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Purpose: To evaluate the performance and safety of minimally invasive glaucoma surgery with a supraciliary drainage device (MINIject; iSTAR Medical, Wavre, Belgium) in primary open-angle glaucoma (POAG) as a stand-alone procedure., Design: Meta-analysis., Methods: At 11 sites in Colombia, France, Germany, India, Panama, and Spain, 82 patients were treated in 3 prospective, multicenter, interventional, nonrandomized trials (STAR-I, II, III). Data were pooled in a meta-analysis of up to 2 years of follow-up postimplantation. The main outcome measures were mean relative and absolute reduction in diurnal intraocular pressure (IOP) compared to baseline. Secondary outcomes included patients with IOP ≤18 mmHg, patients with IOP reduction ≥20%, number of IOP-lowering medications, adverse events, and endothelial cell density loss., Results: At the 2-year follow-up (n = 66), mean IOP was reduced from 23.8 ± 3.3 mmHg at baseline to 14.4 ± 4.5 mmHg (-39.3%; P < 0.0001). An IOP reduction of ≥20% was achieved in 89.4% of patients, with 84.8% having an IOP ≤18 mmHg. IOP-lowering medications were reduced from a mean of 2.4 ± 1.1 to 1.4 ± 1.4 (P < 0.0001), with 37.9% of patients being medication-free at 2 years. Mean endothelial cell density loss at 2 years was 6.2 ± 9.1% compared to baseline and no patient had a loss >30%., Conclusions: This meta-analysis demonstrates the favorable safety and efficacy profile of a supraciliary device implanted in a stand-alone, ab-interno procedure in patients with mild-to-moderate POAG. The data demonstrate that MINIject is a safe and effective, bleb-free treatment option for patients requiring low target IOP up to 2 years., (Copyright © 2023 The Authors. Published by Elsevier Inc. All rights reserved.)

Purpose: Reintervention rate is an important factor impacting on patients, surgeons, and society. To date, only a few studies have focused on this topic. For this reason, a systematic review and meta-analysis was undertaken to assess the reintervention rate after glaucoma filtering surgery., Materials and Methods: Prospective studies reporting the reintervention rate after glaucoma filtering surgery and with at least 12 months of follow-up were systematically searched on PubMed, Medline and Embase databases. The primary outcome was the total reintervention rate following surgery. Secondary outcomes were: the rate of manipulation, in-clinic and in-operating room reintervention; the reintervention rate for intraocular pressure (IOP) control and for complications; demographic, clinical and surgical variables associated with reintervention rate., Results: Ninety-three studies with a total of 8345 eyes were eligible. The total reintervention rate was 1.84 (95% CI 1.57-2.13), with a lower rate for Baerveldt (0.53, 95% CI 0.29-0.83) and Preserflo (0.60, 95% CI 0.15-1.29), and a higher rate for Xen (4.26, 95% CI 2.59-6.31). The manipulation rate was 0.99 (95% CI 0.77-1.23), the in-clinic reintervention rate was 0.08 (95% CI 0.05-0.12) and the in-operating room reintervention rate was 0.28 (95% CI 0.22-0.35). The reintervention rate for IOP control was 1.26 (95% CI 1.04-1.51) and the reintervention rate for complications was 0.27 (95% CI 0.21-0.35)., Conclusions: All types of surgery presented a total reintervention rate similar to the overall findings, except studies on Baerveldt and Preserflo Microshunt, with a lower rate, and Xen, with a higher rate. None of the variables evaluated were found to be directly associated with the explored outcomes.

Purpose: To identify the risk factors associated with failure of tube shunt surgery., Design: Pooled analysis of 3 prospective multicenter, randomized clinical trials., Methods: A total of 621 patients with medically uncontrolled glaucoma were enrolled, including 276 from the Ahmed Baerveldt Comparison Study, 238 from the Ahmed Versus Baerveldt Study, and 107 from the tube group of the Tube Versus Trabeculectomy Study. Patients were randomized to treatment with an Ahmed glaucoma valve (model FP7) or Baerveldt glaucoma implant (model 101-350). The associations between baseline risk factors and tube shunt failure were assessed using a Cox proportional hazards regression model. The primary outcome measure was the rate of surgical failure defined as intraocular pressure (IOP) > 21 mmHg or reduced < 20% from baseline, IOP ≤ 5 mmHg, loss of light perception vision, reoperation for glaucoma, or removal of implant., Results: The cumulative probability of failure after tube shunt surgery was 38.3% after 5 years. In multivariable analyses, baseline factors that predicted tube shunt failure included preoperative IOP (≤ 21 mmHg compared to IOP > 21 and ≤ 25 mmHg; HR, 2.34; 95% CI, 1.52-3.61; P < .001), neovascular glaucoma (HR, 1.79; 95% CI, 1.28-2.52; P = .001), randomized treatment (for Ahmed glaucoma valve; HR, 1.36; 95% CI, 1.04-1.78; P = .025), and age (for 10 year decrease in age; HR, 1.19; 95% CI, 1.09-1.31; P < .001)., Conclusions: Lower preoperative IOP, neovascular glaucoma, Ahmed implantation, and younger age were predictors of tube shunt failure. This Study provides the largest prospectively collected dataset on tube shunt surgery., (Copyright © 2022 Elsevier Inc. All rights reserved.)

