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Introduction To analyze the effects of PRESERFLO on corneal endothelial cell density (ECD). Methods Forty-six eyes that underwent PRESERFLO implantation were followed up for 12 months. Specular microscopy was performed preoperatively and at 1, 3, 6, and 12 months postoperatively to measure central ECD and mean monthly reduction (MMR). Anterior segment optical coherence tomography (AS-OCT) was applied to measure the tube–endothelium (TE 500 μm) distance. The relationship between TE distance and ECD was analyzed with a linear mixed-effects model. Results Central ECD decreased significantly at 1 year (7.4%, p = 0.04), with an MMR of −15 ± 25 cells/mm2. Regarding TE distance groups, there was an 18% ECD reduction in the 500 μm group (p = 0.08). Endothelial cell loss was related to TE distance (mean 482.9 ± 238 μm), with a higher rate at 1 month in comparison to 12 months for the same tube position in the anterior chamber (−174.8 ± 65.2 cells/mm2 at 1 month vs. 30.2 ± 11.3 cells/mm2 at 12 months, p 600 μm from the endothelium showed EC loss close to zero. Conclusions The PRESERFLO implant is associated with a loss of EC from the immediate postoperative period that continues over time at lower rates. A shorter TE distance appears to cause more severe ECD loss.

Implant devices for micro invasive glaucoma surgery (MIGS) are gaining increasing acceptance in clinical ophthalmic use. The implant requirements are defined in international standards, such as ANSI Z80.27-2014 and the 2015 Guidance for Industry and Food and Drug Administration Staff “Premarket Studies of Implantable Minimally Invasive Glaucoma Surgical (MIGS) Devices”. The exact fluid-mechanical characterization represents a crucial part of the development and approval of innovative implant devices for MIGS. The current work describes the development and preliminary validation of a versatile test facility for pivotal characterization of glaucoma drainage devices. The test setup enables a pressurization of test specimens by means of two water columns. For measurement of pressure and volume flow, a pressure transducer and a total of three liquid flow meters were implemented into the test setup. Validation was conducted by experimental pressureflow characterization of standardized tubes and a comparison to theoretical results according to Hagen Poiseuille's law for stationary laminar flow of a Newtonian fluid in a tube with a circular cross section. Ultrapure water at (35 ± 2) °C was used for the analyses. The developed test setup potentially enables pressure-flow characterization of test specimens in a wide flow range of 0 μl min-1 ≤ Q ≤ 5.000 μl min-1. The preliminary test facility validation showed a good agreement of measured and theoretical volume flow characteristics as a function of the pressure difference, in the currently investigated flow range of Q < 80 μl min-1. The developed test facility is suitable for pivotal in vitro characterization of glaucoma drainage devices. Future investigations will focus on the final validation of the whole flow range and on the use of the test facility for fluid-mechanical characterization of self-developed prototypes of glaucoma microstents as well as commercially available glaucoma drainage devices.

International ophthalmology 41(12), 4047-4053 (2021). doi:10.1007/s10792-021-01977-w, Published by Springer Science + Business Media B.V., Dordrecht

Purpose To compare clinical success rates and reductions in intraocular pressure (IOP) and IOP-lowering medication use following suture trabeculotomy ab interno (S group) or microhook trabeculotomy (μ group). Methods This retrospective review collected data from S (n = 104, 122 eyes) and μ (n = 42, 47 eyes) groups who underwent treatment between June 1, 2016, and October 31, 2019, and had 12-month follow-up data including IOP, glaucoma medications, complications, and additional IOP-lowering procedures. The Kaplan–Meier survival analysis was used to evaluate treatment success rates defined as normal IOP (> 5 to ≤ 18 mm Hg), ≥ 20% reduction of IOP from baseline at two consecutive visits, and no further glaucoma surgery. Results Schlemm’s canal opening was longer in the S group than in the μ group (P P = 0.230). The Kaplan–Meier survival analysis of eyes with preoperative IOP ≥ 21 mmHg showed cumulative clinical success rates in S and μ groups were 80.4% and 60.0% (P = 0.0192). There were no significant differences in postoperative IOP at 1, 3, and 6 months (S group, 14.9 ± 5.6, 14.6 ± 4.5, 14.6 ± 3.9 mmHg; μ group, 15.8 ± 5.9, 15.2 ± 4.4, 14.7 ± 3.7 mmHg; P = 0.364, 0.443, 0.823), but postoperative IOP was significantly lower in the S group at 12 months (S group, 14.1 ± 3.1 mmHg; μ group, 15.6 ± 4.1 mmHg; P = 0.0361). There were no significant differences in postoperative numbers of glaucoma medications at 1, 3, 6, and 12 months (S group, 1.8 ± 1.6, 1.8 ± 1.5, 2.0 ± 1.6, 1.8 ± 1.5; μ group, 2.0 ± 1.6, 2.0 ± 1.6, 2.1 ± 1.6, 2.2 ± 1.7; P = 0.699, 0.420, 0.737, 0.198). Conclusion S and µ group eyes achieved IOP reduction, but μ group eyes had lower clinical success rates among patients with high preoperative IOP at 12 months.

Background: A single-center prospective randomized observational study to compare three types of canaloplasty, i.e., ab externo (ABeC), minicanaloplasty (miniABeC) and ab interno, (ABiC) combined with cataract surgery in primary open-angle glaucoma (POAG) patients over 12 months. Methods: 48 POAG patients underwent one of three canaloplasty procedures: ABeC (16 eyes), miniABeC (16 eyes) or ABiC (16 eyes) or combined with phacoemulsification. Patients were assessed at baseline, at day 0–1–7 and at month 1–3–6–12. Successful treatment was defined as unmedicated IOP reduction ≥20%. Complete surgical success was defined as an IOP ≤ 15 mmHg without medications, and a qualified surgical success as IOP ≤ 15 mmHg with or without medications. Results: Pre-washout IOP median values (mmHg) were 17 (ABeC), 18 (miniABeC) and 17 (AbiC) and decreased at 12-month follow up postoperatively to 13 (p = 0.005), 13 (p = 0.004) and 14 (p = 0.008), respectively—successful treatment was achieved in approximately 100% of patients for ABeC and in 93.8% for both miniABeC and AbiC groups. Preoperatively, the median number of medications was 2.0 (range 1–3) (ABeC), 2.0 (1–3) (miniABeC) and 2.0 (0–4) (ABiC); 12-month post-operatively, all medications were withdrawn except in two patients (followed miniABeC and AbiC). Conclusions: The three variants of canaloplasty significantly reduced IOP and the number of medications in patients with mild to moderate POAG and gave no significant complications.

Purpose: To describe the efficacy and safety of open versus closed conjunctival implantation of the XEN45 Gel Stent (Allergan Inc). Design: Retrospective, multicenter study. Participants: A total of 137 patients with glaucoma who underwent XEN45 implantation via open or closed conjunctival methods. The XEN45 was implanted as a stand-alone procedure or at the time of cataract surgery by 5 surgeons. Methods: Patient demographics, diagnoses, preoperative and postoperative clinical data, outcome measures including intraocular pressure (IOP), use of glaucoma medications, visual acuity, and complications were collected. Statistical analyses were performed with P < 0.05 as significant. Main Outcome Measures: Failure was defined as less than 20% reduction of IOP from medicated baseline or IOP >21 mmHg at 2 consecutive visits at postoperative month 1 and beyond, the need for subsequent operative intervention or additional glaucoma surgery, or a catastrophic event such as loss of light perception. Eyes that had not failed by these criteria and were not on glaucoma medications were considered complete successes. Eyes that had not failed but required glaucoma medications were defined as qualified successes. Results: Complete success was achieved in 31% and 56% of the closed and open groups, respectively (P = 0.01). Qualified success was achieved in 53% and 71% of the closed and open groups, respectively (P = 0.06). At postoperative month 12, the open conjunctiva group was using fewer glaucoma medications than the closed group (0.9 vs. 1.8, respectively; P = 0.02). At postoperative month 12, the open group had a significantly greater percentage of IOP reduction compared with the closed group (43.1% vs. 24.8%, respectively; P = 0.02). Postoperative needling rates were higher in the closed group compared with the open group (36.1% vs. 11.8%, P = 0.001). Conclusions: Implantation of the XEN45 with opening of the conjunctiva is a safe and efficacious procedure to lower IOP with comparable success rate and lower needling rate compared with the closed conjunctiva technique. Prospective evaluation of the various methods for XEN45 implantation will allow for further comparison.

