Phase 3 Randomized Clinical Trial of the Safety and Efficacy of Travoprost Intraocular Implant in Patients with Open-Angle Glaucoma or Ocular Hypertension.

PURPOSE: To evaluate the safety and intraocular pressure (IOP)-lowering efficacy of 2 models of the travoprost intraocular implant (fast-eluting [FE] and slow-eluting [SE] types) from 1 of 2 phase 3 trials (the GC-010 trial). DESIGN: Multicenter, randomized, double-masked, sham-controlled, noninferiority trial. PARTICIPANTS: Patients with open-angle glaucoma or ocular hypertension having an unmedicated baseline mean diurnal IOP (average of 8 am, 10 am, and 4 pm time points) of ≥ 21 mmHg, and IOP of ≤ 36 mmHg at each of the 8 am, 10 am, and 4 pm timepoints at baseline. METHODS: Study eyes were randomized to the travoprost intraocular implant (FE implant [n = 200] or SE implant [n = 197] model) or to timolol ophthalmic solution 0.5% twice daily (n = 193). MAIN OUTCOME MEASURES: The primary outcome was mean change from baseline IOP in the study eye at 8 am and 10 am, at each of day 10, week 6, and month 3. Safety outcomes included adverse events (AEs) and ophthalmic assessments. RESULTS: Mean IOP reduction from baseline over the 6 time points ranged from 6.6 to 8.4 mmHg for the FE implant group, from 6.6 to 8.5 mmHg for the SE implant group, and from 6.5 to 7.7 mmHg for the timolol group. The primary efficacy end point was met; the upper limit of the 95% confidence interval of the difference between the implant groups and the timolol group was < 1 mmHg at all 6 time points. Study eye AEs, most of mild or moderate severity, were reported in 21.5%, 27.2%, and 10.8% of patients in the FE implant, SE implant, and timolol groups, respectively. The most common AEs included iritis (FE implant, 0.5%; SE implant, 5.1%), ocular hyperemia (FE implant, 3.0%; SE implant, 2.6%), reduced visual acuity (FE implant, 1.0%; SE implant, 4.1%; timolol, 0.5%), and IOP increased (FE implant, 3.5%; SE implant, 2.6%; timolol, 2.1%). One serious study eye AE occurred (endophthalmitis). CONCLUSIONS: The travoprost intraocular implant demonstrated robust IOP reduction over the 3-month primary efficacy evaluation period after a single administration. The IOP-lowering efficacy in both implant groups was statistically and clinically noninferior to that in the timolol group, with a favorable safety profile. FINANCIAL DISCLOSURE(S): Proprietary or commercial disclosure may be found in the Footnotes and Disclosures at the end of this article.

Canaloplasty and trabeculotomy with the OMNI® surgical system in OAG with prior trabecular microbypass stenting.

PURPOSE: Evaluate effectiveness and safety outcomes for patients treated with canaloplasty and trabeculotomy previously treated with a trabecular microbypass stent (TBS). METHODS: Retrospective, multicenter, IRB approved study. Patients treated with TBS (iStent/iStent inject, Glaukos) and subsequently with OMNI surgical system (OSS) (Sight Sciences). From 5 practices in 5 US states. Open-angle glaucoma (OAG), minimum 3 months follow-up after OSS surgery, Pre-OSS IOP ≥ 17 mmHg on ≥ 1 medication. No glaucoma procedures between TBS and OSS. ENDPOINTS: proportion with ≥ 20% reduction in IOP, IOP between 6 and 18 mmHg, mean IOP, change in IOP, mean number of medications. Adverse events and secondary surgical interventions (SSI). Mann-Whitney rank sum test compared pre-OSS IOP and medications with follow-up. RESULTS: Twenty seven patients. Average age (SD) 72.2 (10.8), 22/27 primary OAG (82%), mean MD - 6.2 (7.0) dB. Mean IOP before OSS 22.3 (4.3) mmHg on 2.2 (1.3) medications. At last follow-up (mean 11 months) IOP was 17.2 mmHg on 1.8 medications, - 5.1 mmHg (- 23%, p < .001), - 0.4 meds (- 18%, p = .193); ≥ 20% IOP reduction (41%), IOP ≤ 18 (56%). Adverse events were non-serious. Hyphema > 1 mm (3, 11%), BCVA decrease (4, 15%), IOP spike (2, 7%). SSI (4, 15%) had higher pre-OSS IOP (23.4 mmHg) and worse MD (- 9.6 dB). CONCLUSION: Patients uncontrolled by medication and a prior TBS would once have been candidates for trabeculectomy and tube shunts. OSS offered a minimally invasive option that provided IOP control and avoidance of traditional surgery for the majority over follow-up averaging 11 months and up to 42 months.