Background/aims: Determine the efficacy of stand-alone implantation of the ab externo SIBS or poly(styrene-block-isobutylene-block-styrene) microshunt with mitomycin C in glaucomatous eyes, refractory to previous subconjunctival filtering surgery, over 1 year of follow-up., Methods: Consecutive retrospective cohort of patients with intraocular pressure (IOP) above target and previous subconjunctival filtering surgery, who received the microshunt between July 2015 and April 2019. Primary outcome was a complete success, with failure defined as IOP <6 mm Hg with vision loss, >17 mm Hg or <20% reduction in IOP without medications. Secondary outcomes included thresholds of 6 to 14 mm Hg and 6 to 21 mm Hg for both complete (no medications) and qualified (with medications) success as well as qualified success for thresholds of 6 to 17 mm Hg. Risk factors for failure, IOP, medications and complications were also assessed., Results: 85 eyes of 79 patients with a preoperative median IOP of 22.0 mm Hg (IQR 18.0-29.0) on four (IQR 3-4) medications were included. Postoperative median IOP was 13.0 mm Hg (IQR 10.0-17.0) on zero (IQR 0-2) medication at 1 year. 61.0% achieved complete success and 79.7% achieved qualified success. Mild-to-moderate disease was associated with failure (adjusted HR 2.37; 95% CI 1.23 to 4.59). Needling was performed in 11.8%, and 8.2% underwent anterior chamber reformation. Complications were transient, consisting of hyphaema, choroidal detachment and hypotony maculopathy, with 7.1% of patients undergoing reoperation., Conclusions: In a group of high-risk eyes that had already failed at least one subconjunctival filtering surgery, the SIBS microshunt demonstrates reasonable surgical success over 1-year follow-up, with relatively few complications., Competing Interests: Competing interests: GMD: honoraria from, and consultant to, Alcon (Fort Worth, Texas, USA); honoraria from, and consultant to, Allergan (Irvine, California, USA), honoraria from, and consultant to Bausch and Lomb (Rochester, New York, USA), honoraria from, and consultant to, Glaukos (San Clemente, California, USA); honoraria from Novartis (Basel, Switzerland); honoraria from Thea-Labtician (Oakville, Ontario, Canada); honoraria from MicroSurgical Technology (Redmond, Washington, USA); honoraria from, and consultant to Santen Pharmaceutical Co, (Kita-ku, Osaka, Japan); honoraria from Sight Sciences (Menlo Park, California, USA). MBS: Honoraria from, and consultant to, Alcon (Fort Worth, Texas, USA); honoraria from, and consultant to, Allergan (Irvine, California, USA); consultant to Light Matter Interaction (Toronto, Ontario, Canada); consultant to Santen Pharmaceutical Co (Kita-ku, Osaka, Japan); honoraria from Aequus (Vancouver, British Columbia, Canada); honoraria from Johnson & Johnson (Jacksonville, Florida, USA); honoraria from Thea-Labtician (Oakville, Ontario, Canada). SS: No financial disclosures. IKA: speaker’s honoraria and research support from, and consultant to, Abbott Medical Optics (Abbott Park, Illinois, USA); consultant to Acucela (Seattle, Washington, USA); research support from, and consultant to, Aerie Pharmaceuticals (Durham, North Carolina, USA); speaker’s honoraria and research grant support from, and consultant to, Alcon (Fort Worth, Texas, USA); speaker’s honoraria and research support from, and consultant to, Allergan (Irvine, California, USA); consultant to ArcScan (Golden, Colorado, USA); consultant to Bausch and Lomb (Rochester, New York, USA); speaker’s honoraria and research support from, and consultant to, Carl Zeiss Meditec (Jena, Germany); consultant to Centervue (Padova, Italy); consultant to Clarity Medical Systems (Pleasanton, California, USA); consultant to ElutiMed (New Orleans, Louisiana, USA); consultant to Envisia Therapeutics (Morrisville, North Carolina, USA); consultant to Equinox (Newport Beach, California, USA); consultant to Eyelight (Funo, Italy); consultant to ForSight Labs (Menlo Park, California, USA); research support from, and consultant to, Glaukos (San Clemente, California, USA); consultant to Gore (Newark, Delaware, USA); consultant to InjectSense (Emeryville, California, USA); consultant to Iridex (Mountain View, California, USA); consultant to iStar (Wavre, Belgium); research support from, and consultant to, Ivantis (Irvine, California, USA); consultant to KeLoTec (Orange County, California, USA); consultant to LayerBio (Medford, Massachusetts, USA); consultant to Leica Microsystems (Wetzlar, Germany); research support from, and consultant to, New World Medical (Rancho Cucamonga, California, USA); consultant to Omega Ophthalmics (Lexington, Kentucky, USA); consultant to Ono Pharma (Chuo-ku, Osaka, Japan) consultant to PolyActiva (Melbourne, VIC, Australia); consultant to Sanoculis (Kiryat Ono, Israel); consultant to Santen Pharmaceutical Co (Kita-ku, Osaka, Japan); consultant to Science Based Health (Spring, Texas, USA); consultant to SOLX (Waltham, Massachusetts, USA); consultant to Stroma (Irvine, California, USA); consultant to TrueVision (Santa Barbara, California, USA)., (© Author(s) (or their employer(s)) 2022. No commercial re-use. See rights and permissions. Published by BMJ.)

