Systematic Review of Current Devices for 24-h Intraocular Pressure Monitoring.
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ABSTRACT:
SUBMITTER: Ittoop SM
PROVIDER: S-EPMC5055550 | biostudies-other | 2016 Oct
REPOSITORIES: biostudies-other
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Systematic Review of Current Devices for 24-h Intraocular Pressure Monitoring.
Ittoop Sabita M SM SooHoo Jeffrey R JR Seibold Leonard K LK Mansouri Kaweh K Kahook Malik Y MY
Advances in therapy 20160816 10
Glaucoma is a common optic neuropathy that can lead to irreversible vision loss, and intraocular pressure (IOP) is the only known modifiable risk factor. The primary method of treating glaucoma involves lowering IOP using medications, laser and/or invasive surgery. Currently, we rely on in-office measurements of IOP to assess diurnal variation and to define successful management of disease. These measurements only convey a fraction of a patient's circadian IOP pattern and may frequently miss pea ...[more]
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Project description:Abstract Aims High blood pressure (BP) is the commonest modifiable cardiovascular risk factor, yet its monitoring remains problematic. Wearable cuffless BP devices offer potential solutions; however, little is known about their validity and utility. We aimed to systematically review the validity, features and clinical use of wearable cuffless BP devices. Methods and results We searched MEDLINE, Embase, IEEE Xplore and the Cochrane Database till December 2019 for studies that reported validating cuffless BP devices. We extracted information about study characteristics, device features, validation processes, and clinical applications. Devices were classified according to their functions and features. We defined devices with a mean systolic BP (SBP) and diastolic BP (DBP) biases of <5 mmHg as valid as a consensus. Our definition of validity did not include assessment of device measurement precision, which is assessed by standard deviation of the mean difference—a critical component of ISO protocol validation criteria. Study quality was assessed using the Quality Assessment of Diagnostic Accuracy Studies version 2 tool. A random-effects model meta-analysis was performed to summarise the mean biases for SBP and DBP across studies. Of the 430 studies identified, 16 studies (15 devices, 974 participants) were selected. The majority of devices (81.3%) used photoplethysmography to estimate BP against a reference device; other technologies included tonometry, auscultation and electrocardiogram. In addition to BP and heart rate, some devices also measured night-time BP (n = 5), sleep monitoring (n = 3), oxygen saturation (n = 3), temperature (n = 2) and electrocardiogram (n = 3). Eight devices showed mean biases of <5 mmHg for SBP and DBP compared with a reference device and three devices were commercially available. The meta-analysis showed no statistically significant differences between the wearable and reference devices for SBP (pooled mean difference = 3.42 mmHg, 95% CI: −2.17, 9.01, I2 95.4%) and DBP (pooled mean = 1.16 mmHg, 95% CI: −1.26, 3.58, I2 87.1%). Conclusion Several cuffless BP devices are currently available using different technologies, offering the potential for continuous BP monitoring. The variation in standards and validation protocols limited the comparability of findings across studies and the identification of the most accurate device. Challenges such as validation using standard protocols and in real-life settings must be overcome before they can be recommended for uptake into clinical practice. Graphical Abstract Graphical abstract Wearable BP device system.
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Project description:PurposeTo study performance of a contact lens sensor (CLS) for 24-hour monitoring of IOP-related short-term patterns and compare with IOP obtained by pneumatonometry.MethodsProspective clinical trial. Thirty-one healthy volunteers and 2 glaucoma patients were housed for 24 hours in a sleep laboratory. One randomly selected eye was fitted with a CLS (Triggerfish, Sensimed, Switzerland), which measures changes in ocular circumference. In the contralateral eye, IOP measurements were taken using a pneumatonometer every two hours with subjects in the habitual body positions. Heart rate (HR) was measured 3 times during the night for periods of 6 minutes separated by 2 hours. Performance of CLS was defined in two ways: 1) recording the known pattern of IOP increase going from awake (sitting position) to sleep (recumbent), defined as the wake/sleep (W/S) slope and 2) accuracy of the ocular pulse frequency (OPF) concurrent to that of the HR interval. Strength of association between overall CLS and pneumatonometer curves was assessed using coefficients of determination (R2).ResultsThe W/S slope was statistically significantly positive in both eyes of each subject (CLS, 57.0 ± 40.5 mVeq/h, p<0.001 and 1.6 ± 0.9 mmHg/h, p<0.05 in the contralateral eye). In all, 87 CLS plots concurrent to the HR interval were evaluated. Graders agreed on evaluability for OPF in 83.9% of CLS plots. Accuracy of the CLS to detect the OPF was 86.5%. Coefficient of correlation between CLS and pneumatonometer for the mean 24-h curve was R2 = 0.914.ConclusionsCLS measurements compare well to the pneumatonometer and may be of practical use for detection of sleep-induced IOP changes. The CLS also is able to detect ocular pulsations with good accuracy in a majority of eyes.Trial registrationClinicalTrials.gov NCT01390779.