Prospective, Randomized, Controlled Pivotal Trial of an Ab Interno Implanted Trabecular Micro-Bypass in Primary Open-Angle Glaucoma and Cataract: Two-Year Results.

PURPOSE: Evaluate the safety and effectiveness of an ab interno implanted (iStent inject) Trabecular Micro-Bypass System (Glaukos Corporation, San Clemente, CA) in combination with cataract surgery in subjects with mild to moderate primary open-angle glaucoma (POAG). DESIGN: Prospective, randomized, single-masked, concurrently controlled, multicenter clinical trial. PARTICIPANTS: Eyes with mild to moderate POAG and preoperative intraocular pressure (IOP) ≤24 mmHg on 1 to 3 medications, unmedicated diurnal IOP (DIOP) 21 to 36 mmHg, and cataract requiring surgery. METHODS: After uncomplicated cataract surgery, eyes were randomized 3:1 intraoperatively to ab interno implantation of iStent inject (Model G2-M-IS; treatment group, n = 387) or no stent implantation (control group, n = 118). Subjects were followed through 2 years postoperatively. Annual washout of ocular hypotensive medication was performed. MAIN OUTCOME MEASURES: Effectiveness end points were ≥20% reduction from baseline in month 24 unmedicated DIOP and change in unmedicated month 24 DIOP from baseline. Safety measures included best spectacle-corrected visual acuity (BSCVA), slit-lamp and fundus examinations, gonioscopy, pachymetry, specular microscopy, visual fields, complications, and adverse events. RESULTS: The groups were well balanced preoperatively, including medicated IOP (17.5 mmHg in both groups) and unmedicated DIOP (24.8±3.3 mmHg vs. 24.5±3.1 mmHg in the treatment and control groups, respectively, P = 0.33). At 24 months, 75.8% of treatment eyes versus 61.9% of control eyes experienced ≥20% reduction from baseline in unmedicated DIOP (P = 0.005), and mean reduction in unmedicated DIOP from baseline was greater in treatment eyes (7.0±4.0 mmHg) than in control eyes (5.4±3.7 mmHg; P < 0.001). Of the responders, 84% of treatment eyes and 67% of control eyes were not receiving ocular hypotensive medication at 23 months. Furthermore, 63.2% of treatment eyes versus 50.0% of control eyes had month 24 medication-free DIOP ≤18 mmHg (difference 13.2%; 95% confidence interval, 2.9-23.4). The overall safety profile of the treatment group was favorable and similar to that in the control group throughout the 2-year follow-up. CONCLUSIONS: Clinically and statistically greater reductions in IOP without medication were achieved after iStent inject implantation with cataract surgery versus cataract surgery alone, with excellent safety through 2 years.

Collagen matrix vs mitomycin-C in trabeculectomy and combined phacoemulsification and trabeculectomy: a randomized controlled trial.

BACKGROUND: Antifibrotic agents are commonly utilized to enhance the success rates of trabeculectomy. Novel approaches to further improve success rates and reduce the risks of complications are needed. The purpose of this study was to compare intraocular pressure (IOP)-lowering efficacy and safety of trabeculectomy or combined phacoemulsification and trabeculectomy with mitomycin-C (MMC) vs. Collagen Matrix (CM). METHODS: A prospective, multicenter, randomized controlled trial was performed. Ninety-five eyes of 94 patients with uncontrolled glaucoma despite medical therapy, without previous incisional glaucoma surgery underwent trabeculectomy (85 eyes) or combined phacoemulsification and trabeculectomy (10 eyes) and were randomized to MMC or CM. One eye of each subject was analyzed. Patients were followed for 24 months. The criteria for complete success were IOP >5 and ≤21 mmHg with at least a 20% reduction below medicated baseline without additional glaucoma surgery or medications. The main outcome measures were complete success rates at 24 months with Kaplan-Meier analysis and incidence of adverse events. RESULTS: The baseline IOPs were 20.4 ± 6.0 mmHg and 21.2 ± 6.1 (mean ± standard deviation, p = 0.49) on 3.2 ± 1.1 and 3.1 ± 1.0 medications (p = 0.53) compared to 11.8 ± 5.2 and 12.8 ± 3.7 (p = 0.36) on 0.5 ± 0.8 and 0.6 ± 1.0 medications (p = 0.63) at 2 years in the MMC and CM groups, respectively. Kaplan-Meier analysis demonstrated complete success rates were similar in both groups at 24 months: 38.4 ± 7.6% with MMC and 56.2 ± 7.9% with CM (mean ± standard error, p = 0.112, log rank test); however, a significantly higher incidence of failure due to persistent hypotony was observed with MMC (p = 0.002). CONCLUSIONS: Use of the CM implant at the time of trabeculectomy or combined phacoemulsification and trabeculectomy is associated with similar complete success rates compared to adjunctive MMC; however, the risk of persistent hypotony is higher with MMC. TRIAL REGISTRATION: ClinicalTrials.gov registration number NCT01440751 . Registered 9/14/11.

