOP and medications.Trial registrationClinicalTrials.gov identifier, NCT04452279.

IStent Trabecular Microbypass Stent Implantation with Phacoemulsification in Patients with Open-Angle Glaucoma: 6-Year Outcomes.

PurposeTo investigate the long-term safety and efficacy of an iStent trabecular microbypass stent in combination with cataract surgery in eyes with primary open-angle glaucoma (POAG).SettingPrivate practice; Sioux Falls, South Dakota.DesignRetrospective, consecutive case series.MethodsThis case series included eyes implanted with a single trabecular microbypass stent in combination with phacoemulsification in patients with mild to severe POAG. Data were collected preoperatively and at day 1, week 1, month 1, and up to 6 years postoperatively. Primary outcome measures included mean intraocular pressure (IOP) and number of glaucoma medications. Safety was noted by assessing the incidence of IOP spikes and need for additional surgery.ResultsThe study comprised 411 eyes. Mean IOP was reduced to 14.9±4.2 mmHg compared to 18.8±5.6 mmHg at baseline at 6 years postoperative. The mean number of medications was reduced to 1.2±1.0 from 1.4±1.1 at baseline. In eyes with severe stage of disease, there was a mean IOP reduction >6 mmHg at 6 years postoperative. Eyes with baseline IOP ≥18 mmHg achieved a more robust reduction in IOP. Fifteen eyes underwent a secondary glaucoma procedure. There were no intra- or postoperative complications.ConclusionTrabecular microbypass stent implantation in combination with cataract surgery provides a sustained IOP reduction in eyes with mild-to-severe POAG. The degree of IOP reduction was more significant in eyes with higher baseline IOP and severe stage of disease.

Effect of iStent Trabecular Micro-Bypass device on outflow system morphology

Purpose: Rigorous clinical testing has established that Schlemm’s canal cross-sectional area (SC-CSA) is reduced in glaucomatous eyes. However, to date, it is unclear whether trabecular bypass procedures impact the morphology of the proximal aqueous outflow tract, or if the introduction of a local region of low outflow resistance adversely affects SC-CSA elsewhere, specifically presenting as SC diminution. This study quantifies changes in the morphology of the distal outflow pathway after iStent Trabecular Micro-Bypass stent (Glaukos Corp, Laguna Hills, CA, USA) implantation in living eyes by anterior segment optical coherence tomography (OCT).&#x0D; Design: This was a prospective observational study.&#x0D; Subjects: This study included six patients (eight eyes) with primary-open angle glaucoma.&#x0D; Methods: Patients underwent iStent placement in the nasal anterior chamber angle quadrant. OCT imaging was obtained of both nasal and temporal eye quadrants before and after surgery. For each SC parameter, an average of ten consecutive, evenly spaced measurements were manually obtained over a 1 mm segment of SC on FIJI ImageJ. Linear mixed effects modeling quantified the effect of the iStent on these parameters.&#x0D; Main outcome measures: Main outcome measures were changes in SC-CSA, inner-to-outer wall distance (IOD), and trabecular meshwork (TM) thickness following iStent placement.&#x0D; Results: Following iStent placement, total SC-CSA increased an average of 1,039.12 μm2 (P = 0.05). Individually, there were no significant changes in SC-CSA in the nasal or temporal quadrants. Total SC-IOD and nasal SC-IOD increased an average of 2.35 μm (P = 0.01) and 2.96 μm (P = 0.04), respectively. There were no significant changes in temporal quadrant SC-IOD. There were no significant changes in TM thickness in either quadrant.&#x0D; Conclusions: Implantation of the iStent Trabecular Micro-Bypass stent significantly increases SC-IOD in the nasal quadrant at the location of implant, with no evidence of SC diminution in the temporal quadrant. It remains unclear how these observations relate to the surgical efficacy of trabecular bypass procedures.

Outcomes of Combined iStent Trabecular Micro-Bypass and Cataract Surgery for the Treatment of Open-Angle Glaucoma in a Saudi Population.

PurposeTo assess the effectiveness and safety of a single iStent trabecular micro-bypass stent implantation in combination with cataract surgery in lowering the intra ocular pressure (IOP) and number of anti-glaucoma medications in Saudi patients with open-angle glaucoma (OAG).SettingKing Fahad Hospital of the University, Al Khobar, Saudi Arabia.DesignProspective, non-comparative, uncontrolled, non-randomized interventional case series.MethodsOne iStent was implanted during phacoemulsification cataract surgery for adult patients with OAG by a single surgeon over a period of 3 years. Main outcome measures include number of anti-glaucoma medications, IOP, corrected distance visual acuity (CDVA) and complications.ResultsThirty-six eyes of 33 patients with OAG underwent the surgery. The pre-operative mean IOP and mean anti-glaucoma medications were 17.47 ± 5.44 mmHg and 2.69 ± 0.92, respectively. At 1 year of follow-up mean, IOP decreased to 13.44 ± 1.99 (23.1% reduction) (P<0.001) and mean anti-glaucoma medications decreased to 1.47±1.13 (45.4% reduction) (P<0.001).ConclusionAfter 12-month follow-up, phacoemulsification with the implantation of a single iStent seems to be an effective and safe procedure to lower IOP and the number of anti-glaucoma medications, and to overcome the problems associated with medication nonadherence in OAG patients with cataracts.

IStent inject trabecular microbypass stent implantation with cataract extraction in open-angle glaucoma: early clinical experience

BackgroundRetrospective, consecutive case series to evaluate the implantation of two second-generation trabecular microbypass stents in combination with cataract surgery in a real-world, clinical setting.MethodsThe series included 56 eyes implanted with the iStent inject device with phacoemulsification. The series consisted of eyes with primary open-angle glaucoma (n = 52) and pseudoexfoliative glaucoma (n = 4). Primary outcome measures included intraocular pressure (IOP) and number of glaucoma medications. Safety outcomes included the need for secondary surgical intervention and the incidence of IOP spikes ≥10 mmHg and ≥ 15 mmHg.ResultsIOP was reduced by 21% to 14.7 ± 2.9 mmHg (p < 0.01) at 6 months postoperative from 18.7 ± 5.8 mmHg at baseline. Preoperatively, the mean number of glaucoma medications was 1.5 ± 0.9 and reduced by 39% to 0.9 ± 1.2 (p < 0.01) at 6 months. At 6 months, 68% of eyes had an IOP ≤15 mmHg, increased from 30% at baseline. 55% of eyes were medication-free at 6 months, up from 18% at baseline. There were no severe postoperative complications. No eyes underwent an additional glaucoma procedure.ConclusionsImplantation of the iStent inject device with concomitant cataract surgery effectively provides a sustained reduction in IOP with a markedly improved medication burden out to 6 months postoperative. The safety profile is excellent.