Safety and performance of a suprachoroidal sensor for telemetric measurement of intraocular pressure in the EYEMATE-SC trial

AimTo investigate the safety and performance of a telemetric suprachoroidal intraocular pressure (IOP) sensor (EYEMATE-SC) and the accuracy of its IOP measurements in open angle glaucoma (OAG) patients undergoing simultaneous non-penetrating glaucoma surgery (NPGS).MethodsProspective, multicentre, open-label, single-arm, interventional clinical trial. Twenty-four eyes of 24 patients with OAG regularly scheduled for NPGS (canaloplasty or deep sclerectomy) were simultaneously implanted with an EYEMATE-SC sensor. Six-month follow-up on the sensor’s safety and performance as well as on the level of agreement between the EYEMATE-SC measurements and IOP measurements with Goldmann applanation tonometry (GAT).ResultsThe eyes underwent canaloplasty (n=15) or deep sclerectomy (n=9) and achieved successful implantation of the sensor. No device migration, dislocation or serious device-related complications occurred. A total of 367 comparisons were included in the IOP agreement analysis. The overall mean difference between GAT and EYEMATE-SC measurements was 1.31 mm Hg (lower limit of agreement (LoA) 7.55 mm Hg; upper LoA –4.92 mm Hg). The maximum difference of 2.5 mm Hg ±3.96 (LoA 0.30–2.29) was reached on day 10 and continuously improved to an agreement of –0.15 mm Hg ±2.28 (LoA –1.24 to 0.89) after 6 months. Accordingly, the percentage of eyes within an IOP difference of ±5 mm Hg improved from 78% (day 3) to 100% (6 months).ConclusionsAfter 6 months, the EYEMATE-SC sensor was safe and well tolerated, and allowed continual IOP monitoring.Trial registration numberNCT03756662.

Circadian Rhythm of Core Body Temperature (Part II): Hyperbaric Environment Influence on Circadian Rhythm of Core Body Temperature

The aim of this study was to analyse dynamic fluctuations in the circadian rhythm of the core body temperature in healthy adults exposed to conditions in a hyperbaric chamber, using fully objective-telemetric measurement methods. The study group consisted of 13 healthy males (age 32±6.4 years, height 1.85±0.1 m, body weight 84.00±6.3 kg; BMI 24.7±1.2 kg/m2). The core body temperature (CBT) was measured with the Vital Sense telemetry system. The volunteers were placed in a hyperbaric chamber, exposed to compression of 400 kPa, with the exposure plateau of approx. 30 minutes, followed by gradual decompression. The mean core temperature was 36.71°C when registered within 10 minutes before the exposure, 37.20°C during the exposure, 37.27°C one hour after the exposure, 37.36°C 2 hours after the exposure, and 37.42°C three hours after the exposure. The conducted observations show that one-hour stay in a hyperbaric chamber at a depth of 30 m results in an increase in the body temperature, particularly significant after the exposure ends, and maintained for at least 3 hours after the exposure.

Cardiovascular and Thermal Response to Dry-Sauna Exposure in Healthy Subjects

Dry-sauna is a strong thermal stimulus and is commonly used all over the world. The aim of this experiment was to comprehensively analyse cardiovascular and autonomic changes that result from an increase in core body temperature during sauna bath. The study included 9 healthy men with mean age 26.7 ± 3.0 years and comparable anthropomorphical characteristics. Each subject was exposed to one 15-minute session of dry-sauna treatment at 100°C and 30–40% humidity. The autonomic and baseline cardiovascular (i.e., hemodynamic and contractility) parameters were measured noninvasively with Task Force Monitor. Cardiovascular autonomic functions were assessed using baroreceptor reflex sensitivity (BRS) and spectral analysis of heart rate (HRV) and blood pressure (BPV) variability. Measurements were performed four times, at the following stages “before sauna,” “after sauna,” “sauna + 3 h,” and “sauna + 6 h.” The first recording constituted a baseline for the subsequent three measurements. The changes in core body temperature were determined with the Vital Sense telemetric measurement system. Results show that exposure to the extreme external environmental conditions of dry-sauna does not compromise homeostasis in healthy persons. The hemodynamic changes induced by heating are efficiently compensated by the cardiovascular system and do not exert negative effects upon its short-term regulatory potential.

Telemetric Measurement of Heat Transfer Coefficients in Gaseous Flow: First Test of a Recent Sensor Concept in a Rotating Application

Heat transfer coefficients are very important for the design of the various flow paths found in turbomachinery. An accurate measurement of heat transfer is difficult for circumstances of gaseous flow in combination with good thermal conductivity of the boundaries along the flow path. The majority of the measurement methods applied frequently have at least one of the following problems: (1) the measurement system as for instance a heat flux sensor is a thermal barrier in the object of interest, and (2) the sensor introduces for measurement reasons a lot of heat into the object of interest. In both cases the main error results from the modification of the system, which is critical for the investigation of any kind of flow influenced by buoyancy. Furthermore, insufficient fluid reference temperature and/or heat flux with changing sign corrupts any attempt to calculate reliable heat transfer coefficients. The measurement of heat transfer coefficients becomes even more complicated if the flow path of interest rotates at some thousand rpm as for instance in gas turbines or any other fast rotating machine with fluid flow. This contribution presents a new test rig and an experimental investigation of a setup for the direct telemetric measurement of local heat transfer coefficients in gaseous flow with metallic boundaries. The test rig has a complex instrumentation and the measurements are transferred from the rotating to the stationary frame via newly in house developed telemetry system. The measurements presented are based on a recent measurement/sensor concept tested for the first time in the rotating frame. The measurement setup features miniaturized sensor dimensions and low energy consumption. Therefore, the sensor concept is very well suited for use with telemetry system as necessary for many turbomachinery research applications. Furthermore, measurements of the radial distribution of the heat transfer coefficient of a rotating free disc are presented. Additionally a comparison with correlations found in literature as well as a discussion of the results is included.