Risk factors for hyphema following goniotomy or trabecular bypass stent placement combined with phacoemulsification.

PURPOSE: To report the rates and risk factors for layered hyphemas after goniotomy (PG) and trabecular bypass stent (PTBS) surgery combined with phacoemulsification. METHODS: Patient data was obtained using a retrospective chart review from adult patients (18 years of age or older) undergoing either PG or PTBS at the West Virginia University Eye Institute between 2013 and 2023. Generalized estimating equations were used to identify significant predictors of layered hyphema on post-operative day one. Predictors evaluated included age, race, glaucoma severity, glaucoma type, surgical time, complex cataract extraction, pre-operative intraocular pressure, post-operative day one intraocular pressure, peri-operative anti-thrombotic therapy (ATT) use, body mass index, and surgery type (i.e., PG or PTBS). RESULTS: Of the 405 eyes from 279 patients included in the study, the overall layered hyphema rate was 10.1% in the whole sample. In multivariate generalized estimating equation model controlling for glaucoma stage and preoperative IOP, only surgery type (PG vs PTBS) predicted post-operative day one hyphema (ß = 2.47, SE = 1.01, p = 0.02). The hyphema rates in the PG group and PTBS groups were 40/316 (12.7%) and 1/89 (1.1%), respectively. Eyes of patients on ATT had a hyphema rate of 16/189 (8.5%) compared to 25/216 (11.6%) in eyes of patients not on ATT. CONCLUSIONS: Performing PG over PTBS was a significant predictor of a post-operative day one layered hyphema. No other systemic or ocular features, including the use of ATT, showed a statistically significant relationship with post-operative hyphemas. KEY MESSAGES: What is Known. • The prevalence of minimally invasive glaucoma surgery has significantly increased in recent years. • Hyphema is a common postoperative complication of minimally invasive glaucoma surgery, however risk factors for hyphema in this setting have not been thoroughly evaluated. WHAT IS NEW: • The use of perioperative antithrombotic therapy did not significantly increase the risk for postoperative hyphema following angle based minimally invasive glaucoma surgery. • Hyphema risk was significantly higher in patients undergoing goniotomy combined with phacoemulsification compared to trabecular bypass stent surgery with phacoemulsification.

Comparison of 1-year effectiveness between phaco-microhook ab-interno trabeculotomy and phaco-iStent trabecular micro-bypass stent in primary open-angle glaucoma with low-teen intraocular pressure.

PURPOSE: To investigate the surgical effectiveness of combined cataract surgery with microhook ab-interno trabeculotomy (phaco-µLOT) or iStent trabecular micro-bypass stent (phaco-iStent) in eyes with primary open-angle glaucoma (POAG) and preoperative intraocular pressure (IOP) controlled below 15 mmHg (low-teen IOP). METHODS: This retrospective cohort study included consecutive patients with POAG and low-teen IOP who underwent phaco-µLOT or phaco-iStent as their initial glaucoma surgery and were followed up for 1 year postoperatively. Surgical failure was defined as the inability to achieve the following criteria twice in a row: (A) IOP of 6-15 mmHg with over 20% IOP reduction; (B) IOP of 6-12 mmHg with over 20% IOP reduction. RESULTS: A total of 75 eyes from 75 subjects were included, with 48 in the phaco-µLOT group and 27 in the phaco-iStent group. The mean preoperative IOP and number of antiglaucoma medications were 13.1 ± 2.1 mmHg and 3.4 ± 0.9 in the phaco-µLOT group, and 12.6 ± 2.0 mmHg and 2.5 ± 1.2 in the phaco-iStent group, respectively. The number of antiglaucoma medications was significantly reduced to 2.5 ± 0.9 (phaco-µLOT) and 2.0 ± 1.1 (phaco-iStent) at 1-year postoperatively (all p < 0.05). For criteria A and B, the survival rates were significantly higher in the phaco-µLOT group than in the phaco-iStent group (all p < 0.01). CONCLUSION: Both phaco-µLOT and phaco-iStent hold promise in reducing the need for antiglaucoma medications in POAG eyes with low-teen IOP. Phaco-µLOT may be more effective than phaco-iStent in controlling IOP. KEY MESSAGES: What is known Minimally invasive glaucoma surgeries (MIGS) procedures target the pressure gradient pathways in patients with higher preoperative intraocular pressure (IOP) levels, however, evidence on their effectiveness in normotensive glaucoma patients remains limited. What is new Combined cataract surgery with microhook ab-interno trabeculotomy (phaco-µLOT) or iStent trabecular micro-bypass stent (phaco-iStent) significantly reduced the number of antiglaucoma medications in primary open-angle glaucoma (POAG) eyes with preoperative IOP controlled below 15 mmHg (low-teen IOP). Phaco-µLOT may be more effective than phaco-iStent in controlling IOP. These procedures should be limited to reducing the number of antiglaucoma medications used, as they did not significantly reduce the postoperative IOP in POAG eyes with low-teen IOP.

