Validation of a Wearable Virtual Reality Perimeter for Glaucoma Staging, The NOVA Trial: Novel Virtual Reality Field Assessment.

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.

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?

Minimally Invasive Glaucoma Surgery: Latest Developments and Future Challenges.

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.

Challenging the "Topical Medications-First" Approach to Glaucoma: A Treatment Paradigm in Evolution.

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.

New Devices in Glaucoma.

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.

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?

Negative Pressure Application via a Multi-Pressure Dial to Lower IOP in Patients with Suspected Glaucoma or Open Angle Glaucoma.

PRCIS: 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.

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.

Extreme intraocular pressure and steroid-dependent iritis.

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.

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.

A mysterious myopic surprise.

A 73-year-old man with an ocular history of inactive age-related macular degeneration and chronic angle-closure glaucoma (CACG) in both eyes recently underwent femtosecond laser-assisted cataract surgery/phacoemulsification and intraocular lens (IOL) implantation with simultaneous Hydrus microstent (Ivantis, Inc.) implantation in the left eye. Although there was some reported subincisional iris prolapse due to intraoperative floppy iris, the case was otherwise uneventful according to the referring surgeon. Two months postoperatively, he was referred to our office for a myopic surprise of approximately 2.0 diopters (D) in the left eye (Figure 1JOURNAL/jcrs/04.03/02158034-202202000-00022/figure1/v/2022-01-26T192641Z/r/image-tiff). Of note, he has a distant history of acute ACG and complicated cataract surgery in the right eye with a failed trabeculectomy. He subsequently had laser peripheral iridoplasty to pull the iris away from the angle in the right eye (Figure 2JOURNAL/jcrs/04.03/02158034-202202000-00022/figure2/v/2022-01-26T192641Z/r/image-tiff). His topical intraocular pressure (IOP)-lowering medications at presentation included dorzolamide-timolol 1 drop twice daily in the left eye and 1 drop of timolol in the right eye once daily. His past medical history is significant for hypertension and benign prostatic hyperplasia, and his oral medications include Tamsulosin (Flomax), Irbasartan (Avapro), and Atenolol. On examination, he had an UCDVA of 20/20 in the right eye and 20/80 in the left eye, and a BCDVA of 20/20 in the right eye and 20/25 in the left eye. His manifest refraction was plano in the right eye and 1.50 -0.75 × 90 in the left eye. IOP measured 19 mm Hg in the right eye and 26 mm Hg in the left eye. Pupil examination revealed a nonreactive pupil in the right eye and a round sluggish pupil in the left eye without an obvious relative afferent pupillary defect. Extraocular motility and confrontational visual fields were full in both eyes. On slitlamp examination, pertinent findings included the following: 1+ corneal guttata without edema in both eyes; anterior chambers were shallow but adequate in both eyes with scattered peripheral anterior synechiae in the right eye and a uniformly shallow but adequate chamber in the left eye; there was no cell or flare in either eye. Iris findings included a surgical pupil with a fibrotic pupillary membrane, laser iridoplasty scars with scattered temporal transillumination defects (TIDs) in the right eye, and 2.5 clock hours of TIDs and a patent peripheral iridotomy at 1 o'clock in the left eye; lens examination revealed centered posterior chamber IOLs with open posterior capsules in both eyes and lens pitting in the left eye. Pertinent findings on dilated fundus examination included a cup-to-disc ratio of 0.3 in both eyes with good neuroretinal rims and macular examination revealed medium-sized drusen with pigment clumping in both eyes and no active choroidal neovascular membranes. The remainder of the examination was unremarkable. What is the etiology of this myopic surprise? What diagnostic testing will help confirm the diagnosis and what are the best management options for this patient?

Acute iris toxicity following bilateral gel stent implantation with mitomycin-C and intracameral moxifloxacin January consultation #1.