Purpose To compare efficacy and safety of needling and open bleb revision after XEN-45 surgery. Methods This retrospective study represents real-life data of patients who underwent XEN-45 surgery between November 2014 and June 2018 in the Vienna General Hospital. The following groups were formed for data evaluation: (PSEA) primary surgery secondary intervention allowed (n = 268); (PS) primary surgery until secondary intervention (n = 268); (N) first needling until additional secondary intervention (n = 55); (BR) first bleb revision until additional secondary intervention (n = 105). Main outcome measures were pre- and postoperative intraocular pressure (IOP), number of glaucoma medication (GM), Kaplan–Meier success rates, and secondary intervention rates. Success was defined as postoperative IOP Results IOP (and GM) was lowered from 23.5 ± 8.0 (GM 3.1 ± 1.0) to 14.9 ± 8.2 mmHg (1.2 ± 1.4) in group PSEA and 18.1 ± 8.2 mmHg (1.5 ± 1.4) in group PS, in group N from 23.2 ± 10.1 (1.5 ± 1.0) to 19.3 ± 8.5 mmHg (2.2 ± 1.3) and in group BR from 22.0 ± 8.0 mmHg (2.5 ± 1.1) to 15.5 ± 6.4 mmHg (1.3 ± 1.5) after a median follow-up of 16.0, 8.4, 4.8, and 7.3 months, respectively. Success rates at 1 year were significantly higher in group BR (50.7%) compared to PS (37.7%, p = 0.019) and N (24.3%; p = 0.015). An additional intervention was required less frequently in group BR (17.1%) compared to group PS (49.6%, p p Conclusion Our data appear to indicate favorable outcomes for open XEN bleb revision in terms of Kaplan–Meier success rates and secondary intervention rate compared to the needling procedure.

Ricardo Augusto Paletta Guedes,1 Daniela Marcelo Gravina,1 Vanessa Maria Paletta Guedes,1 Alfredo Chaoubah2 1Glaucoma Department, Paletta Guedes Eye Institute, Juiz de Fora, MG, Brazil; 2Statistics Department, Federal University of Juiz De Fora, Juiz de Fora, MG, BrazilCorrespondence: Ricardo Augusto Paletta GuedesGlaucoma Department, Paletta Guedes Eye Institute, 79, Oscar Vidal streeet, Juiz de Fora, MG, 36010-060, BrazilTel: +55 32 3213-1927Email palettaguedes@yahoo.comIntroduction: This retrospective comparative study assessed real-world effectiveness and safety of first-generation (iStent®) and second-generation (iStent inject®) trabecular micro-bypass stents with cataract surgery in patients with open-angle glaucoma (OAG).Material and Methods: Through a 24-month postoperative follow-up, the effectiveness was quantified by intraocular pressure (IOP) reduction; mean glaucoma medication reduction; proportional analysis of eyes meeting IOP cutoffs (< 18, < 15, < 12 mmHg) either with or without medications; and proportional analysis of medication burden. Safety measures included visual acuity, adverse events, and secondary surgery.Results: A total of 82 consecutive eyes (39 iStent, 43 iStent inject) with a 24-month follow-up were analyzed. Most eyes (74.4%) had primary open-angle glaucoma, with the remainder having pseudoexfoliative or pigmentary glaucoma; all eyes had mild-to-moderate disease. At 24 months postoperative, the mean IOP was lower, and the percent reduction from baseline was greater, in iStent inject eyes (26.0% reduction, 17.7mmHg to 13.1mmHg) than in iStent eyes (9.8% reduction, 16.4mmHg to 14.8mmHg) (between-groups comparison, p=0.019). Within each group, the postoperative IOP reduction was greater in eyes with higher baseline IOP (p< 0.001). Medication burden decreased significantly in both groups, from 1.74 to 0.51 mean medications for iStent (70.7% reduction, p< 0.0001), and 2.19 to 0.65 for iStent inject (70.3% reduction, p< 0.0001). Both groups exhibited excellent safety.Conclusion: iStent or iStent inject with phacoemulsification produced significant IOP and medication reductions, with effects enduring for two years. IOP reductions were greater for iStent inject than for iStent. Within each group, higher preoperative IOP was associated with greater postoperative IOP reduction.Keywords: iStent, iStent inject, trabecular micro-bypass, micro-invasive, MIGS

Juliana Wons,1,* Nadine Mihic,2,* Isabel B Pfister,1 Stefano Anastasi,1 Justus G Garweg,1,2 Markus Halberstadt3 1Swiss Eye Institute, Rotkreuz, and Berner Augenklinik am Lindenhofspital, Bern, Switzerland; 2Department of Ophthalmology, University of Bern, Bern, Switzerland; 3Private Practice for Ophthalmology, Flums, Switzerland*These authors contributed equally to this workCorrespondence: Markus HalberstadtAugenärzte Flums, Marktstrasse 21, Flums, 8890, SwitzerlandEmail augenaerzte-flums@hin.chPurpose: This study aimed to compare the effect of trabectome surgery in patients with and without intolerance to their medication and with preoperatively sufficiently controlled, insufficiently controlled, and uncontrolled intraocular pressure (IOP) on the surgical outcome.Patients and Methods: A total of 155 eyes (133 patients) with different forms of open angle glaucoma with or without intolerance to their glaucoma medication undergoing trabectome surgery alone (AIT) or combined with phacoemulsification (phaco-AIT) were included in this retrospective monocentric study. Patients were corresponding to IOP ≤ 18 mmHg (controlled but glaucoma progression or intolerance, group 1), 19– 26 mmHg (insufficiently controlled, group 2), and ≥ 26 mmHg (not controlled, group 3), respectively. Pre- and postoperative IOP and the number of IOP-lowering medications were registered over 12 months. Surgical success was defined as a postoperative IOP of ≤ 18mmHg and/or reduction of the topical treatment demand after 1 year.Results: Of the 155 included eyes, 79 received AIT and 76 received phaco-AIT. Sixty-nine eyes had a preoperatively sufficiently controlled IOP, 63 had an insufficiently controlled IOP, and 23 had an uncontrolled IOP. In all groups, the IOP significantly dropped by 6 and 12 months after surgery (p < 0.001). Surgical success war similar in all groups [47.8% (group 1), 38.1 (group 2) and 34.8% (group 3); p= 0.47]. The effect of AIT on IOP and glaucoma medication independent of intolerance to the anti-glaucoma medication and type of surgery (AIT/phaco-AIT).Conclusion: Independently of the preoperative IOP, a satisfying surgical success was achieved using AIT. In instances that do not qualify for filtrating surgery, trabectome surgery alone or in combination with phacoemulsification thus represents a safe and effective minimally invasive glaucoma surgery technique regardless of an intolerance to the topical medication.Keywords: glaucoma, ab interno trabeculectomy, trabectome, minimally-invasive glaucoma surgery, minimally-invasive glaucoma surgery, MIGS

Mark J Gallardo El Paso Eye Surgeons, PA, El Paso, TX, USACorrespondence: Mark J GallardoEl Paso Eye Surgeons, PA, 1201 N Mesa St, Ste G, El Paso, TX, 79902, USATel +1 915 542 0279Email gallardomark@hotmail.comPurpose: This study aimed to evaluate the 24-month efficacy of viscodilation of Schlemm’s canal and the distal outflow system with iTrack ab-interno canaloplasty in reducing intraocular pressure (IOP) and antiglaucoma medication use in patients with primary open-angle glaucoma (POAG).Patients and Methods: This retrospective, comparative, and consecutive case series assessed the 24-month outcomes of iTrack as a standalone procedure (iTrack-alone) or in conjunction with cataract surgery (iTrack+phaco), in cases of mild, moderate or severe POAG. Data were collected at baseline and the 12- and 24-month follow-up visits.Results: The study included 53 patients (60 eyes) with a mean age of 73.6± 9 years. For all eyes, a significant reduction in mean IOP was seen at 12 and 24 months, reducing from 20± 4.9 mmHg at baseline to 13.6± 1.9 mmHg and 13.5± 2.6 mmHg, respectively (P< 0.001). The reduction in medications was also significant, reducing to 1.12± 1.09 and 1.7± 1.29 medications at 12 months and 24 months, respectively, from a baseline of 2.77± 0.91 (P< 0.001). Similar results were achieved whether iTrack was performed as a standalone procedure, or in conjunction with cataract surgery. While the iTrack-alone group started with a higher IOP at baseline, both groups experienced similar and stable IOP reduction of more than 30% from baseline. The reduction in medication use was also significant in both groups, decreasing from 3± 0.7 for iTrack-alone and 2.5± 1.1 for iTrack+phaco at baseline to 2.1± 1.3 and 1.3± 1.2 at 24 months, respectively (P< 0.001). The 24-month efficacy outcomes were similar in cases of mild–moderate versus severe glaucoma. No serious adverse events were recorded.Conclusion: Twenty-four-month follow-up data demonstrate that iTrack ab-interno canaloplasty can effectively reduce IOP and medication dependence, with a good safety profile. These results also demonstrate that iTrack can be effectively performed as a standalone procedure or in combination with cataract surgery, and in all grades of glaucoma severity.Keywords: MIGS, canaloplasty, viscodilation, intraocular pressure, glaucoma medication, iTrack