Purpose: To assess 5-year effectiveness and safety of 2 iStent® trabecular micro-bypass stents in eyes with open-angle glaucoma (OAG) not controlled on 1 medication., Materials and Methods: This prospective, interventional, single-arm, multi-surgeon study (NCT #1252862, clinicaltrials.gov) enrolled eyes with OAG, preoperative intraocular pressure (IOP) of 18-30 mmHg on 1 ocular hypotensive medication, and 22-38 mmHg after medication washout. Eyes underwent standalone implantation of 2 iStent devices and were followed through 60 months postoperatively. Efficacy was quantified by mean diurnal IOP and medication usage. Efficacy endpoints included the proportion of eyes with ≥20% IOP reduction versus baseline unmedicated IOP (primary efficacy), and the proportion of eyes with IOP ≤18 mmHg (secondary efficacy) without medication or secondary glaucoma surgery. Safety parameters included visual acuity, cup-to-disc ratio, visual field, and complications and adverse events., Results: Preoperative mean IOP on 1 medication was 20.6 ± 2.0 mmHg and post-washout unmedicated IOP was 24.1 ± 1.4 mmHg (n = 39). At 5 years postoperative, medication-free mean diurnal IOP reduced to 14.5 ± 2.2 mmHg, constituting a 40% decrease versus preoperative washed-out IOP ( p < .0001). In addition, this 5-year medication-free IOP constituted a 30% decrease versus preoperative IOP on 1 medication ( p < .0001). At Month 60, 89.7% (26/29) of eyes achieved the primary efficacy endpoint of ≥20% IOP reduction versus baseline unmedicated IOP, and 86.2% (25/29) of eyes achieved the secondary efficacy endpoint of IOP ≤18 mmHg, without medication or secondary glaucoma surgery. Throughout follow-up, 89.7-91.3% of eyes were on no medications. Favorable safety included no secondary glaucoma surgeries, minimal adverse events, and stable visual acuity, cup-to-disc ratio, and visual fields through 5 years postoperative., Conclusions: This prospective interventional study demonstrates persistent 5-year reductions in IOP and freedom from medications, together with favorable safety, following implantation of 2 first-generation trabecular micro-bypass stents in eyes with OAG on 1 preoperative medication.

Purpose: To determine the efficacy, risk factors for failure, and adverse events of a standalone novel ab externo SIBS microshunt with mitomycin C (MMC) during 1-year follow-up., Design: Retrospective, interventional case series., Subjects: Glaucomatous eyes with an intraocular pressure (IOP) above target and/or progressing on maximally tolerated medical therapy., Methods: Consecutive patients with open-angle glaucoma (OAG) and no previous filtering surgery received an ab externo SIBS microshunt with MMC from July 2015 to November 2017. Main outcome measures were proportion of eyes at 1-year with (1) no 2 consecutive IOP readings >17 mm Hg or clinical hypotony without (complete) or with glaucoma medications (qualified); and (2) at least a 20% reduction from decision IOP. Secondary outcomes included upper IOP thresholds of 14 mm Hg and 21 mm Hg with and without a 20% IOP reduction from baseline, median IOP, medications, risk factors for failure, interventions, complications, and reoperations., Results: A total of 164 eyes in 132 patients were included. Complete success was achieved in 76.9% of eyes, qualified success in 92.5%. Complete success was 75.6% for an upper IOP cut-off of 14 mm Hg and 76.9% for 21 mm Hg, and qualified success was 91.9% and 92.5%. MMC dose of 0.2 vs 0.4-0.5 mg/mL (hazard ratio [HR] 2.51; 95% CI 1.12-5.65) and primary open-angle glaucoma vs secondary open-angle glaucoma (SOAG) (HR 2.51; 95% CI 1.01-6.23) represented the only risk factors for failure in multivariable analysis. Needling was performed in 8.5% of eyes. Two eyes received surgical revision, and 1 a reoperation., Conclusions: One-year results of the ab externo SIBS microshunt demonstrated promising rates of qualified and complete success, decreased drop use, few complications, and infrequent postoperative interventions., (Copyright © 2020 Elsevier Inc. All rights reserved.)