A 72-year-old woman with moderate primary open-angle glaucoma was referred for management of her glaucoma and photophobia. Her ocular history is significant for routine cataract surgery in both eyes 6 years prior to presentation. She was diagnosed with glaucoma 7 months prior to presentation at which time the patient underwent sequential, ab externo, open conjunctival, Xen Gel Stent (Allergan, Inc.) placement with mitomycin-C (MMC) in each eye, approximately 2 weeks apart. The history obtained directly from the surgeon revealed that MMC dosing was 0.2 mL in a concentration of 0.2 mg/mL delivered through subconjunctival injection after placement of the gel stent. Intracameral moxifloxacin was injected at the time of surgery, and moxifloxacin and Maxitrol eyedrops were used in the postoperative period. The patient noted that, approximately 1 month after each surgery, she developed significant photophobia. An outside examination noted bilateral tonic pupils and concern for early bleb failure in the left eye. 2 months after the initial gel stent placement in the left eye, she underwent a bleb revision with a McCannel suture iris cerclage in the left eye. The intraocular pressure (IOP) in both eyes remained well controlled off pressure-lowering medications; however, the tonic pupils and photophobia persisted. The patient was subsequently referred for further assessment. At presentation, the patient's corrected distance visual acuity was 20/20 in each eye. Applanation tonometry IOP was 17 mm Hg and 14 mm Hg for the right and left eyes, respectively. Pupils were tonic and irregular. The lack of pupillary response prevented testing for relative afferent pupillary defects directly or by reverse testing. Slitlamp examination of the right eye was notable for a minimally elevated superior bleb and severe iris stromal atrophy with diffuse transillumination defects. The intraocular lens (IOL) appeared well positioned in the capsular bag without signs of pseudophacodonesis (Figure 1JOURNAL/jcrs/04.03/02158034-202201000-00021/figure1/v/2021-12-20T152346Z/r/image-tiff). The left eye was notable for a diffuse superior bleb and similar iris and IOL findings to the right eye, except for 2 McCannel iris sutures in the iris stroma (Figure 2JOURNAL/jcrs/04.03/02158034-202201000-00021/figure2/v/2021-12-20T152346Z/r/image-tiff). In both eyes, the anterior chambers were deep and quiet, and there were no corneal endothelial abnormalities. Fundus examinations of both the right and left eyes were notable for glaucomatous-appearing optic nerves and otherwise healthy macula, vessels, and periphery. Gonioscopy revealed open angles in each eye with fairly marked, densely layered pigment throughout the inferior angle and trabecular meshwork. The gel stents were positioned just anteriorly to the trabecular meshwork superiorly, well away from iris tissue. Optical coherence tomography (OCT) of the nerve fiber layer (NFL) showed moderate to severe thinning inferiorly and superiorly in the right eye, with mild to moderate thinning inferiorly in the left eye (Supplemental Figure 1, http://links.lww.com/JRS/A510). Ganglion cell analysis correlated with the NFL findings (Supplemental Figure 2, http://links.lww.com/JRS/A510). Humphrey visual field testing revealed a dense superior arcuate in the right eye and moderate inferior arcuate in the left eye (Supplemental Figures 3 and 4, http://links.lww.com/JRS/A510). OCT of the macula in both eyes was unremarkable. Finally, specular microscopy showed normal endothelial density and configuration of each eye (Supplemental Figure 5, http://links.lww.com/JRS/A510). What part of the patient's ocular history would you consider relevant to the development of tonic, atrophic pupils? What additional information would you want to know to help refine your differential diagnosis? What is your preferred surgical technique when implanting the Xen Gel Stent? Please include whether ab interno or ab externo and open or closed conjunctival approach to be used and mention antifibrosis dosing and method of administration. Finally, what would be your approach for managing this patient's severe photophobia, in the setting of her moderate open-angle glaucoma?

Spontaneous filtering bleb with subsequent secondary glaucoma June consultation #1.

