CyPass Micro-Stent Research Articles

Corneal endothelial safety profile in minimally invasive glaucoma surgery.

To compare 5-year corneal endothelial safety of 3 minimally invasive glaucoma surgery (MIGS) devices (iStent inject , Hydrus Microstent, CyPass Micro-Stent). U.S. multicenter trials. Post hoc 5-year analysis from prospective randomized single-masked pivotal trials. Mild to moderate open-angle glaucoma subjects received a MIGS implant with phacoemulsification (implant + phaco) or phaco alone (control). In addition, 5-year end points comparing the implant and control groups included proportion of eyes with significant endothelial cell loss (ECL) (>30% or ≥30% vs baseline) and mean endothelial cell density (ECD). Comparable proportions of eyes in the iStent inject + phaco and control groups had significant 60-month ECL (9.4% vs 6.3%, respectively, diff: 3.2%, 95% CI, -5.0% to 11.3%, P = .77). Hydrus (20.8% vs 10.6%, diff: 10.2%, 95% CI, 3.2% to 17.2%, P = .01) and CyPass (27.2% vs 10.0%, diff: 17.2%, 95% CI, 5.6% to 28.7%, P = .02) had more eyes with ECL vs controls (iStent inject 1.49X, Hydrus 1.96X, CyPass 2.72X vs controls). Mean ECD over 60 months for iStent inject was indistinguishable vs control, whereas greater ECL was observed primarily 3 months postoperative (Hydrus) or accelerated after 2 years (CyPass). No iStent inject or Hydrus subjects developed persistent corneal edema, whereas 7 CyPass-implanted eyes developed ECL-related complications. Through 5 years postoperative, there were no differences in proportion of eyes with significant ECL or mean ECD between the iStent inject and control groups. There was greater 5-year ECL and lower ECD in the Hydrus and CyPass groups vs controls. The Hydrus ECL rate mirrored control after 3 months; the CyPass ECL rate accelerated vs control.

Minimally Invasive Glaucoma Surgery: A Review of the Literature.

Minimally invasive glaucoma surgery (MIGS) has emerged as a novel approach in the glaucoma treatment spectrum, offering a range of diverse procedures and devices aimed at reducing intraocular pressure (IOP). MIGS can be broadly classified into several categories: those that enhance trabecular outflow (Trabectome, iStent, Hydrus Microstent, Kahook Dual Blade, high frequency deep sclerotomy, and gonioscopy-assisted transluminal trabeculotomy), those that augment suprachoroidal outflow (CyPass Microstent and iStent Supra), those that target Schlemm's canal (TRAB360 and the OMNI Surgical System, Streamline, and Ab Interno Canaloplasty), and conjunctival bleb-forming procedures (EX-PRESS Glaucoma Filtration Device, Xen Gel Stent and PreserFlo MicroShunt). MIGS is considered to have a shorter surgical time and fewer severe complications when compared to traditional glaucoma surgeries such as trabeculectomy and glaucoma drainage device implantation (Ahmed, Baerveldt, and Molteno valves). This literature review comprehensively examines the distinct MIGS devices and procedures, their underlying mechanisms, and clinical outcomes, emphasizing the importance of evaluating the efficacy and complications of each approach individually. As the field of MIGS continues to evolve, it is crucial to prioritize high-quality, long-term studies to better understand the safety and effectiveness of these innovative interventions in glaucoma management.

The influence of trace elements on the therapeutic success of suprachoroidal draining devices

