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Introduction: To assess the effect of iStent trabecular microbypass implantation combined with phacoemulsification on intraocular pressure (IOP) and glaucoma medications and to compare this to outcomes of phacoemulsification alone in patients with mild to moderate primary open-angle glaucoma (POAG) depending on initial IOP. Materials and Methods: Eighty subjects with cataract and POAG were randomized 1:1 into either iStent implantation and cataract surgery (iStent group) (n = 44) or cataract surgery alone (control group) (n = 36). Groups were divided according to initial IOP (after washout period) into IOP <26 mm Hg and IOP ≥26 mm Hg. Patients were assessed preoperatively and at postoperative day 1, week 1, and months 1, 3, 6, 12, and 24. Outcome measures included best-corrected visual acuity, IOP, and glaucoma medications. Results: Postoperatively at 24 months, mean IOP decreased from 20.93 ± 1.28 to 17.79 ± 2.50 mm Hg in the IOP subgroup <26 mm Hg and from 26.00 ± 0.00 to 19.86 ± 2.19 in the subgroup ≥26 mm Hg in the control group. In the iStent group <26 mm Hg, IOP decreased from 22.04 ± 1.64 to 15.57 ± 2.13 mm Hg and from 26.6 ± 1.09 to 17.06 ± 2.43 mm Hg in the iStent group ≥26 mm Hg. Conclusion: In patients with open-angle glaucoma and cataract, iStent implantation combined with cataract surgery reduced IOP significantly through 2 years, with greater reductions achieved versus phacoemulsification alone. In patients with baseline IOP <26 mm Hg, surgery reduced IOP and medication use significantly declined through 2 years, with greater reductions achieved versus patients with baseline IOP ≥26 mm Hg. The study was registered at ClinicalTrials.gov under the number NCT03807869. [ABSTRACT FROM AUTHOR]

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. 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. 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. 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. [ABSTRACT FROM AUTHOR]

Purpose: To report a case of post-operative endophthalmitis following combined cataract extraction and minimally invasive glaucoma surgery with placement of the iStent drainage device. Observation: An 87-year-old woman with a nuclear sclerotic cataract and primary open angle glaucoma underwent elective phacoemulsification cataract extraction with iStent placement. Surgery was complicated only by the inability to properly place the second iStent despite several attempts. At 4 days post-operatively she was diagnosed with endophthalmitis. Despite the prompt intravitreal injections of broad spectrum antibiotics, she lost all perception of light. Cultures of anterior chamber aspirates failed to identify a causative organism. Conclusion and importance: In what we believe to be the first report of endophthalmitis associated with placement of the iStent, complete loss of vision occurred. Surgeons need to be aware that iStent placement may be complicated by severe endophthalmitis.

Glaucoma surgery is performed to lower intraocular pressure (IOP); ideally, the IOP reduction is safely maintained for an extended period of time. Although trabeculectomy was considered the gold standard for glaucoma surgery for many years because of its effective IOP reduction, yet now it is considered unsafe because of serious complications. In recent years, minimally invasive glaucoma surgery (MIGS), which emphasizes safety and can be performed rapidly, has become widespread. Because MIGS does not involve conjunctival incisions, patients can undergo future trabeculectomy. If IOP reduction can be maintained safely, the number of anti-glaucoma drops can be reduced and visual function maintained, good outcomes for patients with glaucoma. Currently, many types of MIGS approved in Japan are reported to yield relatively good results, with targets of approximately 15–19 mmHg. However, the IOP-lowering effects of MIGS are limited. In procedures targeting Schlemm's canal, it is difficult to lower IOP beyond episcleral venous pressure. In some instances, a beneficial effect cannot be achieved if function is reduced beyond the collector channel. There are many unclear aspects regarding long-term outcomes following MIGS. Notably, investigation is ongoing to determine which patients are likely to benefit most from surgery. Based on previous reports, this review describes the characteristics and results of MIGS, approved in Japan, as well as underlying factors that affect the preoperative predictions and outcomes of the surgical procedure. [ABSTRACT FROM AUTHOR]

Purpose: To achieve a highly balanced comparison of trabecular bypass stenting (IS2, iStent inject) with ab interno trabeculectomy (T, Trabectome) by exact matching. Methods: Fifty-three IS2 eyes were matched to 3446 T eyes. Patients were matched using exact matching by baseline intraocular pressure (IOP), the number of glaucoma medications, and glaucoma type, and using nearest neighbor matching by age. Individuals without a close match were excluded. All surgeries were combined with phacoemulsification. Results: A total of 78 eyes (39 in each group) could be matched as exact pairs with a baseline IOP of 18.3 ± 5.1 mmHg and glaucoma medications of 2.7 ± 1.2 in each. IOP in IS2 was reduced to 14.6 ± 4.2 mmHg at 3 months and in T to a minimum of 13.1 ± 3.2 mmHg at 1 month. In IS2, IOP began to rise again at 6 months, eventually exceeding baseline. At 24 months, IOP in IS2 was 18.8 ± 9.0 mmHg and in T 14.2 ± 3.5 mmHg. IS2 had a higher average IOP than T at all postoperative visits (p < 0.05 at 1, 12, 18 months). Glaucoma medications decreased to 2.0 ± 1.5 in IS2 and to 1.5 ± 1.4 in T. Conclusion: T resulted in a larger and sustained IOP reduction compared with IS2 where a rebound occurred after 6 months to slightly above preoperative values. [ABSTRACT FROM AUTHOR]

Purpose: We conducted a retrospective study to evaluate the intraocular pressure (IOP) lowering effect, the success rates, and the risk of bleeding events of patients receiving an iStent inject combined with phacoemulsification under anticoagulation therapy compared with a matched control group. Methods: In this retrospective study, sixty-four eyes underwent an iStent inject implantation combined with phacoemulsification at two centers. Thirty-two eyes received surgery while under anticoagulation therapy, and another thirty-two eyes served as a control group matched for visual acuity, IOP, and medication score. Success was defined as criteria A and B (IOP < 18/21 mmHg, > 20% IOP reduction, no resurgery) and criteria C (IOP ≤ 15 mmHg, IOP reduction ≥ 40%, no resurgery). The clinical goal of the study was to determine the difference between the study and control groups with respect to IOP, medication score, and the frequency of intraoperative and postoperative bleeding events. Results: After a mean follow-up time of 1 year, the IOP lowered 28% from 20.1 ± 4.8 to 14.5 ± 3.7 mmHg in the group of 64 eyes. The medication score lowered 38% from 2.1 ± 1.1 to 1.3 ± 1.2. The two groups with and without anticoagulant agents did not significantly differ in postoperative IOP, medication score, success rates, or number of bleeding events. Conclusion: We conclude that in cataract surgery combined with the iStent inject a discontinuation of anticoagulant agents might not be necessary. It might be a good option in glaucoma surgery when anticoagulation treatment should not be interrupted and the target pressure is not very low. [ABSTRACT FROM AUTHOR]