Roles of Toric intraocular Lens implantation on visual acuity and astigmatism in glaucomatous eyes treated with iStent and cataract surgery.

BACKGROUND: To assess the efficacy of toric intraocular lenses (IOLs) in combined cataract and minimally invasive glaucoma surgery (MIGS), visual and refractive outcomes were compared between eyes implanted with non-toric and toric IOLs during iStent triple procedures. METHODS: In this retrospective study, open angle glaucoma eyes with preexisting corneal astigmatism of -1.5 diopter (D) or more and implanted with non-toric (n = 9) or toric (n = 9) IOLs were included. The main outcome measures were the intergroup difference in the uncorrected visual acuity (UCVA) and refractive astigmatism at 3 months postoperatively. RESULTS: Preoperatively, the logarithm of the minimum angle of resolution (logMAR) UCVAs and refractive astigmatism were equivalent between the groups. Postoperatively, the logMAR UCVA (non-toric, 0.45 ± 0.31; toric, 0.14 ± 0.15; P = 0.021) was significantly better and the refractive astigmatism (non-toric, -2.03 ± 0.63 D; toric, -0.67 ± 0.53 D; P = 0.0014) significantly less in the toric group. The toric group had postoperative improvements in the logMAR UCVA (-0.21, P = 0.020) and refractive astigmatism (+ 1.72 D, P = 0.0039). Vector analyses showed the postoperative centroid magnitude and confidence eclipses of refractive astigmatism was less in the toric group (0.47 D at 173°±0.73D) than the non-toric group (1.10 D at 2°±1.91D). Postoperatively, 78% of eyes in the toric group had 1.0 D or less refractive astigmatism compared with 11% in the non-toric group. Surgically induced astigmatism (non-toric, 0.18 D at 65°; toric, 0.29 D at 137°) did not differ between groups. CONCLUSION: Use of toric IOLs is a reasonable option for better visual outcomes when the combined cataract and iStent surgery is performed in glaucomatous eyes with corneal astigmatism.

Refractive outcomes of toric intraocular lens in combined trabecular micro bypass stent implantation and cataract surgery in glaucomatous eyes.

PURPOSE: To evaluate the impact of trabecular micro bypass stents (iStent Inject) on refractive outcomes with toric intraocular lens (IOL) in glaucomatous eyes. METHODS: We identified glaucomatous eyes receiving a toric IOL between October 2017 and December 2020. Eyes with iStent implantation were included in the study group and eyes undergoing isolated phacoemulsification served as controls. Corrected and uncorrected visual acuity, manifest refraction, intraocular pressure (IOP), and number of hypotensive drugs three months after surgery were evaluated. RESULTS: 26 eyes comprised the study group and 41 eyes the control group. Mean postoperative refractive cylinder was 0.26D in the control and 0.11D in the iStent group, with 63% and 85% of eyes with a cylinder of 0 and 85% and 92% of eyes with a cylinder ≤ 0.5D respectively. The mean absolute difference between target and outcome spherical equivalent was 0.26D in the control and 0.22D in the iStent group, with all eyes within 0.75D of target. LogMar uncorrected postoperative vision in eyes targeted for emmetropia was 0.04 in the control and 0.03 in the iStent group. There was a statistically significant reduction in IOP and number of hypotensive drugs in both groups, with a mean decrease in IOP of 8.6% in the control and 15.7% in the iStent group. The number of hypotensive drugs dropped from 1.63 ± 0.80 to 1.34 ± 0.91 in the control group and from 2.12 ± 0.65 to 0.44 ± 0.71 in the iStent group. CONCLUSION: Toric IOLs provide predictable refractive outcomes in glaucomatous eyes undergoing combined phacoemulsification with iStent implantation, reducing postoperative spectacle dependence.