PurposeThe therapeutic success of minimal invasive glaucoma surgery (MIGS) is challenging due to many factors including fibrotic or occlusive events. Recent clinical data show sudden peaks of intraocular pressure (IOP) in the postoperative care of glaucoma patients after suprachoroidal draining stents. Yet, the reasons for the IOP peaks are speculative. As a link between trace elements and fibrosis had been previously observed in systemic disorders, the present study aimed to investigate the impact of trace elements on the therapeutic success of the suprachoroidal draining stents in patients with open-angle glaucoma (OAG). Material and MethodsAn analysis of a prospective single-center study was done: fifty-five eyes of patients with OAG (29 female, 26 male) underwent Cypass Micro-Stent implantation either as a stand-alone procedure or combined with cataract surgery. All patients underwent pre-operatively an ophthalmological examination which included slit lamp biomicroscopy and fundoscopy. IOP was measured by Goldmann applanation tonometry. Functional and morphometric data were assessed by Octopus G1-perimetry, which included measurement of retinal nerve fiber layer thickness (Spectralis OCT). Data of the patients’ follow-ups were recorded during 18 months post-operatively. The therapeutic success of CyPass Micro-Stent was classified as ‘success’ (IOP reduction ≥20% compared to a pre-operative baseline without any medication), ‘qualified success’ (IOP reduction ≥20 % with same or lower additional eye medication), and ‘failure’ (IOP reduction ≤20 % or additional surgical treatment necessary). Aqueous humour was extracted once during surgery for analysis of the level of 14 trace elements: Copper (Cu), Cadmium (Cd), Cobalt (Co), Chromium (Cr), Iron (Fe), Lithium (Li), Magnesium (Mg), Manganese (Mn), Phosphorus (P), Lead (Pb), Titanium (Ti), Uranium (U), Vanadium (V), and Zinc (Zn). Analysis of the trace elements was done using an ELEMENT 2, ICP-sf-MS instrument (Thermo-Fisher Scientific, Bremen, Germany). Analysis of levels of trace elements was done across the patients’ groups of the three subclasses of therapeutic success. Statistical investigations for substantial differences were conducted using the method of least squares to fit general linear models and mixed models. The last one for the repeated measurements of IOP. ResultsLevels of Mg were significantly lower one month postoperatively in the success group (LS-Mean 1.30 mg/L) compared to the qualified success group (LS-Mean 1.22 mg/L; p-value = 0.04). Fe was significantly increased in the failure group (LS-Mean 2.07 µg/L) compared to the qualified success group (LS-Mean 1.64 µg/L; p-value = 0.019) after 3 months of follow-up. Additionally, Fe levels were significantly lower in the success group (LS-Mean 1.47 µg/L) compared to the failure cohort (LS-Mean 2.07 µg/L; p-value = 0.009). After a period of 18 months, significantly higher levels of Mn were observed in the success group (LS-Mean 1.24 µg/L) than in the failure group (LS Mean 0.30 µg/L, p-value = 0.019). ConclusionThe present data might suggest that trace elements can influence therapeutic success of suprachoroidal draining devices postoperatively and thus offer first hints for potential novel therapeutic options.

Minimally Invasive Glaucoma Surgery: Safety of Individual Devices.

Primary open-angle glaucoma progression in those already on maximal medical therapy has traditionally been treated with trabeculectomy, a surgical procedure that carries a high degree of morbidity. In the last few decades, significant advances have been made in the field of minimally invasive glaucoma surgery (MIGS) devices, which aim to defer or prevent trabeculectomy via less arduous surgical techniques in certain types of glaucoma. Although reviews have been published examining the efficacy of various MIGS techniques, no article synthesises the comparative safety of all available devices. We performed a literature review examining the safety of MIGS devices. Fifteen devices were included, variously attempting to increase aqueous outflow through the trabecular meshwork or the suprachoroidal space, shunting into the subconjunctival space, or reducing aqueous production through ciliary body ablation. Notably, the earliest product attempting to increase outflow to the suprachoroidal space, Alcon's CyPass Micro-Stent, was withdrawn from the market due to concerns regarding increased corneal endothelial cell loss at five years post-implantation. All other devices were described as well-tolerated, with the most common adverse effects including hyphaema, intraocular pressure spikes, and device migration or obstruction. MIGS devices are purported to be uniformly safe, and many studies report no statistically significant increased complications beyond those associated with cataract surgery alone. It is important to note, however, the generally poor quality of current studies, with a dearth of randomised, or even prospective, data, and a large proportion of studies funded by device producers.

Corneal Endothelial Cell Loss in Patients After Minimally Invasive Glaucoma Surgery: Current Perspectives.

