Mitomycin C 0.2 mg/ml vs. Mitomycin C 0.4mg/ml during the implantation of an ab externo SIBS microshunt: A mega-analysis.

PURPOSE: To compare the effectiveness and adverse event profile of standalone SIBS microshunt implantation with adjunct MMC 0.2 mg/ml and MMC 0.4 mg/ml. DESIGN: Mega-analysis using individual patient data from international prospective and retrospective clinical studies. STUDY POPULATION: Patients with glaucoma who underwent implantation of a SIBS microshunt with MMC as a standalone procedure. METHODS: A comparison of eyes that received MMC 0.2 mg/ml or 0.4 mg/ml MAIN OUTCOMES MEASURES: Primary outcome was complete success defined as the proportion of eyes at one year with all of the following: (1) no two consecutive IOPs > 17 mmHg; (2) no clinical hypotony (3) ≥20% IOP reduction from baseline and (4) no use of glaucoma medications. Secondary outcomes included IOP thresholds of 12 mmHg,14 mm Hg and 21mmHg, median IOP, number of medications, risk factors for failure, interventions, adverse events, and reoperations. RESULTS: At 1 year, the complete success rate was significantly higher (71.3% vs 50.46%, p<0.001) and the median IOP significantly lower (13.0 vs. 14.2 mmHg, p<0.05) in the MMC 0.4 mg/ml group. MMC 0.2 mg/ml was found to be a significant risk factor for failure (HR 1.75 95%CI 1.14 to 2.67). Needling and surgical revision occurred at a lower rate in the MMC 0.4 mg/ml group (7% vs. 18.8%, p= 0.002 and 4.3% vs.13.7% p= 0.0087, respectively). Adverse events occurred at a similar frequency in both groups (26.6% MMC 0.2 mg/ml vs. 29.6% MMC 0.4 mg/ml, p=0.46), most of which were early and transient. CONCLUSION: SIBS microshunt implantation with MMC 0.4 mg/ml resulted in a higher success rate with greater IOP reduction compared to MMC 0.2 mg/ml. Higher MMC concentration was not associated with increased serious adverse events.

Intraocular Pressure While Using Gonioscopy, SLT, and Laser Iridotomy Lenses: An Ex Vivo Study.

Purpose: The purpose of this study was to measure intraocular pressure (IOP) elevation while applying standard gonioscopy, selective laser trabeculoplasty (SLT), and laser iridotomy procedural lenses. Methods: Twelve cadaver eyes were mounted to a custom apparatus and cannulated with a pressure transducer which measured IOP. The apparatus was mounted to a load cell which measured the force on the eye. Six ophthalmologists performed simulated gonioscopy (Sussman 4 mirror lens), SLT (Latina lens), and laser iridotomy (Abraham lens) while a computer recorded IOP (mm Hg) and force (grams). The main outcome measures were IOP and force applied to the eye globe during ophthalmic diagnostics and procedures. Results: The average IOP's during gonioscopy, SLT, and laser iridotomy were 43.2 ± 16.9 mm Hg, 39.8 ± 9.9 mm Hg, and 42.7 ± 12.6 mm Hg, respectively. The mean force on the eye for the Sussman, Latina, and Abraham lens was 40.3 ± 26.4 grams, 66.7 ± 29.8 grams, and 65.5 ± 35.9 grams, respectively. The average force applied to the eye by the Sussman lens was significantly lower than both the Latina lens (P = 0.0008) and the Abraham lens (P = 0.001). During gonioscopy indentation, IOP elevated on average to 80.5 ± 22.6 mm Hg. During simulated laser iridotomy tamponade, IOP elevated on average to 82.3 ± 27.2 mm Hg. Conclusions: In cadaver eyes, the use of standard ophthalmic procedural lenses elevated IOP by approximately 20 mm Hg above baseline.

Bent ab interno needle goniotomy versus gonioscopy-assisted transluminal trabeculotomy in primary open-angle glaucoma: study protocol of a randomized clinical trial.