Complications of tube implants and their management.

PURPOSE OF REVIEW: The use of glaucoma drainage devices (GDD) in the treatment of glaucoma has become widely accepted for cases of refractory glaucoma. Expansion in the indications for implantation of GDD beyond refractory glaucoma is increasingly common. As such, tube implant complications are reviewed to aid in prevention and improve their management. RECENT FINDINGS: Findings of the Tube Versus Trabeculectomy study resulted in an expanded use of tube implants in cases of refractory glaucoma. As interest in GDD implantation flourished, so too, did investigative comparison between devices; which includes the Ahmed Baerveldt Comparison study and Ahmed Verses Baerveldt study. Comparative analysis of success and complication rates between implantable devices is not only expanding the technology of tube implants, but also building a body of evidence that tube implantation has a strong safety profile and usage among specialists will continue to increase and indications will evolve. Complications resulting from GDD implantation include hypotony, postoperative elevated intraocular pressure, tube erosion, diplopia, motility disturbances, and corneal decompensation. SUMMARY: Tube implant use is increasing and indications are expanding beyond refractory glaucoma. Understanding differences in GDD, their complications and management will result in improved patient care.

Real-World Analysis of the Efficacy of Bimatoprost Sustained-Release Glaucoma Implant Where American Indians Comprise the Largest Minority Population.

Purpose: 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. Methods: 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. Results: 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 t-test showed no significant differences in the outcomes between the overall population and the American Indian population (number of eyes, 23). Conclusion: 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.

Efficacy and Safety of the Travoprost Intraocular Implant in Reducing Topical IOP-Lowering Medication Burden in Patients with Open-Angle Glaucoma or Ocular Hypertension.

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.

Travoprost Intracameral Implant for Open-Angle Glaucoma or Ocular Hypertension: 12-Month Results of a Randomized, Double-Masked Trial.

INTRODUCTION: This prospective, multicenter, randomized, double-masked pivotal phase 3 trial evaluated the efficacy and safety of the travoprost intracameral SE-implant (slow-eluting implant, the intended commercial product) and FE-implant (fast-eluting implant, included primarily for masking purposes) compared to twice-daily (BID) timolol ophthalmic solution, 0.5% in patients with open-angle glaucoma (OAG) or ocular hypertension (OHT). METHODS: The trial enrolled adult patients with OAG or OHT with an unmedicated mean diurnal intraocular pressure (IOP) of ≥ 21 and unmedicated IOP ≤ 36 mmHg at each diurnal timepoint (8 A.M., 10 A.M., and 4 P.M.) at baseline. The eligible eye of each patient was administered an SE-implant, an FE-implant or had a sham administration procedure. Patients who received an implant were provided placebo eye drops to be administered BID and patients who had the sham procedure were provided timolol eye drops to be administered BID. The primary efficacy endpoint, for which the study was powered, was mean change from baseline IOP at 8 A.M. and 10 A.M. at day 10, week 6, and month 3. Non-inferiority was achieved if the upper 95% confidence interval (CI) on the difference in IOP change from baseline (implant minus timolol) was < 1.5 mmHg at all six timepoints and < 1 mmHg at three or more timepoints. The key secondary endpoint was mean change from baseline IOP at 8 A.M. and 10 A.M. at month 12. Non-inferiority at month 12 was achieved if the upper 95% CI was < 1.5 mmHg at both timepoints. Safety outcomes included treatment-emergent adverse events (TEAEs) and ophthalmic assessments. RESULTS: A total of 590 patients were enrolled at 45 sites and randomized to one of three treatment groups: 197 SE-implant (the intended commercial product), 200 FE-implant, and 193 timolol. The SE-implant was non-inferior to timolol eye drops in IOP lowering over the first 3 months, and was also non-inferior to timolol at months 6, 9, and 12. The FE-implant was non-inferior to timolol over the first 3 months, and also at months 6 and 9. Of those patients who were on glaucoma medication at screening, a significantly greater proportion of patients in the SE- and FE-implant groups (83.5% and 78.7%, respectively) compared to the timolol group (23.9%) were on fewer topical glaucoma medications at month 12 compared to screening (P < 0.0001, chi-square test). TEAEs, mostly mild, were reported in the study eyes of 39.5% of patients in the SE-implant group, 34.0% of patients in the FE-implant group and 20.1% of patients in the timolol group. CONCLUSIONS: The SE-travoprost intracameral implant demonstrated non-inferiority to timolol over 12 months whereas the FE-implant demonstrated non-inferiority over 9 months. Both implant models were safe and effective in IOP lowering in patients with OAG or OHT. TRIAL REGISTRATION: ClinicalTrials.gov identifier, NCT03519386.