Minimally invasive glaucoma surgery (MIGS) is a rapidly expanding category of surgical glaucoma treatment options that offer a superior safety profile compared with traditional approaches for reducing intraocular pressure. However, MIGS may cause corneal endothelial cell loss; therefore, it has been receiving increasing attention. This systematic review aimed to evaluate and compare the rate and degree of corneal endothelial loss after MIGS. First, this paper presents an overview of the theoretical effectiveness of MIGS, the fundamental aspects regarding the roles of endothelial cells, and the effect of cataract surgery on the quality and count of endothelial cells. Further, we detail the various surgical techniques involved in MIGS, the development of these techniques over the time, and clinical aspects to consider with respect to the endothelial cell count. We discuss in detail the COMPASS-XT study, which was based on data collected over 5 years, reported that withdrawal of the CyPass Micro-Stent (Alcon Laboratories) yielded increased corneal endothelial cell loss. Generally, MIGS procedures are considered safe, with the incidence of complications ranging from 1% to 20% depending on the surgery type; however, there is still need for studies with longer follow-up. Thus, an adequate count of endothelial cells in the central cornea portion is recommended as necessary for candidate patients for MIGS.

CyPass microstent trimming with special cutting forceps : Video article

A CyPass®-microstent (Alcon, Fort Worth, TX, USA) extending too far into the anterior chamber should be trimmed as close as possible to the scleral spur to avoid progression of endothelial cell reduction. After CyPass implantation, if there is a significant loss of corneal endothelial cells due to the Cypass microstent extending too far into the anterior chamber, trimming or removal of the CyPass stent is necessary. There are no contraindications. As shown in our video, which is available online, aspecial cutter (19 Gauge Ahmed Micro Stent Cutter, MicroSurgical Technology Inc, Redmond, WA, USA) is inserted into the anterior chamber via a 1.5-mm wide corneal paracentesis made directly opposite to the CyPass stent. It is then possible to trim the anterior part of the stent. The severed fragment is removed using the head of the forceps. Finally, the previously inserted viscoelastic agent can be aspirated and the paracentesis can be hydrated. After the surgery vision testing as well as control of intraocular pressure and location of the stent are carried out. Antibiotic eye drops and ointment are postoperatively applied. There is still no standardized protocol for the procedure to trim the CyPass stent. Performing the trimming in our clinic using the procedure described here has so far not led to any complications. Long-term data about the development of the endothelial cell measurement after CyPass trimming are not yet available.

Ultrastructural analysis of explanted CyPass microstents and correlation with clinical findings

PurposeThe purpose of this study was to obtain insight into cellular processes after CyPass microstent implantation into the supraciliary space. With this knowledge, we expected to find some reason for surgical failure.MethodsNine CyPass microstents of 8 patients with primary open-angle glaucoma (n = 1), pseudoexfoliation glaucoma (n = 5), uveitic glaucoma (n = 1), and posttraumatic open-angle glaucoma (n = 1) were explanted due to recurrence of IOP elevation, corneal decompensation, or persistent hypotony. The explants were processed for light and transmission electron microscopy.ResultsFibrotic material, consisting of collagen fibrils, microfibrils, pseudoexfoliation fibrils produced by activated fibroblasts, was detected in the stent lumen of 4/5 pseudoexfoliation glaucoma patients and also in posttraumatic open-angle glaucoma. Fibrotic material was also present on the outer surface and within fenestrations of the majority of stents. Complete absence of fibrotic reaction was noticed in 3 of 9 microstents.ConclusionAlthough MIGS is known to be less invasive than conventional surgery, implants placed in the suprachoroidal space may be adversely affected by a fibrotic tissue reaction resulting in implant failure. Understanding mechanisms and risk factors leading to fibrotic scarring following antiglaucomatous surgery may help to develop novel strategies that improve surgical outcome.

Endothelial cell loss associated with minimally invasive glaucoma surgery.