BACKGROUND: Minimally invasive glaucoma surgery (MIGS) is a new class of surgeries, which combines moderate to high success rates and a high safety profile. Bent Ab interno Needle Goniotomy (BANG) and Gonioscopy-Assisted Transluminal Trabeculotomy (GATT) are two low-cost MIGS procedures that communicate the anterior chamber to Schlemm's canal. Most of the available publications on MIGS are either case series or retrospective studies, with different study protocols. The aim of this manuscript is to describe a randomized clinical trial (RCT) protocol to compare the long-term intraocular pressure (IOP) control and the safety of both procedures in eyes with primary open-angle glaucoma. METHODS: This is a parallel, double-arm, single-masked RCT that includes pseudophakic primary open-angle glaucoma (POAG) eyes. After inclusion criteria, medications will be washed out to verify baseline IOP before surgery. Patients will be randomized to BANG or GATT using a sealed envelope. Follow-up visits will be 1, 7, 15, 30, 60, 90, 180, 330 and 360 days after surgery. On PO330, a new medication washout will be done. The main outcome is the IOP reduction following the procedures. Complimentary evaluation of functional and structural parameters, safety, and quality of life will be done after 30, 90, 180, and 360 days. DISCUSSION: Our study was designed to compare the long-term efficacy and safety of two low-cost MIGS. Most of the published studies on this subject are case series or retrospective cohorts, with different study protocols, which included different types and severities of glaucomas, combined with cataract extraction. Our study only included mild to moderate POAG eyes, with previous successful cataract extraction. Moreover, it provides a standardized protocol that could be replicated in future studies investigating various types of MIGS. This would allow comparison between different techniques in terms of efficacy, safety, and patients' quality of life. TRIAL REGISTRATION: Retrospectively registered at the Registro Brasileiro de Ensaios Clínicos (ReBEC) platform RBR-268ms5y . Registered on July 29, 2023. The study was approved by the Ethics Committee of the University of Campinas, Brazil.

Corneal endothelial safety profile in minimally invasive glaucoma surgery.

PURPOSE: To compare 5-year corneal endothelial safety of 3 minimally invasive glaucoma surgery (MIGS) devices (iStent inject , Hydrus Microstent, CyPass Micro-Stent). SETTING: U.S. multicenter trials. DESIGN: Post hoc 5-year analysis from prospective randomized single-masked pivotal trials. METHODS: 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). RESULTS: 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. CONCLUSIONS: 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.

Difficult decisions, filtration surgery, and the heartbreak of the numerator.

A 70-year-old man had progressive and severe glaucoma in each eye. He was intolerant to dorzolamide, brimonidine, and netarsudil. Each eye had prior selective laser trabeculoplasty (SLT) as well as phacoemulsification plus minimally invasive glaucoma surgery (MIGS) 6 years before current presentation (iStent [Glaukos Corp.] in the right eye and Cypass [Alcon Laboratories, Inc.] in the left eye). Postoperative acuities were 20/20 and 20/25 in the right and left eyes, respectively. When his left eye progressed with loss of central acuity despite peak intraocular pressures (IOPs) in the middle to upper teens, neuro-ophthalmology consultation was obtained (Figure 1JOURNAL/jcrs/04.03/02158034-202401000-00017/figure1/v/2023-12-22T124801Z/r/image-tiff). That workup included magnetic resonance imaging scan and hematologic screening, but all results were negative, and the neuro-ophthalmic consultant concluded that the vision loss was likely on the basis of glaucoma. Accordingly, a trabeculectomy was performed in the left eye achieving consistent IOPs in the range of 7 to 10 mm Hg without medications, rending the left eye stable since the filtration surgery nearly 2 years previously. The right eye continued to progress both subjectively and objectively, and on recent examination, the IOP measured 20 mm Hg and 09 mm Hg in the right and left eyes, respectively (Figure 2JOURNAL/jcrs/04.03/02158034-202401000-00017/figure2/v/2023-12-22T124801Z/r/image-tiff). Medications included timolol and latanoprostene bunod in the right eye only. Central corneal thickness was 526 µm and 527 µm in the right and left eyes, respectively. The visual acuity now measured 20/25 in the right eye and 20/250 in the left eye. The vertical cup-to-disc ratio was 0.9 in the right eye and 1.0 in the left eye. Gonioscopy revealed a wide open angle in each eye with a patent sclerostomy superiorly in the left eye. The conjunctiva and sclera were healthy and without scarring in the right eye. The bleb in the left eye was diffuse, lightly vascularized, and seidel negative. Axial length (AL) was 26.88 µm in the right eye and 26.77 µm in the left eye. The patient was in good health and was not anticoagulated. An extensive discussion ensued about the best course of action for the right eye. How would you proceed in managing definite progression in this individual's right eye, knowing that he had lost fixation in his left eye at similar pressures?

