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To assess the effectiveness and safety of bimatoprost sustained release (SR) glaucoma implant as a treatment for open-angle glaucoma and ocular hypertension in a real-world private practice setting with a significant American Indian population. This retrospective study included 156 eyes from adult patients who received a single injection of bimatoprost implant between June 2020 and May 2022 at the Oklahoma Eye Surgeons. Patients were stratified by baseline intraocular pressure (IOP) (≥21 mmHg versus IOP<21 mmHg). The co-primary endpoints were changes in the mean IOP and the number of topical IOP-lowering medications from baseline to Month 6. At 6 months, eyes with baseline IOP≥21 mmHg had a significantly lower mean IOP (19.85±8.01 versus 26.25±4.84 mmHg; p<0.0001) and the mean number of IOP-lowering medications (1.04±1.44 versus 1.38±1.50; p=0.048) compared with baseline. One year after implantation, 73.58% of eyes had a ≥20% reduction in IOP, 41.51% were medication-free and 30.19% were receiving at least one fewer medication. Among eyes with baseline IOP<21 mmHg, there was a significant reduction in the mean number of IOP-lowering medicines by Month 6 (0.61±1.03 versus 1.93±1.21 at baseline; p<0.0001), with no change in IOP. At 12 months, 24.27% of eyes had a ≥20% decrease in IOP, 43.69% of eyes did not require any medications and 63.11% had at least one fewer medication compared with baseline. An analysis using Welch's two-sample -test showed no significant differences in the outcomes between the overall population and the American Indian population (number of eyes, 23). Bimatoprost SR glaucoma implant lowered IOP in eyes with high, uncontrolled baseline IOP, while it reduced the number of medications in eyes with a controlled baseline IOP. No clinically meaningful and statistically significant differences in the efficacy of bimatoprost were observed in patients of American Indian descent.

To report 12-month efficacy outcomes of 360° canaloplasty and 180° trabeculotomy using the OMNI surgical system in combination with phacoemulsification in patients with mild-moderate open-angle glaucoma (OAG) and visually significant cataract. Fifteen multi-subspecialty ophthalmology practices and surgery centers located in 14 US states. Prospective, multicenter, IRB approved study of patients treated with canaloplasty (360°) and trabeculotomy (180°). Eligible patients had cataract and mild-moderate OAG with intraocular pressure (IOP) ≤33 mmHg on 1 to 4 hypotensive medications. Unmedicated post-washout mean diurnal IOP (DIOP) ≥21 and ≤36 mmHg. Medication washout preoperatively and prior to month 12 DIOP. Effectiveness outcomes were IOP and IOP lowering medication use. Safety outcomes included adverse events and secondary surgical interventions (SSIs). Evaluations at 1, 3, 6, and 12 months. A total of 149 subjects underwent surgery and 120 were included in the final effectiveness analysis. Mean (standard deviation) unmedicated diurnal IOP was reduced from 23.8 (3.1) mmHg at baseline to 15.6 (4.0) at month 12 (-35%) and medications (before washout) were reduced from 1.8 (0.9) at baseline to 0.4 (0.9) at month 12 (-80%). At month 12, 84.2% of eyes achieved IOP reductions >20% from baseline, 80% of eyes were medication-free, and 76% of eyes achieved IOP between 6-18 mmHg inclusive. Adverse events were uncommon. Most were mild and self-limited including transient hyphema (9 of 149; 6%) and transient IOP elevations (3 of 149; 2.0%). No eyes required SSIs or experienced loss of VA that was attributable to the device or procedure. Canaloplasty and trabeculotomy performed with the OMNI surgical system at the time of phacoemulsification significantly reduces unmedicated mean diurnal IOP and medication use 12 months postoperatively, with an excellent safety profile. This procedure should be considered for eyes with mild-moderate OAG to reduce IOP, medication burden, or both.

