Introduction: Prospective, open-label, non-randomized, single site study to assess the safety and tolerability of a multi-pressure dial.
Methods: 30 healthy subjects received application of negative pressure (-15 mmHg) in one eye for 30 minutes and ambient atmospheric pressure in the contralateral eye. To evaluate safety, the primary outcome measures included best corrected visual acuity (BCVA), intraocular pressure (IOP) changes from baseline, slit-lamp and dilated fundus examination findings, and rate of adverse events. Exploratory analyses included in this study also evaluated changes from baseline measurement in tear break-up time (TBUT) and RNFL thickness measured by OCT. In addition to baseline screening, subjects underwent testing and negative pressure application on day 0 and returned 1 week after the initial visit for clinical testing. The follow-up visit did not include use of the multi-pressure dial (MPD) but repeated baseline testing and evaluated for adverse events.
Results: No adverse events were reported in the study. After short-term wear of the MPD on day 0, there was a minimal but statistically significant increase of half a line (LogMAR) in BCDVA for study eyes; this increase was not present at 1 week. There were no observed changes in cup-disk ratio and TBUT 1 week after the initial testing. There was a statistically significant pressure reduction in both study and fellow eyes at 1 week following the study, but clinical significance has yet to be determined.
Conclusion: The MPD, which consists of a pair of goggles connected to a handheld, programmable pump, was well tolerated by subjects enrolled in the study. Key safety parameters remained stable after short-term exposure. The favorable safety results of this study support the safety profile of the MPD and promote further investigation of the device as a potential treatment of glaucoma.
Funding: Equinox Ophthalmic, Inc. (Newport Beach, CA).
Download full-text PDF |
Source |
|---|---|
| http://www.ncbi.nlm.nih.gov/pmc/articles/PMC6513913 | PMC |
| http://dx.doi.org/10.1007/s40123-019-0181-y | DOI Listing |
Publication Analysis
Top Keywords
Similar Publications
Outcomes With Radiation Therapy as Primary Treatment for Unresectable Cutaneous Head and Neck Squamous Cell Carcinoma.
Clin Oncol (R Coll Radiol)
December 2024
Radiation Oncology Network, Westmead Hospital, Westmead, NSW, Australia; Sydney Medical School, The University of Sydney, Camperdown, NSW 2006, Australia. Electronic address:
Aims: Unresectable cutaneous squamous cell cancer of the head and neck (HNcSCC) poses treatment challenges in elderly and comorbid patients. Radiation therapy (RT) is often employed for locoregional control. This study aimed to determine progression-free survival (PFS) and overall survival (OS) outcomes achieved with upfront RT in unresectable HNcSCC.
View Article and Find Full Text PDFOrthopedic Resident Intern Foundations: A Cross-Institutional, Month-Long Skills Training Boot Camp for PGY-1 Residents.
J Surg Educ
January 2025
Washington University of St. Louis, Department of Orthopaedic Surgery, St. Louis, Missouri.
Objective: Orthopedic residents are tasked with rapidly acquiring clinical and surgical skills, especially during their PGY-1 year. However, resource constraints and other factors frequently cause skills training to fall short of established guidelines. We aimed to design and evaluate a cross-institutional, month-long curriculum aimed at pooling resources to optimize training.
View Article and Find Full Text PDFWho is coming in? Evaluation of physician performance within multi-physician emergency departments.
Am J Emerg Med
January 2025
Department of Emergency Medicine, Yale University School of Medicine, New Haven, CT, USA; Center for Outcomes Research and Evaluation, Yale University, New Haven, CT, USA.
Background: This study aimed to examine how physician performance metrics are affected by the speed of other attendings (co-attendings) concurrently staffing the ED.
Methods: A retrospective study was conducted using patient data from two EDs between January-2018 and February-2020. Machine learning was used to predict patient length of stay (LOS) conditional on being assigned a physician of average speed, using patient- and departmental-level variables.
National early warning score 2 plus non-invasive capnography and perfusion index to estimate poor outcomes in emergency departments.
Am J Emerg Med
January 2025
Faculty of Medicine, Universidad de Valladolid, Valladolid, Spain; Emergency Department, Hospital Clínico Universitario, Gerencia Regional de Salud de Castilla y León, Valladolid, Spain.
Background: The study of the inclusion of new variables in already existing early warning scores is a growing field. The aim of this work was to determine how capnometry measurements, in the form of end-tidal CO2 (ETCO2) and the perfusion index (PI), could improve the National Early Warning Score (NEWS2).
Methods: A secondary, prospective, multicenter, cohort study was undertaken in adult patients with unselected acute diseases who needed continuous monitoring in the emergency department (ED), involving two tertiary hospitals in Spain from October 1, 2022, to June 30, 2023.
GradeDiff-IM: An Ensembles Model-based Grade Classification of Breast Cancer.
Biomed Phys Eng Express
January 2025
School of Engineering and Computing, University of the West of Scotland, University of the West of Scotland - Paisley Campus, Paisley PA1 2BE, UK, City, Paisley, PA1 2BE, UNITED KINGDOM OF GREAT BRITAIN AND NORTHERN IRELAND.
Cancer grade classification is a challenging task identified from the cell structure of healthy and abnormal tissues. The partitioner learns about the malignant cell through the grading and plans the treatment strategy accordingly. A major portion of researchers used DL models for grade classification.
View Article and Find Full Text PDFWant AI Summaries of new PubMed Abstracts delivered to your In-box?
Enter search terms and have AI summaries delivered each week - change queries or unsubscribe any time!