Surgical Augmentation of the Suprachoroidal Space: A Novel Material and Implant.

Microinvasive glaucoma surgery (MIGS) has emerged as a safer method to lower IOP with minimal impact on patient quality of life compared to traditional glaucoma surgeries. With the advent of MIGS, there has been a renewed interest in exploring the suprachoroidal route. MIGS targeting the suprachoroidal space allow for a safe reduction in IOP while sparing conjunctiva and allowing "blebless" surgery, thus avoiding bleb-related complications. This article aims to review the rationale behind the suprachoroidal MIGS procedures and the literature surrounding the efficacy and safety of a novel suprachoroidal device, the MINIject. The available literature has shown promising IOP lowering results with the MINIject implant with a potentially safer and less invasive approach than traditional glaucoma surgeries.

Managing primary open-angle glaucoma in the setting of suboptimal surgical outcomes in the fellow eye.

A 62-year-old woman with mild myopia presented to her local optometrist for a routine examination and was found to have intraocular pressure (IOP) of 30 mm Hg in both eyes and cupped nerves. She had a family history of glaucoma in her father. She was started on latanoprost in both eyes and was referred for a glaucoma evaluation. On initial evaluation, her IOP was 25 mm Hg in the right eye and 26 mm Hg in the left eye. Central corneal thickness measured 592 µm in the right eye and 581 µm in the left eye. Her angles were open to gonioscopy without any peripheral anterior synechia. She had 1+ nuclear sclerosis with a corrected distance visual acuity (CDVA) of 20/25 in the right eye and 20/30- in the left eye and uncorrected near visual acuity of J1+ in each eye. Her nerves were 0.85 mm in the right eye and 0.75 mm in the left eye. Optical coherence tomography (OCT) showed retinal nerve fiber layer thinning and a dense superior arcuate scotoma into fixation in her right eye, and superior and inferior arcuate scotomas in her left eye (Figures 1 and 2JOURNAL/jcrs/04.03/02158034-202307000-00019/figure1/v/2023-06-26T195222Z/r/image-tiffJOURNAL/jcrs/04.03/02158034-202307000-00019/figure2/v/2023-06-26T195222Z/r/image-tiff, Supplemental Figures 1 and 2, available at http://links.lww.com/JRS/A882 and http://links.lww.com/JRS/A883). She was successively trialed on fixed combination brimonidine-timolol, dorzolamide, and netarsudil, in addition to her latanoprost, but her IOP remained in the mid- to upper 20s in both eyes. The addition of acetazolamide lowered the pressure to 19 mm Hg in both eyes, but she tolerated it poorly. Methazolamide was also attempted with similar side effects. We elected to perform left eye cataract surgery combined with 360-degree viscocanaloplasty and insertion of a Hydrus microstent (Alcon Laboratories, Inc.). Surgery was uncomplicated with IOP of 16 mm Hg on postoperative day 1 with no glaucoma medications. However, by postoperative week 3, IOP returned to 27 mm Hg, and despite restarting latanoprost-netarsudil and finishing her steroid taper, IOP remained at 27 mm Hg by postoperative week 6. Brimonidine-timolol was added back to her left eye regimen and at postoperative week 8, IOP had elevated to 45 mm Hg. Maximizing her therapy with the addition of topical dorzolamide and oral methazolamide brought her IOP back down to 30 mm Hg. At that point, the decision was made to proceed with trabeculectomy of the left eye. The trabeculectomy was uneventful. However, postoperative attempts to augment filtration were rendered less successful by extremely thick Tenon layer. At her most recent follow-up the pressure in the left eye was mid-teens with brimonidine-timolol and dorzolamide. Her right eye IOP is in the upper 20s on maximum topical therapy. Knowing her postoperative course in the left eye, how would you manage the right eye? In addition to currently available options, would you consider a supraciliary shunt such as the MINIject (iSTAR) if such a device were U.S. Food and Drug Administration (FDA)-approved?