Effectiveness and Safety of iStent Infinite Trabecular Micro-Bypass for Uncontrolled Glaucoma.

PRCIS: The iStent Infinite Trabecular Micro-Bypass System implanted in patients with open angle glaucoma (OAG) (uncontrolled by prior surgical or medical therapy) was effective in reducing mean diurnal intraocular pressure with a favorable safety profile. PURPOSE: The purpose of this study is to evaluate safety and effectiveness of the iStent infinite Trabecular Micro-Bypass System in patients with OAG uncontrolled by prior surgical or medical therapy. DESIGN: Prospective, multicenter, single-arm, open-label clinical trial. METHODS: Implantation of iStent infinite (3 iStent inject W stents) was performed as a stand-alone surgical procedure in eyes with OAG uncontrolled by prior incisional or cilioablative surgeries or maximum tolerated medical therapy (MTMT). Prospectively declared effectiveness endpoints were proportion of eyes achieving ≥20% mean diurnal intraocular pressure (MDIOP) reduction from baseline at month 12 on the same or fewer intraocular pressure (IOP)-lowering medication classes (responder endpoint) and mean change in MDIOP from baseline at month 12. Safety parameters included visual acuity, slit-lamp and fundus examinations, gonioscopy, perimetry, surgical complications, and adverse events. RESULTS: Seventy-two eyes of 72 patients (mean age 71.9 y) with preoperative mean medicated MDIOP of 23.4±2.8 mm Hg on a mean of 3.1±0.9 IOP-lowering medication classes were enrolled: 61 eyes with failed prior surgery/ies (Failed-Surgery subgroup) and 11 eyes uncontrolled on MTMT (MTMT subgroup). A total of 76.1% of all enrolled patients met the responder endpoint (73.4% Failed-Surgery, 90.9% MTMT), with mean reduction (SE) in MDIOP at month 12 of 5.9(0.6) mm Hg [5.5(0.7) mm Hg Failed-Surgery subgroup, 8.1(0.9) mm Hg MTMT subgroup]. For patients on the same or fewer medication(s) as baseline, 53.0% achieved ≥30% MDIOP reduction without surgical interventions/other events. Safety was favorable, with no explants, infection, or device-related interventions or hypotony. CONCLUSIONS: iStent infinite stand-alone surgery achieved clinically significant IOP reduction and favorable safety in patients with OAG uncontrolled by prior therapy.

36-Month Outcomes from the Prospective GEMINI Study: Canaloplasty and Trabeculotomy Combined with Cataract Surgery for Patients with Primary Open-Angle Glaucoma.

Purpose: 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. Setting: Eleven ophthalmology practices in 10 US states. Design: Non-interventional 36-month extension of the 12-month, prospective, multicenter, GEMINI study. Methods: 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. Results: 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. Conclusion: 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.

New Devices in Glaucoma.

Glaucoma remains a leading cause of blindness globally. Minimally invasive treatment techniques are rapidly expanding the availability of therapeutic options for glaucoma. These include devices aimed at enhancing outflow through the subconjunctival space, Schlemm's canal, and suprachoroidal space, sustained-release drug delivery devices, and extraocular devices aiming to reduce glaucomatous progression through other novel means. In this review, we provide an overview of several novel devices either newly available or in development for the medical and surgical management of glaucoma. Further studies are required to determine the long-term efficacy of these devices and how they will integrate into the current landscape of glaucoma management.