Ricardo Augusto Paletta Guedes Glaucoma Department, Paletta Guedes Eye Institute, Juiz de Fora, MG, BrazilCorrespondence: Ricardo Augusto Paletta GuedesGlaucoma Department, Paletta Guedes Eye Institute, 79 Oscar Vidal Street, Juiz de Fora, MG, BrazilTel/Fax +55 32 3213 1927Email palettaguedes@yahoo.com Read the original article

L Jay Katz,1 Carl Erb,2 Amadeu Carceller Guillamet,3 Antonio M Fea,4 Lilit Voskanyan,5 Jane Ellen Giamporcaro,6 Dana M Hornbeak6 1Glaucoma Service, Wills Eye Hospital, Philadelphia, PA, USA; 2Glaucoma Service, Eye Clinic Wittenbergplatz, Berlin, Germany; 3Department of Ophthalmology, Hospital Quirón, Barcelona, Spain; 4Department of Surgical Sciences, University of Torino, Torino, Italy; 5Glaucoma Service, S. V. Malayan Ophthalmology Centre, Yerevan, Armenia; 6Department of Clinical Research and Medical Affairs, Glaukos Corporation, San Clemente, CA, USA Purpose: Evaluate long-term outcomes after one, two, or three trabecular micro-bypass stents implanted in a standalone procedure in eyes with open-angle glaucoma taking ocular hypotensive medication.Patients and methods: Prospective randomized ongoing study of 119 subjects (109 with 42-month follow-up) with open-angle glaucoma, preoperative intraocular pressure (IOP) 18–30 mmHg on one to three glaucoma medications, and unmedicated (post-washout) IOP 22–38 mmHg. Subjects were randomized to receive one (n=38), two (n=41), or three (n=40) iStent trabecular micro-bypass stents in a standalone procedure. Postoperatively, IOP was measured with medication and annually following washout. Data included IOP, medications, gonioscopy, pachymetry, visual field, visual acuity, adverse events, and slit-lamp and fundus examinations.Results: Preoperative mean medicated IOP was 19.8±1.3 mmHg on 1.71 medications in one-stent eyes, 20.1±1.6 mmHg on 1.76 medications in two-stent eyes, and 20.4±1.8 mmHg on 1.53 medications in three-stent eyes. Post-washout IOP prior to stent implantation was 25.0±1.2, 25.0±1.7, and 25.1±1.9 mmHg in the three groups, respectively. Postoperatively, Month 42 medicated IOP was 15.0±2.8, 15.7±1.0 and 14.8±1.3 mmHg in the three groups, and post-washout IOP (Months 36–37) was 17.4±0.9, 15.8±1.1 and 14.2±1.5 mmHg, respectively. IOP reduction ≥20% without medication was achieved in 89%, 90%, and 92% of one-, two-, and three-stent eyes, respectively, at Month 12; and in 61%, 91%, and 91% of eyes, respectively, at Month 42. The need for additional medication remained consistent at Months 12 and 42 in multi-stent eyes (four two-stent eyes and three three-stent eyes at both time points), whereas it increased in single-stent eyes (four eyes at Month 12 versus 18 eyes at Month 42). Safety parameters were favorable in all groups.Conclusion: The standalone implantation of either single or multiple iStent® device(s) produced safe, clinically meaningful IOP and medication reductions through 42 months postoperatively, with incrementally greater and more sustained reductions in multi-stent eyes. Keywords: microinvasive glaucoma surgery/MIGS, iStent, surgery, standalone, multiple

Purpose: To determine the quality of life (QOL) in glaucoma patients undergoing combined cataract and minimally invasive glaucoma surgery from various perspectives ranging from personal, social, occupational life, and economic status. Settings and Design: A cross-sectional study design at King Fahd Hospital of the University, Khobar, Saudi Arabia. Methods: Patients undergoing phacoemulsification in conjunction with various forms of minimally invasive glaucoma surgery (MIGS) for each patient, including either Kahook Dual Blade (KDB) goniotomy, iStent, iStent inject and gonioscopy-assisted transluminal trabeculotomy (GATT), were included in the study between 2018 and 2019. Data were collected through a self-administered questionnaire based on the Visual Function Questionnaire (VFQ-25) for the 25-item National Eye Institute. Results: The study included 93 eyes of 78 patients (40 males and 38 females) who had MIGS: 50 KDB, 13 iStent, 23 iStent inject, and 7 GATT. An overall reduction in the number of anti-glaucoma medications (p< 0.001) was statistically significant. In the study, 36.6% of patients had a better social life, but 85.2% had no change in occupational life. Eventually, 86% were satisfied with the operation's outcome, and 79% confirmed that the overall quality of life improved after the procedure. Conclusion: Evaluating QOL is a crucial component of glaucoma treatment. More research is needed on MIGS and their relationship to QOL. In the future, MIGS may provide the desired outcomes in controlling glaucoma and improving the QOL. [ABSTRACT FROM AUTHOR]

Importance: Use of the trabecular micro‐bypass stent with cataract surgery is well established to be safe and effective in primary open‐angle glaucoma. This is the first study to exclusively evaluate use of the device in pigmentary glaucoma. Background: This study aimed to investigate the safety and efficacy of a trabecular micro‐bypass stent in combination with cataract surgery in pigmentary glaucoma. Design: Retrospective, consecutive case series. Participants: Twenty‐four eyes of 12 patients with pigmentary glaucoma implanted with one trabecular micro‐bypass stent with concomitant cataract surgery. Methods: Baseline data was collected and compared to the following postoperative time points: 1 day, 1 week, 1 month out to 36 months (M36) after the procedure. Main Outcome Measures: These included intraocular pressure (IOP), number of glaucoma medications and need for additional surgery. Results: At M36 there was a 25% reduction in IOP to 14.68 ± 3.0 (P <.01) from 19.50 ± 6.7 mmHg at baseline. The mean number of glaucoma medications was 0.75 ± 1.0 prior to the surgery and 0.59 ± 0.6 (P >.05) at 36 M. At the 36 M time‐point, 95% of eyes had IOP ≤ 18 mmHg and 68% of eyes were ≤ 15 mmHg. No eyes underwent a secondary glaucoma procedure. Conclusions and Relevance: The insertion of a single trabecular micro‐bypass stent in combination with cataract surgery effectively provides a sustained reduction in IOP up to 3 years after surgery in patients with pigmentary glaucoma. The safety profile is favourable with low rate of IOP spikes and no patients requiring additional surgery. [ABSTRACT FROM AUTHOR]