All Consecutive Ab Externo SIBS Microshunt Implantations With Mitomycin C: One-Year Outcomes and Risk Factors for Failure.

PURPOSE: To present the effectiveness, risk factors for surgical failure, and adverse events over 12 months in a consecutive diverse cohort of glaucoma patients who underwent solo or combined ab externo SIBS microshunt with mitomycin C (MMC) with or without previous subconjunctival surgery. DESIGN: Retrospective, consecutive, interventional case series. METHODS: Consecutive glaucomatous eyes on maximally tolerated medical therapy received ab externo SIBS microshunt with MMC implantation as a solo or combined procedure with phacoemulsification from July 2015 to January 2020. The primary outcome was the proportion of eyes at 12-months with the following: (1) no 2 consecutive intraocular pressures (IOPs) >17 mm Hg or clinical hypotony, without (complete success) or with (qualified success) glaucoma medications; and (2) ≥20% reduction from baseline IOP. Secondary outcomes included upper IOP thresholds of 14 and 21 mm Hg with and without a 20% IOP reduction from baseline, median IOP, medications, risk factors for failure, postoperative interventions, complications, and reoperations. RESULTS: A total of 436 eyes underwent surgery; 86 (20%) combined with phacoemulsification, 127 (29%) in eyes with refractory glaucoma, and 234 (51%) stand-alone procedures in non-refractory eyes. Complete success (6-17 mm Hg with no medications) was achieved in 64.0% of combined eyes, 58.1% of refractory eyes, and 74.8% of stand-alone non-refractory eyes; and qualified success rates (6-17 mm Hg with medications) were 90.7%, 84.7%, and 92.4% of eyes, respectively. At 12 months, 67% of eyes were medication free. Significant risk factors for failure included combined procedures in refractory eyes (hazard ratio [HR] = 3.2; 95% CI = 1.4-7.4), receiving <0.4 mg/mL of MMC (HR = 2.2; 95% CI = 1.6-3.1), refractory eyes (HR = 1.7; 95% CI = 1.2-2.5), combined procedures (HR = 1.6; 95% CI = 1.0-2.5), and each additional baseline medication class (HR = 1.3; 95% CI = 1.1-1.5). Postoperative complications occurred in 31% of eyes, and more often in those receiving ≥0.4 mg/mL MMC (odds ratio [OR] = 2.2, 95% CI 1.2-3.8). Needling occurred in 12% of eyes, with significantly higher frequency in refractory eyes (23%) and combined procedures (13%) compared to stand-alone (7%; P < .001). Revisions and reoperations occurred in 4% and 1.4% of eyes, respectively. CONCLUSIONS: The 1-year follow-up data from this large and diverse cohort support promising rates of qualified and complete surgical success with decreased medication burden and few postoperative complications and interventions. Combined phacoemulsification, refractory glaucoma, and receiving <0.4mg/mL MMC were associated with reduced surgical success rates.

First-in-Human Safety Study of Femtosecond Laser Image-Guided Trabeculotomy for Glaucoma Treatment: 24-month Outcomes.

