Minimally invasive micro-sclerostomy (MIMS): a novel approach to lowering intraocular pressure and reducing medication burden

PurposeThe purpose of this study was to evaluate intraocular pressure (IOP) and topical ocular hypotensive medication burden at 12 months postoperatively in a predominantly Hispanic patient population with primary open-angle glaucoma each implanted with one trabecular micro-bypass stent during cataract surgery.MethodsThis was a retrospective, consecutive case series. The main objective was to assess reduction of IOP and/or medication burden in all eyes at the 12-month postoperative exam. A secondary objective was to assess outcomes in 3 subgroups, distinguished preoperatively by IOP control and by medication burden (suboptimal or maximum therapy) and with different treatment goals. Group 1 had medication-controlled IOP and goal to reduce medications while maintaining IOP control (n=65); Group 2 had uncontrolled IOP on ≤2 medications and goal to reduce IOP and maintain/reduce medication burden (n=31); and Group 3 had uncontrolled IOP on ≥3 medications and goal to reduce IOP and avoid filtering surgery (n=38). Evaluations included IOP, medication use, cup-to-disc ratio, visual fields, complications, and interventions. One hundred subjects (134 eyes) have been followed for 12 months.ResultsMost patients (80%) were Hispanic and had moderate or severe glaucoma (87%). At 12 months, mean IOP reduced to 12.9 mmHg vs 16.5 mmHg preoperatively; 92% had an IOP ≤15 mmHg at 12 months (99% had ≤18 mmHg). Mean medication burden had decreased to 0.9 vs 2.3 preoperatively. At the 12-month time point, 94% of all eyes achieved their predefined treatment goal of reduced IOP and/or medications. Reductions in medication burden for Group 1, and in IOP for Groups 2 and 3, were highly statistically significant (P<0.001). Two eyes in Group 3 had filtering surgery; the remaining 95% avoided such treatment. No other complications were reported.ConclusionThis mainly Hispanic population with predominantly moderate or severe glaucoma had substantial reduction of IOP and medication and favorable safety for 12 months following stent implantation during cataract surgery, with treatment success achieved in all 3 subgroups. These data show this stent technology to be effective in Hispanic eyes with more advanced disease.

Update on Microinvasive Glaucoma Surgery.

This study assesses the safety and efficacy of microinvasive glaucoma surgery (MIGS) with cataract extraction in patients with normal-tension glaucoma (NTG). In our sample of 45 NTG patients, mean intraocular pressure (IOP) decreased from 13.7 to 12.3 mmHg at 2.5 years, and mean medication burden decreased from 2.0 to 1.1 at 1.5 years. For success defined as IOP reduction ≥ 30% from baseline IOP with medication burden reduction from preoperative levels, success probability was 5.4% at 1.5 years. For success defined as medication burden reduction with an IOP reaching goal IOP as determined by the glaucoma specialist, success probabilities were 67.2% at 1.5 years and 29.4% at 2.5 years. At the last follow-up visit, eyes with two MIGS procedures with different mechanisms of action achieved successful medication reduction 68.8% of the time versus 35.7% achieved by a single MIGS procedure (p = 0.052). At their last visit, visual acuity was unchanged or improved in all eyes (100%). MIGS with cataract surgery results in modest reductions in IOP and medication burden in NTG patients, which may lead to lower costs and better therapeutic compliance. A combination of two MIGS procedures with different mechanisms of action may potentially be more effective in reducing medication burden than a single MIGS procedure in NTG patients. Further research is necessary to ascertain whether MIGS for NTG patients may help decrease medication burden while helping achieve goal IOP.

Comparative outcomes of phacoemulsification combined with micro-invasive glaucoma surgery plus: Schlemm canal microstent versus Ab interno trabecular excision