To report interim 6-month safety and efficacy outcomes of 360° canaloplasty and 180° trabeculotomy using the OMNI Surgical System concomitantly with phacoemulsification in patients with open-angle glaucoma (OAG). Fifteen multi-subspecialty ophthalmology practices and surgery centers located in 14 states (Alabama, Arizona, Arkansas, Florida, Georgia, Iowa, Kansas, Montana, Nebraska, North Dakota, Oklahoma, Pennsylvania, Texas, and Wisconsin). Prospective, multicenter, IRB approved study of patients treated with canaloplasty (360°) and trabeculotomy (180°). Eligible patients had cataract and mild-moderate OAG with intraocular pressure (IOP) ≤33 mmHg on 1 to 4 hypotensive medications. Medication washout prior to baseline diurnal IOP (Goldmann). Effectiveness outcomes included mean IOP and medications. Safety outcomes included adverse events (AE), best corrected visual acuity (BCVA) and secondary surgical interventions (SSI). Analysis includes descriptive statistics and t-tests evaluating change from baseline. A total of 137 patients were enrolled and treated. Mean diurnal IOP after washout was 23.8 ± 3.1 mmHg at baseline. At month 6, 78% (104/134) were medication free with IOP of 14.2 mmHg, a mean reduction of 9.0 mmHg (38%). 100% (104/104) had a ≥ 20% reduction in IOP and 86% (89/104) had IOP ≥6 and ≤18 mmHg. The mean number of medications at screening was 1.8 ± 0.9 and 0.6 ± 1.0 at month 6. AE included transient hyphema (4.6%) and IOP elevation ≥10 mmHg (2%). There were no AE for loss of BCVA or recurring hyphema. There were no SSI. Canaloplasty followed with trabeculotomy and performed concomitantly with phacoemulsification has favorable intra and perioperative safety, significantly reduces IOP and anti-glaucoma medications through 6 months in eyes with mild-moderate OAG.

To provide long-term intraocular pressure (IOP) and ocular hypotensive medication usage outcomes through 36 months for patients treated with canaloplasty and trabeculotomy (OMNI Surgical System) combined with cataract surgery as participants in the GEMINI study. Eleven ophthalmology practices in 10 US states. Non-interventional 36-month extension of the 12-month, prospective, multicenter, GEMINI study. GEMINI patients had visually significant cataract, mild-to-moderate glaucoma (ICD-10 guidelines), medicated IOP <33 mmHg, and unmedicated mean diurnal IOP (DIOP) (after washout) 21-36 mmHg. Patients from GEMINI were eligible for inclusion. Outcome measures were reduction in mean unmedicated DIOP, reduction in mean IOP-lowering medications, percent of eyes with ≥20% reduction in unmedicated DIOP, and percent of eyes with unmedicated DIOP ≥6 and ≤18 mmHg. A total of 66 patients provided consent and were enrolled. Mean (SD) unmedicated DIOP was 23.1 (2.7) mmHg at baseline, 16.7 (4.1), 16.3 (3.3) at 24 and 36 months; mean reductions of 6.2 (4.1) and 6.9 (3.4) mmHg. Twelve-month IOP at the end of GEMINI was 15.6 mmHg. The proportion of eyes with ≥20% reduction in IOP was 77% and 78% (months 24 and 36) compared to 87% at month 12 from GEMINI. About 68% of patients had an IOP between 6 and 18 mmHg at 24 months and 71% at 36 months. Mean IOP-lowering medications was 1.7 at baseline, which was reduced to 0.4 (24 months, -1.3) and 0.3 (36 months, -1.4). About 74% of patients (46 of 62) were medication free at 36 months. GEMINI demonstrated 12-month effectiveness of canaloplasty and trabeculotomy with OMNI combined with cataract surgery for IOP and medication reduction in mild-to-moderate glaucoma. However, longer-term data is key to the decision making in the selection of a surgical treatment. This GEMINI extension demonstrates that the 12-month outcomes from GEMINI were sustained through 36 months.