Minimally invasive glaucoma surgery (MIGS) represents a safer, albeit moderately effective surgical option for intraocular pressure control. However, the CyPass Micro-Stent (Alcon Laboratories) was withdrawn from the market in 2018 as the COMPASS-XT study demonstrated greater cornea endothelial cell (CEC) loss in patients who received the CyPass Micro-Stent with phacoemulsification compared with phacoemulsification alone. This led to the increased attention on MIGS-associated CEC loss and thus, this review will summarise the recent, available evidence on MIGS-associated CEC loss. Prospective clinical trials and retrospective observational studies published between 2011 and 2021 reported a wide range of 12 month CEC loss from 'insignificant', and up to 14.6%, for phacoemulsification combined with various MIGS procedures. Recent clinical trials over the same time period reported CEC loss of 12.8-15.2% associated with phacoemulsification alone. Apart from the CyPass Micro-Stent clinical trial, no other studies on combined phacoemulsification with MIGS that is 'phaco-plus' procedures have reported a higher short-term CEC loss compared with phacoemulsification alone. However, studies that specifically examine postprocedural CEC loss following phacoemulsification compared to 'phaco-plus' procedures over a longer follow-up period are required.

Minimally Invasive Glaucoma Surgical Techniques for Open-Angle Glaucoma

Glaucoma affects more than 75 million people worldwide. Intraocular pressure (IOP)-lowering surgery is an important treatment for this disease. Interest in reducing surgical morbidity has led to the introduction of minimally invasive glaucoma surgeries (MIGS). Understanding the comparative effectiveness and safety of MIGS is necessary for clinicians and patients. To summarize data from randomized clinical trials of MIGS for open-angle glaucoma, which were evaluated in a suite of Cochrane reviews. The Cochrane Database of Systematic Reviews including studies published before June 1, 2021. Reviews of randomized clinical trials comparing MIGS with cataract extraction alone, other MIGS, traditional glaucoma surgery, laser trabeculoplasty, or medical therapy. Data were extracted according to Preferred Reporting Items for Systematic Reviews and Meta-analyses guidelines by one investigator and confirmed by a second. Methodologic rigor was assessed using the AMSTAR 2 appraisal tool and random-effects network meta-analyses were conducted. The proportion of participants who did not need to use medication to reduce intraocular pressure (IOP) postsurgery (drop-free). Outcomes were analyzed at short-term (<6 months), medium-term (6-18 months), and long-term (>18 months) follow-up. Six eligible Cochrane reviews were identified discussing trabecular bypass with iStent or Hydrus microstents, ab interno trabeculotomy with Trabectome, subconjunctival and supraciliary drainage devices, and endoscopic cyclophotocoagulation. Moderate certainty evidence indicated that adding a Hydrus safely improved the likelihood of drop-free glaucoma control at medium-term (relative risk [RR], 1.6; 95% CI, 1.4 to 1.8) and long-term (RR, 1.6; 95% CI, 1.4 to 1.9) follow-up and conferred 2.0-mm Hg (95% CI, -2.7 to -1.3 mm Hg) greater IOP reduction at long-term follow-up, compared with cataract surgery alone. Adding an iStent also safely improved drop-free disease control compared with cataract surgery alone (RR, 1.4; 95% CI, 1.2 to 1.6), but the short-term IOP-lowering effect of the iStent was not sustained. Addition of a CyPass microstent improved drop-free glaucoma control compared with cataract surgery alone (RR, 1.3; 95% CI, 1.1 to 1.5) but was associated with an increased risk of vraision loss. Network meta-analyses supported the direction and magnitude of these results. Based on data synthesized in Cochrane reviews, some MIGS may afford patients with glaucoma greater drop-free disease control than cataract surgery alone. Among the products currently available, randomized clinical trial data associate the Hydrus with greater drop-free glaucoma control and IOP lowering than the iStent; however, these effect sizes were small.

Safety profile of minimally invasive glaucoma surgery.