Background/Objectives: Evaluation of real-world outcomes of standalone implantation of the third-generation trabecular micro-bypass device (iStent infinite) in eyes with mild to severe primary open-angle glaucoma (POAG). Materials: This retrospective, uncontrolled consecutive case series included eyes undergoing standalone iStent infinite implantation at a single U.S. practice. Outcomes were assessed through 12 months, including changes in intraocular pressure (IOP) and medication burden (primary), proportions achieving IOP ≤ 12/15/18 mmHg and medication categories (secondary), and safety. Subgroup analyses were completed based on preoperative IOP, glaucoma severity, and medication burden. Results: Fifty-one eyes (mean age 66.5 ± 10.8 years) were included. Mean baseline IOP was 20.1 ± 5.4 mmHg on 2.1 ± 1.2 medications. At month 12, the mean IOP decreased to 16.0 ± 3.6 mmHg (−4.1 mmHg, −20.4%; p < 0.001), and mean medications decreased to 1.5 ± 1.2 (−28.6%; p < 0.001). The proportion of eyes achieving IOP ≤ 18/15/12 mmHg increased from 41.2%/15.7%/3.9% to 79.6%/42.9%/16.3%, respectively (all p < 0.001). Medication-free eyes increased from 15.7% to 30.6%, while eyes requiring ≥ 3 medications decreased from 47.1% to 20.4%. Eyes with baseline IOP > 18 mmHg achieved greater IOP reduction (−27.8%), whereas eyes with baseline IOP ≤ 18 mmHg maintained stable IOP with reduced medications. Kaplan–Meier analysis demonstrated 12-month freedom from incisional reintervention of 92.2%. No intraoperative complications occurred. Transient self-resolving hyphema was observed in 3.9% of eyes. A secondary incisional surgery was performed in four eyes (7.8%); no vision-threatening complications were reported. Conclusions: Standalone iStent infinite implantation resulted in significant IOP and medication reductions with a favorable safety profile over 12 months, with outcomes aligned with preoperative treatment goals. These results suggest potential benefit as a less invasive real-world glaucoma intervention, warranting confirmation in larger prospective studies.

PurposeTo assess the safety and effectiveness of augmented MicroPulse (MP-TSCPC) with limited Continuous Wave Transscleral Cyclophotocoagulation (CW-TSCPC) in patients with refractory glaucoma.MethodsThirty-eight eyes of 38 patients underwent combined MP-TSCPC and CW-TSCPC at Massachusetts Eye and Ear. Kaplan–Meier survival curves and Wilcoxon paired sign rank tests were performed to evaluate intraocular pressure (IOP), glaucoma medication burden, best corrected visual acuity (BCVA), and adverse events.ResultsWith success defined as IOP reduction ≥ 30% and IOP between 5 and 18 mmHg, the cumulative probability of success at 1 year and 1.5 years were 0.81 (95% confidence interval (CI), 0.68–0.96) and 0.65 (95% CI, 0.50–0.86), respectively. With success defined as IOP reduction ≥ 50% and IOP between 5 and 18 mmHg, the success probability at 1 year and 1.5 years were 0.72 (95% CI, 0.57–0.89) and 0.56 (95% CI, 0.40–0.78), respectively. IOP and medication burden reductions were significant at all follow-up visits compared to baseline. Average IOP decreased from 27.9 mmHg at baseline to 11.4 mmHg at 1 year (p < 0.001) and 10.0 mmHg at 1.5 years (p < 0.001). Average medication burden decreased from 3.8 to 1.7 at 1.5 years (p = 0.001). No significant differences in visual acuity were observed at any time point. No long-term sight-threatening complications due to the combined procedure were observed, and most of the complications observed were mild and transient.ConclusionIn patients with refractory glaucoma, the combination of augmented MP-TSCPC with limited CW-TSCPC provides a significant IOP-lowering effect and decrease in medication burden without increased risk of postoperative complications.

To report on the efficacy of combined endoscopic cyclophotocoagulation (ECP) and phacoemulsification cataract extraction (PCE) with intraocular lens placement for reduction of intraocular pressure (IOP) and medication burden in glaucoma. A retrospective case review of 91 eyes (73 patients) with glaucoma and cataract that underwent combined PCE/ECP surgery was performed. Baseline demographic and ocular characteristics were recorded, as well as intraocular pressure, number of glaucoma medications, and visual acuity postoperatively with 12-month follow-up. Treatment failure was defined as less than 20% reduction in IOP from baseline on two consecutive visits (at 1, 3, 6, or 12mo postoperatively), IOP ≥21 mm Hg or ≤5 mm Hg on two consecutive visits, or additional glaucoma surgery performed within 12mo after PCE/ECP. Overall, mean medicated IOP was reduced from 16.65 mm Hg at baseline to 13.38 mm Hg at 12mo (P<0.0001). Mean number of glaucoma medications was reduced from 1.88 medications at baseline to 1.48 medications at 12mo (P=0.0003). At 3mo postoperatively, the success rate was 73.6% (95%CI: 63.3, 81.5), 57.1% at 6mo (95% CI: 46.3, 66.6), and 49.7% at 12mo (95%CI: 38.9, 59.6). Patient demographic characteristics were not associated with treatment success. The only ocular characteristic associated with treatment success was a higher baseline IOP. Combined PCE/ECP surgery is an effective surgical option for the reduction of IOP and medication burden in glaucoma patients. Patients with higher baseline IOP levels are most likely to benefit from this procedure.