Mark J Gallardo,1 Steven R Sarkisian Jr,2 Steven D Vold,3 Inder Paul Singh,4 Brian E Flowers,5 Anita Campbell,6 Kavita Dhamdhere,7 Thomas W Samuelson8 On behalf of the GEMINI study group1El Paso Eye Surgeons, PA, El Paso, TX, USA; 2Oklahoma Eye Surgeons, PLLC, Oklahoma City, OK, USA; 3Vold Vision, Fayetteville, AR, USA; 4Eye Centers of Racine & Kenosha, Racine, WI, USA; 5Ophthalmology Associates, Fort Worth, TX, USA; 6Grene Vision Group, Wichita, KS, USA; 7Sight Sciences, Menlo Park, CA, USA; 8Minnesota Eye Consultants, Minneapolis, MN, USACorrespondence: Kavita Dhamdhere Email kdhamdhere@sightsciences.comPurpose: To report interim 6-month safety and efficacy outcomes of 360° canaloplasty and 180° trabeculotomy using the OMNI® Surgical System concomitantly with phacoemulsification in patients with open-angle glaucoma (OAG).Setting: Fifteen multi-subspecialty ophthalmology practices and surgery centers located in 14 states (Alabama, Arizona, Arkansas, Florida, Georgia, Iowa, Kansas, Montana, Nebraska, North Dakota, Oklahoma, Pennsylvania, Texas, and Wisconsin).Design: Prospective, multicenter, IRB approved study of patients treated with canaloplasty (360°) and trabeculotomy (180°). Eligible patients had cataract and mild-moderate OAG with intraocular pressure (IOP) ≤ 33 mmHg on 1 to 4 hypotensive medications.Methods: Medication washout prior to baseline diurnal IOP (Goldmann). Effectiveness outcomes included mean IOP and medications. Safety outcomes included adverse events (AE), best corrected visual acuity (BCVA) and secondary surgical interventions (SSI). Analysis includes descriptive statistics and t-tests evaluating change from baseline.Results: A total of 137 patients were enrolled and treated. Mean diurnal IOP after washout was 23.8 ± 3.1 mmHg at baseline. At month 6, 78% (104/134) were medication free with IOP of 14.2 mmHg, a mean reduction of 9.0 mmHg (38%). 100% (104/104) had a ≥ 20% reduction in IOP and 86% (89/104) had IOP ≥ 6 and ≤ 18 mmHg. The mean number of medications at screening was 1.8 ± 0.9 and 0.6 ± 1.0 at month 6. AE included transient hyphema (4.6%) and IOP elevation ≥ 10 mmHg (2%). There were no AE for loss of BCVA or recurring hyphema. There were no SSI.Conclusion: Canaloplasty followed with trabeculotomy and performed concomitantly with phacoemulsification has favorable intra and perioperative safety, significantly reduces IOP and anti-glaucoma medications through 6 months in eyes with mild-moderate OAG.Keywords: viscodilation, MIGS, open-angle glaucoma, glaucoma surgery, canaloplasty, trabeculotomy, OMNI

Background Excimer laser trabeculotomy (ELT) is a minimally invasive procedure to lower the intraocular pressure (IOP) via a photo-ablative laser that is applied to the trabecular meshwork. With this procedure, it is possible to improve the outflow of the aqueous humor. Until now, a limited number of studies examining mostly relatively small sample sizes with midterm follow-up exist. We therefore present the analysis of a large ELT cohort in a long-term follow-up. Methods We recorded data from 580 patients who underwent ELT or combined ELT with cataract surgery at our institution from November 2000 until March 2011. A total of 512 patients with primary open angle glaucoma (POAG), pseudoexfoliation glaucoma (PEX), and ocular hypertension (OHT) were included in the analysis. At every follow-up examination, the usage of IOP-lowering medication and the IOP were recorded. Failure criteria were defined as the need for another surgical glaucoma procedure, when the IOP was not 21 mmHg or less and a reduction of 20% from the baseline was not achieved with (qualified success) or without (absolute success) additional medication. Statistical analysis was done using Kaplan-Meier analysis and Cox regression. Results Four hundred twenty-eight patients underwent combined cataract and ELT surgery, and 84 underwent solitary ELT surgery. After a median follow-up time of 656 days, 87% (combined surgery) and 66% (ELT) of the patients did not have to undergo another IOP-lowering intervention; 47/31% were classified as a qualified success and 31/11% as a complete success. The IOP-lowering medication, however, could not be significantly reduced within that time period. Conclusion Especially when combined with cataract surgery, ELT is a feasible minimally invasive procedure to lower the IOP on a mid- to long-term basis. Over the long term, however, IOP-lowering medication could not be reduced.

The challenges of glaucoma management are many: the disease is chronic, progressive, often asymptomatic, and very often, the quality of life and costs of treatment is unacceptable to the patient. This is true for both medical therapy and conventional glaucoma surgery. The choice of therapy, especially the transition from the former to the latter, is now being bridged by Minimally Invasive Glaucoma Surgeries (MIGS). Choosing from the several options now available in the surgical armamentarium requires a deeper understanding of the available modalities. This review aims to provide an overview of the decision-making process, keeping in mind age, type of glaucoma, life expectancy, socioeconomic status, patient expectations, and coexisting cataract.

Purpose The last decade has witnessed an unprecedented growth in glaucoma treatment options through the introduction of minimally invasive glaucoma surgeries (MIGS). The aim of the present review is to provide an understanding of the currently available MIGS and to examine what data are currently available to guide treatment choice. Design Meta-analysis and systematic review of randomized and non-randomized control trials. Methods Out of 2567 articles identified, a total of 77 articles were retained for analysis, including 28 comparative studies and 12 randomized control trials. Overall, 7570 eyes were included. When data permitted, the weighted mean difference in intraocular pressure reduction was calculated for comparison purposes. Results Weighted mean intraocular pressure reductions from all analyzed studies were: 15.3% (iStent), 29.1% (iStent inject), 36.2% (ab interno canaloplasty), 34.4% (Hydrus), 36.5% (gonioscopically-assisted transluminal trabeculotomy), 24.0% (trabectome), 25.1% (Kahook dual blade), 30.2% (Cypass), 38.8% (XEN), and 50.0% (Preserflo). Conclusions One of the advantages of the heterogenous range of available MIGS options is the chance to tailor therapy in an individualized manner. However, high-quality data are required to make this choice more than an educated guess. Overall, this review confirms the efficiency of assessed MIGS compared with standalone phacoemulsification, but it highlights that only few studies compare different MIGS techniques and even fewer assess MIGS against criterion standard treatments. Current evidence, while non-negligible, is mostly limited to heterogenous nonrandomized studies and uncontrolled retrospective comparisons, with few quality randomized control trials. We suggest that future research should be comparative and include relevant comparators, standardized to report key outcome features, long-term to assess sustainability and late complications, and ideally randomized.

Purpose To assess the comparative efficacy and the long-term cost–utility of alternative minimally invasive glaucoma surgeries (MIGSs) when combined with cataract surgery in patients with primary open-angle glaucoma (POAG). Methods Treatment effects, as measured by the 1-year reduction in intraocular pressure (IOP), were estimated with an adjusted indirect treatment comparison. Evidence from randomized clinical trials was identified for four different MIGS methods. A disease-transition model was developed by capturing clinically relevant POAG stages and the expected natural disease evolution. Outcomes of the disease-transition model were the comparative utility [quality-adjusted life years (QALYs)], cost and cost–utility of included strategies in a lifetime horizon. Results Estimated 1-year IOP reductions were: cataract surgery − 2.05 mmHg (95% CI − 3.38; − 0.72), one trabecular micro-bypass stent − 3.15 mmHg (95% CI − 5.66; − 0.64), two trabecular micro-bypass stents − 4.85 mmHg (95% CI − 7.71; − 1.99) and intracanalicular scaffold − 2.25 mmHg (95% CI − 4.87; 0.37). Discounted outcomes from the disease-transition model appraised the strategy of two trabecular micro-bypass stents with cataract surgery in the moderate POAG stage as the one providing the greatest added value, with 10,955€ per additional QALY. Improved outcomes were seen when assessing MIGS in the moderate POAG stage. Conclusions When indirectly comparing alternative MIGS methods combined with cataract surgery, the option of two trabecular micro-bypass stents showed both a superior efficacy and long-term cost–utility from a German perspective. Moreover, outcomes of the disease-transition model suggest POAG patients to beneficiate the most from an earlier intervention in the moderate stage contrary to waiting until an advanced disease is present.