Purpose: Pilot study to evaluate adverse events and intraocular pressure (IOP)-lowering of a novel, noninvasive glaucoma procedure, femtosecond laser, image-guided, high-precision trabeculotomy (FLIGHT). Design: Prospective, nonrandomized, single-center, interventional, single-arm clinical trial. Participants: Eighteen eyes from 12 patients with open-angle glaucoma. Methods: Eighteen eyes from 12 patients underwent FLIGHT, creating a single channel measuring 500-µm wide by 200-µm high through the trabecular meshwork and into Schlemm's canal. Adverse events, IOP, and other parameters were evaluated out to 24 months. Main Outcome Measures: Outcomes were the rates and types of adverse events and the rate of postprocedure best-corrected visual acuity loss (≥ 2 lines) compared with baseline. Efficacy outcomes were reduction in mean intraocular pressure (IOP) with respect to baseline and the percentage of eyes with a ≥ 20% reduction in IOP. Results: Eighteen eyes from 12 patients were enrolled in the study; 11 patients (17 eyes) returned at 24 months. There were no serious adverse events related to the laser treatment. Well-defined channels were clearly visible at 24 months by gonioscopy and anterior segment OCT, with no evidence of closure. At 24 months, the mean IOP was reduced by 34.6% from 22.3 ± 5.5 to 14.5 ± 2.6 mmHg (P < 5e-5), with an average of 2.0 ± 1.2 hypotensive medications compared with 2.2 ± 1.1 at baseline (P = 0.22). Fourteen out of the 17 study eyes (82.3%) achieved a ≥ 20% reduction in IOP at 24 months when compared with baseline. Conclusion: The FLIGHT system demonstrated a favorable safety profile in this initial pilot study, with no device-related serious adverse events. The channels appeared patent at 24 months, indicating medium-term durability. Financial Disclosures: Proprietary or commercial disclosure may be found after the references.

Intermediate Outcomes of the Novel 63-µm Gelatin Microstent versus the Conventional 45-µm Gelatin Microstent.

PURPOSE: To determine intermediate intraocular pressure (IOP)-lowering and adverse event profile of the 63-µm gelatin microstent (Xen63) with mitomycin C (MMC) compared with the 45-µm gelatin microstent (Xen45) with MMC. DESIGN: Single center, consecutive, retrospective cohort study. PARTICIPANTS: Eighty-four glaucomatous eyes (42 63-µm gelatin microstent and 42 45-µm gelatin microstent) with or without previous subconjunctival glaucoma surgery. METHODS: Consecutive eyes that underwent 63-µm gelatin microstent implantation with MMC from February 2020 to June 2021 were compared with eyes that underwent 45-µm gelatin microstent implantation with MMC. Standalone and combined cases with phacoemulsification were included. MAIN OUTCOME MEASURES: Primary outcome was the hazard ratio of failure of 45-µm gelatin microstent vs. 63-µm gelatin microstent eyes at 12 months, with failure defined as 2 consecutive IOPs, (1) >17 mmHg, (2) <6 mmHg with 2 lines of vision loss, or (3) <20% reduction from baseline IOP, without (complete) or with (qualified) glaucoma medications. Secondary outcomes included IOP thresholds of 14 mmHg and 21 mmHg, postoperative IOP, medications, adverse events, interventions, and reoperations. RESULTS: The complete success rate was higher in the 63-µm gelatin microstent group (59.5% vs. 28.6%, P = 0.009) at the primary IOP threshold of 6 to 17 mmHg but did not differ significantly for qualified success (66.7% vs. 45.2%, P = 0.08). The crude hazard ratio of failure of 45-µm gelatin microstent relative to 63-µm gelatin microstent was 2.28 (95% confidence interval [CI], 1.21-4.32), and the adjusted hazard ratio was 7.90 (95% CI, 2.12-29.43). 63-µm gelatin microstent eyes had significantly lower mean IOP (12.7 ± 4.8 vs. 15.5 ± 5.1 mmHg, P = 0.001) and fewer medication classes (0.6 ± 1.1 vs. 1.7 ± 1.6 medications, P = 0.0005), with the degree of reduction in IOP and medication count being significantly greater in 63-µm gelatin microstent eyes. There were 28 and 21 distinct interventions in 63-µm gelatin microstent and 45-µm gelatin microstent eyes respectively, with 11.9% of eyes undergoing needling in each group. There were 34 and 19 distinct adverse events, in 63-µm gelatin microstent and 45-µm gelatin microstent eyes, respectively, most of which were early and transient. Nine Xen63 eyes (21.4%) and 6 45-µm gelatin microstent eyes (14.3%) underwent reoperation. CONCLUSIONS: 63-µm gelatin microstent resulted in higher surgical success rates and fewer medications compared with 45-µm gelatin microstent. This was tempered by more postoperative interventions and adverse events, although most were transient. FINANCIAL DISCLOSURE(S): Proprietary or commercial disclosure may be found in the Footnotes and Disclosures at the end of this article.

Ab Externo SIBS Microshunt with Mitomycin C for Open-Angle Glaucoma: Three-Year Results as a Primary Surgical Intervention.