Background/Objectives: This paper will compare the outcomes-safety and efficacy-of three minimally invasive glaucoma surgeries (MIGSs),the Hydrus Microstent, iStent, and Gonioscopy-Assisted Transluminal Trabeculotomy (GATT), for intraocular pressure (IOP) reduction in patients with primary open-angle glaucoma (POAG). Methods: A literature search of Ovid Medline and Embase identified studies evaluating the Hydrus, iStent, and GATT. Data on IOP reduction, medication use, and complications were analyzed. Results: Studies show the Hydrus, iStent, and GATT reduce IOP and medication burden in POAG patients, with some complications. For the Hydrus, studies showed 37.09% (27.5 ± 4.4 to 17.3 ± 3.7 mmHg) and 25% (16.8 to 12.6 mmHg) IOP reduction. Meanwhile, medication burden decreased from 2.5 ± 0.7 to 1.0 and from 2.1 to 1.15. For the iStent, studies showed a 36.39% (21.1 to 13.4 mmHg) and 8.19% (17.1 to 15.7 mmHg) IOP drop. Medication burden decreased from 2.87 to 1.24 and from 1.7 to 0.26. For GATT, studies showed a 49.33% (27.70 ± 10.30 to 14.04 ± 3.75) and 39.09% (26.40 ± 6.37 to 16.08 ± 2.38) IOP drop. Medication burden reduced from 3.73 ± 0.98 to 1.82 ± 1.47 and from 3.12 ± 0.80 to 0.45 ± 0.96. Conclusions: The Hydrus, iStent, and GATT are effective alternatives to trabeculectomy for mild to moderate POAG. They reduce and control IOP and dependence on medications with manageable safety profiles. In all three options, there were some clinically significant complications based on the p-value. For the Hydrus, it was PAS. For the iStent, they were PAS, FB sensation, IOP spikes, and microhyphema. For GATT, it was IOP spikes. However, further long-term studies, especially randomized controlled trials, are needed to support these results.

To evaluate the efficacy and safety of Kahook dual blade (KDB) goniotomy combined with phacoemulsification for open-angle glaucoma in Chinese patients. We retrospectively enrolled 78 Chinese patients (100 eyes) with open-angle glaucoma who underwent KDB goniotomy combined with phacoemulsification at the Third People's Hospital of Dalian, Liaoning Province, China, between September 2021 and December 2024, of whom 63 eyes had primary open-angle glaucoma (POAG) and 37 eyes had pseudoexfoliation glaucoma (PXFG). Intraocular pressure (IOP), the number of glaucoma medications used preoperatively and at 1day, 1 week, 1 month, 3, 6, 12, and 36 months postoperatively, surgical success rates, and surgical complications were recorded. Surgical success was defined as: Criterion A (IOP reduction ≥ 20% with IOP ≤ 21 mmHg), Criterion B (IOP reduction ≥ 20% with IOP ≤ 18 mmHg), and Criterion C (IOP reduction ≥ 20% with IOP ≤ 15 mmHg). The mean IOP reduced from 25.25 ± 6.54 mmHg at baseline to 14.09 ± 3.48 mmHg at 36 months (P < 0.01). The number of medications decreased from 3.0 (2.0, 4.0) to 1.0 (0.0, 2.0) at 36 months (P < 0.01). Surgical success rates at 36 months, defined by Criteria A, B, and C, were 76.32%, 67.11%, and 48.68%. The mean IOP reduced from 24.57 ± 5.71 mmHg at baseline to 14.83 ± 3.35 mmHg at 36 months for POAG (P < 0.01) and from 26.41 ± 7.70 mmHg at baseline to 12.90 ± 3.40 mmHg at 36 months for PXFG (P < 0.01).The number of medications decreased from 3.0 (2.0, 4.0) to 1.0 (0.0, 2.0) for POAG (P < 0.01) and from 3.0 (2.0, 4.0) to 0.0 (0.0, 1.0) for PXFG (P < 0.01) at 36 months. Between the two groups, IOP showed no statistical difference at baseline, 3 months, and 36 months (P > 0.05). At 1day, 1 week, 1 month, 6 months, 12 months, and 24 months, IOP in the PXFG group was significantly lower than that in the POAG group (P < 0.05). From 3 months to 36 months, the number of medications in the PXFG group was significantly lower than that in the POAG group (P < 0.05). Surgical success rates at 36 months according to Criterion A were 72.34% in POAG and 82.76% in PXFG (P = 0.127); according to Criterion B, 59.57% vs. 79.31% (P = 0.087); and according to Criterion C, 42.55% vs. 62.07% (P = 0.036). Twenty-four-hour IOP fluctuations at 12 months were 4.02 ± 2.01 mmHg in POAG and 3.69 ± 1.31 mmHg in PXFG, both significantly decreased compared with baseline (10.02 ± 3.58 mmHg and 10.39 ± 3.32 mmHg, respectively; P < 0.01 for both groups). Common surgical complications included hyphema and IOP spike. KDB goniotomy combined with phacoemulsification was safe and effectively reduced IOP and the medication burden in patients with POAG and PXFG. In the first and second year, significantly lower IOP was noted in PXFG compared with POAG.

