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

INTRODUCTION: 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: ClinicalTrials.gov NCT02247804, NCT02250651, and NCT01157364.

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

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.

The Appropriateness of Digital Diabetic Retinopathy Screening Images for a Computer-Aided Glaucoma Screening System.

PURPOSE: The purpose of this study was to evaluate the ability to screen for glaucoma using a Food Drug Administration (FDA) Class II diagnostic digital fundus photography system used for diabetic retinopathy screening (DRS). METHODS: All research participants underwent a comprehensive eye examination as well as non-mydriatic 45°single photograph retinal imaging centered on the macula. Optic nerve images within the 45° non-mydriatic and non-stereo DRS image were evaluated by two methods: 1) grading by three glaucoma specialists, and 2) a computer-aided automated segmentation system to determine the vertical cup-to-disc ratio (VCDR). Using VCDR from clinical assessment as gold standard, VCDR results from two methods were compared to that from clinical assessment. Inter-grader agreement was assessed by computing intraclass correlation coefficient (ICC). In addition, sensitivity and specificity were calculated. RESULTS: Among 245 fundus photos, 166 images met quality specifications for analysis. Fifty images were not processed by the automated system due to the poor quality of the optic disc, and 29 images did not include the optic nerve head due to the patient movement during the photo acquisition. The ICC value for the VCDR between the gold standard clinical exam and the automated system was 0.41, indicating fair agreement. The ICC value between the three ophthalmologists and the gold standard was 0.51, 0.56, and 0.69, respectively, indicating fair to moderate agreement. DISCUSSION: Assessing the VCDR on non-mydriatic and non-stereo DRS fundus photographs by either the computer-aided automated segmentation system or by glaucoma specialists showed similar fair to moderate agreement. In summary, optic nerve assessment for glaucoma from these 45° non-mydriatic and non-stereo DRS images is not yet suitable for tele-glaucoma screening.

Cyclodialysis cleft repair with goniotomy for the control of post-operative ocular hypertension.

PURPOSE: In this case of iatrogenic cyclodialysis cleft, we describe a technique in which a nasal goniotomy is coupled with indirect cyclodialysis cleft (CDC) repair in order to minimize acute post-operative ocular hypertension, which is common following cyclodialysis cleft closure. OBSERVATIONS: This novel technique was simple, convenient, and effective in controlling intraocular pressure (IOP) for the patient. CONCLUSIONS AND IMPORTANCE: IOP frequently spikes to dangerously high levels following CDC closure. Pairing CDC repair with goniotomy may help prevent acute post-operative ocular hypertension in these patients.

Application of the Sight Outcomes Research Collaborative Ophthalmology Data Repository for Triaging Patients With Glaucoma and Clinic Appointments During Pandemics Such as COVID-19.

Importance: During the coronavirus disease 2019 (COVID-19) pandemic, eye care professionals caring for patients with sight-threatening diseases, such as glaucoma, have had to determine whether some patient appointments could safely get postponed, weighing the risk that the patient's glaucoma could worsen during the interim vs the morbidity risk of acquiring COVID-19 while seeking ophthalmic care. They also need to prioritize appointment rescheduling during the ramp-up phase (when pandemic-associated service reductions are eased). Objective: To describe a flexible and scalable scoring algorithm for patients with glaucoma that considers glaucoma severity and progression risk vs the presence of high-risk features for morbidity from COVID-19, using information from a large data repository. Design, Setting, and Participants: In this cross-sectional study, patients with upcoming clinic appointments for glaucoma from March 16, 2020, to April 16, 2020, at an academic institution enrolled in the Sight Outcomes Research Collaborative (SOURCE) Ophthalmology Electronic Health Record Data Repository were identified. A risk stratification tool was developed that calculated a glaucoma severity and progression risk score and a COVID-19 morbidity risk score. These scores were summed to determine a total score for each patient. Main Outcomes and Measures: Total scores and percentages of clinic appointments recommended for rescheduling. Results: Among the 1034 patients with upcoming clinic appointments for glaucoma, the mean (SD) age was 66.7 (14.6) years. There were 575 women (55.6%), 733 White individuals (71%), and 160 Black individuals (15.5%). The mean (SD) glaucoma severity and progression risk score was 4.0 (14.4) points, the mean (SD) COVID-19 morbidity risk score was 27.2 (16.1) points, and the mean (SD) total score was 31.2 (21.4) points. During pandemic-associated reductions in services, using total score thresholds of 0, 25, and 50 points would identify 970 appointments (93.8%), 668 appointments (64.6%), and 275 appointments (26.6%), respectively, for postponement and rescheduling. The algorithm-generated total scores also helped prioritize appointment rescheduling during the ramp-up phase. Conclusions and Relevance: A tool that considers the risk of underlying ophthalmic disease progression from delayed care receipt and the morbidity risk from COVID-19 exposure was developed and implemented, facilitating the triage of upcoming ophthalmic appointments. Comparable approaches for other ophthalmic and nonophthalmic care during the COVID-19 pandemic and similar crises may be created using this methodology.

Integrating Patient Education Into the Glaucoma Clinical Encounter: A Lean Analysis.

PURPOSE: The main purpose of this study was to use Lean analysis to identify how often and when wait times occur during a glaucoma visit to identify opportunities for additional patient engagement. METHODS: This prospective observational time-motion study measured process and wait times for 77 patient visits from 12 ophthalmologists at an academic glaucoma clinic over a 3-month period. Value stream maps visually diagramed the process of a clinical visit from the patient's perspective. Descriptive statistics were calculated for process times, wait times, and the frequency of 10+ minute wait times during each part of the visit. Key stakeholders participated in a root cause analysis to identify reasons for long wait times. The main outcome measure was average times (hours: minutes: seconds) for process times and wait times. RESULTS: Twenty-nine new visit (NV) patients and 48 return visit (RV) patients were included. Total time in clinic was 187.1±44.5 (mean±SD) minutes for NV patients and 102.0±44.7 minutes for RV patients. Wait time for NV patients was 63.7±33.4 minutes (33.1% of total appointment time) and for RV patients was 52.6±31.6 minutes (49.4% of the total appointment time). All NV patients and 87.5% of RV patients had at least one 10+ minute wait time during their clinic visit and the majority (75.9% NV, 60.4% RV) had >1. CONCLUSIONS: Currently, sufficient wait time exists during the visit for key portions of glaucoma education such as teaching eye drop instillation.