Trabecular micro-bypass stent implantation with cataract extraction in pigmentary glaucoma.

IMPORTANCE: Use of the trabecular micro-bypass stent with cataract surgery is well established to be safe and effective in primary open-angle glaucoma. This is the first study to exclusively evaluate use of the device in pigmentary glaucoma. BACKGROUND: This study aimed to investigate the safety and efficacy of a trabecular micro-bypass stent in combination with cataract surgery in pigmentary glaucoma. DESIGN: Retrospective, consecutive case series. PARTICIPANTS: Twenty-four eyes of 12 patients with pigmentary glaucoma implanted with one trabecular micro-bypass stent with concomitant cataract surgery. METHODS: Baseline data was collected and compared to the following postoperative time points: 1 day, 1 week, 1 month out to 36 months (M36) after the procedure. MAIN OUTCOME MEASURES: These included intraocular pressure (IOP), number of glaucoma medications and need for additional surgery. RESULTS: At M36 there was a 25% reduction in IOP to 14.68 ± 3.0 (P < .01) from 19.50 ± 6.7 mmHg at baseline. The mean number of glaucoma medications was 0.75 ± 1.0 prior to the surgery and 0.59 ± 0.6 (P > .05) at 36 M. At the 36 M time-point, 95% of eyes had IOP ≤ 18 mmHg and 68% of eyes were ≤ 15 mmHg. No eyes underwent a secondary glaucoma procedure. CONCLUSIONS AND RELEVANCE: The insertion of a single trabecular micro-bypass stent in combination with cataract surgery effectively provides a sustained reduction in IOP up to 3 years after surgery in patients with pigmentary glaucoma. The safety profile is favourable with low rate of IOP spikes and no patients requiring additional surgery.

Contralateral eye comparison study in MICS & MIGS: Trabectome® vs. iStent inject®.

PURPOSE: To compare the safety and efficacy profile after combined micro-incision cataract surgery (MICS) and micro-invasive glaucoma surgery (MIGS) with the ab interno trabeculectomy (Trabectome®) in one eye versus two iStent® inject devices in the contralateral eye in patients with open-angle glaucoma (OAG) and cataract. METHODS: This retrospective, intraindividual eye comparison study included 27 patients (54 eyes) who were treated with combined MICS and ab interno trabeculectomy (group I, Trabectome®) in one eye and two iStent® inject devices (group II, GTS 400) in the fellow eye. Primary outcome measures included intraocular pressure (IOP) and glaucoma medication after 6 weeks, 3, 6, and 12 months follow-up. Secondary outcome measures were number of postoperative interventions, complications, and best-corrected visual acuity (BCVA). RESULTS: Mean preoperative IOP decreased from 22.3 ± 3.7 mmHg in group I and 21.3 ± 4.1 mmHg in group II to 15.6 ± 3.6 mmHg for Trabectome (p < 0.001) and 14.0 ± 2.3 mmHg for iStent inject (p < 0.001) at 12 months after surgery without a significant difference between the two groups (p > 0.05). No vision-threatening complications such as choroidal effusion, choroidal hemorrhage, or infection occurred. In each group trabeculectomy had to be performed in two eyes due to insufficient IOP lowering effect. CONCLUSIONS: Ab interno trabeculectomy and iStent® inject were both effective in lowering IOP with a favourable and comparable safety profile in an intraindividual comparative study over a 12-months follow-up in OAG. However, longer follow-up of these patients will be necessary to determine long-term outcomes and to evaluate significant differences.