Introduction: This real-world retrospective case series assessed 12-month effectiveness and safety following implantation of iStent® or iStent inject® trabecular micro-bypass with cataract surgery. Methods: Consecutive patients were implanted with either iStent (comprising 1 stent) or iStent inject (comprising 2 stents), together with cataract surgery. Most patients had primary open-angle glaucoma. Effectiveness outcomes through 12 months included intraocular pressure (IOP) and glaucoma medications. Proportional analyses were completed for eyes achieving IOP ≤ 18 mmHg, IOP ≤ 15 mmHg, or IOP reduction ≥ 20% from preoperative; and eyes on 0 medications or ≥ 2 medications. Safety outcomes included adverse events, secondary surgeries, visual acuity, and visual fields. Results: This analysis included 137 eyes (67 iStent, 70 iStent inject) with cataract and mild to moderate glaucoma or ocular hypertension. Over 73% of eyes in both groups had early disease, and ~ 22% had prior glaucoma surgery. At 12 months postoperatively, mean IOP decreased from 18.4 ± 4.2 mmHg to 14.2 ± 2.5 mmHg in iStent eyes (p < 0.0001), and from 20.4 ± 5.6 mmHg to 14.4 ± 2.1 mmHg in iStent inject eyes (p < 0.0001). The IOP reduction was significantly greater for iStent inject eyes than iStent eyes (6.0 mmHg versus 4.2 mmHg reduction, p = 0.034). Both groups had high proportions of patients achieving the 12-month IOP endpoints, although consistently greater proportions reached these endpoints after iStent inject than iStent: 95.7% versus 92.5% had IOP ≤ 18 mmHg, respectively; 74.3% versus 71.6% had IOP ≤ 15 mmHg, respectively; and 68.6% versus 62.7% had IOP reduction ≥ 20% from baseline, respectively. Mean medication burden at 12 months decreased from 1.8 ± 0.7 to 0.3 ± 0.5 medications in iStent eyes (84.0% reduction, p < 0.0001), and from 1.3 ± 0.9 to 0.1 ± 0.3 medications in iStent inject eyes (94.7% reduction, p < 0.0001). Significantly more iStent inject eyes were medication-free at 12 months than iStent eyes (92.9% versus 76.1% medication-free, respectively; p = 0.0068). Favorable safety included few adverse events, no secondary glaucoma surgeries, and stable visual acuity and visual fields in both groups. Conclusion: Significant and safe IOP and medication reductions were achieved through 12 months after iStent or iStent inject implantation with cataract surgery. iStent inject eyes had greater absolute IOP reduction and more eyes medication-free versus iStent eyes. Funding: Glaukos Corporation. [ABSTRACT FROM AUTHOR]

Lutz E Pillunat,1 Carl Erb,2 Anselm GM Jünemann,3 Friedemann Kimmich4 1Department of Ophthalmology, University Hospital Carl Gustav Carus, Dresden, 2Augenklinik am Wittenbergplatz, Berlin, Germany; 3Department of Ophthalmology University of Rostock, Rostock, Germany; 4eyecons, Karlsruhe, Germany Abstract: Over the last decade several novel surgical treatment options and devices for glaucoma have been developed. All these developments aim to cause as little trauma as possible to the eye, to safely, effectively, and sustainably reduce intraocular pressure (IOP), to produce reproducible results, and to be easy to adopt. The term “micro-invasive glaucoma surgery (MIGS)” was used for summarizing all these procedures. Currently MIGS is gaining more and more interest and popularity. The possible reduction of the number of glaucoma medications, the ab interno approach without damaging the conjunctival tissue, and the probably safer procedures compared to incisional surgical methods may explain the increased interest in MIGS. The use of glaucoma drainage implants for lowering IOP in difficult-to-treat patients has been established for a long time, however, a variety of new glaucoma micro-stents are being manufactured by using various materials and are available to increase aqueous outflow via different pathways. This review summarizes published results of randomized clinical studies and extensive case report series on these devices, including Schlemm’s canal stents (iStent®, iStent® inject, Hydrus), suprachoroidal stents (CyPass®, iStent® Supra), and subconjunctival stents (XEN). The article summarizes the findings of published material on efficacy and safety for each of these approaches. Keywords: glaucoma, micro-invasive glaucoma surgery, MIGS, iStent, iStent inject, CyPass, Hydrus, XEN

AIM: To describe a novel technique of creating a landing strip within the trabecular meshwork to guide trabecular micro-bypass stent (iStent) implantation in patients who underwent phacoemulsification. METHODS: Thirty-four eyes from 30 patients who underwent iStent implantation after phacoemulsification from May 2014 to February 2015 were included in our retrospective study. All iStents were implanted via the “landing strip” technique. A 25-gauge microvitreoretinal blade was used to bisect the trabecular meshwork to less than 1 clock-hour, effectively creating a landing strip. The iStent applicator was pressed along the landing strip and then the stent was released into the trabecular meshwork. RESULTS: Of the 34 eyes with iStent implantation, 27 (79.4%) eyes had primary open-angle glaucoma, 6 (17.6%) eyes had pseudoexfoliation glaucoma, and 1 (2.9%) eye had ocular hypertension. At 6-month follow-up (n=17), the mean number of hypotensive medications decreased from 2.2±1.2 at baseline to 0.8±1.3 (P=0.05) and mean intraocular pressure decreased from 19.7±4.1 mm Hg at baseline to 16.7±2.1 mm Hg (P=0.58). Two eyes (5.9%) required subsequent trabeculectomy. CONCLUSION: The “landing strip” technique appears to be an effective way to assist with iStent implantation.