Purpose: To report 3-year results of the Primary Tube Versus Trabeculectomy (PTVT) Study., Design: Unmasked multicenter randomized clinical trial., Participants: Two hundred forty-two eyes of 242 patients with medically uncontrolled glaucoma and no previous incisional ocular surgery, including 125 in the tube group and 117 in the trabeculectomy group., Methods: Patients were enrolled at 16 clinical centers and were assigned randomly to treatment with a tube shunt (350-mm 2 Baerveldt glaucoma implant) or trabeculectomy with mitomycin C (MMC; 0.4 mg/ml for 2 minutes)., Main Outcome Measures: The primary outcome measure was the rate of surgical failure, defined as intraocular pressure (IOP) of more than 21 mmHg or reduced less than 20% from baseline, IOP of 5 mmHg or less, reoperation for glaucoma, or loss of light perception vision. Secondary outcome measures included IOP, glaucoma medical therapy, visual acuity, and surgical complications., Results: The cumulative probability of failure after 3 years of follow-up was 33% in the tube group and 28% in the trabeculectomy group (P = 0.17; hazard ratio, 1.39; 95% confidence interval, 0.9-2.2). Mean ± standard deviation IOP was 14.0±4.2 mmHg in the tube group and 12.1±4.8 mmHg in the trabeculectomy group at 3 years (P = 0.008), and the number of glaucoma medications was 2.1±1.4 in the tube group and 1.2±1.5 in the trabeculectomy group (P < 0.001). Serious complications requiring reoperation or producing loss of 2 or more Snellen lines developed in 3 patients (2%) in the tube group and 9 patients (8%) in the trabeculectomy group (P = 0.11)., Conclusions: There was no significant difference in the rate of surgical failure between the 2 surgical procedures at 3 years. Trabeculectomy with MMC achieved lower IOP with use of fewer glaucoma medications compared with tube shunt surgery after 3 years of follow-up in the PTVT Study. Serious complications producing vision loss or requiring reoperation occurred with similar frequency after both surgical procedures., (Copyright © 2019 American Academy of Ophthalmology. Published by Elsevier Inc. All rights reserved.)

PRéCIS:: Our retrospective study examined the use of neodymium laser in 53 eyes with high intraocular pressure (IOP) following Ex-Press filtration device implantation. We found a statistically significant immediate IOP-lowering effect in all eyes, with a mean IOP reduction of 13.34±8.99 mm Hg, and a posttreatment IOP of 14.30±8.57 mm Hg (P<0.0001). Of a subset of 43 eyes on which 6 months follow-up IOP data was available, 28 eyes achieved treatment success (IOP<18 without further surgical interventions) with a mean IOP of 11.39±4.03 mm Hg at 6 months., Purpose: The purpose of this study was to report on the use of neodymium laser for treatment of eyes with IOP rise following Ex-Press glaucoma filtration device implantation., Methods: We retrospectively examined the medical records of 73 patients who underwent Ex-Press device implantation at 4 medical institutions between 2007 and 2015 and subsequently developed an IOP rise. Enrollment criteria included patients with POAG on whom posttreatment IOP data is available. Indications for treatment with neodymium laser were an IOP above target and a flat bleb. To disrupt the presumed microblockage, the neodymium laser was aimed at the axial and relief ports of the Ex-Press device. Applanation tonometry measurements were followed up after neodymium treatment for variable time intervals. Success was defined as an IOP <18 mm Hg at 6 months without further surgical or laser-based glaucoma interventions., Results: A total of 73 charts were reviewed. Twenty patients were excluded due to insufficient data or a diagnosis other than POAG. Data from 53 eyes of the remaining 53 patients was analyzed. The mean duration between Ex-Press implantation and rise in IOP requiring neodymium intervention was 34.2 months (range, 1.1 to 67.2). We found a statistically significant immediate IOP-lowering effect in all eyes, with a mean IOP drop of 13.34±8.99 mm Hg, and a mean posttreatment IOP of 14.30±8.57 mm Hg (P<0.0001). Of a subset of 43 eyes on which 6 months follow-up IOP data was available, 11 eyes required further glaucoma intervention (surgery or laser-based); 4 eyes had an IOP of ≥18 at 6 months. In the remaining 28 successful eyes, a sustained IOP<18 mm Hg was observed at 6 months, with a mean pressure of 11.39±4.03 mm Hg (P<0.0001). Hypotony (IOP<5) occurred in 3 eyes immediately following treatment and self-resolved by 1 week., Conclusion: Our retrospective case series suggests that neodymium laser is a potential consideration in eyes with sustained IOP rise after Ex-Press device implantation.