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

INTRODUCTION: 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. METHODS: 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 10 years postoperatively; examinations included intraocular pressure (IOP), medications, corrected-distance visual acuity (CDVA), and adverse events. RESULTS: A total of 63 eyes of 45 patients with OAG (n = 60 eyes) or ocular hypertension (n = 3 eyes) and data through 10 years were analyzed. Mean preoperative IOP was 18.6 ± 4.4 mmHg on 1.83 ± 1.03 mean medications. At study visits through 10 years 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 10 years postoperatively, 77.8% of eyes had IOP ≤ 18 mmHg and 47.6% had IOP ≤ 15 mmHg (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. CONCLUSIONS: Significant and safe IOP and medication reductions were observed through 10 years after iStent implantation with cataract surgery in patients with OAG or ocular hypertension.

Efficacy and Safety of Pairing iStent Inject Trabecular Micro-Bypass and iAccess Precision Blade Goniotomy in Patients with Open-Angle Glaucoma.

INTRODUCTION: This study evaluated efficacy and safety of implanting two second-generation trabecular micro-bypass stents (iStent inject/iStent inject W) with phacoemulsification, either with or without iAccess Precision Blade goniotomy, in patients with mild-to-moderate open-angle glaucoma (OAG). METHODS: This retrospective, non-randomized, unmasked, dual-arm, single-site, multi-surgeon, consecutive case series evaluated all OAG eyes that underwent phacoemulsification and iStent inject implantation either as a dual procedure (group A) or paired with iAccess goniotomy (group B) from July 2020 to May 2022. Effectiveness outcomes analyzed from 1 month onward included intraocular pressure (IOP), proportions of eyes with IOP ≤ 12/≤ 15/≤ 18, proportion medication-free, and medication number. Safety outcomes at all timepoints included adverse events and secondary surgeries. RESULTS: In group A, mean IOP reduced from 14.9 ± 3.2 mmHg on 1.22 ± 1.31 mean medications preoperatively (n = 63) to 13.5 ± 2.5 mmHg on 0.24 ± 0.61 medications at month 3 (n = 34; p = 0.048 IOP, p < 0.001 medications). In group B, mean IOP reduced from 16.0 ± 4.2 mmHg on 1.12 ± 1.07 medications preoperatively (n = 93) to 12.2 ± 2.3 mmHg on 0.57 ± 1.27 medications at month 3 (n = 23; p < 0.001 IOP, p = 0.003 medications). From preoperative to 3 months, the percent of eyes with IOP ≤ 12 mmHg remained at 32.4% in group A (p = 1.0) and rose from 21.7% to 60.9% in group B (p = 0.0177); eyes with IOP ≤ 15 mmHg rose from 52.9% to 76.5% in group A (p = 0.0963) and from 43.5% to 91.3% in group B (p = 0.0034). Adjusting for baseline between-group differences, group B had significantly greater postoperative IOP reduction than group A (p = 0.043); medication reductions were similar. Safety was favorable in both groups. CONCLUSIONS: Phacoemulsification and iStent inject with or without iAccess Precision Blade goniotomy produced clinically meaningful and safe IOP and medication reductions. The paired iStent inject + iAccess + phacoemulsification procedure enabled greater IOP reduction and lower IOP thresholds than iStent inject + phacoemulsification. The study provides some of the first data on this paired approach and on the novel iAccess Precision Blade.

Standalone Implantation of 2-3 Trabecular Micro-Bypass Stents (iStent inject ± iStent) as an Alternative to Trabeculectomy for Moderate-to-Severe Glaucoma.

