IntroductionThe purpose of this study was to determine the effect on intraocular pressure (IOP) of applying negative pressure (NP) to the periocular space, as measured by an intraocular IOP sensor in human eyes.MethodsEyes with open-angle glaucoma (OAG) and previously implanted with the eyemate®-IO IOP-measuring device (Implandata Ophthalmic Products GmbH (now G-Metrics GmbH)) wore an early prototype of the FSYX™ Ocular Pressure Adjusting Pump (OPAP; Balance Ophthalmics, Inc.) in two separate studies: “Eyemate 1” and “Eyemate 2.” In Eyemate 1, study eyes received periorbital NP application at -10mmHg with OPAP for 70 to 110 minutes vs no NP in the fellow control eye. In Eyemate 2, eyes wore OPAP for 8 hours of continuous NP application set to 50% of the eye’s baseline IOP vs no NP in the fellow control eye. In both studies, IOP was measured in real time using the implanted eyemate-IO device. The primary effectiveness endpoint in both studies was the change from baseline IOP in the study eye, as measured with eyemate-IO.ResultsAll seven study eyes demonstrated immediate and sustained reductions in IOP during NP application. In Eyemate 1, three study eyes had individual mean steady-state IOP reductions of 31%, 51%, and 23% from baseline. In Eyemate 2, four study eyes had a mean 8-hour IOP reduction of 20% from baseline. All patients tolerated goggle wear and NP application.ConclusionThese studies provided early proof-of-concept evidence that NP application to the periocular space lowers IOP, as measured by an implanted intraocular sensor, and was well tolerated over short-term use. Given the small, uncontrolled or open-label designs, these findings are hypothesis-generating; larger, controlled studies are required to confirm efficacy and characterize safety.
Purpose To evaluate the safety and intraocular pressure (IOP)-lowering efficacy of the ocular pressure adjusting pump in subjects with normal-tension glaucoma (NTG). Design Prospective, multicenter, masked, randomized, fellow-eye controlled trial. Subjects, Participants, and/or Controls Subjects with NTG with an IOP ≥12 mm Hg and ≤21 mm Hg were enrolled. One eye of each subject was randomized to receive negative pressure application; the fellow eye served as a control. Methods Subjects wore the device overnight for 1 year and the applied negative pressure was programmed by subtracting a reference IOP of 6 mm Hg from the baseline IOP. Main Outcome Measures The primary effectiveness endpoint was the proportion of eyes achieving an IOP reduction ≥20% at Week 52 during the day. The secondary endpoint was the proportion of eyes achieving a nocturnal IOP reduction ≥20% at Week 52. Exploratory endpoints included mean IOP reduction in clinic and in the sleep lab. Results A total of 186 eyes were randomized across 11 sites. 120 eyes successfully completed all visits across 52 weeks without protocol deviations. At Week 52, 88.3% (n = 53) of study eyes vs 1.7% (n = 1) of control eyes met the primary endpoint. For the secondary endpoint, 96.7% (n = 58) of study eyes vs 5.0% (n = 3) met the endpoint. For exploratory IOP analysis, the mean nocturnal IOP reduction at Week 52 was 8.0 mm Hg (39.1%) from a baseline of 20.4 ± 2.5 mm Hg to 12.4 ± 2.7 mm Hg. There were no serious adverse events. The most commonly reported adverse events were lid (11.8% study, 1.1% control) and periorbital edema (12.9%, 1.1%). Conclusions The ocular pressure adjusting pump safely and effectively lowers both daytime and nocturnal IOP in patients with NTG.
The XEN®45 Glaucoma Treatment System (gel stent; Allergan, an AbbVie company, Irvine, CA, USA) is a minimally invasive bleb-forming surgical device that was originally approved to lower intraocular pressure by diverting the aqueous humor from the anterior chamber to the subconjunctival space (like trabeculectomy) following ab-interno placement. Since approval of the gel stent in multiple countries, the implantation technique has evolved considerably, being performed ab interno or ab externo with open or closed conjunctiva, based on patients' needs and/or surgeons' preferences. Additional technical variations that can facilitate gel stent placement and/or improve outcomes have also emerged. This article aims to increase awareness of these developments to facilitate informed decision-making and improve surgical success and outcomes for patients.