Purpose: To compare the efficacy of different microinvasive glaucoma surgery (MIGS) devices for reducing intraocular pressure (IOP) and medications in open-angle glaucoma (OAG)., Design: Prospective, multicenter, randomized clinical trial., Participants: One hundred fifty-two eyes from 152 patients aged 45 to 84 years with OAG, Shaffer angle grade III-IV, best-corrected visual acuity (BCVA) 20/30 or better, and IOP 23 to 39 mmHg after washout of all hypotensive medications. Eyes with secondary glaucoma other than pseudoexfoliative or pigmentary glaucoma, angle closure, previous incisional glaucoma surgery, or any significant ocular pathology other than glaucoma were excluded., Intervention: Study eyes were randomized 1:1 to standalone MIGS consisting of either 1 Hydrus Microstent (Ivantis, Inc, Irvine, CA) or 2 iStent Trabecular Micro Bypass devices (Glaukos Inc, San Clemente, CA). Follow-up was performed 1 day, 1 week, and 1, 3, 6, and 12 months postoperatively., Main Outcome Measures: Within-group and between-group differences in IOP and medications at 12 months and complete surgical success defined as freedom from repeat glaucoma surgery, IOP 18 mmHg or less, and no glaucoma medications. Safety measures included the frequency of surgical complications, changes in visual acuity, slit-lamp findings, and adverse events., Results: Study groups were well matched for baseline demographics, glaucoma status, medication use, and baseline IOP. Twelve-month follow-up was completed in 148 of 152 randomized subjects (97.3%). At 12 months, the Hydrus had a greater rate of complete surgical success (P < 0.001) and reduced medication use (difference = -0.6 medications, P = 0.004). More Hydrus subjects were medication free at 12 months (difference = 22.6% P = 0.0057). Secondary glaucoma surgery was performed in 2 eyes in the 2-iStent group (3.9%) and in none of the Hydrus eyes. Two eyes in the Hydrus group and 1 in the 2-iStent group had BCVA loss of ≥2 lines., Conclusion: Standalone MIGS in OAG with the Hydrus resulted in a higher surgical success rate and fewer medications compared with the 2-iStent procedure. The 2 MIGS devices have similar safety profiles., (Copyright © 2019 American Academy of Ophthalmology. All rights reserved.)

Purpose: To describe the safety and efficacy of a novel, supraciliary, microinvasive glaucoma surgery drainage system, MINIject (iSTAR Medical, Wavre, Belgium), in the study., Design: Prospective, multicenter, interventional, single-arm trial., Participants: Twenty-six patients with primary open-angle glaucoma uncontrolled with 1 or more intraocular pressure (IOP)-lowering medications., Methods: Using an ab interno approach, 25 eyes were implanted successfully in a stand-alone procedure with a 5-mm long device made of biocompatible STAR material, which is soft and flexible silicone in a microporous, network design. Intraocular pressure, medication use, and other ocular parameters were evaluated before surgery, 1 day, 1 and 2 weeks, and 1, 3, and 6 months after surgery., Main Outcome Measures: Intraocular pressure reduction at 6 months compared with baseline analyzed using a paired t test. Safety evaluation entailed tabulation of the nature and frequency of adverse events., Results: Mean baseline diurnal IOP was 23.2 mmHg (standard error, 0.6 mmHg) using a mean ± standard deviation of 2.0±1.1 IOP-lowering medication classes. During the 6-month follow-up period, mean IOP ranged from 10.0-16.3 mmHg (mean reductions, 6.9-13.2 mmHg or 31.0%-56.8%). Six months after surgery, mean diurnal IOP was 14.2 mmHg (standard error, 0.9 mmHg), equivalent to a reduction of 9.0 mmHg or 39.1% (P < 0.0001). The mean ± standard deviation number of IOP-lowering medications was 0.3±0.7. Of 24 patients seen at 6-month follow-up, 21 (87.5%) were medication-free and 23 (95.8%) achieved a minimum 20% IOP reduction from baseline. There were no serious adverse events related to the device or procedure, and no additional glaucoma surgery was required. Frequently reported events included anterior chamber inflammation (n = 8), IOP elevation (n = 6), of which 1 event was an IOP spike per protocol, visual acuity reduction (n = 3), and hyphema (n = 3), all of which resolved. There was no change to mean central or peripheral corneal endothelial cell density. No device-related adverse events were reported., Conclusions: The MINIject glaucoma drainage system significantly lowered IOP and eliminated the need for medication in most patients 6 months after surgery when implanted in a standalone procedure. There were no serious ocular adverse events., (Copyright © 2019 American Academy of Ophthalmology. Published by Elsevier Inc. All rights reserved.)