Background: Glaucoma is the leading cause of irreversible blindness around the world and is characterized as a group of irreversible optic neuropathies with multiple risk factors such as age, race/ethnicity, sex, and intraocular pressure (IOP), amongst many others that play a role in disease etiology. However, IOP is the only modifiable risk factor, with higher IOP often causing increased damage to the optic nerve, resulting in the vast majority of medical and surgical treatments aiming to reduce IOP. There are a number of interventions available to treat glaucoma including micro-invasive glaucoma surgery (MIGS), whose usage has drastically increased due to its safety and efficacy. Studies also highlight the IOP-reducing effect of cataract surgery, which is the most common procedure performed globally. However, other, more targeted therapies and surgeries have been shown to have a more significant effect on IOP reduction. The objective of this study is to compare the IOP and medication reduction between cataract surgery (CS), MIGS, and MIGS and cataract surgery (MACS) clinical trials. Methods: This analysis consisted of publicly available data on CS, MIGS, and MACS clinical trials from 2005 to 2017 using ClinicalTrials.gov. Data reporting and synthesis adhered to PRISMA guidelines. MIGS interventions studied in this analysis include iStent®, CyPass® Micro-Stent, Ex-PRESS®, Hydrus®, PRESERFLO™ MicroShunt, and XEN® Gel Stent. The main variables of interest are the mean IOP and mean number of glaucoma medications used. The primary outcomes were the baseline, post-procedure, and reduction in IOP and glaucoma medication use. Cohorts were further subdivided by the follow-up period (6, 12, and 24 months), as well as their medicated or unmedicated status for pre-op IOP measurement. PROSPERO CRD42025102892. Results: A total of 21 trials were included in this review, comprising 3330 clinical trial participants: 7 CS trials (N = 570), 13 MIGS trials (N = 1577), and 9 MACS trials (N = 1183). All interventions studied resulted in a decrease in both the IOP and medication usage with varying degrees. At 12 months, the wash-out baseline IOP reduction (mmHg) was 6.9 (27.5%) for CS, 8.8 (34.0%) for MIGS, and 8.2 (32.6%) for MACS. The medication reduction was 0.8 (56.1%) following CS, 1.0 (39.5%) for MIGS, and 1.3 (86.4%) for MACS. At 24 months, the wash-out baseline IOP reduction was 6.3 (25.1%) for CS, 8.4 (33.1%) for MIGS, and 7.6 (30.1%) for MACS. At 24 months, the medication reduction was 0.9 (58.3%) for CS, 1.5 (79.8%) for MIGS, and 1.3 (86.1%) for MACS. Conclusions: The results indicate that CS, MIGS, and MACS all result in a decrease in the IOP and glaucoma medications; however, MIGS and MACS outperform CS in IOP and medication reduction. Adopting MIGS and MACS for patients with ocular hypertension or mild-to-moderate glaucoma will help improve patient outcomes through reducing the IOP and medication burden. Given that glaucoma affects certain populations to a greater degree, future research analyzing racial representation is critical in ensuring the appropriate applicability of clinical trial results toward diverse populations.

Real World Outcomes of Kahook Dual Blade Goniotomy in Black and Afro-Latinx Adult Patients with Glaucoma: A 6-Month Retrospective Study

Tube revision with capsule excision in failed glaucoma drainage devices (GDDs) has good medium-term success effectively reducing the intraocular pressure (IOP) and medication burden. Implantation of Ologen may limit the complications, particularly erosion. To evaluate the 36-month outcomes of tube shunt revision with capsule excision using Mitomycin C (MMC) versus MMC with Ologen-a collagen matrix implant. Twenty-three eyes with failed GDD underwent tube revision with fibrotic capsule excision. 12 of them received a MMC application whereas the other 11 also received an Ologen implant. Qualified success, changes in IOP, medication burden, and complication rates were evaluated and compared. Three years post-revision, qualified success for the whole cohort was 58% with no significant difference between the MMC group (52%) and MMC+Ologen group (67%; P=0.606). Mean survival time for each group was 27.4 and 29.8 months, respectively. With no intergroup differences through 3 years, capsule excision leads to a significant decrease in IOP from 28.6±6.5 to 15.1±4.3 mm Hg (47% reduction) and in antiglaucoma medications, from 3.6±1.2 to 2.5±1.3 mm Hg (30% reduction; P<0.001). Complication rates were significantly lower in the MMC+Ologen group (27%) compared with the MMC group (75%; P=0.022). Plate erosion happened in 25% of the eyes in the MMC group which required excision of the tube and plate, but no such complication was observed in the MMC+Ologen group. Revision of a failed tube shunt by excision of the encapsulated bleb offers good medium-term outcomes by reducing the IOP and glaucoma medications. Although the addition of Ologen did not affect the medium-term success, IOP, or medication burden, its implantation yielded significantly lower complication rates.