PURPOSE:Effective glaucoma treatment is limited by nonadherence to medications and access to selective laser trabeculoplasty (SLT). The GLAUrious study compared automated, gonioscopy-free, noncontact, image-guided direct selective laser trabeculoplasty (DSLT) with conventional SLT in open-angle glaucoma (OAG) and ocular hypertension (OHT) to reduce intraocular pressure (IOP). DESIGN:Prospective, multicenter, randomized, controlled, evaluator-masked noninferiority trial. PARTICIPANTS:Participants aged ≥ 40 years with OAG or OHT, on 0-3 hypotensive medications at screening, and washout IOP of 22-35 mmHg at 14 centers. METHODS:After washout, 192 participants randomized 1:1 to DSLT (n = 99) or SLT (n = 93). Intraocular pressure was assessed before treatment and through 12 months after the procedure, with washout IOP at baseline and 6 months. MAIN OUTCOME MEASURES:Difference between DSLT and SLT in mean IOP change from baseline to 6 months (noninferiority margin, -1.95 mmHg). Exploratory efficacy and safety outcomes were assessed over 12 months. RESULTS:Of 156 participants (81.3%) without major protocol deviations analyzed at 6 months, the mean ± standard error (SE) washout IOP reduction from baseline was 5.5 ± 0.5 mmHg (-20.6%) after DSLT and 6.2 ± 0.5 mmHg (-23.6%) after SLT. The between-group difference (SLT-DSLT) in mean IOP reduction was -0.7 mmHg (95% confidence interval [CI], -2.2 to 0.8 mmHg; P = 0.09 [not significant] for noninferiority). Of 161 participants (83.9%) without major protocol deviations analyzed at 12 months, mean ± SE nonwashout IOP reduction from screening was 3.2 ± 0.4 mmHg (-12.2%) after DSLT and 3.2 ± 0.4 mmHg (-9.4%) after SLT. The between-group difference in mean IOP reduction was 0.01 mmHg (95% CI, -1.1 to 1.1 mmHg; P < 0.001 for noninferiority). Safety profiles were similar between groups, although clinically nonsignificant punctate subconjunctival hemorrhage was more frequent in the DSLT group. Ocular AEs generally were mild and resolved without intervention. CONCLUSIONS:The 6-month primary end point did not achieve statistical noninferiority compared with conventional SLT. Nonetheless, DSLT was well tolerated and provided an effective reduction in IOP that was sustained for 12 months. Failure to demonstrate noninferiority does not prove inferiority; DSLT remains an effective option in the early treatment paradigm and can be considered as a first-line treatment when SLT is not readily accessible. FINANCIAL DISCLOSURE(S):Proprietary or commercial disclosure may be found in the Footnotes and Disclosures at the end of this article.