This article reviews the safety profile of trabecular meshwork/Schlemm's canal-based, subconjunctival, and suprachoroidal minimally invasive glaucoma surgery (MIGS). Prospective randomized clinical trials and metaanalyses published during the 2019-2020 review period provided important data regarding the safety profile of trabecular meshwork/Schlemm's canal-based MIGS. Transient hyphema and intraocular pressure spikes are among the most common complications associated with this category of MIGS, but more serious adverse events such as cyclodialysis cleft formation may also occur. Trabecular bypass microstents and the intracanalicular scaffold are further subject to device-related complications, including malposition and obstruction. Recent case reports and retrospective case series have further characterized the safety profile of the subconjunctival gel stent, with adverse events ranging from self-limited hypotony to visually devastating endophthalmitis and suprachoroidal hemorrhage. Five-year results of the COMPASS XT study demonstrated significantly greater endothelial cell loss in patients randomized to receive CyPass Micro-Stent (Alcon Laboratories, Fort Worth, TX, USA) in combination with cataract surgery versus those who underwent cataract surgery alone, and ultimately led to a Food and Drug Administration Class I recall of the device. Trabecular meshwork/Schlemm's canal-based procedures are generally among the safest MIGS, with mostly self-limited and nonvision-threatening complications. Subconjunctival gel stent insertion is associated with both bleb-related and stent-specific adverse events, which are similar to those observed with trabeculectomy and tube shunt surgery, respectively. Removal of the CyPass Micro-Stent from the market underscores the need for high-quality, long-term safety data regarding MIGS.

Minimally Invasive Glaucoma Surgery: A Critical Appraisal of the Literature.

Micro- or minimally invasive glaucoma surgeries (MIGS) have been the latest addition to the glaucoma surgical treatment paradigm. This term refers not to a single surgery, but rather to a group of distinct procedures and devices that aim to decrease intraocular pressure. Broadly, MIGS can be categorized into surgeries that increase the trabecular outflow [Trabectome, iStent (first and second generations), Hydrus microstent, Kahook Dual Blade and gonioscopy-assisted transluminal trabeculotomy], surgeries that increase suprachoroidal outflow (Cypass microstent and iStent Supra), and conjunctival bleb-forming procedures (Xen gel stent and InnFocus microshunt). Compared to traditional glaucoma surgeries, such as trabeculectomy and glaucoma drainage device implantation (Ahmed, Baerveldt, and Molteno valves), MIGS are touted to have less severe complications and shorter surgical time. MIGS represent an evolving field, and the efficacy and complications of each procedure should be considered independently, giving more importance to high-quality and longer-term studies.

Intraocular Pressure Peaks After Suprachoroidal Stent Implantation.

To study the efficacy and safety of suprachoroidal stent in everyday clinical practice at a tertiary glaucoma center. This retrospective single-center consecutive case series involved patients treated at Helsinki University Hospital with the CyPass Micro-Stent. Preoperative IOP was ≥18 mm Hg. Success was IOP between 6 and 18 mm Hg and lowering of IOP at least 20% from baseline without an increase in glaucoma medications over baseline or use of oral acetazolamide, and no subsequent glaucoma surgery. Of the total 38 eyes of 33 patients, 17 had primary open-angle glaucoma, 16 had exfoliative glaucoma, 2 each had uveitic glaucoma or steroid-induced glaucoma, and 1 had pigmentary glaucoma. Median preoperative IOP was 25.8 [interquartile range (IQR), 9.7] mm Hg with a median of 3 (IQR, 2) glaucoma medications. Kaplan-Meier estimate of median survival time was 79 days (95% confidence interval, 37-121 d). Success rate at 12-month follow-up was 24%. Sudden IOP elevation to over 30 mm Hg occurred in 14 eyes (37%). Highest IOP was 68 mm Hg. IOP peaks occurred between 1 week and 8 months after the surgery. In total, 43% of those with IOP elevation to >30 mm Hg had no symptoms. After the CyPass implantation, 15 eyes (39%) needed additional glaucoma surgery within a median of 167 (IQR, 109) days. Suprachoroidal stenting in a heterogenous clinical population resulted in a high incidence of sudden IOP peaks with a low success rate.