Purpose: Micro-invasive glaucoma surgery involves a group of treatment methods associated with a low rate of side effects and good effectiveness outcomes. One of the most frequently performed procedures belonging to this group is iStent microstent implantation. The aim of this study was to perform a retrospective evaluation of the safety and efficacy of a combined procedure involving cataract phacoemulsification and single iStent microstent implantation, performed simultaneously., Materials and Methods: The complete medical records of 62 patients (91 eyes) were analyzed retrospectively, including the best corrected visual acuity, intraocular pressure, the mean defect of visual fields, and the number of active substances used in eye drops. The follow-up times were 1, 3, 6, 9, and 12 months after the surgical procedure., Results: A significant improvement in the best corrected visual acuity and a reduction of the intraocular pressure were achieved after the surgery. On average, after 12 months, the best corrected visual acuity improved from 0.70 (0.25) to 0.91 (0.18; p = 0.001), the intraocular pressure reduced from 17.76 (3.95) to 14.91 (3.04; p = 0.0001), and the number of active substances used in eye drops reduced from 2.07 (1.08) to 0.70 (0.06; p = 0001). In addition, we found that patients who initially showed higher intraocular pressure values did not benefit from surgery in the aspect of the number of active substances used in their eye drops. Intraoperative and postoperative adverse events were transient and ultimately did not affect the outcomes., Conclusion: Simultaneous cataract phacoemulsification with single iStent implantation in patients with open-angle glaucoma is a safe and effective method for reducing intraocular pressure and the number of topical medications that must be used. Having initially higher intraocular pressure values may limit the beneficial effects of iStent implantation by subordinating patients from topical treatment; thus, single iStent implantation may not be the most favorable choice in uncontrolled glaucoma cases., Competing Interests: AS was employed by the GlaucoTech Co. The remaining authors declare that the research was conducted in the absence of any commercial or financial relationships that could be construed as a potential conflict of interest., (Copyright © 2023 Hajduga-Szewczyk, Smedowski, Filipecka and Mrukwa-Kominek.)

Introduction: This retrospective consecutive case series assessed 12-month effectiveness and safety of iStent® or iStent inject® trabecular micro-bypass implants with cataract surgery in patients with open-angle glaucoma (OAG) in a real-world clinical setting.Methods: Effectiveness outcomes consisted of intraocular pressure (IOP) reduction; glaucoma medication reduction; proportions of eyes achieving IOP < 18, < 15, or < 12 mmHg; and proportional analysis of medication usage. Safety outcomes included adverse events, secondary surgeries, and best-corrected visual acuity (BCVA).Results: This evaluation included 58 eyes with OAG (35 iStent, 23 iStent inject), with 96.6% of eyes having mild or moderate glaucoma. Diagnoses included primary open-angle glaucoma (the majority; 72.4%), pseudoexfoliative glaucoma, and pigmentary glaucoma. Baseline mean IOP and medications were statistically comparable between groups: 16.1 ± 3.6 mmHg on a mean of 1.8 ± 0.8 medications in the iStent group, and 16.2 ± 3.1 mmHg on a mean of 1.7 ± 0.8 medications in the iStent inject group. Twelve months after stent-cataract surgery, mean IOP was significantly lower in the iStent inject group than in the iStent group (13.1 mmHg vs. 15.4 mmHg, respectively; p < 0.001), and the percent reduction in IOP from baseline was significantly greater in iStent inject eyes than in iStent eyes (19.1% vs. 4.3% reduction, respectively; p < 0.001). At 12 months postoperative, significantly greater proportions of iStent inject eyes than iStent eyes achieved IOP < 18 mmHg (100% vs. 80.0% of eyes, respectively; p = 0.035), IOP < 15 mmHg (73.9% vs. 34.3% of eyes, respectively; p = 0.003), and IOP < 12 mmHg (26.1% vs. 0% of eyes, respectively; p = 0.002). Meanwhile, both groups achieved significant medication reductions at 12 months vs. baseline (94.1% reduction in iStent inject eyes, p < 0.0001; and 72.2% reduction in iStent eyes, p < 0.0001), with the percent reduction being significantly greater in iStent inject eyes than in iStent eyes (p = 0.023). At 12 months, mean number of medications was significantly lower in iStent inject eyes than iStent eyes (0.1 vs. 0.5 medications, respectively; p = 0.021), and significantly more iStent inject eyes (95.7%) than iStent eyes (71.4%) were off medications entirely (p = 0.021). A similarly high safety profile was observed in both groups.Conclusion: iStent or iStent inject implantation with cataract surgery resulted in substantial and safe reductions in IOP and medications through 12 months postoperative. Consistent with prior observations, greater efficacy was observed with iStent inject than with iStent.Funding: The Rapid Service Fees were funded by Glaukos Corporation. [ABSTRACT FROM AUTHOR]

Importance Minimally invasive glaucoma surgery has gained significant traction in recent years. This study evaluates the first‐ and second‐generation trabecular micro‐bypass stents "iStent" and "iStent inject". Background: To evaluate and compare the effect of a single iStent and double iStent inject in primary open angle glaucoma. Design Prospective comparative case series. Participants: Primary open angle glaucoma patients undergoing trabecular micro‐bypass stent insertion combined with cataract surgery. Methods: Baseline demographic information, preoperative, intraoperative and postoperative outcomes including intraocular pressure (IOP), visual acuity, reliance on glaucoma medication and complications were collected and analysed. Main Outcome Measures: Primary, secondary and tertiary outcome measures were consecutively defined as an IOP of ≤18 mmHg with zero medications, an IOP of ≤18 mmHg with reduced medications or a 20% reduction in IOP with or without medication. Results: The study comprised 145 eyes in the iStent and 100 eyes in the iStent inject group. At 12 months, 56.0% of the iStent and 51.3% of the iStent inject eyes had achieved primary success and 63.1% and 57.7% secondary success. The mean postoperative IOP was 16.6 mmHg in iStent and 16.9 mmHg in iStent inject. Survival analysis demonstrated a greater incidence of failure in the iStent inject beyond 5 months. Conclusions and Relevance: Both trabecular micro‐bypass stents in this study were effective in reducing IOP and the burden of medication when combined with cataract surgery. There was no statistically significant difference between the two groups across our outcome measures although the iStent inject required earlier recommencement of medications for optimal IOP control. [ABSTRACT FROM AUTHOR]