Purpose To assess the efficacy and safety of the XEN Gel Stent in patients with primary open-angle glaucoma. Materials and methods Twenty eyes of 17 patients (6 males, 11 females) with primary open-angle glaucoma were implanted with XEN Gel Stent. The following data were ascertained in each participant at baseline and at 1, 3, 6, 9 and 12 months following implanting procedure: intraocular pressure, number of anti-glaucoma medications, retinal sensitivity (PS 24/2 w/w), pattern electroretinogram (ISCEV standard), as well as the number of complications. Results The mean intraocular pressure reduction in a 1-year follow-up was 18% (21.56 vs. 17.69 mmHg, p p = 0.001). The PERG parameters at baseline and at 12 months postoperatively included a stable amplitude of P50 (2.55 µV vs. 2.65 µV, p = 0.024) and N95 (3.45 µV vs. 3.38 µV, p = ns) waves. The delta N95 and delta P50 amplitudes remained stable over the follow-up period (p = ns). The mean deviation (MD) of PS 24/2 was − 6.54 dB vs. − 8.43 dB, p = ns, whereas the pattern standard deviation (PSD) was 6.18 dB vs. 6.91 dB, p = ns. Transient hypotony within the first postoperative week occurred in 18 eyes (90%), whereas hyphema occurred in two eyes (10%). Needle revision of a filtration bleb was performed in five eyes (25%). Conclusions The XEN Gel Stent enables significant reduction in intraocular pressure with very low complication rates. It ensures a stabilization of the retinal function as established with the PERG.

The availability of ab interno minimally invasive glaucoma surgery (MIGS) has promoted an international interest in this procedure. Our purpose is to define the role of MIGS in the constant evolving glaucoma treatment algorithm. Current MIGS approaches to lowering intraocular pressure (IOP) include increasing trabecular outflow (iStent trabecular microbypass stent, iStent inject, Hydrus Microstent, Kahook Dual Blade goniotomy, Trabectome ab interno trabeculectomy, Excimer laser trabeculotomy, and goniotomy-assisted transluminal trabeculotomy), increasing uveoscleral outflow with suprachoroidal shunts (Cypass microstent), and developing subconjunctival filtration (XEN gel stent and InnFocus microshunt). The efficacy of each depends on the achievement of desired target IOP reduction in a specific patient. The determination of whether a procedure is either a MIGS or minimally effective glaucoma surgery (MEGS) procedure is based on their efficacy and complications. Aqueous humor angiography suggests that success of trabecular bypass MIGS may not be patient-dependent only, but it may be affected by the location and flow of aqueous through collector channels. The future use of aqueous angiography may permit customized treatment of trabecular meshwork dependent MIGS procedures.

Background Despite the XEN gel stent low-risk profile, various complications following the implant have been described, including internal and external occlusion, with a consequent postoperative rise in intraocular pressure (IOP). In this case report we aimed to present a XEN45 stent internal occlusion successfully treated by trimming in situ its proximal end with a 25 G vitreous scissors using a bimanual technique. Case presentation A 63-year-old male patient affected by primary open angle glaucoma (IOP = 25 mmHg) and a full thickness macular hole in his right eye, underwent ab-interno Xen gel stent implantation and, 1 month later, a 25 G vitrectomy surgery. Despite a significant IOP reduction after stent implant, 6 days after vitrectomy, IOP increased (25 mmHg) and the conjunctival bleb flattened following occlusion of stent internal ostium by a clot of presumed fibrinous material. The Nd:YAG laser failed to remove the clot, so that we decided to snip a small bit of the proximal end of the Xen tube (about 0,5 mm length) with a 25 G vitreous scissors, using a bimanual technique. In the postoperative day 1 and month 1, the IOP was 8 mmHg and 12 mmHg, respectively. The Anterior Segment OCT confirmed a functional, layered, filtering bleb, and the normal appearance and patency of the XEN proximal segment. No side effects from the intervention were observed. Conclusions Ab interno trimming with vitreous scissors of the occluded proximal end of the XEN stent may represent a safe, rapid and efficient method to restore aqueous humor subconjunctival drainage.

Primary open angle glaucoma represents an eye disease that usually is associated with an increased intraocular pressure (IOP). Implants for micro-invasive glaucoma surgery (MIGS) are gaining importance as a promising option for IOP lowering. Currently available devices are implanted into the eye ab interno based on a clear corneal incision and drain aqueous humour into the schlemm’s canal, suprachoroidal or subconjunctival space. Fibrosis is known as a major limitation for long term success and often leads to the necessity of an additional medication or a surgical re-intervention. The current work focusses on the development of an antifibrotic drug-eluting coating for a minimally invasive implantable glaucoma microstent. Tubular microstent base bodies manufactured from a polycarbonate based silicone elastomer were spray-coated with a chloroform based mixture of the same polymer and the antifibrotic drug pirfenidone (PFD, P2116, Merck KGaA, Germany) in a polymer/drug ratio of 85/15% (w/w). Coating mass of 89 μg according to a drug loading of 1.96 μg mm-2 was aspired. Coating mass was measured using an ultramicrobalance (XP6U, Mettler-Toledo International, Inc., Switzerland). Glaucoma microstent prototypes with a drugeluting coating mass of (84 ± 19) μg (n = 12) were manufactured. Characterization by means of scanning electron microscopy (Quattro S, Thermo Fisher Scientific, FEI Deutschland GmbH, Germany) yielded a reproducible smooth surface of the coating. High performance liquid chromatography (KNAUER Wissenschaftliche Geräte GmbH, Germany) was used for analysis of drug release behaviour in 0.9% NaCl solution at 37°C. The in vitro PFDrelease is characterized by an initial burst phase of approximately 6 h followed by a more retarded release phase. The entire drug was released within 36 h (n = 3). Sterilization processing has a minor impact on drug release kinetics. Appropriate drug stability after sterilization could be proven. Future studies will focus on the antifibrotic properties of drug-eluting glaucoma microstents in animal studies.

Precis: This study confirms the safety and efficacy of XEN gel stents in the management of pseudoexfoliative glaucoma 2 years after implantation, with success rates similar to primary open-angle glaucoma regardless of the definition of success. Purpose: To compare the long-term safety and efficacy of XEN gel implant surgery (Allergan Inc., Irvine, CA) in patients with pseudoexfoliative glaucoma (PEXG) and primary open-angle glaucoma (POAG). Setting: Prospective, interventional study in a tertiary glaucoma center. Methods: A total of 110 eyes of 85 patients with POAG (57 eyes) or PEXG (53 eyes) and uncontrolled intraocular pressure (IOP) despite medical treatment underwent combined XEN+cataract surgery or standalone XEN surgery. Mean IOP, mean number of medications, needling rates, and incidence of adverse effects were compared between the 2 groups. Complete surgical success was defined as an unmedicated IOP

Colin I Clement,1–4 Frank Howes,5 Alexandros S Ioannidis,6 Michael Shiu,7 David Manning8 1Eye Associates, Sydney, NSW, Australia; 2Fairfield Eye Surgery, Fairfield, NSW, Australia; 3Glaucoma Unit, Sydney Eye Hospital, Sydney, NSW, Australia; 4Discipline of Ophthalmology, The University of Sydney, Sydney, NSW, Australia; 5Eye & Laser Centre Gold Coast, Southport, QLD, Australia; 6Vision Eye Institute, Melbourne, VIC, Australia; 7Laser Sight Laser Cataract & Lens Specialists, Sydney, NSW, Australia; 8Hunter Cataract & Eye Centre, Sydney, NSW, Australia Purpose: To assess the utility and safety of implanting two second-generation trabecular micro-bypass stents following cataract surgery in eyes with mild to advanced glaucoma or ocular hypertension (OHT). Patients and methods: Retrospective study of iStent®inject trabecular micro-bypass implantation with cataract surgery by five surgeons at five sites in Australia. Eyes had mild to advanced glaucoma (predominantly primary open-angle, appositional angle-closure, or pseudoexfoliative glaucoma) or OHT and cataract requiring surgery. Effectiveness measures included intraocular pressure (IOP); medication burden; and proportions of eyes with no medications, ≥2 medications, stable or decreased medications vs preoperative, and IOP ≤18 mmHg. Safety measures included visual acuity, cup-to-disc ratio (CDR), visual field (VF), complications, adverse events, and secondary surgical interventions. Patients have been followed for 12 months, and follow-up is ongoing. Results: Of the 290 total eyes that underwent surgery, 165 eyes had 12-month outcomes at the time of data collection and are included in this report. In these eyes, mean Month 12 IOP reduced by 23.2% from 18.27±5.41 mmHg preoperatively to 14.04±2.98 mmHg (P