A 32-year-old previously healthy woman was referred for evaluation and management of newly diagnosed hypotony in the right eye. Her ocular history was significant only for moderate myopia and an idiopathic Horner syndrome in the left eye diagnosed at age 13. The patient endorsed a history of fluctuating and decreasing vision in the right eye over the past 6 months. She denied any ocular pain, previous ocular surgery, or recent trauma. The patient was otherwise healthy and denied any previous autoimmune disease or systemic infection. She wore soft, daily disposable contact lenses and reported no abnormalities on previous routine eye examinations. At presentation, the patient's uncorrected distance visual acuity was 20/25 in the right eye and 20/200 in the left. Lensometry revealed a previous refraction of -3.00 + 0.50× 150 in the right eye and -4.00 + 1.75× 174 in the left. Intraocular pressures (IOPs) were 4 mm Hg and 15 mm Hg by applanation, and central corneal thicknesses were 573 µm and 564 µm in the right and left eyes, respectively. Slitlamp examination revealed an area of scleral thinning near the limbus in the right eye from 5 to 7 o'clock with mild overlying chemosis (Figure 1JOURNAL/jcrs/04.03/02158034-202107000-00023/figure1/v/2021-06-26T110826Z/r/image-tiff). Gonioscopy showed an open angle with mild trabecular meshwork pigmentation in both eyes without any cyclodialysis clefts, peripheral anterior synechiae (PAS), or other abnormalities. Dilated fundus examination was significant for mild optic nerve edema and chorioretinal folds in the right eye. Optical coherence tomography (OCT) of the optic nerve confirmed mild disc edema (Figure 2JOURNAL/jcrs/04.03/02158034-202107000-00023/figure2/v/2021-06-26T110826Z/r/image-tiff) and OCT of the macula confirmed mild chorioretinal folds. Anterior segment OCT (AS-OCT) and ultrasound biomicroscopy failed to show any other abnormalities. The patient was initially observed without treatment and presented urgently approximately 1 month later with decreased vision and ocular discomfort. Repeat examination revealed an IOP of 31 mm Hg and a focal area of PAS to the previous area of scleral thinning (Figure 3JOURNAL/jcrs/04.03/02158034-202107000-00023/figure3/v/2021-06-26T110826Z/r/image-tiff). In one respect, the newly elevated IOP was considered transiently therapeutic to help reverse the hyperopic shift, disc edema, and hypotony-related maculopathy. However, the situation quickly became more worrisome when shortly thereafter the IOP elevated to 55 mm Hg at subsequent follow-up, and multiple IOP-lowering medications were initiated. Over numerous additional visits, the patient's IOPs ranged from 30 to 39 mm Hg in the right eye despite rapidly advancing to maximally tolerated medical therapy including acetazolamide. She was noted to have a new relative afferent pupillary defect of the right eye, and Humphrey visual fields showed early arcuate defects (Figure 4JOURNAL/jcrs/04.03/02158034-202107000-00023/figure4/v/2021-06-26T110826Z/r/image-tiff). What would be your approach to managing this healthy, young, myopic woman who presented with hypotony due to a spontaneous, perilimbal filtration bleb that later occluded with PAS, resulting in intractably elevated IOP and field loss? What is the differential diagnosis? Would you perform a systemic workup for her initial scleral thinning, and if so, what would you check? Would you intervene for her elevated IOP in the right eye? If so, what would be your surgical approach?

Management of hypotony-related maculopathy after combined phacoemulsification and trabeculectomy: January consultation #1.

A 59-year-old man with mild to moderate pigmentary glaucoma was referred for management of hypotony-related maculopathy 3 years after combined phacoemulsification and trabeculectomy in his right eye. His ocular history is significant for retinal detachment in the right eye that was surgically treated with a pars plana vitrectomy and scleral buckle 5 years prior to the current presentation and 1 year prior to his combined phacoemulsification-trabeculectomy procedure. After trabeculectomy, he reportedly had a wound leak with hypotony and choroidal effusion. The patient was referred to a second surgeon who performed a bleb revision with a pericardial patch graft, but the patient had a severe intraocular pressure (IOP) spike in the immediate postoperative period requiring suture removal. This resulted in recurrent hypotony with maculopathy. A second bleb revision with pericardial patch graft was performed but was not successful in raising the IOP out of the single digits or in resolving the maculopathy. Accordingly, the patient was referred for further assessment. At presentation, the patient's corrected distance visual acuity was 20/100 in the right eye and 20/20 in the left eye. Applanation tonometry IOP was 4 mm Hg and 16 mm Hg for the right and left eyes, respectively. Central corneal thickness was 609 µm in the right eye and 574 µm in the left eye. The right pupil was noted to be slightly irregular with a relative afferent pupillary defect. Slitlamp examination of the right eye was notable for a moderately elevated, Seidel test-negative bleb, and deep anterior chamber. The left eye had a Krukenberg spindle and mild nuclear sclerotic cataract but was otherwise unremarkable. Fundus examination of the right eye was notable for significant macular folds with edematous nerve fiber layer (NFL) and optic nerve. The left optic nerve and fundus examination were unremarkable. Gonioscopy revealed open angles with dense trabecular meshwork pigment in both eyes. There was a nicely patent superior sclerostomy in the right eye. There was no cyclodialysis cleft. Optical coherence tomography (OCT) of the macula showed chorioretinal folds and NFL edema in the right eye and was normal in the left eye (Figure 1JOURNAL/jcrs/04.03/02158034-202101000-00022/figure1/v/2021-01-04T143903Z/r/image-tiff). The OCT of the optic nerve in the right eye was distorted secondary to the chorioretinal folds, whereas the left eye was notable for mild superior thinning of the NFL (Figure 2JOURNAL/jcrs/04.03/02158034-202101000-00022/figure2/v/2021-01-04T143903Z/r/image-tiff). Humphrey visual field revealed a superior nasal step in the right eye (Figure 3JOURNAL/jcrs/04.03/02158034-202101000-00022/figure3/v/2021-01-04T143903Z/r/image-tiff). Axial lengths were 25.33 mm and 26.53 mm in the right and left eye, respectively; it is notable that the right eye had a shorter axial length despite the scleral buckle, which demonstrates the degree of axial shortening from hypotony (Figure 4JOURNAL/jcrs/04.03/02158034-202101000-00022/figure4/v/2021-01-04T143903Z/r/image-tiff). What would be your approach for managing this patient's hypotony? Does the fact that the referring surgeon had performed 2 failed bleb revision procedures prior to referral influence your approach? Given that a previous attempt at revision resulted in an extreme IOP spike would you also recommend a glaucoma procedure? If so, what procedure would you perform? Would you do it coincident with the revision or in a staged procedure later on an as-needed basis?