Purpose A randomized, double-masked, multicenter, phase 2 trial to evaluate the long-term safety and efficacy of travoprost intraocular implant, an extended-release drug delivery system designed to provide uninterrupted sustained intraocular pressure (IOP)-lowering therapy, thereby reducing patient treatment burden and improving adherence with IOP-lowering medication. Methods Patients with open-angle glaucoma or ocular hypertension were administered a fast-eluting implant (FE implant, n = 51) and received twice-daily (BID) placebo eye drops, a slow-eluting (SE implant, n = 54) and received BID placebo eye drops, or underwent a sham surgical procedure and received BID timolol 0.5% ( n = 49). IOP was measured at baseline, day 1–2, day 10, week 4, week 6, month 3, and every 3 months thereafter through 36 months. Efficacy was evaluated by mean change from 8:00 AM unmedicated baseline IOP through month 36, and the percentage of patients receiving the same or fewer topical IOP-lowering medications as at screening (pre-study). Safety was evaluated by adverse events and ophthalmic parameters. Results Clinically and statistically relevant IOP-lowering treatment effects were observed through month 36 after a single administration of the travoprost implant compared with BID timolol with mean IOP reductions ranging from 7.6 to 8.8 mmHg for the FE implant group, from 7.3 to 8.0 mmHg for the SE implant group, and from 7.3 to 7.9 for the timolol group at the 8:00 AM timepoint ( P < 0.0001 for all treatment groups at all visits). At months 12, 24, and 36, a greater percentage of FE and SE implant patients versus timolol patients were well controlled on the same or fewer topical IOP-lowering medications compared with screening with 63 and 69% for the FE and SE implants groups, respectively, versus 45% for the timolol group at month 36. The safety profile of the implant was favorable; there were no dislodgements, no explantations, no adverse events of conjunctival hyperemia or periorbital fat atrophy, no discontinuations due to study eye adverse events, nor any serious adverse events in the study eye. Comparable changes from baseline in corneal endothelial cell counts were observed in the three treatment groups over the 36 months. Conclusion The travoprost intraocular implant demonstrated robust IOP-lowering and substantially reduced topical IOP-lowering medication burden for up to 36 months following a single administration, while maintaining a favorable safety profile. The travoprost intraocular implant promises to be a meaningful addition to the interventional glaucoma armamentarium by addressing the key shortcomings of topical IOP-lowering medications, including low adherence and topical side effects while controlling IOP for up to 36 months. Trial Registry ClinicalTrials.gov identifier NCT02754596 registered 28 April 2016.

Aim The purpose of this study was to conduct and interpret a pooled 12-month analysis of two prospective, multi-center, randomized, double-masked, controlled trials designed to assess the efficacy and safety of the travoprost intracameral implant (slow-eluting [SE] implant in development as a new therapeutic and fast-eluting [FE] implant included for masking purposes) in subjects with open-angle glaucoma (OAG) or ocular hypertension (OHT). Methods Subjects with OAG or OHT, on 0–3 intraocular pressure (IOP)-lowering medications, baseline unmedicated mean diurnal IOP of ≥ 21 mmHg, and IOP ≤ 36 mmHg at each baseline diurnal timepoint, received either a travoprost implant and twice-daily (BID) placebo eye drops or BID timolol 0.5% eye drops and a sham procedure. Subjects were followed through 12 months and assessed for IOP, reduction in topical IOP-lowering medications, and safety parameters including treatment-emergent adverse events (TEAEs). IOP at 8AM was prospectively collected at all study visits through 12 months and diurnal IOP, measured at 8AM, 10AM, and 4PM, was prospectively collected at baseline, day 10, week 6, and months 3 and 12. Results A total of 1150 subjects were randomized (385 FE implant, 380 SE implant, and 385 sham/timolol) across the two trials. Statistical non-inferiority to timolol and clinically relevant reductions in 8AM IOPs were demonstrated at month 12. In more detail, both implant groups demonstrated statistical non-inferiority to timolol and clinically relevant reductions from baseline in mean diurnal IOP at all visits over the 12-month evaluation period when diurnal IOP was collected. Additionally, both implant groups demonstrated robust treatment effect based on 8AM average IOP from day 10 through the specified visit which ranged from day 10 to month 12 from 6.9 to 8.5 mmHg in the FE implant group; 6.8 to 8.5 mmHg in the SE implant group; and 7.3 to 7.5 mmHg in the sham/timolol group. With regards to reduction in topical pharmacotherapy, at month 12, 77.6% of FE and 81.4% of SE implant eyes were completely free of all topical IOP-lowering medications and a significantly greater proportion of FE and SE implant eyes (89.9% and 93.0%) versus sham/timolol eyes (66.9%) were on the same or fewer topical IOP-lowering medications compared with pre-study ( p <  0.0001). Furthermore, of subjects on topical IOP medications at screening, a significantly greater proportion of FE implant (80.2%) and SE implant (85.1%) eyes versus sham/timolol (22.8%) eyes were on fewer topical IOP-lowering medications at month 12 compared with pre-study ( p <  0.0001). Lastly, of SE implant eyes on same or fewer topical IOP-lowering medications at month 12, the average through month 12 decreased by 0.9 medications, and of those SE implant eyes on fewer topical IOP-lowering medications compared with pre-study, the average through month 12 decreased by 1.4 medications. The most common TEAEs related to study treatment were hyperemia (conjunctival or ocular), iritis, and IOP increased. Conclusion The travoprost intracameral implant demonstrated robust IOP-lowering efficacy that was sustained and statistically non-inferior to timolol over the entire 12 months, resulting in a significant reduction in topical IOP-lowering medication use, with the majority of SE implant eyes remaining completely free of all topical IOP-lowering medications. In addition, the implant demonstrated a favorable safety and tolerability profile based on this pooled 12-month analysis of two pivotal trials. Trial Registration ClinicalTrials.gov identifiers NCT03519386 (registered May 09, 2018) and NCT03868124 (registered March 08, 2019).

