Real-World Assessment of Second-Generation Trabecular Micro-Bypass Stents in Open-Angle Glaucoma Patients

Update on Microinvasive Glaucoma Surgery.

In African American patients with glaucoma, iStent/phacoemulsification lowered intraocular pressure and reduced glaucoma medication usage for up to 1 year, even in patients with prior selective laser trabeculoplasty (SLT). Currently, no studies have examined the outcomes of a trabecular microbypass stent and phacoemulsification in African American patients. Here, the authors investigate whether iStent/phacoemulsification decreases intraocular pressure (IOP) and/or medication usage in African American patients with glaucoma. They are also interested in whether prior SLT would affect outcomes of iStent/phacoemulsification. A multicenter, retrospective case series of eyes that underwent iStent/phacoemulsification between 2013 and 2017 with up to 1-year follow-up. Eyes with a confirmed diagnosis of glaucoma in African American patients were included. Eyes with neovascular glaucoma or closed angle glaucoma and eyes that underwent previous incisional glaucoma surgery were excluded. Eighty-nine eyes were included in the study and data for 66 eyes were available at postoperative year 1 (POY1). IOP decreased from 18.3±5.7 mm Hg to 15.9±4.6 (P<0.001) and glaucoma medication usage decreased from 1.9±1.1 to 1.1±1.1 (P<0.001) at POY1. Eyes that underwent prior SLT experienced less of a decrease in IOP when compared with eyes without prior SLT, but IOP at POY1 was not significantly different between these groups. Both groups had a similar reduction in medication usage. The most common complications were IOP spikes on postoperative day 1 and microhyphemas. In this cohort, there was a significant decrease in IOP and medication usage 1 year after iStent/phacoemulsification. iStent/phacoemulsification is an effective and safe treatment option in African American patients with glaucoma.

To compare the effect of time on therapy, efficacy, tolerability and resource utilization of latanoprost or non-prostaglandin analogues (non-PGs) in patients who required a change in intraocular pressure (IOP)-lowering monotherapy. This open-label, multicentre study (Sweden, 19 sites; Finland, seven sites) included adults with glaucoma or ocular hypertension with mean diurnal IOP > or = 21 mmHg on ocular hypotensive monotherapy. Patients were randomized to latanoprost monotherapy or non-PG therapy (commercially available therapy other than a PG) and followed for 36 months. End-points included: time to treatment failure (baseline to visit with a change in/addition to treatment); diurnal IOP (mean of 08.00, 12.00 and 16:00 hr measurements) at months 6, 12, 24 and 36; tolerability; and resource utilization, where analyses used Swedish and Finnish 2006 unit costs. Three hundred and twenty-six patients received >or = 1 dose of latanoprost (n = 162) or non-PGs (n = 164). Median time to treatment failure was longer for latanoprost (36 months) than for non-PGs (12 months; p < 0.001); 51% and 24% of patients remained on randomized therapy after 36 months, respectively (p < 0.001). Decreases in mean diurnal IOP from baseline were significantly greater for latanoprost than for non-PGs at months 6 and 12 (p < 0.01). No serious adverse events were judged to be treatment-related. Mean total 36-month direct costs were similar in patients initiated with latanoprost and non-PGs. Patients who failed previous monotherapy remained on therapy longer when switched to latanoprost. Latanoprost's IOP-reducing effect and tolerability were sustained over the long term. Resource utilization and costs were generally similar in those initiating latanoprost or non-PG therapy.