A 62-year-old woman with a history of moderate myopia, long-standing open-angle glaucoma (OAG), and Fuchs dystrophy in both eyes was referred for consultative care. She had prior trabeculectomy in 1984 and 1992 in the left and right eyes, respectively. She is 3 months post–Descemet-stripping endothelial keratoplasty (DSEK) in the left eye, now referred with uncontrolled intraocular pressure (IOP) despite maximum tolerated medical therapy. Current medical therapy for IOP consists of acetazolamide 250 mg by mouth 2 times a day, brimonidine 2 times a day in the left eye, dorzolamide 2 times a day in the left eye, and timolol 2 times a day in the left eye. The patient has a history of presumed steroid response; however, her corneal surgeon has requested that the steroid be continued for the next several months because of the recent DSEK. The IOP in the left eye has ranged from the mid-20s to mid-30s since DSEK. The right eye has consistently had pressure in the low teens and below for many years without topical antihypertensive medications. Examination revealed stable visual acuity at 20/30 and 20/40 in the right and left eyes, respectively, IOP was 12 mm Hg in the right eye and 25 mm Hg in the left eye by Goldman applanation, irregular but reactive pupils without afferent defect, and full confrontational visual fields. Slitlamp examination showed superior low avascular bleb, moderate-to-severe guttae, and posterior chamber IOL in the right eye. The left eye showed superior low diffuse bleb, clear DSEK graft, quiet chamber, superonasal iridectomy, and posterior chamber IOL with an open posterior capsule. The conjunctiva was moderately scarred but a repeat trabeculectomy or Xen Gel stent (Abbvie) appeared possible. The angles were wide open in each eye. Fundus examination was normal aside from myopic, anomalous-appearing nerves with an approximate cup-to-disc ratio of 0.90 in both eyes. Humphrey visual field showed nonspecific changes on the right and moderate nasal defect on the left eye, stable to previous examinations dating back to 2018 (Figure 1 JOURNAL/jcrs/04.03/02158034-202407000-00018/figure1/v/2024-07-10T174240Z/r/image-tiff and Figure 2 JOURNAL/jcrs/04.03/02158034-202407000-00018/figure2/v/2024-07-10T174240Z/r/image-tiff ). Optical coherence tomography (OCT) of the retinal nerve fiber layer (RNFL) revealed moderated thinning in both eyes that was also stable to prior examinations (Figure 3 JOURNAL/jcrs/04.03/02158034-202407000-00018/figure3/v/2024-07-10T174240Z/r/image-tiff ). Her axial length measured 25.23 and 26.34 mm in the right and left eyes, respectively. Central corneal thickness was 553 μm in the right eye and 563 μm in the left eye before her DSEK procedure. What would be your approach to management of this patient's left eye, addressing the following: Rationale for your procedure of choice? Would you over-rule the corneal surgeon and stop the steroid in an attempt to obviate the need for glaucoma surgery? Does the age of onset of glaucoma affect your surgical decision making? Note that patient age at the time of trabeculectomy was 22 years. Are some procedures better suited for patients after DSEK surgery?
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 1 JOURNAL/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 2 JOURNAL/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?
The glaucoma treatment paradigm is in evolution. The topical medications-first approach is limited by significant barriers such as high rates of nonadherence and side effects including ocular surface disease. The era of interventional glaucoma has seen the development of selective laser trabeculoplasty (SLT), procedural pharmaceuticals, and minimally invasive glaucoma surgeries (MIGS). New and emerging data support the use of these interventional treatment modalities early in the course of glaucoma rather than reserving them for advanced or treatment-recalcitrant cases. The various treatments available represent multiple mechanisms (e.g., trabecular outflow, uveoscleral outflow, aqueous suppression) and modalities (medications, laser, incisional surgery) by which intraocular pressure (IOP) is reduced. Many patients require more than one treatment to achieve adequate IOP reduction and glaucoma control. Comprehensive IOP control—reduction of both mean IOP and IOP fluctuation—can best be achieved by targeting multiple mechanisms of IOP reduction and taking advantage of the attributes of multiple treatment modalities.
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.
Nocturnal intraocular pressure (IOP) profiling has shown that the peak IOP usually occurs at night, particularly in patients with glaucoma. Multiple studies have demonstrated that these nocturnal IOP elevations drive glaucomatous progression, often despite stable daytime IOP. Existing vascular dysregulation and decreased nighttime blood pressure compound the damage via low ocular perfusion pressure while elevated nocturnal IOP disrupts axonal transport. These findings are consistent with studies that indicate lowering nocturnal IOP is important for slowing glaucoma progression. Many of the current treatment options lower nighttime IOP significantly less than daytime IOP. Non-invasive IOP-lowering treatments that effectively lower nocturnal IOP remain an unmet need in the treatment of glaucoma.