Purpose: To compare the efficacy and safety of combined cataract extraction and either excisional goniotomy performed with the Kahook Dual Blade (KDB; phaco-KDB group) or single iStent trabecular bypass implantation (phaco-iStent group) in eyes with mild to moderate glaucoma and visually significant cataract.Methods: This was a retrospective analysis of 315 eyes from 230 adults with mild or moderate glaucoma treated with one or more intraocular pressure (IOP)-lowering medications (190 eyes of 134 subjects in the phaco-KDB group and 125 eyes of 96 subjects in the phaco-iStent group) that required no subsequent surgical intervention for IOP control through 12 months of follow-up. Data included best-corrected visual acuity (BCVA), IOP, and IOP-lowering medications, collected preoperatively and at 1 week and 1, 3, 6, and 12 months postoperatively as well as intraoperative and postoperative adverse events. The primary efficacy outcomes were the proportion of subjects in each group achieving ≥ 20% IOP reduction and ≥ 1 medication reduction at month 12. Subgroup analysis by baseline IOP (≤ 18 mmHg vs. > 18 mmHg) was also performed.Results: Mean (standard error) baseline IOP was 18.2 (0.3) mmHg in the phaco-KDB group and 16.7 (0.3) mmHg in the phaco-iStent group (p = 0.001). Statistically significant mean IOP and mean IOP medication reductions from baseline were achieved at all time points in both groups. Mean IOP reductions were significantly greater in the phaco-KDB group than in the phaco-iStent group at all time points including month 12 [- 5.0 (0.3) mmHg vs. - 2.3 (0.4) mmHg, p < 0.001], while mean medication reductions were similar between groups at all time points except week 1, when greater mean medication reduction was seen in the phaco-iStent group (- 1.23 vs. - 0.60 medications, p < 0.001). At month 12, IOP reductions ≥ 20% were achieved by 64.2% and 41.6% (p < 0.001) in the phaco-KDB and phaco-iStent groups, respectively, and IOP medication reductions of ≥ 1 medication were achieved by 80.4% and 77.4% (p = 0.522), respectively. Intraocular pressure subgroup analysis revealed significant reductions in IOP-lowering medications without compromise of IOP control in lower IOP subgroups and significant reductions in both IOP and IOP-lowering medications in the higher IOP subgroups. The most common adverse events were transient IOP elevations and transient anterior chamber inflammation, which occurred with similar frequency in both groups and resolved spontaneously.Conclusion: Goniotomy with the KDB lowered IOP significantly more than iStent implantation, with few adverse events in both groups. In eyes with mild to moderate glaucoma undergoing combined cataract extraction and glaucoma surgery, goniotomy with the KDB can safely deliver statistically significant and clinically meaningful reductions in both IOP and IOP medication burden through 12 months of follow-up.Funding: New World Medical, Inc., provided funding for the study, medical writing assistance, Rapid Service Fees, and the open access fee. [ABSTRACT FROM AUTHOR]

Introduction: In this real-world, retrospective, comparative study we evaluated 6-month performance and safety in consecutive eyes following implantation of the iStent® or iStent inject® trabecular micro-bypass device with concomitant cataract surgery.Methods: Performance outcomes included intraocular pressure (IOP) reduction; glaucoma medication reduction; proportions of eyes achieving an IOP of < 18, < 16, < 14, or < 12 mmHg; and proportions of eyes on 0, 1, 2, or ≥ 3 medications. Safety outcomes included adverse events, secondary surgeries, and best-corrected visual acuity (BCVA).Results: A total of 73 eyes with open-angle glaucoma and cataract were included in the study; of these, 38 eyes were implanted with the iStent device and 35 were implanted with the iStent inject device. The two groups of patients had similar baseline characteristics, with the exception of mean age and medication burden (both higher in patients receiving the iStent inject device); over 90% of eyes in both groups had early glaucoma. At 6 months after surgery, mean IOP had fallen from 16.5 ± 3.9 to 13.9 ± 2.3 mmHg in eyes with the iStent implant (p < 0.001), and from 17.3 ± 3.0 to 12.7 ± 1.8 mmHg in those with the iStent inject implant (p < 0.001). This reduction was significantly greater in the iStent inject eyes than in the iStent eyes (26.6 vs. 15.8%) (p = 0.005). Significantly more eyes receiving the iStent inject device compared to the iStent device achieved an IOP of < 18 mmHg at 6 months post surgery (100 vs. 86.8%) (p = 0.033). Average medication usage was reduced from 1.8 to 0.4 medications in iStent eyes (p < 0.001) and from 2.3 to 0.4 medications in iStent inject eyes (p < 0.001). Over 70% of eyes in both groups became medication-free by 6 months post implantation. Adverse events in iStent eyes were mild and resulted in no sequelae; two iStent eyes underwent non-penetrating deep sclerectomy during follow-up. No complications or secondary surgeries were noted in iStent inject eyes. All eyes in both groups maintained or showed improved BCVA versus baseline.Conclusion: Significant and safe IOP and medication reductions were observed after iStent or iStent inject implantation with concomitant cataract surgery. Trends toward greater effectiveness and fewer adverse events were observed with the iStent inject device compared with the iStent device.Funding: Article processing charges were provided by Glaukos Corporation. [ABSTRACT FROM AUTHOR]

Purpose: To produce an economic comparison of the iStent ab interno trabecular microbypass implant accompanying cataract surgery and selective laser trabeculoplasty (SLT) as first-line treatment versus topical medications for open-angle glaucoma in New Zealand in 2016.Methods: The current annual costs of 19 available fully subsidised topical glaucoma medications by Pharmaceutical Management Agency (Pharmac) in 2016 were identified. Adjustments for pharmacist prescribing charges and previously described wastage levels were applied. The costs to perform iStent implantation and the cost to perform SLT were obtained from the local distributors, with the latter taking into account staff and consumable cost. Procedure costs divided by eye drops’ cost produced a break-even level in equivalent years of eye drops use.Results: The range of annual eye drop cost was NZD$42.25 to NZD$485.11, with an average of NZD$144.81. Comparison of annual eye drop cost with iStent cost revealed 3 of 19 (15.8%) drops breaking even within 5 years, 9 of 19 (47.3%) within 10 years, and 12 of 19 (63.2%) within 15 years. The cost of bilateral SLT performed by a consultant was NZD$102.30 (breaking even in 0.71 years). The equivalent cost for a registrar was NZD$97.59 (breaking even in 0.67 years).Conclusion: Economically, the iStent would appear to be a reasonably cost-effective treatment for glaucoma patients undergoing cataract surgery in a public healthcare setting in New Zealand, particularly for those using more expensive topical glaucoma medications, whilst SLT appears to be a worthwhile consideration as a first-line treatment for glaucoma in New Zealand. [ABSTRACT FROM AUTHOR]