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Abstract: Posterior capsule opacity (PCO) is a common complication following cataract surgery, caused by the proliferation of residual lens epithelial cells. This study aimed to evaluate the long-term effects of Nd:YAG laser capsulotomy on intraocular pressure (IOP) and visual acuity in PCO patients. This was a retrospective descriptive study. Samples were 24 patients diagnosed with PCO who underwent Nd:YAG laser capsulotomy at Prof. Dr. R. D. Kandou Hospital, Manado, from January 1, 2022, to January 1, 2024. The study recorded pre- and post-procedure IOP and best-corrected visual acuity (BCVA) data. Descriptive analysis, including paired t-tests, was used to assess changes in IOP and BCVA over an average follow-up period of 19.2 months. The results showed a statistically significant improvement in BCVA (p=0.000), with mean values improving from 0.72 to 0.27 LogMAR. A significant reduction in IOP was also observed (p=0.015), with long-term IOP remaining stable. A weak correlation was found between follow-up duration and IOP variation (p=0.02). In conclusion, Nd:YAG laser capsulotomy significantly improves visual acuity and stabilizes intraocular pressure in the long term for PCO patients, suggesting its effectiveness in managing post-cataract surgery complications. Keywords: posterior capsule opacity; Nd:YAG laser capsulotomy; intraocular pressure; visual acuity; cataract surgery Methods: A retrospective descriptive study was conducted on 24 patients diagnosed with PCO who underwent Nd capsulotomy at RSUP Prof Dr. R. D. Kandou Central Hospital, Manado, from January 1, 2022, to January 1, 2024. The study recorded pre- and post-procedure IOP and Best-Corrected Visual Acuity (BCVA) data. Descriptive analysis, including paired t-tests, was used to assess changes in IOP and BCVA over an average follow-up period of 19.2 months. Results: The study revealed a statistically significant improvement in BCVA (p = 0.000), with mean values improving from 0.72 to 0.27 LogMAR. A significant reduction in IOP was also observed (p = 0.015), with long-term IOP remaining stable. A weak correlation was found between follow-up duration and IOP variation (p = 0.02). Conclusion: Nd capsulotomy significantly improves visual acuity and stabilizes IOP in the long term for PCO patients, suggesting its effectiveness in managing post-cataract surgery complications.

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.

To analyze the outcomes of the iStent inject in a real-world clinical setting as a standalone procedure to lower intraocular pressure (IOP) in open-angle glaucoma. Patients with open-angle glaucoma having undergone iStent inject insertion without concurrent cataract extraction were included in this multicenter observational real-world study in Australia. Patient data was entered into the Fight Glaucoma Blindness! Registry. Assessments through 12 months included glaucoma subtype, IOP, medications, best-corrected visual acuity (BCVA), secondary surgical procedures, and adverse events. Kaplan-Meier survival curves for outcomes were reported according to the World Glaucoma Association (WGA). Sixty-one eyes from 44 patients with a mean age of 76 ± 11.4 underwent standalone iStent inject implantation. The mean ± SD preoperative IOP was 17.5 ± 7.5 mm Hg, and the mean preoperative number of topical medications was 2.5 ± 1.5. At 12 months postoperatively, there was no statistically significant IOP reduction, while the number of glaucoma medications used was reduced to 1.4 ± 1.5 (p < 0.001). Fourteen point one percent of eyes required a secondary pressure-lowering procedure within the 12-month follow-up window. This assessment of standalone iStent inject implantation did not show any significant reduction in IOP, but there was a significant decrease in medication use in the real-world clinical setting. The procedure is safe with minimal adverse outcomes; however, a subset of patients required secondary procedures within 12 months of follow-up. Huynh B, Clement C, Nguyen V, et al. 12-month Safety and Efficacy Outcomes of a Standalone Trabecular Bypass Device. J Curr Glaucoma Pract 2024;18(3):103-109.

Evaluate the efficacy, safety, and complication rates of phacoemulsification cataract surgery when combined with either gonioscopy-assisted transluminal trabeculotomy (GATT) or iStent Inject. This is a retrospective case-control study to compare the surgical outcomes of combined phacoemulsification cataract surgery with either GATT (phaco-GATT) or iStent Inject (phaco-iStent). Both groups had at least 1-year follow-up. The primary outcome measures were IOP and number of glaucoma medications (NGMs) at 1 year. Secondary outcomes measures were best corrected visual acuity (BCVA) and intra- or postoperative complications within the first year of follow-up. Success was defined as intraocular pressure (IOP) < 21 mmHg and ≥ 20% reduction in IOP at 1 year regardless of the NGM. Each group included 37 patients. The median baseline IOP (24 vs 17) and NGM (3 vs 2) were higher in the phaco-GATT group (p < 0.001). Phaco-GATT achieved a 38% (p < 0.0001) reduction in IOP compared to 13.2% (p < 0.001) in the phaco-iStent group at 1-year follow-up. The reduction in IOP and NGM was significantly higher in the phaco-GATT group (p < 0.01). After adjusting for baseline IOP, the reduction in IOP at 12 months was still significantly higher in the phaco-GATT group (p = 0.042). At 1 year, 86.4% of patients in the phaco-GATT group met the success criteria compared to 35.1% in the phaco-iStent group. Safety outcomes were slightly favourable in the phaco-iStent group. Phaco-GATT and phaco-iStent showed a significant reduction in IOP and NGM, with phaco-GATT having a significantly higher reduction. Phaco-iStent appears to have a higher safety profile and is probably preferable in monocular patients and those with a high risk of bleeding.