Background: Glaucoma surgery has significantly evolved over the last years. This paper aims to evaluate the midterm clinical outcomes of the XEN63 device in a real-world scenario. Methods: A retrospective clinical study was conducted on consecutive patients who underwent an XEN63 implant insertion, either alone or in combination with phacoemulsification. The primary endpoint was the mean intraocular pressure (IOP) at the month 18 visit. Results: Twenty-three eyes (23 patients) were included in the analysis. The preoperative IOP was significantly lowered from 27.0 ± 7.8 mmHg to 14.1 ± 3.4 mmHg at month 18 (p < 0.0001). At month 18, 14 (77.8%) and 11 (61.1%) eyes had an IOP ≤ 16 mmHg and ≤ 14 mmHg, respectively, without ocular hypotensive medication. The mean number of ocular hypotensive medication taken was significantly reduced from 2.3 ± 0.9 drugs at baseline to 1.0 ± 1.4 drugs at month 18 (p = 0.0020). Four (17.4%) eyes had hypotony at postoperative day 1, which was successfully resolved without sequelae. Four (17.4%) eyes underwent a needling procedure and four (17.4%) eyes underwent additional surgeries. Conclusions: The XEN63, either alone or in combination with cataract surgery, significantly lowered the IOP and reduced the need for ocular hypotensive drugs over a period of 18 months.

Purpose To describe the effectiveness of the XEN® 63 gel stent in a refractory uveitic glaucoma after failure of an Ahmed Glaucoma Valve. Case description We report the case of a 54-year-old man with a history of uveitic glaucoma on his left eye due to Fuchs heterochromic iridocyclitis and neovascular glaucoma after a central retinal vein occlusion. Pre-operative intraocular pressure was 30 mmHg despite a QD (once-daily) dosed bimatoprost 0.3 mg and timolol 5 mg topical medication. At week 1, the eye exam showed an intraocular pressure of 6 mmHg with a well-formed bleb, a very mild hyphema and a localized choroidal detachment. At month 1, intraocular pressure was 14 mmHg with a formed bleb. Both hyphema and choroidal detachments had resolved. After a year, intraocular pressure was 16 mmHg without any medication and the bleb was still well-formed. Conclusion The XEN® 63 gel stent provides a good intraocular pressure reduction and can be an efficient alternative for tube and filtration surgery in refractory glaucoma. Its long-term effectiveness needs to be evaluated.

Mark J Gallardo,1,2 Richard A Supnet,1 Iqbal Ike K Ahmed3 1El Paso Eye Surgeons, PA, El Paso, TX, USA; 2Department of Ophthalmology, University of Texas Health Sciences Center in San Antonio, San Antonio, TX, USA; 3Department of Ophthalmology and Vision Sciences, University of Toronto, Toronto, ON, Canada Purpose: To compare the efficacy of minimally invasive ab-interno canaloplasty (ABiC) vs ab-externo canaloplasty (CP) in reducing intraocular pressure (IOP) and glaucoma medication dependence.Patients and methods: This nonrandomized, retrospective, single-center, paired eye study assessed the 12-month outcomes of 12 patients with primary open-angle glaucoma who underwent ABiC in one eye and CP in the other eye, either as stand-alone procedures or combined with cataract extraction. Primary endpoints included mean IOP and number of glaucoma medications at 12 months postoperative. Secondary endpoints included surgical complications and secondary interventions.Results: Four males and eight females with a mean age of 73.8±12.6 years were included. In the CP group, the mean preoperative IOP was 18.1±3.9 mmHg on 2.4±0.5 medications, which reduced to 13.5±2.2 mmHg (P

Ayesha Karimi, Dan Lindfield Department of Ophthalmology, Royal Surrey County Hospital, Guildford, UK Purpose: To assess whether a first day review is needed following Xen surgery in glaucoma patients. Patients and methods: We performed a retrospective case note review of all Xen surgeries performed across four centers between August 2015 and May 2017. Intraocular pressure (IOP), number of medications, complications, and all further procedures were recorded. Results: Two hundred and fifty-nine cases from 226 patients were analyzed, 78 of 259 cases (30.1%) had numerical hypotony (

The hazy corneal donor-recipient interface after corneal transplant may cause difficulties when implanting the XEN gel stent via ab-interno approach. We aim to describe XEN gel stent implantation via ab-externo approach in refractory steroid-induced glaucoma after corneal lamellar keratoplasty. Under local anaesthesia, the XEN injector needle was inserted 7 mm behind the limbus with the bevel facing up, directly beneath the conjunctiva and advanced to the marked 2.5 mm scleral entry wound. The needle then pierced the sclera until the needle tip was just visible in the anterior chamber (AC). The slider was pushed until the tip of the XEN stent was seen in the AC. The needle was slowly withdrawn while still pushing the slider to complete stent deployment. Subconjunctival Mitomycin C 0.01% (30 µg/0.3 mL) was then injected posterior to the bleb. Three eyes of three patients with steroid-induced glaucoma after lamellar keratoplasty underwent XEN gel stent implantation via ab-externo approach placed at the superotemporal quadrant. Pre-operatively, all patients had uncontrolled IOP between 30-45 mmHg despite maximum medications and selective laser trabeculoplasty. After XEN gel stent implantation, IOP ranged between 10-17 mmHg with one or two topical antiglaucoma at 12 months. Complications include hypotony maculopathy, stent migration and hyphaema, all of which were successfully managed. Corneal graft remained clear at 12 months. XEN gel stent implantation via ab-externo approach is able to achieve good intraocular pressure (IOP) control without compromising cornea graft in patients with steroid-induced glaucoma after lamellar keratoplasty at 12 months.

To assess the efficacy of all forms of ropivacaine administration for the management of pain and opioid use, specifically in patients undergoing laparoscopic hysterectomy. We searched PubMed, Cochrane CENTRAL, Web of Science, and SCOPUS for relevant clinical trials matching our eligibility criteria. Outcomes of interest included: Pain intensity (measured either by visual analog scale score or by numerical rating scale score), QoR-40 score (Overall quality of recovery tool, designed to measure physical comfort, physical independence, pain, emotional status, and need for support), and the need for opioid rescue. We performed the analysis under the fixed-effects model for homogeneous data and random-effects model for heterogeneous data. Most heterogeneous data were solved by the leave-one-out method, in cases where this was not successful, we then proceeded to conduct at least one subgroup meta-analysis in an attempt to solve heterogeneity. We assessed the risk of bias using Cochrane's risk of bias tool. A total of five clinical trials were included. Regarding the pain score, there was no significant difference between either group [standardized mean difference=-0.17, 95% confidence interval (CI): (-0.56, 0.23); p=0.41]. The analysis of the overall RoQ40 scores favored the ropivacaine group over the control group significantly [mean difference (MD)=17.68, 95% CI: (1.48, 33.87); p

Background/Aims Surgical procedures in ophthalmology underlie variations over different time periods and are strongly dependent on the technical process and the invention of innovative surgical techniques. Especially, in glaucoma surgery a lot of surgical devices and techniques have been introduced during the last years. Until now, the use of these newer techniques has not been shown on a robust data basis. We herein present the numbers of different types of glaucoma surgeries performed at German hospitals between 2006 and 2018. Methods and Design The quality reports of hospitals in Germany from 2006 to 2018 were analyzed concerning all procedural codes for glaucoma surgery and intervention. Especially, the change in usage of “classical” and “modern” surgical techniques (MIGS: “minimally invasive glaucoma surgery”) or devices was compared. Results The number of glaucoma procedures performed increased by 75% from 27,811 in 2006 to 48,794 in 2018. Absolute numbers of trabeculectomies, goniotomies, ab externo trabeculotomies and to a certain level cyclodestructive procedures decreased during the examined years while use of MIGS has increased in absolute and relative numbers since 2012. From 2015 a strong increase in the usage of XEN implants could be seen. Drainage implants (such as Baerveldt/Ahmed) showed stable absolute numbers over the time period covered. Absolute numbers of laser trabeculoplasty peaked in 2014 and decreased afterwards. Iridotomies and iridectomies increased by 120%/248% over the whole period. Conclusion Our data show a trend towards the modern surgical options and especially MIGS during the recent years. Classical procedures showed a decrease in total numbers emphasized from 2013. These numbers confirm the assumption that modern glaucoma surgery is becoming more and more popular and established in German hospitals.