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 ≥ 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 (≤ 21/18/15/12 mmHg and > 6 mmHg); health-economic and quality-of-life (QoL) measures; and 2-vs-3-stent subgroup analysis. RESULTS: The baseline groups (n = 70 Multi-Stent/40 Trab) were similar: mean IOP (21.1 mmHg/22.3 mmHg); medications (2.87/3.10 medications); disease stage (30%/35% severe); VF MD (- 10.1 dB/- 10.4 dB); and mean last follow-up (LFU, 13.1 months/15.7 months) (all differences non-significant). Primary effectiveness: treatment success at LFU was 62.9% vs 30.0% in Multi-Stent vs Trab eyes, respectively (p = 0.001). Secondary effectiveness: At LFU in Multi-Stent vs Trab groups, respectively: mean IOP decreased by 31% to 14.2 mmHg (p < 0.001) vs by 43% to 12.5 mmHg (p < 0.001); mean medications decreased by 51% to 1.31 medications (p < 0.001) vs by 84% to 0.43 medications (p < 0.001). Multi-Stent eyes, compared to Trab eyes, had fewer visits ± reinterventions within 3 months (3.6 vs 6.1, p < 0.001); longer time to first reintervention (12.2 months vs 4.5 months, p = 0.01); fewer total reinterventions (0.26 vs 0.75, p = 0.006); and earlier lifting of postoperative restrictions (12.6 vs 32.1 days, p < 0.001). In 2-vs-3-stent analysis, there was a trend toward more 3-stent eyes achieving target IOP than 2-stent eyes. Visual fields remained stable in both Multi-Stent and Trab eyes. CONCLUSION: Implanting 2-3 trabecular micro-bypass stents was a viable alternative to trabeculectomy for moderate-to-severe OAG, with clinically appropriate IOP/medication reductions and higher safety-adjusted treatment success vs trabeculectomy.

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

INTRODUCTION: We report 2-year outcomes after implantation of iStent trabecular micro-bypass stent with phacoemulsification, in Japanese patients with mild-moderate open-angle glaucoma (OAG). METHODS: This 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. RESULTS: Overall, 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. CONCLUSIONS: Following 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.

Two-Year Comparative Outcomes of First- and Second-Generation Trabecular Micro-Bypass Stents with Cataract Surgery.

INTRODUCTION: This retrospective comparative study assessed real-world effectiveness and safety of first-generation (iStent®) and second-generation (iStent inject®) trabecular micro-bypass stents with cataract surgery in patients with open-angle glaucoma (OAG). MATERIAL AND METHODS: Through a 24-month postoperative follow-up, the effectiveness was quantified by intraocular pressure (IOP) reduction; mean glaucoma medication reduction; proportional analysis of eyes meeting IOP cutoffs (<18, <15, <12 mmHg) either with or without medications; and proportional analysis of medication burden. Safety measures included visual acuity, adverse events, and secondary surgery. RESULTS: A total of 82 consecutive eyes (39 iStent, 43 iStent inject) with a 24-month follow-up were analyzed. Most eyes (74.4%) had primary open-angle glaucoma, with the remainder having pseudoexfoliative or pigmentary glaucoma; all eyes had mild-to-moderate disease. At 24 months postoperative, the mean IOP was lower, and the percent reduction from baseline was greater, in iStent inject eyes (26.0% reduction, 17.7mmHg to 13.1mmHg) than in iStent eyes (9.8% reduction, 16.4mmHg to 14.8mmHg) (between-groups comparison, p=0.019). Within each group, the postoperative IOP reduction was greater in eyes with higher baseline IOP (p<0.001). Medication burden decreased significantly in both groups, from 1.74 to 0.51 mean medications for iStent (70.7% reduction, p<0.0001), and 2.19 to 0.65 for iStent inject (70.3% reduction, p<0.0001). Both groups exhibited excellent safety. CONCLUSION: iStent or iStent inject with phacoemulsification produced significant IOP and medication reductions, with effects enduring for two years. IOP reductions were greater for iStent inject than for iStent. Within each group, higher preoperative IOP was associated with greater postoperative IOP reduction.

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.