Efficacy of Combined Suprachoroidal Stent and Cataract Surgery in Patients With Glaucoma.

The purpose of this study was to evaluate the efficacy of intraocular pressure (IOP) control after combined CyPass Micro-Stent implantation and cataract surgery (combined surgery). All cases of combined surgery performed from February 2017 to July 2018 at Stein and Doheny Eye Institutes were reviewed. The primary outcome was a qualified success with stratified IOP targets based on criteria: final IOP (A) ≤18 mm Hg and reduction of 20%, (B) ≤15 mm Hg and reduction of 25%, (C) ≤12 mm Hg and reduction of 30%. Secondary outcome measures included postoperative IOP and number of medications, complications, additional glaucoma surgery, and postoperative refractive error. Predictive factors for failure were investigated. IOP spike was defined as a postoperative IOP ≥30 or >10 mm Hg increase from preoperative IOP. One hundred forty-one eyes (107 patients) were included. Mean (±SD) preoperative IOP was 15.4±3.4 mm Hg on an average of 2.2±1.1 medications. A statistically significant reduction in IOP and number of medications was seen at 12 months (13.8±4.2 mm Hg, 1.3±1.3 medications, P<0.001). Fifteen eyes (10.6%) had a postoperative IOP spike. Thirteen eyes (9.2%) experienced 17 complications (12.1%). Additional glaucoma surgery was performed in 3 eyes (2 patients). Cumulative success rates at 1 year based on criteria A, B, and C were 42%, 33%, and 28%, respectively. Lower preoperative IOP, greater preoperative medication number, the occurrence of postoperative IOP spike, and non-Caucasian ethnicity were associated with failure. Combined CyPass Micro-Stent implantation and cataract surgery may reduce glaucoma medication burden with a success rate of 28% to 42% at 1 year.

Explantation of the CyPass implant in acase series of patients with corneal decompensation

In microinvasive glaucoma surgery (MIGS) the CyPass microstent (Alcon Inc.) was implanted in the suprachoroidal space to increase the uveoscleral outflow, thereby lowering the intraocular pressure. Due to the excessive loss of corneal endothelial cells, the implant was withdrawn from the global market in August 2018. Aloss of corneal endothelial cells was observed in 6patients (8eyes in total) with early to moderate primary open-angle glaucoma 3years after CyPass implantation. One eye developed abullous keratopathy. In all patients an implant migration in the anterior chamber compared to the original postoperative position was detected, with more than one ring of the CyPass implant being visible in the anterior chamber. In all eight cases the CyPass implant was removed. The local therapy with cortisone eye drops in combination with a5% sodium chloride solution did not improve chronic corneal edema in one patient. Therefore, aDescemet membrane endothelial keratoplasty (DMEK) was performed with postoperative improvement of visual acuity. In patients with more than one visible ring of the CyPass implant in the anterior chamber and subsequent localized loss of corneal endothelial cells, CyPass trimming or removal is recommended to avoid the progression of generalized corneal endothelial cell reduction and the onset of refractory, chronic corneal edema.

Glaucoma surgery: how to manage failing MIGS

AbstractGlaucoma surgery is very effective at achieving good and long‐term pressure control with an acceptable safety profile. There are, however, patients for whom a previously successful procedure starts to fail. Minimally invasive glaucoma surgery (MIGS) techniques are becoming widely used for mild to moderate glaucoma. These techniques have an improved safety profile compared to more traditional filtration surgery, but there are still occasions when these techniques fail. This presentation, using surgical videos, personal experience and evidence from the literature, will aim to discuss a range of the most recently used MIGS techniques, including the iStent, Cypass microstent, endocyclophotocoagulation and Xen gel stent. The presentation will cover patient selection, complications, techniques to improve success and device misplacement.

Which Patients Would Most Likely to Benefit: MIGS or MEGS, Which One Is It?

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.