Purpose: To report a case of fully dislocated XEN Gel Implant device into the anterior chamber, 18 months after its implantation and its impact on endothelial cell density. Result: A 75-year-old man with a history of multiple glaucoma surgeries during the last three years presented with an entirely dislocated XEN Gel implant into the anterior chamber. An endothelial cell density reduction was observed over 18 months. Thus, the implant was removed. In the short-term after surgery, the endothelial cell loss rate reduced. Conclusion: XEN Gel Implant can dislocate into the anterior chamber, increasing endothelial cell loss in an eye already underwent multiple surgical procedures with subsequent adverse events. Therefore, if the implant seems displaced, the endothelial cell density should be monitored, and the length of the free-tube segment within the anterior chamber should be measured, during the patient’s follow-up.

Background The aim of this retrospective study was to compare the efficacy and safety profile of a single XEN-microstent in different types of primary and secondary open angle glaucoma. Methods A single XEN microstent was implanted in patients with primary open-angle glaucoma (POAG), normal-tension glaucoma (NTG), pseudoexfoliation glaucoma (PEX) and secondary glaucoma (Sec.Gl). The intraocular pressure (IOP), the active substances of the applied IOP-lowering drugs, the best corrected visual acuity (BCVA) and the mean deviation (MD) of the perimetry were measured at baseline and at regular follow-ups, scheduled at 2 days and 1, 3, 6 and 12 months after surgery. Results 153 eyes were included in this analysis. 113 eyes were affected by POAG (74%), 5 eyes by NTG (3%), 22 eyes by PEX (14%) and 13 eyes by Sec.Gl (9%). Mean IOP decreased in all treatment groups during the 12 months of follow-up (complete group: 23.9±7.4 to 15.4±5.1 mmHg (pConclusion As in eyes suffering from POAG, IOP and number of IOP-lowering drugs applied can be effectively reduced by XEN implantation in eyes suffering from NTG, PEX and secondary glaucoma while leaving BCVA and visual field unchanged. Trial registration Trial was registered at DRKS (registration number: DRKS00020800, Registered 25.February 2020 - Retrospectively registered, https://www.drks.de/drks_web/navigate.do?navigationId=trial.HTML&TRIAL_ID=DRKS00020800)

PURPOSE: To assess the 3-year effectiveness and safety of the XEN gel stent implanted ab interno in open-angle glaucoma (OAG). METHODS: This study was a multicentre, retrospective chart review of consecutive patients with OAG who underwent ab-interno gel stent placement alone or combined with phacoemulsification between 1 January 2014 and 1 October 2015. Outcome measures included mean changes in intraocular pressure (IOP) and IOP-lowering medication count from medicated baseline at 1, 2, 3 (primary outcome) and 4 years (if available) postimplantation. Intraoperative complications, adverse events of special interest (AESIs) and secondary surgical interventions (SSIs) were recorded. RESULTS: The safety and effectiveness populations included 212 eyes (primary and secondary) and 174 eyes (primary), respectively. Mean IOP and medication decreased from 20.7 mmHg and 2.5 at baseline (n = 163 primary/first implanted eyes) to 13.9 mmHg and 1.1 medications (n = 76) at 3 years postimplantation, respectively. Mean changes from baseline in IOP (-5.6, -6.2 and -6.6 mmHg) and IOP-lowering medication count (-1.8, -1.6 and -1.4) were statistically significant at 1, 2 and 3 years postimplantation, respectively. Results appeared comparable when implantation was performed with (n = 76) or without (n = 98) phacoemulsification. In primary eyes with 4-year IOP and medication count data (n = 27), mean IOP was 14.0 mmHg on 1.3 medications at 4 years postimplantation. Fifteen (7.1%) eyes had intraoperative complications, 31 (14.6%) experienced 46 postoperative AESIs, and 26 (12.3%) required SSI. CONCLUSION: The gel stent effectively lowered IOP and IOP-lowering medication count over 3 years, with a predictable and acceptable safety profile, when implanted via the traditional ab-interno technique. ispartof: ACTA OPHTHALMOLOGICA vol:100 issue:1 pages:E233-E245 ispartof: location:England status: published

Purpose: Preserflo MicroShunt is a minimally-invasive glaucoma drainage micro-tube used to shunt aqueous humor from the anterior chamber to the subtenon space. The safety of the procedure was considered satisfactory with a majority of minor side effects. Observation: We describe the 5 year endothelial cell loss after Preserflo implantation in 2 primary open angle glaucoma patients. The case 1 presented a device-cornea touch after a backward migration of the device. The case 2 presented a modified aspect of the device compatible with an inflammatory reaction. Both cases were explanted. Conclusion: As described in Ahmed glaucoma valve, Xen gel stent and Cypass, Preserflo MicroShunt can lead to endothelial cell loss in some cases. A long-term prospective study with pre and postoperative endothelial cell count and AS-OCT or UBM evaluation of the device positioning would be of great interest to assess the real impact of Preserflo MicroShunt and risk factors for endothelial cell loss.

Glaucoma management has changed dramatically over the last decades, through clinical advances and technological revolutions. This review discusses the latest innovations and challenges faced in the field around three major axes: minimally-invasive glaucoma surgery (MIGS), implantable sensors and injectable therapeutics. Indeed, the vast number of recently developed MIGS techniques has not only provided clinicians with a wide range of therapeutic options, but they have also enabled them to adjust their therapies more finely which may have contributed a more patient-centric decision-making process. Yet, despite considerable advances in the field, the wide heterogeneity in clinical trial designs blurs the surgical outcomes, specificities and indications. Thus, more high-quality data are required to make the choice of a specific MIGS procedure more than an educated guess. Beyond the scope of MIGS, the potential of IOP telemetry for self-assessment of IOP-control through implantable sensors is developing into a real option for clinicians and an empowering opportunity for patients. Indeed, providing patients with direct feedback enables them to take control and have a clearer representation of their care, in turn leading to a better control of the disease. However, there are potential issues with self-monitoring of IOP, such as increased anxiety levels induced by measured IOP fluctuations and peaks, leading to patients self-treating during IOP spikes and additional office visits. Furthermore, the advent of implantable therapeutics may soon provide yet another step towards personalized glaucoma treatment, by offering not only an efficient alternative to current treatments, but also a therapeutic option that may better adapt to patients’ lifestyle. After several decades of relative stagnation through the last century, glaucoma has now entered what many view as a golden age for the specialty. Like every revolution, this one brings its fair share of uncertainty, clinical questioning and uneasy periods of adaptation to ever-changing expectations. Yet, while it is impossible to guess what the landscape of glaucoma surgery will be like in ten or fifteen years, data suggest a bright outlook both for patients and clinicians. Keywords: Glaucoma; MIGS; Quality of Life; Telemetry; Eyemate; Bimatoprost SR

Purpose Efficacy and safety evaluation of Kahook Dual Blade (KDB) goniotomy vs iStent inject implantation. Materials and Methods Retrospective study in patients that underwent goniotomy with KDB or iStent inject implantation, stand-alone or combined with cataract surgery. Main outcome parameters were intraocular pressure (IOP), number of glaucoma medications, proportion of eyes achieving >20% IOP reduction and number of eyes with postoperative IOP

Purpose: To evaluate the 3-year treatment outcomes of XEN 45 gel stent in open-angle glaucoma patients. Methods: In this prospective, single-centre interventional study, consecutive eyes with uncontrolled intraocular pressure (IOP) or signs of disease progression despite medical treatment underwent XEN implantation either alone or combined with phacoemulsification (Phaco + XEN). Main outcome measures: Surgical success was defined as 'complete' when 36-month unmedicated IOP was ≤15 mmHg with a relative IOP reduction ≥ 20% from medicated baseline, while the definition of qualified success allowed no more medications than at baseline. Other definitions of success with different IOP thresholds were also analysed. Secondary outcomes included mean IOP reduction, changes in ocular hypotensive medications and rates of reoperations. Results: Out of 149 eyes initially included, 92 eyes (61.7%) of 68 patients had complete 3-year data (XEN: n = 26; Phaco + XEN: n = 66) after 38.2% were lost to follow-up. Mean age was 76.3 ± 9.1 years, and 66.2% were female. Mean medicated IOP decreased from 20.8 ± 7.4 mmHg (21.0 ± 7.4 [XEN] vs. 20.0 ± 6.9 mmHg [Phaco + XEN]) at baseline to 13.1 ± 3.4 mmHg (12.9 ± 2.9 [XEN] vs. 12.9 ± 3.4 [Phaco + XEN]) at 3 years (-37.0%; p < 0.001). Medications decreased from 1.9 ± 1.3 (2.4 ± 1.5 [XEN] vs. 1.9 ± 1.2 [Phaco + XEN]) to 0.4 ± 0.9 (0.3 ± 0.8 [XEN] vs. 0.5 ± 0.9 [Phaco + XEN]) (-78.9%; p < 0.001). Complete success and qualified success were achieved in 29.0% and 31.0% of eyes, respectively. Needling revision was performed in 51 eyes (55.4%), and 26.1% underwent reoperations. Risk factors for surgical failure included male gender (odds ratio [OR]:3.6; p = 0.03), diagnosis of POAG (OR: 4.5; p < 0.01) and undergoing needling revision (OR: 4.6; p < 0.01). While the type of procedure had no effect on the outcomes of PEXG, POAG eyes undergoing combined surgery had significantly higher rates of failure (OR: 7.29; p = 0.023). Most patients stable at 12-month remained so through to 3 years. Conclusions: At 3 years, XEN gel stent implantation achieved clinically significant IOP and medication reduction despite relatively high rates of needling and reoperations. Identifying patients at risk preoperatively may help optimize surgical outcomes.

