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Single Administration of Intracameral Bimatoprost Implant 10 µg in Patients with Open-Angle Glaucoma or Ocular Hypertension

Medeiros, Felipe A; Sheybani, Arsham; Shah, Manjool M; Rivas, Marcos; Bai, Zhanying; Werts, Erica; Ahmed, Iqbal I K; Craven, E Randy
INTRODUCTION/BACKGROUND:This study evaluated the intraocular pressure (IOP)-lowering efficacy and safety of a single intracameral administration of bimatoprost implant 10 µg in adults with open-angle glaucoma or ocular hypertension. METHODS:Two identically designed, randomized, 20-month, parallel-group, phase 3 clinical trials (one study eye/patient) compared three administrations of 10- or 15-µg bimatoprost implant (day 1, weeks 16 and 32) with twice-daily topical timolol maleate 0.5%. An open-label, 24-month, phase 1/2 clinical trial compared one or two implants administered in the study eye with once-daily topical bimatoprost 0.03% in the fellow eye. Separate analyses of the pooled phase 3 and phase 1/2 study datasets evaluated outcomes in the 10-µg bimatoprost implant and comparator treatment arms after a single implant administration, up to the time of implant re-administration or rescue with IOP-lowering medication. RESULTS:In the phase 3 studies, 10-µg bimatoprost implant single administration demonstrated IOP reductions (hour 0) of 4.9-7.0 mmHg through week 15 from a mean (standard deviation, SD) baseline IOP of 24.5 (2.6) mmHg (n = 374); IOP in the topical timolol BID group was reduced by 6.0-6.3 mmHg from a mean (SD) baseline IOP of 24.5 (2.6) mmHg (n = 373). In the phase 1/2 study (n = 21), median time to use of additional IOP-lowering treatment (Kaplan-Meier analysis) was 273 days (approximately 9 months), and 5 of 21 enrolled patients (23.8%) required no additional IOP-lowering treatment up to 24 months after single administration. In each study, after a single implant administration there were no reports of corneal edema, corneal endothelial cell loss, or corneal touch, and no patients had 20% or greater loss in corneal endothelial cell density. CONCLUSIONS:Bimatoprost implant single administration lowers IOP and has a favorable safety profile. Additional studies are needed to further evaluate the duration of effect and factors predicting long-term IOP lowering after a single implant administration. TRIAL REGISTRATION NUMBERS/BACKGROUND:ClinicalTrials.gov NCT02247804, NCT02250651, and NCT01157364.
PMCID:9253216
PMID: 35643967
ISSN: 2193-8245
CID: 5333742

Potentially Missed Opportunities in Prevention of Acute Angle-Closure Crisis

Wu, Annie M; Stein, Joshua D; Shah, Manjool
Importance:If an anatomic narrow angle is not appropriately diagnosed and treated, it can result in acute angle-closure crisis (AACC) and lead to substantial vision loss. Objective:To identify patients who presented with AACC and assess for factors that may have been associated with risk of developing it. Design, Setting, and Participants:This population-based retrospective cohort study conducted from January 1, 2001, to December 31, 2015, included a 20% nationwide sample of 1179 Medicare beneficiaries. Patients aged 40 years or older with AACC were identified with billing codes. A 2-year lookback period from the date of initial presentation of AACC was used to identify patients who had at least 1 eye care visit, received a diagnosis of open-angle glaucoma (OAG) or suspected OAG, or received at least 1 medication associated with risk of AACC. Of the patients who had at least 1 eye care visit, those who underwent gonioscopy, received a diagnosis of an anatomic narrow angle before developing AACC, or both were identified. Main Outcomes and Measures:Proportions of patients who had at least 1 eye care visit, had OAG or suspected OAG, received at least 1 medication associated with risk of AACC, underwent gonioscopy, or received a diagnosis of an anatomic narrow angle before development of AACC. Results:A total of 1179 patients had a confirmed diagnosis of AACC. The mean (SD) age of patients with AACC was 66.7 (11.8) years (range, 40-96 years), 766 were women (65.0%), 57 were Asian (4.8%), 109 were Black (9.2%), 126 were Latino (10.7%), 791 were White (67.1%), and 96 were other race and ethnicity (8.1%). Of these patients, only 796 (67.5%) consulted an optometrist or ophthalmologist at least once during the 2-year lookback period. A total of 464 individuals (39.4%) had OAG or suspected OAG, and 414 (35.1%) had received at least 1 medication associated with increased risk of AACC before developing it. Of the 796 patients who consulted an optometrist or ophthalmologist in the lookback period, less than one-third underwent gonioscopy in the 2 years before developing AACC (n = 264 [33.2%]), and less than one-half of all patients undergoing gonioscopy received a diagnosis of an anatomic narrow angle (n = 113 [42.8%]). Most patients underwent gonioscopy in the 1 to 4 weeks preceding the AACC. Conclusions and Relevance:In this group of Medicare patients, there appear to have been multiple opportunities for interventions that may have averted AACC. Interventions aimed at addressing risk factors associated with AACC and improving performance of gonioscopy might be associated with reduced risk for ocular morbidity.
PMID: 35554487
ISSN: 2168-6173
CID: 5333732