Purpose: To evaluate 5-year safety and efficacy of 2 trabecular micro-bypass stents versus prostaglandin as initial stand-alone treatment for newly diagnosed, treatment-naive primary open-angle glaucoma (POAG)., Design: Prospective, randomized, controlled, multi-surgeon clinical trial., Participants: Enrolled eyes (n = 101) were phakic and had a confirmed POAG diagnosis, normal angle anatomy, mean diurnal intraocular pressure (IOP) 21 to 40 mmHg, and vertical cup-to-disc (C:D) ratio ≤0.9., Methods: Eyes were randomized (1:1) to receive either 2 stents (iStent trabecular micro-bypass; Glaukos Corporation, San Clemente, CA) or once-daily topical travoprost., Main Outcome Measures: The primary and secondary efficacy end points were the change from screening in mean diurnal IOP at months 12 and 24, respectively, without glaucoma surgery or add-on medication (any medication in stent eyes or a second medication in travoprost eyes). Two additional secondary end points were the proportion of eyes achieving treatment success at months 12 and 24, defined as IOP 6 to 18 mmHg without additional medication or glaucoma surgery. This report shows these efficacy measures through 60 months. Safety measures included best-corrected visual acuity, C:D ratio, visual field, pachymetry, complications, and adverse events., Results: Of 101 enrolled eyes (54 stent eyes, 47 travoprost eyes), 90 eyes (49 stent eyes, 41 travoprost eyes) completed 5-year follow-up. Five-year mean diurnal IOP was 16.5±1.2 mmHg in stent eyes (35.3% reduced vs. 25.5±2.5 mmHg preoperatively; P < 0.0001) and 16.3±1.9 mmHg in travoprost eyes (35.1% reduced vs. 25.1±4.6 mmHg preoperatively; P < 0.0001). During follow-up, add-on medication was initiated in 12 stent eyes (22.2% of the initial 54-eyes) and 18 travoprost eyes (38.3% of the initial 47-eyes). By 5 years, 17% (6/35) of stent eyes and 44% (14/32) of travoprost eyes needed add-on medication to control IOP (P = 0.017). Treatment success was achieved in 77% (27/35) of stent eyes and 53% (17/32) of travoprost eyes (P = 0.04). Both groups exhibited excellent safety., Conclusions: This prospective randomized trial demonstrates 5-year effectiveness and safety of 2 trabecular bypass stents in patients with newly diagnosed, treatment-naive POAG, with comparably favorable outcomes as topical prostaglandin., (Copyright © 2019 American Academy of Ophthalmology. Published by Elsevier Inc. All rights reserved.)

Objective: To evaluate and compare the surgeon's learning experience with an ab-interno gelatin microstent (XEN-45, Allergan) to other glaucoma surgeries., Design: Cross-sectional survey study., Methods: All surgeons in Canada who used the gelatin microstent were identified and given an anonymous online survey (FluidSurveys, Survey Monkey) designed to evaluate key factors associated with the device, including prior surgical experience, patient selection criteria, analysis of each surgical step, and postoperative care. The survey was validated using input from 3 experienced glaucoma surgeons., Results: Surgeons were in early to mid-career (11.8 ± 7.2 operating years) and experienced with filtration surgery (94.1% very comfortable). Surgeons would more commonly operate on patients who had moderate to advanced disease (88.2% and 76.5% of surgeons felt appropriate to operate, respectively); had a diagnosis of primary open angle glaucoma or pseudoexfoliative glaucoma (70.6%); were on 2, 3, or 4 glaucoma medications (70.6%, 75.5%, 70.6%, respectively); and had previously undergone microinvasive glaucoma surgery (83.3%). Creation of the scleral tunnel into the subconjunctival space was rated the most difficult step of the surgery. Most surgeons (52.9%) required 6-10 cases to be comfortable with the procedure and felt it was easier to gain proficiency with ab-interno microstent implantation than traditional filtration surgery (94.1% agree or strongly agree)., Conclusion: The group of glaucoma surgeons surveyed felt it was easier to gain proficiency with gelatin microstent implantation than with traditional filtration surgery., (Copyright © 2018 Canadian Ophthalmological Society. Published by Elsevier Inc. All rights reserved.)

