Search results for "Equipment Safety"
showing 10 items of 14 documents
Tolerability of 24-hour intraocular pressure monitoring of a pressure-sensitive contact lens.
2013
Purpose To investigate tolerability and safety of a new diagnostic device for 24-hour intraocular pressure monitoring in healthy subjects and age-matched glaucoma patients. Patients and methods Twenty healthy subjects (group 1) and 20 age-matched glaucoma patients (group 2) were included in this prospective, single-center, open, observational parallel group study. The SENSIMED Triggerfish Sensor is a soft disposable contact lens embedding a telemetry chip and strain gauge sensor for continuous intraocular pressure monitoring. The Sensor was placed in 1 eye for 24 hours. Tolerability was evaluated using a visual analog scale (range, 0 to 100; 0=no discomfort; 100=very severe discomfort). Saf…
Plaque removal efficacy of power and manual toothbrushes: a comparative study
2009
The aim of this study was to compare the plaque removal efficacy of a new oscillating/rotating/pulsating toothbrush [Oral-B® Professional Care® 8500 (PC 8500)] with two manual toothbrushes [Oral-B® CrossAction™ Vitalizer (CAV) and Oral-B® Indicator™ (IND), respectively]. The safety of the PC 8500 was also assessed. The study was a single-use, observer-masked, randomised 3×3 Latin square crossover design balanced for carryover effects. The enrolled subjects (n=66) refrained from brushing for 23–25 h before each clinical examination. Plaque scores were recorded before and after brushing with the allocated toothbrush using the Turesky et al. modification of the Quigley and Hein plaque index. T…
Safety and efficacy of implantable defibrillator therapy with programmed shock energy at twice the augmented step-down defibrillation threshold: resu…
1999
Whether the safety and efficacy of implantable cardioverter defibrillator (ICD) therapy can be assured with lower output devices is an important question. The purpose of this study was to evaluate whether programming the device output at twice the augmented defibrillation threshold was as safe and effective as using the maximum energy. Patients indicated for ICD therapy, but without slow monomorphic ventricular tachycardia (MVT), who achieved an augmented defibrillation threshold (DFT plus)or = 15 joules (J) with a single endocardial lead system and a biphasic defibrillator were included in the study. Prior to ICD implantation, patients were randomized into 2 groups. The shock energies in t…
Heated breathing tubes affect humidity output of circle absorber systems.
1993
Abstract Study Objective: To verify whether the airway climate in circle systems can be improved with heated breathing tubes. Design: Randomized, controlled, prospective clinical study. Setting: Operating theater of the Department of Maxillofacial Surgery. Patients: 26 adult patients undergoing prolonged anesthesia. Interventions: A total of 26 prolonged anesthetics were conducted in adult patients using a minimal fresh gas flow rate (0.6 L/min) and silicon breathing tubes (16 mm internal diameter) containing a heated coil. Group 1 ( n = 10 patients) was the control group; breathing tubes were unheated. In Group 2 ( n = 10 patients), breathing tubes were heated to 30°C. In Group 3 ( n = 6 p…
Femtosecond laser versus mechanical microkeratome laser in situ keratomileusis for myopia: Metaanalysis of randomized controlled trials.
2011
Purpose To examine differences in efficacy, accuracy, safety, and changes in aberrations between femtosecond and mechanical microkeratome laser in situ keratomileusis (LASIK) for myopia. Setting Department of Ophthalmology, Shanghai First People's Hospital Affiliated to Shanghai Jiaotong University, Shanghai, China. Design Evidence-based manuscript. Methods Data sources, including PubMed, Medline, EMBASE, and Cochrane Controlled Trials Register, were searched to identify potentially relevant prospective randomized controlled trials. Primary outcome measures were efficacy (uncorrected distance visual acuity ≥20/20), accuracy (±0.50 diopter mean spherical equivalent), and safety (loss of ≥2 l…
A European Study of the Performance and Safety of MINIject in Patients With Medically Uncontrolled Open-angle Glaucoma (STAR-II)
2020
Precis In this European study (STAR-II), MINIject, a novel, ab-interno, supraciliary MIGS device, effectively lowered intraocular pressure (IOP) and the need for IOP-lowering medications in patients with primary open-angle glaucoma. Purpose To evaluate the safety and performance of a minimally invasive supraciliary glaucoma drainage device (MINIject DO627, iSTAR Medical SA, Wavre, Belgium) for surgical treatment of primary open angle glaucoma in patients refractory to topical hypotensive medications. Methods In a prospective, interventional, single-arm, multi-center, European study (STAR-II), MINIject was successfully implanted in a standalone procedure in 29 of 31 patients in 8 sites in 3 …
Imaging in the catheterization laboratory
1993
Recent work confirms that visual assessment of the effect of widely employed coronary interventions is highly inaccurate. Rapid and reliable on-line angiographic quantitation is a useful advance, but problems in the application of the technique are encountered in a substantial number of cases. New algorithms have been devised to provide a comprehensive assessment of the geometry and likely functional significance of lesions as well as an objective evaluation of lesion morphology, and recent work has provided the framework for the quantitation of diffuse disease. Studies with intravascular ultrasound confirm the inadequate sensitivity of angiography in demonstrating mild to moderate atheroma…
Color Doppler ultrasonography of the eye and orbit
1993
Color Doppler imaging is the recent development in ultrasonography that allows simultaneous two-dimensional structural imaging in Doppler evaluation of blood flow. With this technique, it is possible for the first time to indirectly display the fine orbital vessels such as the ophthalmic artery and its branches, the central retinal artery, the posterior ciliary artery, and the lacrimal artery. Also, the display of venous structures such as the superior ophthalmic vein, the vortex vein, and the central retinal vein is possible. In addition to the qualitative display of those vessels, the hemodynamics in those vessels can be quantitatively assessed by looking at the Doppler spectrum and deter…
Low dose CT of the heart: a quantum leap into a new era of cardiovascular imaging.
2010
In 10 years, computed tomography coronary angiography (CTCA) has shifted from an investigational tool to clinical reality. Even though CT technologies are very advanced and widely available, a large body of evidence supporting the clinical role of CTCA is missing. The reason is that the speed of technological development has outpaced the ability of the scientific community to demonstrate the clinical utility of the technique. In addition, with each new CT generation, there is a further broadening of actual and potential applications. In this review we examine the state of the art on CTCA. In particular, we focus on issues concerning technological development, radiation dose, implementation,…
Patient Alert to detect ICD lead failure: efficacy, limitations, and implications for future algorithms.
2006
Aims An algorithm that alerts implantable cardioverter-defibrillator (ICD) patients, in case of abnormal lead impedance (Patient Alert™, Medtronic), may help to recognize lead dysfunction. We aimed to determine the utility of Patient Alert for ICD lead-failure detection in a prospective study. Methods and results Three hundred and sixty ICD patients were followed for 22±14 months. Patient Alert was active for pacing impedance 2000–3000 Ω, and high-voltage conductor impedance 200 Ω. Ten alert events and a total of 29 severe system complications occurred. Patient Alert detected three of 10 ICD lead failures, with a positive predictive value (PPV) of 77.8% for any severe system complication. R…