PURPOSE: To examine effectiveness outcomes stratified by preoperative disease burden in the pivotal trial of iStent inject ® with cataract surgery (INJ) vs cataract surgery alone (CS). MATERIALS AND METHODS: Prospective, 3:1 randomized, single-masked, concurrently-controlled, multicenter trial enrolling 505 subjects with cataract and mild-to-moderate primary open-angle glaucoma who underwent iStent inject implantation with phacoemulsification or phacoemulsification alone, and were followed for 2 years including annual medication washouts. Post hoc stratification was completed for baseline mean diurnal intraocular pressure (BL DIOP; Low-DIOP <25mmHg, Mid-DIOP ≥25 to <30 mmHg, High-DIOP ≥30mmHg) and preoperative medication burden (Low-Med 1 medication, Mid-Med 2 medications, High-Med ≥3 medications). RESULTS: The 24-month primary and secondary effectiveness endpoints were met, with significant treatment-over-control differences in percent of eyes achieving ≥20% unmedicated DIOP reduction and in unmedicated DIOP reduction, respectively. In subgroup analyses, the proportions of INJ eyes achieving the primary endpoint remained steady across all BL DIOP (75.4%, 77.1%, 74.4% in Low/Mid/High-DIOP strata, respectively) and preoperative medication levels (76.8%, 70.8%, 79.7% in Low/Mid/High-Med strata, respectively); meanwhile, the proportions of CS eyes diminished with higher BL DIOP (64.5%, 63.6%, 33.3%, respectively) and more medications (69.0%, 63.3%, 29.4%, respectively). Regarding secondary effectiveness, postoperative DIOP reduction increased with higher BL DIOP in INJ eyes (6.2mmHg, 7.8mmHg, 9.8mmHg, respectively) but plateaued in CS eyes (5.2mmHg, 5.8mmHg, 5.4mmHg, respectively). INJ eyes also had consistent DIOP reduction regardless of preoperative medication burden (6.8mmHg, 6.7mmHg, 7.8mmHg, respectively), while DIOP reduction diminished with more medications in CS eyes (6.1mmHg, 5.0mmHg, 3.3mmHg, respectively). Safety was favorable, comparable to phacoemulsification alone. CONCLUSION: Significant IOP reductions occurred across all levels of BL DIOP and preoperative medication burden in iStent inject eyes. DIOP reductions increased with higher BL DIOP and remained stable across all levels of preoperative medication burden, suggesting the device's potential utility in more medically challenging cases.

Comparison of Postoperative Hyphemas between Microhook Ab Interno Trabeculotomy and iStent Using a New Hyphema Scoring System.

We have been using our in-house scoring system of hyphemas, i.e., Shimane University RLC postoperative hyphema scoring system (SU-RLC), which we designed to classify postoperative hyphema. SU-RLC classifies the severities of hyphemas based on three factors, i.e., red blood cells (RBCs) (R) 0-3, layer formation (L) 0-3, and clot (C) 0-1, by slit-lamp observation. To test the clinical usefulness of the SU-RLC for quantifying the postoperative hyphema severity, the SU-RLC scores were compared between eyes that underwent different minimally invasive glaucoma surgery (MIGS) procedures, i.e., Tanito microhook ab interno trabeculotomy and cataract extraction (TMH-CE) (n = 64 eyes of 64 subjects; mean age ± standard deviation, 72.4 ± 8.1 years) and iStent-CE (n = 21 eyes of 21 subjects; 76.1 ± 10.6 years). Compared to the iStent-CE, higher hyphema scores with the TMH-CE were found for the R scores on postoperative days 1, 2, and 3; for the L score on postoperative day 1; and for the C score on postoperative day 2. The sums of the R, L, and C scores (RLC) on postoperative day 1 were 3.2 ± 1.1 with the TMH-CE and 1.1 ± 1.3 with the iStent-CE; the scores reached almost 0 by 2 weeks in both groups. Significant differences in the RLC scores between the surgical groups were found on postoperative days 1, 2, and 3. Multivariate analyses showed that the TMH-CE rather than iStent-CE was associated with higher R, C, and RLC scores; anticoagulant/antiplatelet use was associated with higher R score; and myopia was associated with a higher C score. In the TMH-CE group, myopia was associated with a higher C score. In the iStent-CE group, anticoagulant/antiplatelet use was associated with higher R and RLC scores; and higher postoperative 1-day intraocular pressure was associated with a higher C score. The SU-RLC successfully detected the difference in hyphema severity between different MIGS procedures; thus, we concluded that our classification system may be feasible to evaluate hyphemas after glaucoma surgery.

Long-term outcomes of two first-generation trabecular micro-bypass stents (iStent) with phacoemulsification in primary open-angle glaucoma: eight-year results.