Tanner J Ferguson,1 John P Berdahl,2 Justin A Schweitzer,2 Ramu G Sudhagoni1 1Sanford School of Medicine, University of South Dakota, Sanford School of Medicine, Sioux Falls, SD, USA; 2Vance Thompson Vision, Sioux Falls, SD, USA Purpose: To evaluate the safety and efficacy of the iStent trabecular microbypass stent in combination with cataract surgery in patients with open-angle glaucoma (OAG).Methods: Retrospective, consecutive case series from October 2012 to December 2015 with no exclusion criteria. The series comprised of 350 eyes with OAG and cataract. Data were collected both preoperatively and postoperatively at day 1 week 1, months 1, 3, 6, 12, 18, and 24. Data included intraocular pressure (IOP), number of glaucoma medications, visual acuity, the incidence of postoperative IOP pressure spikes of greater than ≥15 mmHg at any time point, and need for additional surgery.Results: The mean preoperative IOP was 19.13±6.34 mmHg. At 2 years postoperation, mean IOP was 15.17±3.53 mmHg (P

L Jay Katz,1 Carl Erb,2 Amadeu Carceller Guillamet,3 Antonio M Fea,4 Lilit Voskanyan,5 Jeffrey M Wells,6 Jane Ellen Giamporcaro6 1Wills Eye Hospital, Jefferson Medical College, Philadelphia, PA, USA; 2Eye Clinic Wittenbergplatz, Berlin, Germany; 3Department of Ophthalmology, Hospital d’Hebron, Barcelona, Spain; 4University Eye Clinic of the University of Turin, Turin, Italy; 5SV Malayan Opthalmology Centre, Yerevan, Armenia; 6Glaukos Corporation, Laguna Hills, CA, USA Purpose: To assess the safety and efficacy of one, two, or three trabecular microbypass stents in eyes with primary open-angle glaucoma (OAG) not controlled on ocular hypotensive medication. A total of 119 subjects were followed for 18 months postoperatively.Materials and methods: Subjects with medicated intraocular pressure (IOP) 18–30 mmHg and postmedication-washout baseline IOP 22–38 mmHg were randomized to implantation of one, two, or three stents. Ocular hypotensive medication was to be used if postoperative IOP exceeded 18 mmHg.Results: A total of 38 subjects were implanted with one stent, 41 subjects with two stents, and 40 subjects with three stents. Both month 12 IOP reduction ≥20% without ocular hypotensive medication vs baseline unmedicated IOP and month 12 unmedicated IOP ≤18 mmHg were achieved by 89.2%, 90.2%, and 92.1% of one-, two-, and three-stent eyes, respectively. Furthermore, 64.9%, 85.4%, and 92.1% of the three respective groups achieved unmedicated IOP ≤15 mmHg. Over the 18-month follow-up period, medication was required in seven one-stent subjects, four two-stent subjects, and three three-stent subjects. At 18 months, mean unmedicated IOP was 15.9±0.9 mmHg in one-stent subjects, 14.1±1.0 mmHg in two-stent subjects, and 12.2±1.1 mmHg in three-stent subjects. Month 18 IOP reduction was significantly greater (P

Introduction: Primary open-angle glaucoma is estimated to affect 3% of the population aged 40-80 years. Trabeculectomy is considered the gold standard in surgical management of glaucoma; however, it is a technically complex procedure that may result in a range of adverse outcomes. Device-augmented, minimally invasive procedures (micro-invasive glaucoma surgeries, MIGS) have been developed aiming for safer and less invasive intraocular pressure (IOP) reduction compared with traditional surgery.Methods: This paper presents results from a systematic literature review conducted in accordance with National Institute for Health and Care Excellence requirements for the Medical Technology Evaluation Programme via multiple databases from 2005 to 2016. For clinical outcomes, randomized clinical trials (RCTs) comparing MIGS with trabeculectomy or other therapies, observational studies, and other non-RCTs were included. Clinical outcomes reviewed were the change from baseline in mean IOP levels and change in topical glaucoma medication. Safety was assessed by reported harm and adverse events. For economic evidence, trials on cost-effectiveness, cost-utility, cost-benefit, cost-consequences, cost-minimization, cost of illness, and specific procedure costs were included. Risk of bias was assessed for clinical studies using the Cochrane Risk of Bias tool.Results: A total of nine RCTs (seven iStents®, one Hydrus®, and one CyPass®), seven non-RCTs (three iStent®, three CyPass®, and one Hydrus®), and 23 economic studies were analyzed. While various forms of trabeculectomy can achieve postoperative IOP of between 11.0 and 13.0 mmHg, MIGS devices described in this review were typically associated with higher postoperative IOP levels. In addition, MIGS devices may result in increased hypotony rates or bleb needling in subconjunctival placed devices, requiring additional medical resources to manage. There is limited available evidence on the cost-effectiveness of MIGS and therefore it remains unclear whether the cost of using MIGS is outweighed by cost savings through decreased medication and need for further interventions.Conclusion: Larger randomized trials and real-world observational studies are needed for MIGS devices to better assess clinical and economic effectiveness. Given the shortage of published data and increasing use of such procedures, living systematic reviews may help to provide ongoing and timely evidence-based direction for clinicians and decision makers. This review highlights the current unmet need for treatments that are easy to implement and reduce long-term IOP levels without increasing postoperative aftercare and cost.Funding: Santen GmbH, Germany. [ABSTRACT FROM AUTHOR]