This retrospective multicentre study of 77 NTG eyes undergoing phacoemulsification and Hydrus implantation showed a sustained reduction in medication burden, while maintaining IOP levels. Complications were rare and nonsight-threatening. To evaluate 36-month outcomes of combined phacoemulsification and Hydrus Microstent implantation (Phaco-Hydrus) in eyes with normal tension glaucoma (NTG). This multicentre retrospective study included 77 NTG eyes from Singapore and Canada that underwent Phaco-Hydrus between 2014 and 2023. Primary outcomes were changes in intraocular pressure (IOP) and medication burden, and cumulative success probabilities from Kaplan-Meier (KM) analyses. Longitudinal changes were analysed using generalized estimating equations. Of 77 eyes, 31 completed 36 months of follow-up. Mean baseline IOP and medications was 13.5±2.5mmHg and 1.7±0.9, respectively. No significant reductions in IOP were observed. A sustained reduction in medication use was observed at all follow-up timepoints ( P ≤0.001). At 36 months, medication use decreased by -0.7±0.2 [adjusted mean difference±SE of the mean [SEM]]. Proportion of medication-free eyes increased from 7.8% (n=6/77) at baseline to 45.2% (n=14/31) at 36 months. Cumulative success probabilities varied widely based on definitions. When defined as a decrease in ≥1 medication from baseline without an increase in IOP, or IOP ≤15mmHg and reduced ≥20% from baseline while medication-free, and no additional laser or incisional glaucoma surgery, this was 40.7% at 36 months. No visual field mean deviation progression was detected. Adverse events were infrequent and nonsight-threatening. In eyes with NTG, Phaco-Hydrus may offer a greater role in medication reduction or achieving a medication-free status over 36 months, rather than absolute IOP reduction.

This prospective study demonstrates that the PreserFlo MicroShunt effectively reduces IOP and medication burden over 24 months in Asian patients with POAG, although risk of complete success failure was higher in combined cataract surgery. Glaucoma is characterized by progressive and irreversible vision loss due to optic nerve degeneration. Lowering intraocular pressure (IOP) remains the mainstay of glaucoma treatment. The PreserFlo MicroShunt (Santen Pharmaceutical Co.) is a form of minimally invasive bleb surgery. We investigate the efficacy and safety of PreserFlo MicroShunt device in Asian patients with primary open angle glaucoma over a 24-month postoperative period. A prospective, single-arm study of subjects with POAG receiving the PreserFlo MicroShunt surgery with or without concurrent cataract surgery. Primary outcome at 2 years was complete success (IOP ≥20% reduction without medications and IOP<22mmHg if baseline IOP>21mmHg). Ten eyes underwent PreserFlo MicroShunt surgery, and 17 eyes underwent combined phacoemulsification and PreserFlo MicroShunt. Mean baseline IOP was 22.1mmHg, and the median baseline medication load was 3.0. At 6, 12, and 24 months, the complete success rate was 55.6%, 48.1%, and 37.0%, respectively. Qualified and complete success at 6, 12, and 24 months was 81.5%, 74.1%, and 63.0%, respectively. Mean reduction in IOP was 7.9, 6.0, 7.1mmHg at POM6 (P<0.001), POM12 (P=0.020), and POM24 (P<0.001). Reduction in median number of medications was from 3 to none at 6, 12, and 24 months (P<0.001). The risk of complete success failure was significantly higher in the combined group compared with the standalone (HR: 10.08; 95% CI: 2.26-45.07). One eye required open revision, 2 eyes required trabeculectomy, and 5 eyes had bleb needling or injection with antimetabolite. Our study demonstrated that the PreserFlo MicroShunt effectively lowered IOP and medication burden in Asian eyes with POAG.

Micropulse Transscleral Cyclophotocoagulation: A Look at Long-Term Effectiveness and Outcomes