A propagation of microinvasive glaucoma surgery (MIGS) techniques and devices has resulted in the availability of multiple new modalities for surgical intervention for open-angle glaucoma. As MIGS devices and methods approach a new phase in maturity, midterm failures will inevitably be reported. Although MIGS techniques prioritize safety, an understanding of the potential mechanisms of failure is paramount. In this case of a midterm failure of a trabecular microbypass, clinical findings and pathological correlates allow for a comprehensive understanding of the means by which MIGS devices might fail and offer the opportunity for intervention and potential prevention., (Copyright © 2018 ASCRS and ESCRS. Published by Elsevier Inc. All rights reserved.)

Purpose: To report 1-year treatment outcomes in the Primary Tube Versus Trabeculectomy (PTVT) Study., Design: Multicenter, randomized clinical trial., Participants: Two hundred forty-two eyes of 242 patients with medically uncontrolled glaucoma and no previous incisional ocular surgery, including 125 in the tube group and 117 in the trabeculectomy group., Methods: Patients were enrolled at 16 clinical centers and assigned randomly to treatment with a tube shunt (350-mm 2 Baerveldt glaucoma implant) or trabeculectomy with mitomycin C (MMC; 0.4 mg/ml for 2 minutes)., Main Outcome Measures: Intraocular pressure (IOP), glaucoma medical therapy, visual acuity, visual fields, surgical complications, and failure (IOP of more than 21 mmHg or reduced by less than 20% from baseline, IOP of 5 mmHg or less, reoperation for glaucoma, or loss of light perception vision)., Results: The cumulative probability of failure during the first year of follow-up was 17.3% in the tube group and 7.9% in the trabeculectomy group (P = 0.01; hazard ratio, 2.59; 95% confidence interval, 1.20-5.60). Mean ± standard deviation IOP was 13.8±4.1 mmHg in the tube group and 12.4±4.4 mmHg in the trabeculectomy group at 1 year (P = 0.01), and the number of glaucoma medications was 2.1±1.4 in the tube group and 0.9±1.4 in the trabeculectomy group (P < 0.001). Postoperative complications developed in 36 patients (29%) in the tube group and 48 patients (41%) in the trabeculectomy group (P = 0.06). Serious complications requiring reoperation or producing a loss of 2 Snellen lines or more occurred in 1 patient (1%) in the tube group and 8 patients (7%) in the trabeculectomy group (P = 0.03)., Conclusions: Trabeculectomy with MMC had a higher surgical success rate than tube shunt implantation after 1 year in the PTVT Study. Lower IOP with use of fewer glaucoma medications was achieved after trabeculectomy with MMC compared with tube shunt surgery during the first year of follow-up. The frequency of serious complications producing vision loss or requiring reoperation was lower after tube shunt surgery relative to trabeculectomy with MMC., (Copyright © 2018 American Academy of Ophthalmology. Published by Elsevier Inc. All rights reserved.)

Objective: To compare the surgical outcomes of combined phacoemulsification with either Ahmed glaucoma valve (AGV) or Baerveldt glaucoma implant (BGI)., Design: Retrospective cohort study., Participants: A total of 104 eyes that underwent combined phacoemulsification with either AGV (PhacoAGV; n = 57) or BGI (PhacoBGI; n = 47) implantation., Methods: Failure was defined as uncontrolled intraocular pressure (IOP; <5 mm Hg, ≥18 mm Hg, or <20% reduction), additional glaucoma surgery, vision-threatening complications, or progression to no-light-perception vision., Results: The PhacoAGV group was older (p = 0.03), had poorer baseline visual acuity (VA; p = 0.001), and had fewer previous glaucoma surgeries (p = 0.04). Both groups had similar baseline IOP (PhacoAGV: 26.4 ± 8.3 mm Hg; PhacoBGI: 25.7 ± 7.3; p = 0.66) and glaucoma medications (PhacoAGV: 3.8 ± 1.0; PhacoBGI: 3.6 ± 1.5; p = 0.54). At 2 years, failure rates were 44% in the PhacoAGV group and 23% in the PhacoBGI group (p = 0.02). Both groups had similar mean IOP reduction (PhacoAGV: 45%; PhacoBGI: 47%, p = 0.67) and medication use reduction (PhacoAGV: 47%; PhacoBGI: 58%, p = 0.38). The PhacoBGI group had higher IOP and medication use up to 1 month (p < 0.05). Both groups improved in VA from baseline (p < 0.05) and had similar overall complication rates (p = 0.31). The PhacoBGI group required more overall interventions (p < 0.0005)., Conclusions: This comparative study found no difference in IOP, glaucoma medications, or complication rates between PhacoAGV and PhacoBGI at 2 years, despite BGIs being implanted in patients at higher risk for failure. The PhacoAGV group had higher failure rates at 2 years. Both groups had significant improvements in VA due to removal of their cataracts. The PhacoBGI group required more interventions, but most of these were minor slit-lamp procedures., (Copyright © 2018. Published by Elsevier Inc.)