Introduction: This study evaluates long-term outcomes of two trabecular micro-bypass stents, one suprachoroidal stent, and postoperative prostaglandin in eyes with refractory open angle glaucoma (OAG).Methods: Prospective ongoing 5-year study of 80 eligible subjects (70 with 4-year follow-up) with OAG and IOP ≥ 18 mmHg after prior trabeculectomy and while taking 1-3 glaucoma medications. Subjects received two iStent® trabecular micro-bypass stents, one iStent Supra® suprachoroidal stent, and postoperative travoprost. Postoperative IOP was measured with medication and annually following medication washouts. Performance was measured by the proportion of eyes with ≥ 20% IOP reduction on one medication (the protocol-specified prostaglandin) versus preoperative medicated IOP (primary outcome); and the proportion of eyes with postoperative IOP ≤ 15 and ≤ 18 mmHg on one medication (secondary outcome). Additional clinical and safety data included medications, visual field, pachymetry, gonioscopy, adverse events, visual acuity, and slit-lamp and fundus examinations.Results: Preoperatively, mean medicated IOP was 22.0 ± 3.1 mmHg on 1.2 ± 0.4 medications, and mean unmedicated IOP was 26.4 ± 2.4 mmHg. Postoperatively, among eyes without later cataract surgery, mean medicated IOP at all visits through 48 months was ≤ 13.7 mmHg (≥ 37% reduction), and annual unmedicated IOP was ≤ 18.4 mmHg (reductions of ≥ 30% vs. preoperative unmedicated IOP and ≥ 16% vs. preoperative medicated IOP). At all postoperative visits among eyes without additional surgery or medication, ≥ 91% of eyes had ≥ 20% IOP reduction on one medication versus preoperative medicated IOP. At month 48, 97 and 98% of eyes achieved IOP ≤ 15 and ≤ 18 mmHg, respectively, on one medication. Six eyes required additional medication, no eyes required additional glaucoma surgery, and safety measurements were favorable throughout follow-up.Conclusion: IOP control was achieved safely with two trabecular micro-bypass stents, one suprachoroidal stent, and postoperative prostaglandin. This microinvasive, ab interno approach introduces a possible new treatment option for refractory disease.Trial Registration: NCT01456390.Funding: Glaukos Corporation. [ABSTRACT FROM AUTHOR]

Purpose: Evaluate long-term outcomes after one, two, or three trabecular micro-bypass stents implanted in a standalone procedure in eyes with open-angle glaucoma taking ocular hypotensive medication. Patients and methods: Prospective randomized ongoing study of 119 subjects (109 with 42-month follow-up) with open-angle glaucoma, preoperative intraocular pressure (IOP) 18-30 mmHg on one to three glaucoma medications, and unmedicated (post-washout) IOP 22-38 mmHg. Subjects were randomized to receive one (n=38), two (n=41), or three (n=40) iStent trabecular micro-bypass stents in a standalone procedure. Postoperatively, IOP was measured with medication and annually following washout. Data included IOP, medications, gonioscopy, pachymetry, visual field, visual acuity, adverse events, and slit-lamp and fundus examinations. Results: Preoperative mean medicated IOP was 19.8±1.3 mmHg on 1.71 medications in one-stent eyes, 20.1±1.6 mmHg on 1.76 medications in two-stent eyes, and 20.4±1.8 mmHg on 1.53 medications in three-stent eyes. Post-washout IOP prior to stent implantation was 25.0±1.2, 25.0±1.7, and 25.1±1.9 mmHg in the three groups, respectively. Postoperatively, Month 42 medicated IOP was 15.0±2.8, 15.7±1.0 and 14.8±1.3 mmHg in the three groups, and post-washout IOP (Months 36-37) was 17.4±0.9, 15.8±1.1 and 14.2±1.5 mmHg, respectively. IOP reduction ≥20% without medication was achieved in 89%, 90%, and 92% of one-, two-, and three-stent eyes, respectively, at Month 12; and in 61%, 91%, and 91% of eyes, respectively, at Month 42. The need for additional medication remained consistent at Months 12 and 42 in multi-stent eyes (four two-stent eyes and three three-stent eyes at both time points), whereas it increased in single-stent eyes (four eyes at Month 12 versus 18 eyes at Month 42). Safety parameters were favorable in all groups. Conclusion: The standalone implantation of either single or multiple iStent® device(s) produced safe, clinically meaningful IOP and medication reductions through 42 months postoperatively, with incrementally greater and more sustained reductions in multi-stent eyes. [ABSTRACT FROM AUTHOR]

For several years, the gold standard for surgical treatment of glaucoma has been trabeculectomy. Although very successful at reducing intraocular pressure (IOP), there are several potential complications of trabeculectomy, including sight-threatening ones. This has stimulated much research aimed at the development of new and effective procedures to lower IOP with an enhanced safety profile. Minimally invasive glaucoma surgery (MIGS) procedures prioritise patient safety but also demonstrate efficacy in reducing IOP. We performed an online search of peer-reviewed literature using PubMed, entering keywords relevant to this clinical discipline. In summary, there is a lack of long-term safety and efficacy data, a lack of comparative data and a lack of data on standalone (i.e. without simultaneous cataract surgery) procedures. Most implants are not yet FDA approved. Although not exhaustive, since it does not discuss MIGS procedures that are not implants, this article summarises the range of different MIGS implants that are available to the ophthalmic surgeon. [ABSTRACT FROM AUTHOR]

The iStent is an intraocular implant that resides within Schlemm canal and allows for direct bypass of the trabecular meshwork by aqueous fluid. It is one of several procedures termed microinvasive glaucoma surgery. The prominence of microinvasive glaucoma surgery is growing because of its role in lowering intraocular pressure in mild to moderate glaucoma combined with its favorable safety profile. With transcleral glaucoma filtering surgery, there is an increased potential for significant complications including hypotony, suprachoroidal hemorrhage, and long-term risk of endophthalmitis. In comparison, the iStent minimizes this risk and has been shown to be similar to cataract surgery in terms of associated complications. As will be discussed, multiple publications have addressed both the safety and efficacy of the implant. This review additionally presents an overview of implantation technique as well as what to expect postoperatively. Looking forward, the second-generation models may ease implantation and the use of multiple stents may potentially play a role in more advanced disease. [ABSTRACT FROM AUTHOR]

Purpose: This study was conducted to assess the impact on the Quality of Life (QOL) of micro-invasive glaucoma surgery (MIGS: iStent, Trabectome) and a penetrating technique such as Trabeculectomy (TE). Methods: This study evaluated 88 eyes of 88 open angle glaucoma patients undergoing glaucoma surgery: 43 (mean age 72.8 ± 8.8y, female 59.5 %, male 40.5 %) Trabectome (NeoMedix, Inc., Tustin, CA, USA), 20 (mean age 68.6 ± 16.4y, female 60 %, male 40 %) iStent (Glaucos Corporation, Laguna Hills, CA, USA), and 25 TE patients (mean age 74.2 ± 9.1y female 58.3 %, male 41.7 %). The National Eye Institute-Visual Functioning Questionnaire (VFQ-25) survey was used to assess the QOL at 6 months post surgery. The following 12 QOL parameters were evaluated: general health, ocular pain, general vision, near and distance activities, mental health, social functioning, role difficulties, dependency, driving, color vision, and peripheral vision. Intraocular pressure (IOP), number of topical medications, and visual acuity (VA) were examined preoperatively, 1 day, 6 weeks, 3 months, and 6 months post surgery. Statistical data were calculated using SPSS (v20.0, SPSS, Inc.). Results: There was no significant difference between TE and MIGS in the quality of life 6 months postoperatively. IOP was significantly lower in TE compared to MIGS at 6 weeks and 3 months postoperatively ( p = 0.046 and p = 0.046). Number of medications was significantly decreased in TE compared to MIGS ( p < 0.001). A significant difference in VA between TE and MIGS could be assessed at day 1 post-op ( p = 0.011). Conclusion: In this study cohort, the QOL can be maintained by all three surgical techniques. Patients, however, need lower numbers of topical medication in TE, which would impact QOL even though it is not included in the NEI-VFQ-25. The decision of the most appropriate surgical technique should be made by including single QOL categories, IOP and glaucoma medication outcome. [ABSTRACT FROM AUTHOR]