PURPOSE: To determine the effectiveness, risk factors for surgical failure, and adverse events in a large cohort of patients receiving stand-alone ab externo poly(styrene-block-isobutylene-block-styrene) (SIBS) microshunt implantation with mitomycin C (MMC) over 3 years of follow-up. DESIGN: Retrospective, interventional case series. PARTICIPANTS: Glaucomatous eyes on maximally tolerated medical therapy with no previous subconjunctival glaucoma surgery. METHODS: Records of eyes that underwent ab externo SIBS microshunt with MMC between July 2015 and November 2017 were reviewed. Data from all follow-up visits were utilized and included intraocular pressure (IOP), medication use, postoperative interventions, complications, and reoperations. MAIN OUTCOME MEASURES: The primary outcome was proportion of eyes at 3 years with (1) no 2 consecutive IOPs > 17 mmHg (or < 6 mmHg with > 2 lines of vision loss from baseline); (2) ≥ 20% reduction from baseline IOP; and (3) using no glaucoma medications (complete success). Secondary outcomes included 14 and 21 mmHg upper IOP thresholds with and without ≥ 20% IOP reduction from baseline, qualified success (with glaucoma medications), risk factors for failure, median IOP/medications, postoperative interventions, complications, and reoperations. RESULTS: One hundred fifty-two eyes from 135 patients were included. Complete and qualified success was achieved in 55.6% and 74.8% of eyes, respectively. Time to first glaucoma medication use was a median of 16.9 (interquartile range [IQR], 12.1-34.1) months; however, 59.4% of eyes remained medication free at 3 years. Significant risk factors for failure included receiving < 0.4 mg/ml of MMC (adjusted hazard ratio [HR], 2.42; 95% confidence interval [CI], 1.44-4.05) and baseline IOP < 21 mmHg (adjusted HR, 1.79; 95% CI, 1.03-3.13). The most common complications were choroidal detachment, hyphema, and anterior chamber shallowing, occurring in 7%, 5%, and 5% of eyes, respectively. The needling rate was 15.1%, with significantly higher frequency for baseline IOP > 21 mmHg (HR, 3.21; 95% CI, 1.38-7.48). Revisions occurred in 7% of eyes and reoperations in 2.6%. Eyes receiving < 0.4 mg/ml of MMC underwent more revisions (odds ratio, 4.9; 95% CI, 1.3-18.3). CONCLUSIONS: Three-year follow-up data from this large cohort continues to support promising rates of qualified and complete success, with decreased medication burden postoperatively and few postoperative complications and interventions. Comparisons to other filtering surgeries will further facilitate integration of the SIBS microshunt into the surgical treatment paradigm. FINANCIAL DISCLOSURE(S): Proprietary or commercial disclosure may be found in the Footnotes and Disclosures at the end of this article.

Long-Term Endothelial Safety Profile With iStent Inject in Patients With Open-Angle Glaucoma.

PURPOSE: To report 5-year postoperative safety data of iStent inject, including overall stability, endothelial cell density (ECD), and endothelial cell loss (ECL) in patients with mild-to-moderate primary open-angle glaucoma (POAG). DESIGN: 5-year follow-up safety study of the prospective, randomized, single-masked, concurrently controlled, multicenter iStent inject pivotal trial. METHODS: In this 5-year follow-up safety study of the 2-year iStent inject pivotal randomized controlled trial, patients receiving iStent inject placement and phacoemulsification or phacoemulsification alone were studied for the incidence of clinically relevant complications associated with iStent inject placement and stability. Corneal endothelial endpoints were mean change in ECD from screening and proportion of patients with >30% ECL from screening, from analysis of central specular endothelial images by a central image analysis reading center at several time points through 60 months postoperatively. RESULTS: Of the 505 original randomized patients, 227 elected to participate (iStent inject and phacoemulsification group, n = 178; phacoemulsification-alone control group, n = 49). No specific device-related adverse events or complications were reported through month 60. No significant differences were observed in mean ECD, mean percentage change in ECD, or proportion of eyes with >30% ECL between the iStent inject and control groups at any time point; mean percentage decrease in ECD at 60 months was 14.3% ± 13.4% in the iStent inject group and 14.8% ± 10.3% in the control group (P = .8112). The annualized rate of ECD change from 3 to 60 months was neither clinically nor statistically significant between groups. CONCLUSIONS: Implantation of iStent inject during phacoemulsification in patients with mild-to-moderate POAG did not produce any device-related complications or ECD safety concerns compared to phacoemulsification alone through 60 months.