Introduction This study sought to assess ocular surface disease changes following cataract surgery combined with trabecular micro-bypass stent(s) implantation (iStent or iStent inject). Methods This prospective interventional single-arm clinical trial enrolled 47 eyes with mild-to-moderate open-angle glaucoma (OAG) on 1–4 glaucoma medications who underwent phacoemulsification and trabecular micro-bypass stent(s) implantation. Key glaucoma and ocular surface data through 3 months postoperatively included the Ocular Surface Disease Index score (OSDI), corneal/conjunctival staining (Oxford Schema), fluorescein tear break-up time (FTBUT), conjunctival hyperemia (Efron Scale), glaucoma medications, and intraocular pressure (IOP). Results Mean OSDI scores improved from 40.1 ± 21.6 (severe) preoperatively to 17.5 ± 15.3 (mild) at 3 months (p

Purpose Minimally invasive glaucoma surgery (MIGS) devices that drain into the subconjunctival space can be inserted via an ab externo or ab interno approach. Limited experimental data exists as to the impact of either technique on intraocular pressure (IOP) control. We performed microfluidic studies by using ex vivo rabbit eyes to assess the effect of each approach on outflow resistance of a subconjunctival drainage device for IOP control. Methods A microfluidic experiment system was designed, consisting of a controlled reservoir of water connected to a pressure pump/flow sensor. The flow rate of water was fixed at 2 μl/min to simulate aqueous humor production. The pressure readings for each approach were recorded at a frequency of 1 Hz. A baseline reading was made before tube insertion into the eye (PEEK tube length set to aim for an initial outflow resistance of 5 to 10 mm Hg/μL/min) followed by measurements for a cumulative 2-ml volume entering the subconjunctival space. Results were adjusted for water viscosity at 37°C and reported as outflow resistance (mm Hg/μL/min ± standard error of mean). Results Outflow resistance via the ab interno approach was 90.4% higher than with the ab externo approach being measured at 0.80 ± 0.11 mm Hg/μL/min and 0.42 ± 0.05 mm Hg/μL/min, respectively. Bleb formation was observed to be less predictable with the ab interno approach. Conclusions The ab interno approach demonstrated greater outflow resistance and less predictable bleb formation than the ab externo approach. These results have implications for long-term IOP control and success depending on the approach to device insertion and could be an important consideration for future MIGS devices. Translational Relevance The effect of the ab interno versus ab externo approach of a MIGS device inserted into the subconjunctival space was assessed. The ab interno approach demonstrated greater outflow resistance and less predictable bleb formation that may have implications for the development of future MIGS devices.

Purpose Evaluation of 1-year-outcome of XEN 45 gel stent surgery in a Swedish cohort with regard to clinical success, complications, and learning curve. Patients and Methods This was a retrospective study of glaucoma patients undergoing glaucoma XEN-stent surgery alone or combined with phacoemulsification between December 2015 and May 2017. Intraocular pressure (IOP), number of medical agents, and adverse events were assessed. Clinical success rate was defined as achieving individual target pressure with/without medication. Results A total of 113 eyes were included in the final statistics. Mean age was 70.8±11.8 years. Primary open angle glaucoma (POAG) accounted for 46.9% and exfoliative glaucoma (PEXG) for 40.7%. Mean preoperative IOP was 23.8±6.2 mmHg and mean number of agents 3.4. After 1 year, mean IOP was reduced to 16.1±4.7 mmHg and medication to 1.34 substances on average. Failure rate at 1-year follow-up was 34% with no significant difference between POAG and PEXG. There was a trend of higher success rate for combined cases (P=0.116). Stents with malpositioned or curved appearance had significantly worse outcome. The failure rate of the most productive surgeon dropped from 33% to 10% from the first implantations. Temporary hypotony (19.5%) and choroidal detachment (9.7%) were the most common complications. Blockage of the inner stent lumen was common (8.8%), with a high proportion of failure. Conclusion XEN-stent surgery is a surgical option in uncontrolled glaucoma in both POAG and PEXG. A XEN-stent can reduce both IOP and the number of antiglaucoma medications needed. The learning curve is significant and stent positioning is crucial for optimal results. Combined XEN-cataract surgery is not inferior to stand-alone procedures. The long-time effectiveness is still to be proven.

Background Excimer laser trabeculostomy (ELT) is a microinvasive glaucoma surgery (MIGS) that creates multiple laser channels through the trabecular meshwork using a cold laser system, which minimizes tissue fibrosis and aids in bypassing the main area of resistance to aqueous outflow. The purpose of this review is to evaluate the current body of evidence surrounding ELT in terms of efficacy and review the safety profile of the procedure. Main text Studies screened had to show clear inclusion and exclusion criteria as well as well-defined outcome measures. PubMed, MEDLINE, EMBASE and the Cochrane Controlled Trial Database were searched. Preferred Reporting Items of Systematic Reviews (PRISMA) guidelines were used to assess for study quality and for any bias. Sixty-four articles were initially identified with 18 meeting preliminary screening criteria. Ultimately, 8 studies met inclusion criteria and 2 additional non-referenced publications were also included: 1 randomized control trial, 4 prospective case series and 5 retrospective studies. Overall studies showed moderate intraocular pressure (IOP) lowering of between 20% and 40% from baseline without medication washout and mostly a decrease in glaucoma medications with few complications. Conclusion Current literature shows a significant IOP-lowering effect of ELT with a favorable safety-profile in standalone cases or combined with cataract surgery. Limitations to these studies are the lack of controls and washout IOP. Overall, ELT is an attractive MIGS option that does not require any residual device remaining in the angle.

Purpose To evaluate reduction in intraocular pressure (IOP) and medications for open-angle glaucoma (OAG) patients 12 months post-ab -interno circumferential viscodilation (VISCO360, Sight Sciences, Menlo Park, CA) in conjunction with cataract surgery. Setting Surgical center (New York, United States). Design Retrospective study of all OAG patients treated with 360-degree ab-interno viscodilation with cataract surgery by a single surgeon (NR) having 12 months of follow-up. Eyes were stratified by baseline IOP. Group 1: ≥18 mmHg (n=111). Group 2: 10 mmHg >30 days post-op 1.1%, mild inflammation

Purpose To investigate the long-term safety and efficacy of an iStent trabecular microbypass stent in combination with cataract surgery in eyes with primary open-angle glaucoma (POAG). Setting Private practice; Sioux Falls, South Dakota. Design Retrospective, consecutive case series. Methods This case series included eyes implanted with a single trabecular microbypass stent in combination with phacoemulsification in patients with mild to severe POAG. Data were collected preoperatively and at day 1, week 1, month 1, and up to 6 years postoperatively. Primary outcome measures included mean intraocular pressure (IOP) and number of glaucoma medications. Safety was noted by assessing the incidence of IOP spikes and need for additional surgery. Results The study comprised 411 eyes. Mean IOP was reduced to 14.9±4.2 mmHg compared to 18.8±5.6 mmHg at baseline at 6 years postoperative. The mean number of medications was reduced to 1.2±1.0 from 1.4±1.1 at baseline. In eyes with severe stage of disease, there was a mean IOP reduction >6 mmHg at 6 years postoperative. Eyes with baseline IOP ≥18 mmHg achieved a more robust reduction in IOP. Fifteen eyes underwent a secondary glaucoma procedure. There were no intra- or postoperative complications. Conclusion Trabecular microbypass stent implantation in combination with cataract surgery provides a sustained IOP reduction in eyes with mild-to-severe POAG. The degree of IOP reduction was more significant in eyes with higher baseline IOP and severe stage of disease.