Introduction:Recent innovations in glaucoma surgery have led to new alternatives for glaucoma patients requiring surgery. We investigate the intraocular pressure (IOP) outcomes following the placement of trabecular bypass devices. Areas covered:The aim of this paper is to analyze the current literature on trabecular bypass devices. The first and second generation iStents (Glaukos Corporation, Laguna Hills, CA, USA) act as a snorkel to increase delivery of aqueous through the trabecular meshwork and into Schlemm’s canal. The Hydrus (Ivantis Inc., Irvine, CA) is a larger device that in addition to acting as a snorkel, maintains Schlemm’s canal patency over several clock hours. The literature reviewed was found by searching Pubmed for iStent, micro-bypass, Schlemm’s canal scaffold, and individual references were followed. Expert commentary:Safer alternatives in Minimally Invasive Glaucoma Surgery (MIGS) procedures continue to be developed, and have a more favorable safety profile compared to traditional penetrating surgeries. However, the IOP reduction associated with these procedures is not as reliably low. There is significant heterogeneity in reported results, particularly with first generation stents. Early data with multiple stent insertion suggests that it is possible to achieve target IOPs in the mid-teens or below in a significant number of patients while still on medication. [ABSTRACT FROM PUBLISHER]

Interventions in the treatment of mild to moderate glaucoma have evolved to include a group of procedures collectively named “Minimally Invasive Glaucoma Surgery (MIGS).” These procedures are less invasive than traditional filtering surgery and setons and offer the benefit of an improved side-effect profile. A review of current published literature has shown that these procedures offer lower intraocular pressure, decrease reliance on topical medications, have no negative effect on refractive outcomes, and can be safely done following failed tube surgery. [ABSTRACT FROM PUBLISHER]

The paper presents the results of a 24-month-long observation comparing the effectiveness and safety of two micro-invasive glaucoma surgery (MIGS) devices: Hydrus Microstent and iStent Trabecular Bypass in combination with cataract phacoemulsification in the treatment of open-angle glaucoma. We also analyzed the impact of preoperative factors on achieving surgical success in both surgical methods. The prospective, comparative, non-randomized study included 65 glaucoma surgeries. In 35 patients (53.8%), an iStent implant procedure was performed, while 30 patients (46.2%) underwent a Hydrus implant procedure. The demographic data was similar in both treatment groups. At 24 months after surgery, the mean IOP in the iStent group was 15.9 ± 3.0 mmHg and in the Hydrus group 16.2 ± 1.8 mmHg. The difference between the mean iStent vs Hydrus after two years of treatment was -0.3 ( p = 0.683). At the 24 month follow-up, the average change in the number of antiglaucoma medications used was 71.7% in the iStent group and 79.6% in the Hydrus group. The difference in mean percentage change between groups was 7.9% in favor of Hydrus. Patients under the age of 70 may benefit from a greater risk reduction in the Hydrus group (HR = 0.81), while those over the age of 70 may benefit from a risk reduction in the iStent group (HR = 1.33). IOP cases with >18 mmHg before the surgery have a better chance of surgical success with the Hydrus method (HR = 0.28), and with IOP < 18 mmHg in the iStent group (HR = 1.93). Cases with more drugs (≥3 drugs) are more favorable in the Hydrus group (HR = 0.23), while those with a maximum of two drugs have a better prognosis in the iStent group (HR = 2.23). The most common postoperative complication was the presence of erythrocytes in the anterior chamber (AC), found in 40.0% of operated eyes in the Hydrus group. The profile of observed complications and significant improvement in visual acuity allows us to consider both implants as a safe way of treating patients with early or moderate glaucoma and co-existing cataracts.

Purpose: To evaluate 3-year safety and intraocular pressure (IOP) following two trabecular microbypass stents in phakic and pseudophakic subjects with open-angle glaucoma (OAG) not controlled on preoperative medication. Patients and methods: In this prospective pilot study, phakic or pseudophakic subjects with OAG and IOP between 18 mmHg and 30 mmHg on one preoperative topical ocular hypotensive medication underwent medication washout. Thirty-nine qualified subjects with preoperative unmedicated IOP ≥22 mmHg and ≤38 mmHg received two stents. Postoperative examinations were scheduled at Day 1, Week 1, Months 1, 3, 6, and 12, and semiannually through Month 60. Ocular hypotensive medication was considered if postoperative IOP exceeded 21 mmHg. IOP, medication use, and safety were assessed at each visit. Subject follow-up through Month 36 was completed. Results: Thirty-six eyes (92.3%; 95% confidence interval [CI] 79.1%, 98.4%) achieved the primary efficacy end point of Month 12 reduction in IOP ≥20% from baseline (unmedicated IOP) without ocular hypotensive medication. Four subjects required medication during the Month 36 follow-up period. Mean IOP at 36 months for subjects not taking medication was 15.2 mmHg. At 36 months, subjects sustained mean IOP decrease of 9.1±2.7 mmHg (95% CI 8.0 mmHg, 10.14 mmHg), or 37% IOP reduction, from unmedicated baseline IOP. Compared to preoperative medicated IOP, subjects had mean reduction at Month 36 of 5.5±2.7 mmHg (95% CI 4.5 mmHg, 6.6 mmHg), or 26% reduction. Both measures of IOP reduction were highly significant (P<0.001). Other than one case of early postoperative hyphema that resolved at 1 week, no postoperative adverse events were attributed to stent implantation. Conclusion: In a pilot study, two trabecular microbypass stents to treat OAG subjects on one preoperative medication provided statistically significant, sustained, and safe reduction of IOP to ≤15 mmHg without medication through 36 months. [ABSTRACT FROM AUTHOR]