A mysterious myopic surprise [Case Report]

Fram, Nicole R; Bedrood, Sahar; Durr, Georges M; Liaboe, Chase A; Samuelson, Thomas W; Shah, Manjool; McCabe, Cathleen
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?
PMID: 35082239
ISSN: 1873-4502
CID: 5333722

Auto-Trabeculotomy Secondary to Blunt Force Trauma

Sun, Lynn W; Schneider, Kevin J; Shah, Manjool M
PMID: 35067276
ISSN: 2589-4196
CID: 5333712

Descemet membrane endothelial keratoplasty in a patient with iris-fixated intraocular lens and prior radial keratotomy: a case report [Case Report]

Annadanam, Anvesh; Soeken, Timothy; Shah, Manjool; Nallasamy, Nambi
BACKGROUND:Anterior segment surgeries such as cataract surgery, intraocular lens (IOL) repositioning, and radial keratotomy (RK) may hasten endothelial dysfunction, particularly in the context of pre-existing Fuchs dystrophy, necessitating future corneal transplantation. CASE PRESENTATION/METHODS:A 68-year-old woman with a history of RK with associated irregular astigmatism in both eyes and iris-fixated intraocular lens (IF-IOL) in the left eye presented with six months of decreased vision in the left eye. She was found to have Fuchs dystrophy and underwent DMEK surgery. She had an uncomplicated postoperative course, with uncorrected visual acuity improving to 20/20 three months after surgery. CONCLUSION/CONCLUSIONS:To our knowledge, this is the first reported case of a highly successful DMEK surgery in a patient with prior RK and IF-IOL.
PMCID:8454097
PMID: 34544369
ISSN: 1471-2415
CID: 5333702

June consultation #5 [Comment]

Shah, Manjool
PMID: 34173387
ISSN: 1873-4502
CID: 5333692

Navigating Challenges after Xen

Vera, V; Shah, Manjool; Smith, T; Pinto, LA; Reitsamer, H
ORIGINAL:0016613
ISSN: 2637-6938
CID: 5443932

Drive-through Intraocular Pressure Checks During the COVID-19 Pandemic

Baughman, Brittanie D; Hansemann, Beth K; Shah, Manjool M; Weizer, Jennifer S
PRECIS:A drive-through clinic was created to obtain intraocular pressure measurements before a virtual visit with their provider, in order to provide care for patients in the Kellogg Glaucoma Clinic while minimizing risk of COVID-19 transmission. PURPOSE:The aim of this study was to establish a drive-through clinic model to provide glaucoma care for patients while minimizing the risk of COVID-19 transmission. PATIENTS AND METHODS:A drive-through clinic was created by adapting a 1-lane, 1-way driveway adjacent to the Kellogg Eye Center building entrance. Patients were physicianselected from the Glaucoma Clinic at Kellogg Eye Center as existing patients who required intraocular pressure (IOP) checks and therapeutic management and were chosen based on their ability to be managed with an IOP measurement primarily. The entrance was otherwise closed to the public, allowing staff to utilize an adjacent vestibule with glass walls and sliding doors as a staffroom. Patients were instructed to arrive within a 15-minute time window at which time they would drive through the lane and stop their cars under an awning over the driveway. Ophthalmic technicians wearing appropriate personal protective equipment then approached each car, confirmed patient information, and measured IOP. Once the data were recorded using a mobile workstation, the physician was able to complete each visit by discussing the findings and therapeutic plan with the patient, either in-person in real time or virtually by phone or video visit at a later time. RESULTS:A total of 241 visits were completed over 14 half day clinic sessions, with number of drive-through visits ranging from 5 to 45 per session. CONCLUSIONS:It is possible to institute a drive-through model of IOP checks for glaucoma patients which is efficient and minimizes the risk of exposure to COVID-19 for patients and staff.
PMID: 33273284
ISSN: 1536-481x
CID: 5333672

Targeted Lens Pitting to Treat Negative Dysphotopsia [Case Report]

Feng, Yilin; Weinlander, Eric; Shah, Manjool
PURPOSE/OBJECTIVE:To describe a patient with negative dysphotopsia who underwent a novel non-invasive technique that uses the Nd:YAG laser to induce nasal light scattering through targeted lens pitting. METHODS:Case report. RESULTS:Symptoms of negative dysphotopsia resolved after targeted lens pitting. CONCLUSIONS:.
PMID: 34038305
ISSN: 1081-597x
CID: 5333682

Illustrated advanced anterior segment surgery : a step-by-step guide for challenging cases

Ahmed, Iqbal Ike K; Campos-Möller, Xavier; Shah, Manjool; Sheybani, Arsham, author
Thorofare, NJ : SLACK Incorporated, [2021]
ISBN: 9781630911843
CID: 5443882