BACKGROUND: The short- and medium-term outcomes of iStent have been extensively studied; however, only few studies have investigated its long-term outcomes. Here, we assessed the long-term efficacy and safety of two iStents with concomitant cataract surgery in glaucomatous eyes while also evaluating measures of disease stability using visual field and optical coherence tomography (OCT) of the optic nerve and the macula throughout 8 years of follow-up. METHODS: This longitudinal, single-center consecutive case series included glaucomatous eyes that underwent implantation of two first-generation trabecular micro-bypass stents (iStent) with concomitant cataract surgery. Eight-year efficacy outcomes included mean intraocular pressure (IOP) and medications, as well as surgical success. Eight-year safety outcomes included best-corrected visual acuity (BCVA), visual field mean deviation (VF-MD), cup-to-disc ratio (CDR), retinal nerve fiber layer (RNFL) thickness, ganglion cell-inner plexiform layer (GC-IPL) thickness, and adverse events. RESULTS: A total of 62 eyes with primary open-angle glaucoma (POAG) were included. At 8 years postoperative, IOP reduced by 26% from 19.2 ± 3.9 mmHg preoperatively to 14.2 ± 2.4 mmHg (P < 0.001), 91.1% of eyes achieved IOP ≤ 18 mmHg (vs. 51.6% preoperatively), 69.6% of eyes achieved IOP ≤ 15 mmHg (vs. 14.5% preoperatively), and 25% of eyes achieved IOP ≤ 12 mmHg (vs. 1.6% preoperatively). Medication use decreased by 17.9% from 2.8 ± 1.1 preoperatively to 2.3 ± 1.2 (P = 0.018). Surgical success was 90%, as six eyes underwent subsequent glaucoma surgeries. Safety measures of BCVA, CDR, RNFL thickness and GC-IPL thickness remained stable through 8 years postoperative. VF-MD remained stable until postoperative year 5 and subsequently progressed according to the natural history of glaucomatous disease. CONCLUSIONS: Implantation of two iStents with concomitant cataract surgery is an effective and safe treatment option for surgery-naïve POAG eyes, evidenced by significant IOP and medication reductions, reasonable surgical success, and favorable safety outcomes, throughout the 8-year follow-up. Our data additionally supports the efficacy of this combined procedure in stabilizing or slowing disease progression.

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.

Refractive Outcomes After Trabecular Micro-Bypass Stents (iStent Inject) with Cataract Extraction in Open-Angle Glaucoma.

PURPOSE: Simultaneous cataract and glaucoma surgery has traditionally been challenging for the anterior segment surgeon. The introduction of minimally invasive glaucoma surgery (MIGS) in conjunction with cataract surgery appears safe and effective in lowering intraocular pressure. Although a significant visual impact leading from the combined procedure is unexpected, we aim to describe the refractive outcomes in a cohort of patients undergoing simultaneous cataract removal and iStent inject and discuss the potential implications of combined surgery in patients with co-existent glaucoma. PATIENTS AND METHODS: This is a retrospective consecutive case series inclusive of patients undergoing combined femtosecond laser-assisted cataract surgery and the insertion of two trabecular micro-bypass stents (iStent inject). Visual acuity, refraction and astigmatic vector analysis were collated and analysed from the preoperative and 4 weeks postoperative visits. RESULTS: One hundred and six eyes of 89 patients from 2 surgeons were included in the original cohort. The mean absolute difference from target refraction was 0.36 ± 0.25D. 73.9% of eyes were within ± 0.5D of the refractive target and 98.9% of eyes were within ± 1.00D. 73.8% of eyes had 0.5D or less residual refractive astigmatism following the procedure. CONCLUSION: We present a novel cohort of glaucoma patients undergoing combined trabecular micro-bypass stents (iStent inject) and cataract surgery achieving excellent refractive outcomes. The results of this study indicate that this second-generation device is refractively neutral.

Four-Year Outcomes of Two Second-Generation Trabecular Micro-Bypass Stents in Patients with Open-Angle Glaucoma on One Medication.