To investigate the effectiveness of repeated injections of intravitreal triamcinolone acetonide (IVTA) in the treatment of macular oedema caused by central retinal vein occlusion (CRVO). Seventeen pseudophakic or aphakic eyes of 17 patients (10 male, seven female) with macular oedema caused by CRVO received a repeat injection of 4 mg IVTA, 16 weeks after the first injection of the same dose. The examination included measurements of best-corrected visual acuity (BCVA) for distance and central foveal thickness (CFT) by optical coherence tomography (OCT), preoperatively and 1, 2, 3 and 4 months postoperatively. The values were compared by paired-t test. Side-effects were monitored. BCVA and CFT were not significantly different before initial and repeat injections. Transient improvements of BCVA and CFT were achieved after both injections. At the end of follow-up, BCVA and CFT were significantly different compared to pre-injection values in the same group (P = 0.032, 0.049 in the initial-injection group and P = 0.001, 0.008 in the repeat-injection group, respectively). However, compared to the initial injection, BCVA measurements were significantly worse at each time-point (P = 0.043, 0.011, 0.010 and 0.012, respectively) after the repeat injection, as were CFT at 1, 2 and 3 months post-injection (P = 0.040, 0.015 and 0.025, respectively). The achieved maximum mean intraocular pressures were 20.00 [standard deviation (SD) 2.06] mmHg and 18.56 (SD 3.65) mmHg after the first and repeat injections, respectively. These values were not significantly different (P = 0.467). No other significant adverse events were noted during the study. A repeat injection of 4 mg IVTA may not be as effective as an initial injection for the treatment of macular oedema caused by CRVO.

Background/Objectives: To compare the efficacy and safety of Hydrus® Microstent and iStent inject® W implants, in combination with phacoemulsification, for lowering intraocular pressure (IOP) in patients with glaucoma in a real-world clinical setting. Methods: This retrospective, single-center study analyzed medical records of glaucoma patients who underwent either Hydrus® Microstent or iStent inject® W implantation combined with cataract surgery at the University Hospital Muenster, Germany. Key outcome measures included absolute and relative IOP reduction, reduction in topical antiglaucoma medication use, overall success rate, and complications. A total of 32 eyes were analyzed, 16 in each treatment group, with a 12-month follow-up. Results: Both groups demonstrated significant postoperative IOP reduction (Hydrus: p < 0.001; iStent inject® W: p = 0.032). The Hydrus group achieved significantly greater relative IOP reduction compared to the iStent inject® W group (p = 0.043). The Hydrus group also showed a significant reduction in daily antiglaucoma medication use (p = 0.002), whereas the iStent inject® W group did not achieve statistical significance in this regard (p = 0.054). The overall success rate was higher in the Hydrus group (38%) than in the iStent inject® W group (13%), though the difference was not statistically significant (p = 0.102). No device-related complications were observed in either group. Conclusions: The Hydrus® Microstent demonstrated superior IOP reduction and a more significant reduction in the need for antiglaucoma medications compared to the iStent inject® W in a real-world setting. These findings support the use of the Hydrus implant as an effective and safe micro-invasive glaucoma surgery (MIGS) option for patients with mild to moderate POAG. Further studies with larger patient populations and long-term follow-up are warranted to confirm the efficacy in patients with PEX and advanced glaucoma.