Background XEN® gel stent (Allergan, Dublin/Republic of Ireland) is a relatively new microinvasive glaucoma device providing an ab-interno approach to the subconjunctival space for aqueous drainage and reduction of intraocular pressure. It is thought to be less invasive, reduce surgical time and post-operative infection rates compared with traditional glaucoma procedures. Little information however, has been published regarding complications and subsequent management. Case presentation The authors highlight five complicated cases of XEN® stent insertion, how they were managed and key learning points. Cases include: entire stent found at the bottom of the anterior chamber several months after uncomplicated insertion, stent broke into multiple pieces during manipulation within subconjunctiva, XEN45 stent migrated into the anterior chamber 7 months post-operatively and a case of limbal-based conjunctival dissection during open revision which lead to additional scarring around the stent and subsequent raised intraocular pressure. Conclusions We present some new and interesting complications of XEN implant as well as potential management options. This can assist clinical decision-making and enable better pre-operative discussions with patients regarding risks of surgery.

Background The placement of a XEN gel stent is an ab-interno, minimally invasive glaucoma surgery which provides a subconjunctival drainage pathway and decreases intraocular pressure (IOP). Case presentation A 75-year-old male patient who had undergone XEN45 gel implantation after phacoemulsification and intraocular lens implantation appealed to the clinic. A filtration bleb was seen that extended through the nasal 180 degrees of the eye which caused ectropion of the lower eyelid. The value of the IOP was 12 mm Hg (mmHg). By the “Drainage Channel with Sutures” method this complication was effectively treated. As with every new method, there is a lack of knowledge about long-term outcomes in terms of effectiveness, technique and complications. Conclusion The “Drainage Channel with Sutures” method has not been described in the literature yet. By this minimal invasive method, hypertrophic bleb complication of XEN gel implant has been successfully treated.

Glaucoma is a common blinding disease; while there is no cure, effective treatments include medications, laser, and incisional surgery. There is significant interest from patients and doctors to develop safer surgical options throughout the spectrum of disease, to minimize treatment burden in mild glaucoma patients and to minimize risk of complications in patients needing more aggressive treatment. Surgical procedures called Minimally or Micro-Invasive Glaucoma Surgery (MIGS) are growing in popularity. Eighty-seven prospective studies on MIGS were identified and assessed for quality. Most (74%) did not have a control group. Twelve of the highest quality were reviewed. MIGS procedures appeared to have fewer complications, and lowered intraocular pressure, and reduced medication use. Studies were limited by small sample size, narrow spectrum of glaucomatous disease, and/or conflicts of interest. There is a need for high quality, independently funded and performed, comparative studies on the MIGS to help make treatment decisions.

A De Gregorio,1 E Pedrotti,2 G Stevan,1 A Bertoncello,1 S Morselli1 1Ophthalmic Unit, San Bassiano Hospital, Bassano del Grappa, Italy; 2Eye Clinic, Department of Neuroscience, Biomedicine and Movement Sciences, University of Verona, Verona, Italy Abstract: The recent development of new devices that are significantly less invasive, collectively termed minimally invasive glaucoma surgery, offers new perspective of intraocular pressure reduction with less risk, short operating times, and rapid recovery. The aim of this work is to provide a panoramic review of the currently published clinical data to assess the potential role of XEN gel stent (Allergan PLC, Irvine, CA, USA) in the management of glaucoma, which is the only filtering minimally invasive glaucoma surgery device that allows the subconjunctival filtration. The ab interno placement of the XEN gel stent offers an alternative for lowering intraocular pressure in refractory glaucoma as a final step, and in patients intolerant to medical therapy as an early surgical approach with minimum conjunctival tissue disruption, restricted flow to avoid hypotony, and long-term safety. Keywords: glaucoma, gel stent, minimally invasive, surgery, subconjunctival drainage

Aim The aim of this study is to report cyclodialysis cleft creation during Kahook dual blade (KDB) goniotomy. Background No known reports of cyclodialysis clefts have been published to the authors' knowledge after KDB goniotomy. Case description A 55-year-old myopic male with primary open angle glaucoma in both eyes (OU) underwent routine cataract extraction and intraocular lens implant with KDB goniotomy in the right eye (OD). Preoperative intraocular pressures (IOP) OD were in the low 20 mm Hg range on timolol and bimatoprost. Postoperative IOP was 4 mm Hg, with a moderate depth anterior chamber. Gonioscopy was slit in all quadrants, with no structures visible, and no improvement on indentation. Mild macular choroidal folds were present OD. Ultrasound biomicroscopy (UBM) revealed an area of supraciliary fluid. Anterior chamber reformation with viscoelastic was performed and repeat gonioscopy revealed a cyclodialysis cleft from 2:00 to 3:00. Treatment with multiple sessions of argon laser photocoagulation successfully closed the cleft. Conclusion KDB goniotomy may be complicated by cyclodialysis cleft formation and hypotony maculopathy. Visualization of a cleft on gonioscopy may require anterior chamber reformation. Clinical significance With an increasing use of KDB for goniotomy, previously unreported complications may arise including cyclodialysis cleft and resultant hypotony maculopathy. Because cleft following KDB goniotomy is rare, suspicion may be low and diagnosis could be delayed in the setting of postoperative hypotony with closed angles. How to cite this article Shue A, Levine RM, et al. Cyclodialysis Cleft Associated with Kahook Dual Blade Goniotomy. J Curr Glaucoma Pract 2019;13(2):74-76.

Purpose To report on the implantation of a XEN 45 gel implant in a patient with glaucoma associated with congenital aniridia. Observations A 60-year old man with familial congenital aniridia and glaucoma presented with intraocular pressure of 30 mmHg in his right eye despite maximal topical treatment with four medications. Implantation of a XEN gel stent was performed without complications after subconjunctival injection of mitomycin-C (0.1 mL of 0.02%). At the two-year follow-up, the patient's intraocular pressure was 12 mmHg with one topical medication. No needling of the filtering bleb was required. No excessive fibrosis of the conjunctiva or worsening of the existing keratopathy was noted. Conclusions The XEN 45 implant could be an option in the treatment of aniridia-associated glaucoma.

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.

David F Chang,1 Eric D Donnenfeld,2 L Jay Katz,3 Lilit Voskanyan,4 Iqbal Ike K Ahmed,5 Thomas W Samuelson,6 Jane Ellen Giamporcaro,7 Dana M Hornbeak,7 Kerry D Solomon8 1Altos Eye Physicians, Los Altos, CA, 2Ophthalmic Consultants of Long Island, Rockville Centre, NY, 3Department of Ophthalmology, Wills Eye Hospital, Jefferson Medical College, Philadelphia, PA, USA; 4S.V. Malayan Ophthalmology Centre, Yerevan, Armenia; 5Department of Ophthalmology and Vision Sciences, University of Toronto, Toronto, ON, Canada; 6Minnesota Eye Consultants, Minneapolis, MN, 7Glaukos Corporation, San Clemente, CA, 8Carolina Eyecare Physicians, Mount Pleasant, SC, USA Purpose: To evaluate the long-term intraocular pressure (IOP)-lowering effect and safety parameters following treatment with two trabecular micro-bypass stents and topical prostaglandin in phakic eyes with open-angle glaucoma (OAG) not controlled on two preoperative medications. Methods: This prospective, single-arm, unmasked study enrolled 39 qualified phakic eyes with OAG not controlled on 2 medications, preoperative medicated IOP of 18–30 mmHg, and IOP following medication washout of 22–38 mmHg. Two trabecular micro-bypass stents were implanted as a standalone procedure, and travoprost was started on postoperative day 1. Evaluations included IOP, best-corrected visual acuity, medication use, fundus and slit-lamp examinations, visual field, cup:disc ratio, central corneal thickness, and ocular complications. Data through 18 months were summarized previously. Thirty-seven of the original 39 subjects have been followed for 3 years postoperatively; follow-up is continuing for 5 years. Results: At 3 years postoperative, 97% of eyes had achieved an IOP reduction of ≥20% from baseline with a reduction of 1 medication. Eighty-six percent of eyes had IOP of ≤18 mmHg with a reduction of 1 medication. Mean medicated IOP decreased to 14.0±2.6 mmHg on 1 medication versus 22.4±2.3 mmHg on 2 medications preoperatively. The mean unmedicated IOP decreased to 17.7±1.7 mmHg at 37 months from 25.3±1.9 mmHg preoperatively. Long-term postoperative adverse events included cataract surgery in 3 eyes due to cataract progression, and trabeculectomy in 1 eye due to uncontrolled IOP of 23 mmHg. No intraoperative or device-related adverse events occurred. Conclusion: Significant and sustained reduction in IOP and medications with a favorable safety profile was shown through 3 years after implantation of 2 trabecular micro-bypass stents combined with postoperative travoprost in phakic OAG eyes uncontrolled on 2 preoperative medications. These findings demonstrate the long-term performance and safety of trabecular bypass stents in combination with topical prostaglandin for OAG patients. Keywords: glaucoma, trabecular micro-bypass, MIGS, IOP, medication