Purpose:To evaluate the sustainability of IOP reduction with continuous negative pressure application over an extended duration with use of the Ocular Pressure Adjusting Pump. Methods:Prospective, controlled, open-label, randomized, single site, pilot study. Subjects with primary open-angle glaucoma (OAG) were enrolled. One eye of each subject was randomized to receive negative pressure application; the fellow eye served as a control. The study eye negative pressure setting was programmed for 60% of the baseline IOP. Subjects wore the Ocular Pressure Adjusting Pump for 8 consecutive hours and IOP measurements occurred at 2-hour intervals for a total of 5 IOP measurements (08:00, 10:00, 12:00, 14:00, 16:00). Results:Nine subjects successfully enrolled and completed the study. The mean programmed negative pressure setting was -12.0 mmHg. At baseline, the mean IOP in the study eye was 21.4 ± 4.3 mmHg. The mean IOP reduction in the study eye at hours 0, 2, 4, 6, and 8 was 8.1 (37%), 6.4 (28%), 6.3 (29%), 7.3 (34%) and 6.7 (31%), respectively. All IOP measurements during negative pressure application were reduced from baseline. There were no serious adverse events. Conclusion:The Ocular Pressure Adjusting Pump provides a sustained reduction in IOP while the device is worn with negative pressure applied with an IOP reduction exceeding 25% across 8 hours of continuous wear.
Purpose: Compare estimated sensitivities of SITA-Standard to the RATA-Standard algorithm of the Radius virtual reality perimeter (VRP), and measure concordance in glaucoma staging. Methods: One hundred adult glaucoma patients—half with suspect or mild glaucoma, and half with moderate or severe—from five clinics performed four 24-2 visual field tests during a single visit, two with the Humphrey Field Analyzer (HFA) and two with Radius, in randomized order: HRHR or RHRH. Only one eye was tested per participant. We used the Wilcoxon rank sum test with Bonferroni correction to compare distributions of estimated sensitivities across all 54 test locations over the 15 to 40 dB measurement range of the Radius. Weighted kappa measured concordance in glaucoma staging between two masked glaucoma experts using Medicare definitions of severity. Results: A total of 62 OD and 38 OS eyes were tested. Estimated sensitivities for SITA-Standard and RATA-Standard were not significantly different for OD, but were for OS—likely because of SITA-Standard OD and OS being significantly different in our sample, but not for RATA-Standard. Low agreement was observed between 15 to 22 dB. Concordance in glaucoma staging was high for both graders: kappa = 0.91 and kappa = 0.93. Average test duration was 298 seconds for RATA-Standard and 341 seconds for SITA-Standard. The correlation in mean deviation was 0.94. Conclusions: Estimated sensitivities of RATA-Standard are comparable to SITA-Standard between 23 to 40 dB with high concordance in glaucoma staging. Translational Relevance: Radius VRP is statistically noninferior to HFA when staging glaucoma using Medicare definitions.
The development of minimally invasive glaucoma surgeries (MIGSs) was intended to provide safe and modestly efficacious modalities for early intervention of mild-to-moderate glaucoma, with minimal trauma and rapid recovery. They were mainly ab interno procedures that reduce intraocular pressure by facilitating the aqueous outflow by bypassing the trabecular meshwork resistance, reinforcing the uveoscleral flow via the supraciliary space, and reducing aqueous production by the ciliary body. While the cumulating evidence helps shape the role of the available MIGS, the exponential new development and advancement in this field has expanded the territory of MIGS. Apart from developing subconjunctival MIGS filtration devices (Xen gel stent and PRESERFLO MicroShunt), there is a tendency to revisit the "traditional" MIGS for alternative use and to modify the procedures with consideration of the fundamental aqueous outflow physiology. Combined MIGS has also been suggested, based on the theory that their different mechanisms may provide additive or synergistic effects. The advancement of laser procedures is also promising and could supplement unmet needs along the glaucoma treatment algorithm. This review examines the broad array of MIGS, updates the recent findings, discusses their potential alternative applications, and explores future challenges.
Topical glaucoma medications are effective and safe, but they have numerous well-documented limitations that diminish their long-term utility and sustainability. These limitations can include high rates of nonadherence (with associated glaucoma progression), concerning side effects, inconsistent circadian intraocular pressure (IOP) control, complex dosing regimens, difficulty with self-administration, costs, and decreased quality of life. Despite these limitations, topical medications traditionally have been first-line in the glaucoma treatment algorithm, as no other minimally invasive treatment alternatives existed. In recent years, however, novel interventional therapies—including sustained-release drug-delivery platforms, selective laser trabeculoplasty, and micro-invasive glaucoma surgery procedures—have made it possible to intervene earlier without relying on topical medications. As a result, the topical medication-first treatment approach is being reevaluated in an overall shift toward earlier more proactive interventions.