Quality of Life in Primary Open-Angle Glaucoma and Cataract: An Analysis of VFQ-25 and OSDI From the iStent inject® Pivotal Trial.

OBJECTIVE: To assess quality of life (QOL) as measured by patient-reported outcomes (PRO) within the iStent inject® pivotal trial. DESIGN: Randomized controlled trial analysis of secondary outcomes. METHODS: The Vision Function Questionnaire (VFQ-25) and Ocular Surface Disease Index (OSDI) questionnaire were administered at baseline and at months 1, 6, 12, and 24. PRO responders were defined as patients reaching improvement based on minimally important differences. RESULTS: A total of 505 patients were randomized (386 iStent inject® [Glaukos], 119 surgery alone). The iStent inject® group exhibited a greater percentage of PRO responders across all follow-up visits over 24 months, averaging 58.0% vs 45.8%; P < .05 for VFQ-25 composite scores and 56.7% vs 48.9%; P < .05 for OSDI composite scores. Odds of being a responder in the iStent inject® group was 60% (P < .05) higher for the VFQ-25 and 32% (P > .05) higher for the ODSI. Driving (49.0% vs 28.8%; P < .05), ocular pain (59.3% vs 47.2%; P < .05), and general vision (71.8% vs 60.0%; P < .05) were the VFQ-25 subscales responsible for differences between treatment groups. At month 24, 76.5% of VFQ-25 responders and 62.5% of nonresponders were medication free regardless of treatment group (P < .05). CONCLUSIONS: Exploratory analysis suggests that by reducing medication dependence, implantation with the micro-scale iStent inject® device with cataract surgery may improve QOL vs cataract surgery alone over 24 months, with improvements influenced by ocular symptoms and vision-related activities.

Canaloplasty and Trabeculotomy Combined with Phacoemulsification in Open-Angle Glaucoma: Interim Results from the GEMINI Study.

PURPOSE: To report interim 6-month safety and efficacy outcomes of 360° canaloplasty and 180° trabeculotomy using the OMNI® Surgical System concomitantly with phacoemulsification in patients with open-angle glaucoma (OAG). SETTING: Fifteen multi-subspecialty ophthalmology practices and surgery centers located in 14 states (Alabama, Arizona, Arkansas, Florida, Georgia, Iowa, Kansas, Montana, Nebraska, North Dakota, Oklahoma, Pennsylvania, Texas, and Wisconsin). DESIGN: Prospective, multicenter, IRB approved study of patients treated with canaloplasty (360°) and trabeculotomy (180°). Eligible patients had cataract and mild-moderate OAG with intraocular pressure (IOP) ≤33 mmHg on 1 to 4 hypotensive medications. METHODS: Medication washout prior to baseline diurnal IOP (Goldmann). Effectiveness outcomes included mean IOP and medications. Safety outcomes included adverse events (AE), best corrected visual acuity (BCVA) and secondary surgical interventions (SSI). Analysis includes descriptive statistics and t-tests evaluating change from baseline. RESULTS: A total of 137 patients were enrolled and treated. Mean diurnal IOP after washout was 23.8 ± 3.1 mmHg at baseline. At month 6, 78% (104/134) were medication free with IOP of 14.2 mmHg, a mean reduction of 9.0 mmHg (38%). 100% (104/104) had a ≥ 20% reduction in IOP and 86% (89/104) had IOP ≥6 and ≤18 mmHg. The mean number of medications at screening was 1.8 ± 0.9 and 0.6 ± 1.0 at month 6. AE included transient hyphema (4.6%) and IOP elevation ≥10 mmHg (2%). There were no AE for loss of BCVA or recurring hyphema. There were no SSI. CONCLUSION: Canaloplasty followed with trabeculotomy and performed concomitantly with phacoemulsification has favorable intra and perioperative safety, significantly reduces IOP and anti-glaucoma medications through 6 months in eyes with mild-moderate OAG.