Canaloplasty and Trabeculotomy Combined with Phacoemulsification for Glaucoma: 12-Month Results of the GEMINI Study.

Purpose: 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. Setting: Fifteen multi-subspecialty ophthalmology practices and surgery centers located in 14 US states. Design: 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. Methods: 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. Results: 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. Conclusion: 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.

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.

Canaloplasty and Trabeculotomy Combined with Phacoemulsification in Open-Angle Glaucoma: Interim Results from the GEMINI Study.

PURPOSE: 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). SETTING: 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). DESIGN: 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. METHODS: 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. RESULTS: 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. CONCLUSION: 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.

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.

Visual outcomes of combined cataract surgery and minimally invasive glaucoma surgery.

Minimally invasive glaucoma surgery (MIGS) has become a reliable standard of care for the treatment of glaucoma when combined with cataract surgery. This review describes the MIGS procedures currently combined with and without cataract surgery with a focus on visual outcomes based on the literature and the experience of the ASCRS Glaucoma Clinical Committee.

Comparison of Silicone- and Porous-Plate Ahmed Glaucoma Valves.

PURPOSE: Our aim was to evaluate and compare the clinical outcomes after implantation of the silicone-plate (model FP7) and porous polyethylene-plate (model M4) Ahmed Glaucoma Valves. PATIENTS AND METHODS: This was a prospective, multicenter, comparative series. A total of 52 eyes (52 patients) were treated with either the silicone or porous plate Ahmed Glaucoma Valve implant. Hypertensive phase was defined as intraocular pressure >21 mmHg during the first 3 months postoperatively. Success was defined as 5 mmHg ≤intraocular pressure ≤21 mmHg (with or without additional glaucoma medications), without loss of light perception and without additional glaucoma procedures. Patients were monitored for 1 year after surgery. RESULTS: The pre-operative intraocular pressure was 29.9 ± 6.6 mmHg and 33.8 ± 10.5 in the silicone-plate and porous-plate groups, respectively (P = 0.118). At 12 months after surgery, the mean intraocular pressure was 13.6 ± 4.7 mmHg in the silicone-plate group and 17.9 ± 10.9 mmHg in the porous-plate group (P = 0.141). The mean number of glaucoma medications at 12 months was 1.64 ± 1.40 mmHg and 1.89 ± 1.54 mmHg in the silicone- and porous-plate groups, respectively (P = 0.605). Hypertensive phase was not significantly different in the two groups (50.0% of the silicone-plate and 57.7% of the porous-plate groups, P = 0.578). At 12 months after surgery, the percent success for the silicone-plate and porous-plate groups was 88.5% and 53.8%, respectively (P = 0.005). Complications were similar in the two groups. CONCLUSION: The porous-plate Ahmed Glaucoma Valve showed similar average intraocular pressure reduction compared with the silicone-plate model. At 12 months after surgery, there was a significantly lower success rate in the porous-plate compared with the silicone-plate group.

Tube shunt complications and their prevention.

PURPOSE OF REVIEW: Glaucoma drainage devices (GDDs) have been generally accepted as a treatment of refractory glaucoma. GDDs have their own unique set of complications that are important to evaluate to prevent them. RECENT FINDINGS: Tube shunts are typically used in eyes with refractory glaucoma. There is increased interest in studying the efficacy of GDDs. Most of the attention has been focused on comparing trabeculectomy with the Baerveldt implant (Advanced Medical Optics, Inc., Santa Anna, California, USA). The other leading implant is the Ahmed Glaucoma Valve. There are several retrospective studies comparing these two devices and a prospective study is ongoing. There is great interest in the complication rate of tube shunts and these have been published both retrospectively and prospectively. Complications such as hypotony, diplopia, strabismus, proptosis, tube erosion, failure, corneal decompensation, endophthalmitis, and visual loss are all important and some have recently been reviewed in the literature. Moreover, the use of glaucoma drainage implants in the pediatric population has been evaluated. SUMMARY: Glaucoma drainage implants have been a powerful tool in our surgical fight to prevent blindness; however, they are not without complications or controversy.

360° ab-interno trabeculotomy in refractory primary open-angle glaucoma.

PURPOSE: 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. SETTING: This study evaluated patients treated in a tertiary-referral clinical practice setting. DESIGN: This study is a retrospective analysis of 81 eyes. METHODS: 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. RESULTS: 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. CONCLUSION: 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.