Précis: The multi-pressure dial applies localized periocular negative pressure to safely and effectively lower IOP and represents the first non-invasive, non-pharmacologic device for IOP reduction. Objective: To evaluate the safety and effectiveness of the Multi-Pressure Dial (MPD) system, a device that applies periocular negative pressure to lower intraocular pressure (IOP). Setting: 6 investigational sites, United States. Design: Prospective, assessor-masked, randomized controlled trial. Methods: Subjects with suspected glaucoma, ocular hypertension (OHTN), and open angle glaucoma (OAG) with baseline IOP ≥13 mmHg and ≤32 mmHg were enrolled. One eye of each subject was randomized to receive negative pressure application; the fellow eye served as a control. The study eye negative pressure setting was programmed for 60% of the baseline IOP. The primary effectiveness endpoint was the proportion of study eyes versus control eyes achieving an IOP reduction ≥20% at Day 90. Secondary endpoints included the proportion of eyes achieving an IOP reduction ≥25% at Day 90 as well as the proportion of eyes achieving an IOP reduction ≥20% at Days 30 and 60. Results: 116 eyes of 58 subjects completed the study. At the Day 90 visit, 89.7% ( n =52) of study eyes versus 3.4% ( n =2) of control eyes achieved an IOP reduction ≥20% ( P <0.001). At Day 90, 77.6% ( n =45) of study eyes achieved a ≥25% IOP reduction compared to 1.7% ( n =1) of control eyes ( P <0.001). The most commonly reported adverse events were lid (17.2% study eye, 7.8% control eye) and periorbital edema (14.1% study eye, 10.9% control eye). Conclusions: This trial demonstrates that the MPD safely and effectively lowers IOP in a group of patients that included glaucoma suspects, OHTN, and patients with OAG.
Selective laser trabeculoplasty (SLT) has been in routine clinical use for over 20 years with millions of patients successfully treated and a low rate of clinically significant complications. The procedure requires the clinician to manually position the laser beam on the trabecular meshwork using a gonioscopy lens and to titrate the SLT laser energy based on the amount of pigmentation in the angle, as well as the observation of small bubbles produced by the laser effect. We propose that SLT energy titration is unnecessary either to achieve intraocular pressure (IOP) reduction or to minimize potential side effects. Ample evidence to support our proposal includes multiple clinical reports demonstrating comparable levels of IOP reduction resulting from different laser energies, a large variety of energy and other laser parameters used in commercially available SLT lasers, and the nature of the laser-induced changes in the trabecular meshwork tissue with respect to energy. Despite these variations in laser parameters, SLT consistently reduces IOP with a low complication rate. We propose that using low fixed energy for all patients will effectively and safely lower patients' IOP while reducing the complexity of the SLT procedure, potentially making SLT accessible to more patients.
Selective laser trabeculoplasty (SLT) has been in routine clinical use for over 20 years with millions of patients successfully treated and a low rate of clinically significant complications. The procedure requires the clinician to manually position the laser beam on the trabecular meshwork using a gonioscopy lens and to titrate the SLT laser energy based on the amount of pigmentation in the angle, as well as the observation of small bubbles produced by the laser effect. We propose that SLT energy titration is unnecessary either to achieve intraocular pressure (IOP) reduction or to minimize potential side effects. Ample evidence to support our proposal includes multiple clinical reports demonstrating comparable levels of IOP reduction resulting from different laser energies, a large variety of energy and other laser parameters used in commercially available SLT lasers, and the nature of the laser-induced changes in the trabecular meshwork tissue with respect to energy. Despite these variations in laser parameters, SLT consistently reduces IOP with a low complication rate. We propose that using low fixed energy for all patients will effectively and safely lower patients' IOP while reducing the complexity of the SLT procedure, potentially making SLT accessible to more patients.