Purpose: To compare the efficacy, safety, and risk factors for failure of standalone ab interno gelatin microstent implantation with mitomycin C (MMC) versus trabeculectomy with MMC., Design: International, multicenter, retrospective interventional cohort study., Participants: Three hundred fifty-four eyes of 293 patients (185 microstent and 169 trabeculectomy) with no prior incisional surgery., Methods: Consecutive eyes with uncontrolled glaucoma underwent microstent or trabeculectomy surgery from January 1, 2011 through July 31, 2015 at 4 academic ophthalmology centers: Toronto, Canada; Frankfurt, Germany; Salzburg, Austria; and Leuven, Belgium., Main Outcome Measures: Primary outcome measure was hazard ratio (HR) of failure, with failure defined as 2 consecutive intraocular pressure (IOP) readings of <6 mmHg with vision loss or >17 mmHg without glaucoma medications (complete success) at least 1 month after surgery despite in-clinic interventions (including needling). Secondary outcome measures included IOP thresholds of 6 to 14 mmHg and 6 to 21 mmHg and same thresholds allowing for medications (qualified success), interventions, complications, and reoperations., Results: Baseline characteristics were similar, except more men (56% vs. 43%), younger patients (average, by 3 years), better preoperative visual acuity (22% vs. 32% with 0.4 logarithm of the minimum angle of resolution vision or worse), and more trabeculoplasty (52% vs. 30%) among microstent eyes. The adjusted HR of failure of the microstent relative to trabeculectomy was 1.2 (95% confidence interval [CI], 0.7-2.0) for complete success and 1.3 (95% CI, 0.6-2.8) for qualified success, and similar for other outcomes. Time to 25% failure was 11.2 months (95% CI, 6.9-16.1 months) and 10.6 months (95% CI, 6.8-16.2 months) for complete success and 30.3 months (95% CI, 19.0-∞ months) and 33.3 months (95% CI, 25.7-46.2 months) for qualified success. Overall, white ethnicity was associated with decreased risk of failure (adjusted HR, 0.49; 95% CI, 0.25-0.96), and diabetes was associated with increased risk of failure (adjusted HR, 4.21; 95% CI, 2.10-8.45). There were 117 and 165 distinct interventions: 43% and 31% underwent needling, respectively, and 50% of trabeculectomy eyes underwent laser suture lysis. There were 22 and 30 distinct complications, although most were transient. Ten percent and 5% underwent reoperation (P = 0.11)., Conclusions: There was no detectable difference in risk of failure and safety profiles between standalone ab interno microstent with MMC and trabeculectomy with MMC., (Copyright © 2017 American Academy of Ophthalmology. Published by Elsevier Inc. All rights reserved.)

Purpose: To determine the relative efficacy of the Ahmed-FP7 and Baerveldt BG101-350 implants., Design: Pooled analysis of 2 multicenter, randomized clinical trials., Methods: A total of 514 patients aged 18 or older with uncontrolled glaucoma that had failed or were at high risk of failing trabeculectomy were randomized to receive an Ahmed implant (n = 267) or Baerveldt implant (n = 247). Cumulative failure rates (using an intraocular pressure [IOP] target of 6-18 mm Hg inclusive), de novo glaucoma surgery rates, mean IOP, mean glaucoma medication use, and visual acuity were compared., Results: Baseline characteristics were similar between groups. Mean preoperative IOP of the study population was 31.5 ± 11.3 mm Hg on an average of 3.3 ± 1.1 glaucoma medications. At 5 years, mean IOP was 15.8 ± 5.2 mm Hg in the Ahmed group and 13.2 ± 4.7 mm Hg in the Baerveldt group (P < .001). Mean glaucoma medication use was 1.9 ± 1.5 in the Ahmed group and 1.5 ± 1.4 in the Baerveldt group (P = .007). The cumulative failure rate at 5 years was 49% in the Ahmed group and 37% in the Baerveldt group (P = .007). High IOP was the most common reason for failure in both groups, and de novo glaucoma surgery was required in 16% of the Ahmed group and 8% of the Baerveldt group (P = .006). Failure owing to hypotony occurred in 0.4% of the Ahmed group and 4.5% of the Baerveldt group (P = .002). Visual outcomes were similar between groups (P = .90)., Conclusions: The Baerveldt group had a lower failure rate, lower rate of de novo glaucoma surgery, and lower mean IOP on fewer medications than the Ahmed group. Baerveldt implantation carried a higher risk of hypotony., (Copyright © 2017 Elsevier Inc. All rights reserved.)