Purpose: To examine effectiveness outcomes stratified by preoperative disease burden in the pivotal trial of iStent inject[R] 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 [greater than or equal to] 25 to <30 mmHg, High-DIOP [greater than or equal to] 30mmHg) and preoperative medication burden (Low-Med 1 medication, Mid-Med 2 medications, High-Med [greater than or equal to] 3 medications). Results: The 24-month primary and secondary effectiveness endpoints were met, with significant treatment-over-control differences in percent of eyes achieving [greater than or equal to] 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. Keywords: microinvasive glaucoma surgery/MIGS, glaucoma, iStent inject, trabecular micro-bypass, IOP, stratification, severity

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. 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. 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. 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. ClinicalTrials.gov identifier, NCT02868190.

This multicenter study evaluated the effectiveness and safety of third-generation trabecular micro-bypass implantation (iStent® infinite) combined with phacoemulsification (n = 233 eyes). Key outcomes through 12 months included the mean change in intraocular pressure (IOP) and the number of topical medications, as well as proportions achieving IOPs ≤ 18/15/12 mmHg or using 0/1/2/ ≥ 3 medications. In all eyes with 12-month follow-up data (n = 96, consistent cohort), the mean IOP reduced from 17.2 ± 4.2 mmHg preoperatively to 13.8 ± 3.0 mmHg at Month 12 (p = 0.001), while the mean number of medications reduced from 1.24 ± 0.91 preoperatively to 0.61 ± 0.96 at Month 12 (p = 0.001). The proportions of eyes achieving IOP ≤ 18/15/12 mmHg increased from 63.5%, 34.4%, and 14.6% preoperatively to 92.7%, 71.9%, and 37.5%, respectively at Month 12, (all p = 0.001). The proportions of eyes off medication increased from 16.7% preoperatively to 62.5% at Month 12 (p = 0.001). This study provides clinically relevant, real-world results that demonstrate significant reductions in IOP and the number of topical glaucoma medications required following iStent infinite trabecular micro-bypass and phacoemulsification.

The purpose of this study was to evaluate the safety and efficacy of microinvasive glaucoma surgery (MIGS) with 360° ab-interno trabeculotomy using the TRAB360 device as a stand-alone procedure in patients with refractory primary open-angle glaucoma (POAG) and preoperative IOP ≥18 mmHg. This study evaluated patients treated in a tertiary-referral clinical practice setting. This study is a retrospective analysis of 81 eyes. Patients with refractory open-angle glaucoma underwent stand-alone 360° ab-interno trabeculotomy using the TRAB360 device. Effectiveness was determined by reduction in medicated IOP and the use of medications from baseline. Safety was determined by the rate of adverse events and secondary surgical interventions. The time points assessed were baseline and postoperative day 1, week 1, and months 1, 3, 6, and 12. A subgroup analysis was performed on eyes with medicated preoperative IOP values of ≥25 mmHg. The reductions in IOP from 1 day to 12 months postoperatively were statistically significant compared to baseline values. The mean reduction in IOP at 12 months was 7.3±6.7 mmHg from baseline. At 12 months, 59% eyes achieved ≥20% reduction in IOP and IOP <18 mmHg with the same or fewer numbers of IOP-lowering medications compared with those at baseline. The mean number of IOP-lowering medications was reduced from 1.7±1.3 at baseline to 1.1±1.0 at 12 months. At 12 months, 67% of eyes with preoperative IOP values of ≥25 mmHg achieved ≥20% reduction in IOP and IOP <18 mmHg with the same or fewer numbers of IOP-lowering medications compared with those at baseline. The most common adverse event for all eyes was mild, transient hyphema (57 eyes). During the first year after the procedure, 20 (25%) eyes were considered failures since they required reinterventions. Trabeculotomy using the TRAB360 device resulted in significant IOP reductions up to 1 year with a favorable safety profile. The device is an effective stand-alone MIGS procedure for patients with refractory POAG.