center dot 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 glau-coma (POAG).center dot DESIGN: 5-year follow-up safety study of the prospec-tive, randomized, single-masked, concurrently controlled, multicenter iStent inject pivotal trial.center dot 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 phacoemul-sification or phacoemulsification alone were studied for the incidence of clinically relevant complications associ-ated 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 endothe-lial images by a central image analysis reading center at several time points through 60 months postoperatively.center dot RESULTS: Of the 505 original randomized patients, 227 elected to participate (iStent inject and phacoemulsifica-tion 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.center dot 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 com-pared to phacoemulsification alone through 60 months. (Am J Ophthalmol 2023;252: 17-25.(c) 2023 The Author(s). Published by Elsevier Inc. This is an open access article under the CC BY license ( http://creativecommons.org/licenses/by/4.0/ ))
A 50-year-old ophthalmic technician was referred by her retina specialist for urgent consultation due to markedly elevated intraocular pressure (IOP) unresponsive to medical therapy. Her history included chronic polyarticular juvenile rheumatoid arthritis and chronic uveitis requiring ongoing topical steroid therapy. She had a sub-Tenon injection of Kenalog (triamcinolone) 18 months prior to referral. Chronic topical anti-inflammatory therapy included nepafenac (Ilevro) and prednisolone acetate 2 times a day. Attempts to discontinue topical steroid resulted in worsening inflammation. The patient was referred when the IOP measured 44 mm Hg in the left eye despite aggressive medical therapy, including acetazolamide. The IOP improved slightly when loteprednol was substituted for prednisolone acetate. Current medications in the left eye include brimonidine 3 times a day, loteprednol 2 times a day, nepafenac 2 times a day, and fixed combination latanoprost + netarsudil at bedtime. Her only medication in the right eye was travoprost. She is intolerant to dorzolamide. She was also taking acetazolamide 500 mg 2 times a day. She was not taking any anticoagulants. Past surgical history included cataract surgery in each eye. She has not had laser trabeculoplasty in either eye. Examination revealed uncorrected visual acuity of J1+ in the right eye (near) and 20/30 in the left eye (mini-monovision). There was no afferent pupillary defect. There was mild band keratopathy in each eye while the central cornea was clear in both eyes without keratic precipitates. Here angles were open to gonioscopy without peripheral anterior synechia. There was mild to moderate flare in each eye with trace cells. The IOP was 17 mm Hg in the right eye and 31 mm Hg in the left. Central corneal thickness measured 560 μm and 559 μm in the right and left eye respectively. There was a well-positioned intraocular lens within each capsule with a patent posterior capsulotomy. There was mild vitreous syneresis but no vitreous cell. The cup to disc ratio was 0.5 in each eye with a symmetrical neural rim. The retina was flat without macular edema. Visual field was normal in both eyes (Figures 1 and 2). Optical coherence tomography of retinal nerve fiber layer (RNFL) is shown in Figure 3 and retinal ganglion cell layer is shown in Supplemental Figure 1 (http://links.lww.com/JRS/A756).JOURNAL/jcrs/04.03/02158034-202301000-00020/figure1/v/2022-12-26T045736Z/r/image-tiffJOURNAL/jcrs/04.03/02158034-202301000-00020/figure2/v/2022-12-26T045736Z/r/image-tiffJOURNAL/jcrs/04.03/02158034-202301000-00020/figure3/v/2022-12-26T045736Z/r/image-tiff Please comment on your management of this patient's left eye.
Glaucoma remains a leading cause of blindness globally. Minimally invasive treatment techniques are rapidly expanding the availability of therapeutic options for glaucoma. These include devices aimed at enhancing outflow through the subconjunctival space, Schlemm's canal, and suprachoroidal space, sustained-release drug delivery devices, and extraocular devices aiming to reduce glaucomatous progression through other novel means. In this review, we provide an overview of several novel devices either newly available or in development for the medical and surgical management of glaucoma. Further studies are required to determine the long-term efficacy of these devices and how they will integrate into the current landscape of glaucoma management.