Deadbolt cataract due to misplanted minishunt.

A 62-year-old woman with stable unilateral glaucoma in the left eye presented for a cataract consultation. In 2010, laser peripheral iridotomies (LPI) were performed on both eyes by a different provider. Her postoperative course was complicated by a recalcitrant steroid response with a highest intraocular pressure (IOP) of 65 mm Hg in the left eye. A trabeculectomy with a glaucoma minishunt (EX-PRESS, Alcon) was then performed by that provider (Supplemental Figure 1, http://links.lww.com/JRS/A603). Thereafter, IOP control of the left eye was normalized and maintained without topical antiglaucoma medications. Historically, her right eye has been always her better eye. Recently, she noticed metamorphopsia in her left eye. Her ocular history was also notable for high refractive errors requiring continuous spectacles wear, possible mild refractive amblyopia of the left eye, history of submacular choroidal nevus with drusen in the right eye, and an epiretinal membrane (ERM) with macular pucker in the left eye. Her husband is an optician. Both inquire about refractive cataract surgery options to correct astigmatism and presbyopia; both have reservations regarding cost and visual quality associated with diffractive optic intraocular lenses (IOLs). Her deteriorating visual acuity in both eyes affects her ability to work. Her corrected distance visual acuity was 20/40 in both eyes (pinhole, no help) while wearing spectacles according to a prescription of -8.50 diopters (D) +1.50 D × 106 for the right eye and -13.00 D +3.25 D × 057 for the left eye. Her corrected near visual acuity was 14/14 in both eyes with the abovementioned prescription and a +3.00 D add. Central corneal thickness was 618 µm in the right eye and 631 µm in the left eye. IOP was 20 mm Hg in the right eye and 10 mm Hg in the left eye on no antiglaucoma medications. Pertinent findings on slitlamp examination included bilateral dermatochalasis, a shallow diffuse thick bleb superiorly in the left eye only, patent LPI superiorly in both eyes, nuclear sclerotic and cortical cataracts in both eyes (with prominent focal spoke superiorly left eye only) (Figure 1, A-C). Fundus photos show posterior vitreous detachment in both eyes, ERM with macular pucker in the left eye, and submacular choroidal nevus (2.5 × 3.0 disc diameter size) with overlying drusen in the right eye (Supplemental Figure 2, A, http://links.lww.com/JRS/A604). Gonioscopy revealed open angles in both eyes, albeit with focal narrowing without synechiae superiorly in the left eye only (Figure 1, D-FJOURNAL/jcrs/04.03/02158034-202207000-00020/figure1/v/2022-06-24T130746Z/r/image-tiff). Most importantly, however, the distal tip of the minishunt was not positioned as expected in the anterior chamber; rather, it was noted to pierce the peripheral iris near the iris root superiorly. Most of the minishunt shaft and spur were positioned in the posterior chamber with the distal tip penetrating into the superior aspect of the capsular bag and cataract in the left eye-like a deadbolt. Visual field testing showed a full field in the right eye and an inferior nasal step in the left eye (Supplemental Figure 2, B, http://links.lww.com/JRS/A604). In addition to slitlamp, gonioscopic, and fundus photos, we also obtained optical coherence tomography of the macula and nerve (Supplemental Figure 2, C, http://links.lww.com/JRS/A604), optical biometry, ultrasound biomicroscopy, endothelial cell counts, and corneal topography (Supplemental Figure 3, http://links.lww.com/JRS/A605). How would you counsel this patient regarding her glaucoma condition, the misplanted minishunt, and her cataract surgery and IOL options? How would you manage the misplanted minishunt? What surgical approaches or specific techniques would you consider for cataract removal and visual rehabilitation?

Long-term Outcomes from the HORIZON Randomized Trial for a Schlemm's Canal Microstent in Combination Cataract and Glaucoma Surgery.