To compare real-world 24-month outcomes of phacoemulsification combined with either iStent inject or Hydrus Microstent. Analysis of data from the Fight Glaucoma Blindness (FGB) international registry. Anonymized data from 344 eyes with mild-to-moderate open-angle glaucoma, normal-tension glaucoma or ocular hypertension that underwent phacoemulsification combined with either iStent inject (224) or Hydrus Microstent (120) were included. Data were adjusted for baseline characteristics using linear regression and propensity score matching. The primary endpoint was a comparison of mean intraocular pressure (IOP) at 24 months. At 24 months, there was no significant difference in IOP reduction between the two groups, consistent across all analyses. The matched cohort showed iStent inject achieved 3.1 mmHg reduction and Hydrus a 2.3 mmHg reduction (p=0.530) and a mean medication reduction of 1.0 for iStent inject versus 0.5 for Hydrus (p=0.081). 5.4% of eyes in the iStent inject group and 7.5% of eyes in the Hydrus group required subsequent procedures to improve IOP control within 24 months. Complications were rare with no significant differences between the groups. Twenty-four-month outcomes showed sustained IOP reduction with a good safety profile for both groups. There was no significant difference in IOP outcomes between the groups. There may be a small additional reduction in glaucoma medication usage following cataract surgery with iStent inject compared to Hydrus.

Aim To evaluate the safety and preliminary efficacy of low-dose subconjunctival adalimumab in patients with non-infectious uveitis (NIU), refractory to conventional immunomodulatory therapy (IMT). Methods Prospective, noncomparative, interventional case series. Five patients with bilateral panuveitis (four post-therapeutic vitrectomy) and persistent intraocular inflammation on conventional IMT for > 2 years received three doses of subconjunctival adalimumab 5 mg/0.1 mL at two-week intervals and followed up for 24 weeks. Results No cases of persistent conjunctival congestion, corneal erosions or infection, or intraocular pressure > 21 mmHg were noted. Improvement in inflammatory scores and best-corrected visual acuity (BCVA) were noted in three patients each and worsening in none. None of the three patients who showed initial improvement in visual acuity had any baseline cystoid macular edema or vitreous haze to account for the improvement in BCVA. Conclusion Subconjunctival administration of 5 mg adalimumab is a safe and effective therapy for NIU refractory to conventional IMT.

IntroductionMinimally invasive glaucoma surgery (MIGS) has become more widespread in open-angle glaucoma (OAG) management. Broad evidence has shown a greater decrease in mean intraocular pressure (IOP) when cataract surgery is combined with MIGS, compared with cataract surgery alone. In this study, we evaluated the effectiveness and safety of second-generation trabecular micro-bypass implantation (iStent inject®) either in combination with cataract surgery (Combined subgroup) or as a standalone procedure (Standalone subgroup) in eyes with OAG. Our hypothesis was that implementing interventional glaucoma management would provide meaningful reductions in IOP and topical medication burden.MethodsThis long-term retrospective consecutive case series included patients with mild to moderate OAG who received the iStent inject® Trabecular Micro-bypass stent with or without phacoemulsification between 2018 and 2024. Eligible patients were ≥ 18 years of age with mild or moderate OAG, cataract requiring surgery (for the Combined subgroup), and the need for IOP and/or medication reduction. Study outcomes included mean and proportional analyses of IOP and medications over time. Analyses were completed for the overall population and for the Combined/Standalone and Mild/Moderate subgroups.ResultsThe study included 271 eyes with mean age 69 years and a mean of 40 months of follow-up (range 10–79 months). In the overall population, mean IOP decreased from 16.4 mmHg at baseline to 13.7 mmHg at last follow-up (p = 0.001), while the mean number of medications decreased from 2.24 at baseline to 0.62 at last follow-up (p = 0.001). IOP reductions were also significant in the Combined/Standalone subgroups and in the Mild/Moderate subgroups (p = 0.001 for all), and all subgroups experienced increased proportions of eyes on no topical medications at last follow-up versus preoperative (p = 0.001 for all).ConclusionThis 5-year real-world study showed significant and sustained reductions in IOP and topical medication burden following iStent inject trabecular micro-bypass with or without cataract surgery in eyes with mild and moderate open-angle glaucoma.

Randomized, Sham-Controlled Trial of Dexamethasone Intravitreal Implant in Patients with Macular Edema Due to Retinal Vein Occlusion