Corneal Endothelial Cell Loss and Morphometric Changes 5 Years after Phacoemulsification with or without CyPass Micro-Stent

To characterize long-term changes in corneal endothelial cells after phacoemulsification with or without supraciliary Micro-Stent (Alcon) implantation in eyes with open-angle glaucoma (OAG) and visually significant cataract. Three-year safety extension of a 2-year randomized clinical trial. Patients from the multicenter Study of an Implantable Device for Lowering Intraocular Pressure in Glaucoma Patients Undergoing Cataract Surgery (COMPASS) trial who underwent Micro-Stent implantation plus phacoemulsification (n= 282) or phacoemulsification alone (n= 67) were analyzed post hoc. Specular microscopy was used to assess endothelial cell loss (ECL), including changes from baseline in endothelial cell density (ECD), coefficient of variation, and percentage of hexagonal cells. Preoperative ECDs in the microstent group (2,432.6 cells/mm2 [95% confidence interval [CI], 2,382.8-2,482.4 cells/mm2]) were similar to those in the control group (2,434.5 cells/mm2 [95% CI, 2,356.5-2,512.4 cells/mm2]) groups. ECL at months 48 and 60 was greater in the Micro-Stent group than in the control group. At month 60, the mean percent of changes in ECD was-20.4% (95% CI,-23.5% to-17.5%) in the Micro-Stent group and-10.1% (95% CI,-13.9%to-6.3%) in the control group. No statistically significant between-group changes from baseline in cellular morphology were observed. Nine adverse events were possibly related to ECL, including 3 eyes with transient focal corneal edema and 4 eyes that required Micro-Stent trimming due to protrusion. In eyes with OAG, ECL after phacoemulsification is acute and stabilizes after 3months, whereas ECL after phacoemulsification plus Micro-Stent implantation proceeds for at least 5 years. Clinical findings associated with ECL in these eyes were uncommon (3.3% of implanted eyes), suggesting that ECL is generally a subclinical phenomenon.

Real world use of loteprednol etabonate ophthalmic gel 0.5% in cases representative of comorbid pathologies responding to minimally invasive glaucoma surgery.

PurposeWith the increasing use of minimally invasive surgical techniques for intraocular pressure (IOP) lowering in glaucoma patients, there is a need to examine best practices regarding the postoperative management of these patients. Corticosteroids, though effective in controlling postoperative ocular pain and inflammation, present distinct challenges in glaucoma surgery patients, as their use can be associated with IOP elevation. Loteprednol etabonate (LE) is an ocular corticosteroid designed to have an improved safety profile relative to other corticosteroids.MethodsWe report here a representative selection of cases in which patients were successfully treated with LE ophthalmic gel 0.5% (LE gel) following a variety of minimally invasive glaucoma surgery (MIGS) procedures. Cases included patients undergoing various procedures including a Trabectome combined with cataract surgery; micro-stent surgery (iStent) combined with cataract surgery; supraciliary CyPass Micro-Stent placement combined with cataract surgery; Kahook Dual Blade goniotomy; and ab interno canaloplasty using the iTrack catheter.ObservationsIn all cases, use of LE gel during the postoperative period appeared effective and safe in reducing inflammation and controlling pain. No adverse events or IOP elevations were noted, even in those patients continuing use of LE gel past the postoperative period for longer than six months with documented follow-up. In two cases, patients with elevated IOP using either prednisolone or difluprednate postoperatively were switched to LE gel, with a subsequent reduction in IOP.ConclusionsThis selection of cases involving patients undergoing MIGS suggests that LE gel may be an effective and safe option for treating postoperative inflammation and pain following such procedures with minimal to no effect on IOP or other negative sequalae.

Management of cataract and glaucoma in patient with a preexisting Cypass microstent in fellow eye: January consultation #1

Journal of Cataract & Refractive Surgery 45(1):p 105, January 2019. | DOI: 10.1016/j.jcrs.2018.10.020

Supraciliary microstent implantation for open-angle glaucoma: multicentre 3-year outcomes

ObjectiveTo describe the safety and effectiveness of CyPass supraciliary microstent implantation alone in eyes with open-angle glaucoma (OAG) followed up for up to 3 years.Methods and analysisThis registry study included...