PURPOSE: To present the 5-year results of the HORIZON trial comparing cataract surgery (CS) combined with an intracanalicular microstent with CS alone. DESIGN: Prospective, multicenter, controlled randomized clinical trial. PARTICIPANTS: Patients with cataract and primary open-angle glaucoma treated with 1 or more glaucoma medications, washed-out diurnal intraocular pressure (DIOP) of 22 to 34 mmHg, and no prior incisional glaucoma surgery. METHODS: Eyes were randomized 2:1 to receive a Hydrus Microstent (HMS; Ivantis, Inc) or no stent after successful CS. MAIN OUTCOME MEASURES: Intraocular pressure (IOP), glaucoma medication use, repeat glaucoma surgery, visual acuity, visual field, procedure-related adverse events, and corneal endothelial cell counts. RESULTS: Three hundred sixty-nine eyes were randomized to HMS treatment, and 187 eyes were randomized to CS only. Study groups were well matched for preoperative IOP, medication use, washed-out DIOP, and glaucoma severity. Five-year follow-up was completed in 80% of patients. At 5 years, the HMS group included a higher proportion of eyes with IOP of 18 mmHg or less without medications than the CS group (49.5% vs. 33.8%; P = 0.003), as well as a greater likelihood of IOP reduction of 20% or more without medications than the CS group (54.2% vs. 32.8%; P < 0.001). The number of glaucoma medications was 0.5 ± 0.9 in the HMS group and 0.9 ± 0.9 in the CS group (P < 0.001), and 66% of eyes in the HMS group were medication free compared with 46% in the CS group (P < 0.001). The cumulative risk of incisional glaucoma surgery was lower in the HMS group (2.4% vs. 6.2%; P = 0.027, log-rank test). No clinical or statistically significant differences were found in the rate of endothelial cell loss from 3 to 60 months between the HMS and CS alone groups (P = 0.261). CONCLUSIONS: The addition of a Schlemm's canal microstent in conjunction with CS was safe, resulted in lowered IOP and medication use, and reduced the need for postoperative incisional glaucoma filtration surgery compared with CS after 5 years. Long-term presence of the implant did not affect the corneal endothelium adversely.

Endothermal pupilloplasty to optimize pupil centration, size, and contour.

Iris defects and distorted pupils are commonly managed with iris suturing techniques that aim to close the defect and/or reform the physiological pupil. The re-creation of an optimally sized and centered pupil is often challenging because of missing iris, asymmetrical iris damage, or variable tension around the pupil. Current options include removing or cutting iris tissue using microscissors or the vitreous cutter, instrument stretching, or postoperative laser photocoagulation. Iris microendodiathermy is a simple technique that is minimally traumatic, titratable, and controlled, avoids excessive tissue manipulation, and is able to create a round cosmetically pleasing pupil. A bipolar endodiathermy cautery is applied to the iris stroma to induce tissue contraction and to gently pull the pupil in the meridian to which probe is applied. Endothermal pupilloplasty (EDP) may be used to recenter or enlarge a small pupil, thereby avoiding additional trauma inflicted by a vitrector or microscissors that physically cuts the iris.

Icare Home Tonometer: A Review of Characteristics and Clinical Utility.

The Icare HOME (TA022, Icare Oy, Vanda, Finland) is rebound tonometer recently approved by the US Food and Drug Administration in March 2017 designed for self-measurement of intraocular pressure (IOP). IOP remains a major modifiable risk factor for glaucoma progression; however, IOP measurements typically occur through single office measurements on Goldmann applanation tonometry (GAT) and do not always reveal the complete picture of patient's IOP patterns and daily fluctuations, which are important for accurate diagnosis and evaluation. Numerous studies have now compared the efficacy of the Icare HOME to that of GAT. The objective of this article is to review the existing literature surrounding the Icare HOME tonometer and its efficacy as a self-tonometer in comparison to GAT. The available literature has shown promising results in its accuracy of measuring IOP but suggests cautious usage in patients with central corneal thicknesses or IOP ranges that are outside of a certain range. This article will also provide details and example cases for when the Icare HOME may be most clinically useful.