INTRODUCTION: This study evaluated long-term reductions in intraocular pressure (IOP) and medication following implantation of 2 second-generation trabecular micro-bypass stents (iStent inject®) in eyes with open-angle glaucoma (OAG) not controlled on 1 preoperative medication. MATERIAL AND METHODS: In this prospective interventional multi-surgeon study, standalone implantation of 2 iStent inject stents was performed in 57 eyes of 57 subjects with OAG, preoperative IOP of 18-30 mmHg on 1 medication, and preoperative post-washout IOP of 22-38 mmHg. The main outcome measures included the proportions of eyes achieving medication-free IOP ≤18 mmHg, IOP ≤15 mmHg, or ≥20% IOP reduction versus preoperative unmedicated IOP. Assessments included IOP, medications, visual acuity, visual field, pachymetry, complications, and interventions. Subjects were followed for 48 months with follow-up continuing in all eyes. RESULTS: At Month 48 (n=57), 95% of eyes achieved an IOP reduction of ≥20% without medication versus preoperative washout IOP; and although they had eliminated medication, 81% of eyes still had an IOP reduction of ≥20% versus preoperative IOP on 1 medication. Mean 48-month unmedicated IOP decreased by 46% to 13.2±1.6 mmHg vs 24.4±1.3 mmHg preoperatively (p<0.0001), with 95% of medication-free eyes having IOP ≤18mmHg and 82% having IOP ≤15mmHg. Over the course of follow-up, 3 eyes had medication added and 1 eye underwent a secondary glaucoma surgery, and safety parameters were favorable. DISCUSSION: Standalone iStent inject implantation in OAG patients on 1 preoperative medication resulted in average IOP reduction to ≤15 mmHg with the elimination of medication and favorable safety through 48 months. TRIAL REGISTRATION: ClinicalTrials.gov identifier, NCT02868190.

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

INTRODUCTION: This study sought to assess ocular surface disease changes following cataract surgery combined with trabecular micro-bypass stent(s) implantation (iStent or iStent inject). METHODS: This 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). RESULTS: Mean 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. CONCLUSION: Implantation 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 REGISTRATION: ClinicalTrials.gov identifier, NCT04452279.

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

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.

Combined iStent® Inject Trabecular Micro-Bypass and Phacoemulsification in Australian Patients with Open-Angle Glaucoma.

PURPOSE: This retrospective audit aimed to evaluate the impact of combined iStent® Inject (iSI) and phacoemulsification on medication number in Australians with open-angle glaucoma. Secondary outcomes included intraocular pressure (IOP), best-corrected visual acuity, refraction and visual fields. PATIENTS AND METHODS: Patients with glaucoma that received combined iSI and phacoemulsification by the same surgeon between 1 February 2016 and 1 February 2018 were audited for postoperative medication number, pressures after 1 day, 1 week, 4 weeks and 6, 12, 18 and 24 months, visual acuity, refraction and visual fields. These parameters were compared to baseline levels and with those from a separate cohort of patients without glaucoma that received standalone phacoemulsification. RESULTS: Forty-one patients (63 eyes) received the combined procedure. Thirty-four patients (59 eyes) received standalone phacoemulsification. Four weeks after receiving combined iSI and phacoemulsification the mean medication number was significantly reduced by 1.3 (p < 0.001) for those on medication at baseline and by 0.5 (p = 0.002) overall. Mean IOP was significantly reduced from baseline after 6 months (-16%; p = 0.012; n = 35) and 12 months (-29%; p = 0.004; n = 16). Patients receiving standalone phacoemulsification had short-term reductions in IOP at 4 weeks (-8%; p < 0.001; n = 57) and 6 months (-16%; p < 0.001; n = 32). These patients without glaucoma had lower pressures overall compared to those with glaucoma that received the combined procedure (p = 0.019). There were no differences in final visual acuity or refractive outcomes between groups. CONCLUSION: This audit suggests that iSI and phacoemulsification are at least as effective in controlling IOP as medical therapy. It may have an important role in reducing the medication burden in Australians with cataract and glaucoma. This study is one of the first to confirm refractive stability in concomitant iSI and phacoemulsification.