Search

Purpose: The purpose of this study is to compare efficacies and safeties of combined phacoemulsification-Micro-Invasive Glaucoma Surgeries (MIGS) to phacoemulsification only in eyes with open angle glaucoma., Design: Systematic Review and Meta-Analysis., Methods: A multi-database literature search was conducted to caputre MIGS articles published prior to April 19 th , 2024. Key exclusion criteria were inadequate follow-up, significant loss to follow-up, standalone MIGS surgery, or primary outcomes unreported. MIGS were grouped according to mechanisms of action: 1) Trabecular Meshwork (TM) bypass which improve aqueous drainage into Schlemm's canal (SC), 2) non-GATT Goniotomies which remove TM with varying devices, and 3) GATT which remove TM with a catheter or suture placed into SC. Efficacy was measured by reductions in IOP and medications while safety was compared using incidence of sight-threatening and other adverse events., Results: A total of 95 studies were included, accounting for 9733 eyes followed up at 1-year. The control group had a baseline IOP of 16.9(95%CI 15.9-17.9) mmHg on 1.43(1.19-1.68) medications and a postoperative IOP of 15.2(14.4-15.9) mmHg on 0.80(0.54-1.00) medications. The TM bypass baseline IOP was 18.2(17.6-18.7) mmHg on 1.89(1.78-2.01) medications which lowered to an IOP of 14.8(14.5-15.1) mmHg on 0.80(0.65-0.95) medications at 1-year-postoperation. The non-GATT goniotomy baseline IOP was 20.0(19.2-20.8) mmHg on 2.30(2.09-2.53) medications, and at 1-year followup the IOP was 14.6(14.3-15.0) mmHg on 1.41(1.22-1.62) medications. Lastly, the GATT baseline IOP of 21.8(19.5-24.1) mmHg on 2.90(2.36-3.44) medications was reduced to an IOP of 12.5(10.0-15.0) mmHg on 0.73(0.37-1.09) medications at 1-year-postoperation. All MIGS groups had equal or lower rates of sight-threatening events and secondary glaucoma surgery when compared to control. GATT had the highest hyphema rate at 27.7(13.5-44.5) % followed by non-GATT goniotomy with 15.5(7.8-25.0) %. These were both significantly higher than TM bypass and control groups, with hyphema rates of 3.5(1.6-5.9) % and 4% (only 1 study reporting hyphema rate), respectively., Conclusion: Based on current peer-reviewed articles, there is strong evidence that when compared to phacoemulsification alone, combined phaco-MIGS is beneficial for patients with open angle glaucoma and does not increase the incidence of vision-threatening events. Key limitations of our review stem from heterogeneities in protocol design or outcome reporting, and a limited number of high-quality studies with long-term follow-up., (Copyright © 2024. Published by Elsevier Inc.)

Prcis: This study demonstrates the efficacy and safety of once-daily 0.002% omidenepag isopropyl (OMDI) in patients with primary open angle glaucoma (POAG) or ocular hypertension (OHT) who do not respond or respond poorly to latanoprost., Purpose: The purpose of this study was to evaluate the intraocular pressure (IOP)-lowering efficacy and safety of OMDI in latanoprost low/nonresponders with POAG or OHT., Materials and Methods: Phase 3, nonrandomized, 2-phase, open-label, multicenter study (NCT03697811) in the United States. Key inclusion criteria included individuals aged 18 years or above, POAG or OHT diagnosis in both eyes, IOP ≥22 mm Hg in ≥1 eye, and ≤34 mm Hg in both eyes at all time points. Overall, 107 patients were enrolled; 104 completed treatment. Included a screening period (≤35-day washout period and 8-week latanoprost run-in period) and a 3-month treatment period comprising one drop of OMDI 0.002% once daily in both eyes. The primary study endpoint was changed from baseline in the mean diurnal (MD) IOP at month 3. Safety endpoints included incidence of adverse events, serious adverse events, and adverse drug reactions., Results: At baseline (visit 4), 75 (70.1%) patients had POAG, 32 (29.9%) had OHT, and 68 (63.6%) had prior use of prostaglandin/prostaglandin analogs (37.4% of whom used latanoprost). The mean (SD) baseline MD IOP was 23.34 mm Hg (2.12). The mean (SD) 3-month (visit 7) MD IOP change from baseline (following latanoprost run-in period and OMDI treatment period) was an additional decrease of 2.96 mm Hg (2.83) ( P <0.0001). No significant safety issues were reported during OMDI treatment., Conclusions: These data demonstrate OMDI efficacy and safety in latanoprost low/nonresponders with POAG or OHT, suggesting OMDI is a treatment option in the patient population in this study., (Copyright © 2023 The Author(s). Published by Wolters Kluwer Health, Inc.)

Purpose: To compare the effectiveness and safety of the MicroShunt versus trabeculectomy in patients with primary open-angle glaucoma (POAG)., Design: One-year results from a 2-year, prospective, randomized, multicenter, noninferiority study (NCT01881425) conducted in the United States and Europe., Participants: Eligible patients were aged 40-85 years with intraocular pressure (IOP) ≥15 and ≤40 mmHg and mild-to-severe POAG inadequately controlled on maximum tolerated medical therapy., Methods: Patients were randomized 3:1 to undergo stand-alone MicroShunt implantation or trabeculectomy, both performed with adjunctive mitomycin C (0.2 mg/ml for 2 minutes)., Main Outcome Measures: The primary effectiveness end point was surgical success, defined as ≥20% reduction in mean diurnal IOP from baseline (no medication washout) at year 1 without increasing the number of glaucoma medications. Secondary effectiveness end points at year 1 were the mean IOP change from baseline and requirement for postoperative intervention. Additional end points included glaucoma medication use and adverse events., Results: Overall, 395 (MicroShunt) and 132 (trabeculectomy) patients were randomized (mean Humphrey visual field mean deviation, -12.34 decibels [dB]). At year 1, probability of success was lower in the MicroShunt group compared with the trabeculectomy group (53.9% vs. 72.7%, respectively; P < 0.01). In the MicroShunt group, mean IOP ± standard deviation decreased from 21.1 ± 4.9 mmHg at baseline to 14.3 ± 4.3 mmHg (-29.1%; P < 0.01) at year 1, with a mean of 0.6 ± 1.1 glaucoma medications (baseline 3.1 ± 1.0; P < 0.01). In the trabeculectomy group, mean IOP decreased from 21.1 ± 5.0 mmHg to 11.1 ± 4.3 mmHg (-45.4%; P < 0.01), with a mean of 0.3 ± 0.9 glaucoma medications (baseline 3.0 ± 0.9; P < 0.01). Postoperative interventions, including laser suture lysis, were reported in 40.8% (MicroShunt) versus 67.4% (trabeculectomy) of patients (P < 0.01). Reported incidence of transient hypotony was higher in the trabeculectomy group versus the MicroShunt group (49.6% vs. 28.9%; P < 0.01). Vision-threatening complications were uncommon and reported in 1.0% of MicroShunt versus 0.8% of trabeculectomy patients., Conclusions: Probability of success was lower with MicroShunt compared with trabeculectomy. Although reductions in IOP and glaucoma medications over 1 year were observed in both groups, the trabeculectomy group had a lower mean IOP on fewer medications., (Copyright © 2021 American Academy of Ophthalmology. Published by Elsevier Inc. All rights reserved.)