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Project description:BACKGROUND:Continuous monitoring of vital signs by using wearable wireless devices may allow for timely detection of clinical deterioration in patients in general wards in comparison to detection by standard intermittent vital signs measurements. A large number of studies on many different wearable devices have been reported in recent years, but a systematic review is not yet available to date. OBJECTIVE:The aim of this study was to provide a systematic review for health care professionals regarding the current evidence about the validation, feasibility, clinical outcomes, and costs of wearable wireless devices for continuous monitoring of vital signs. METHODS:A systematic and comprehensive search was performed using PubMed/MEDLINE, EMBASE, and Cochrane Central Register of Controlled Trials from January 2009 to September 2019 for studies that evaluated wearable wireless devices for continuous monitoring of vital signs in adults. Outcomes were structured by validation, feasibility, clinical outcomes, and costs. Risk of bias was determined by using the Mixed Methods Appraisal Tool, quality assessment of diagnostic accuracy studies 2nd edition, or quality of health economic studies tool. RESULTS:In this review, 27 studies evaluating 13 different wearable wireless devices were included. These studies predominantly evaluated the validation or the feasibility outcomes of these devices. Only a few studies reported the clinical outcomes with these devices and they did not report a significantly better clinical outcome than the standard tools used for measuring vital signs. Cost outcomes were not reported in any study. The quality of the included studies was predominantly rated as low or moderate. CONCLUSIONS:Wearable wireless continuous monitoring devices are mostly still in the clinical validation and feasibility testing phases. To date, there are no high quality large well-controlled studies of wearable wireless devices available that show a significant clinical benefit or cost-effectiveness. Such studies are needed to help health care professionals and administrators in their decision making regarding implementation of these devices on a large scale in clinical practice or in-home monitoring.
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Project description:Continuous intraocular pressure (IOP) monitoring for improving glaucoma diagnosis and treatment has remained a challenge for the past 60 years because glaucoma is the second leading cause of irreversible blindness worldwide. Several devices with different measurement principles and recently developed biosensors with semiconductor materials offer exciting properties. However, none of these devices for continuous IOP monitoring have been fully integrated into clinical practice, primarily due to technical problems. This review summarizes state-of-the-art biosensors developed for IOP monitoring by explaining their basic functions and applications, the main technology (pressure transductors, piezoresistive sensors, capacitive sensors, and resonant sensors), measurement approach (noninvasive, minimally invasive or invasive (surgically implantable)), and telemetry characteristics. To provide updated information for clinicians and researchers, we also describe the advantages and limitations of the application of these new sensors to eye care management. Despite significant improvements in IOP biosensor technology, the accuracy of their measurements must be improved to obtain a clear equivalence with actual IOP (measured in units of mmHg) to facilitate their clinical application. In addition, telemetry systems may be simplified to prevent adverse outcomes for patients and to guarantee the safety of stored data.
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Project description:To present a method to analyze circadian intraocular pressure (IOP) patterns in glaucoma patients and suspects undergoing repeated continuous 24-hour IOP monitoring.Forty patients with established (n = 19) or suspected glaucoma (n = 21) underwent ambulatory 24-hour IOP monitoring on two sessions 1 week apart using a contact lens sensor (CLS). The CLS provides its output in arbitrary units (a.u.). A modified cosinor rhythmometry method was adapted to the CLS output to analyze 24-hour IOP patterns and their reproducibility. Nonparametric tests were used to study differences between sessions 1 and 2 (S1 and S2). Patients pursued their routine daily activities and their sleep was uncontrolled. CLS data were used to assess sleep times.Complete 24-hour data from both sessions were available for 35 patients. Mean (SD) age of the patients was 55.8 ± 15.5 years. The correlation of the cosinor fitting and measured CLS values was r = 0.38 (Spearman r; P < 0.001) for S1, r = 0.50 (P < 0.001) for S2, whereas the correlation between S1 and S2 cosinor fittings was r = 0.76 (P < 0.001). Repeated nocturnal acrophase was seen in 62.9% of patients; 17.1% of patients had no repeatable acrophase. The average amplitude of the 24-hour curve was 143.6 ± 108.1 a.u. (S1) and 130.8 ± 68.2 a.u. (S2) (P = 0.936).Adapting the cosinor method to CLS data is a useful way for modeling the rhythmic nature of 24-hour IOP patterns and evaluating their reproducibility. Repeatable nocturnal acrophase was seen in 62.9% of patients. (ClinicalTrials.gov number, NCT01319617.).
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Project description:Cuff-based home blood pressure (BP) devices, which have been the standard for BP monitoring for decades, are limited by physical discomfort, convenience, and their ability to capture BP variability and patterns between intermittent readings. In recent years, cuffless BP devices, which do not require cuff inflation around a limb, have entered the market, offering the promise of continuous beat-to-beat measurement of BP. These devices take advantage of a variety of principles to determine BP, including (1) pulse arrival time, (2) pulse transit time, (3) pulse wave analysis, (4) volume clamping, and (5) applanation tonometry. Because BP is calculated indirectly, these devices require calibration with cuff-based devices at regular intervals. Unfortunately, the pace of regulation of these devices has failed to match the speed of innovation and direct availability to patient consumers. There is an urgent need to develop a consensus on standards by which cuffless BP devices can be tested for accuracy. In this narrative review, we describe the landscape of cuffless BP devices, summarize the current status of validation protocols, and provide recommendations for an ideal validation process for these devices.
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Project description:An important aspect of eye health in humans and animal models of human diseases is intraocular pressure (IOP). IOP is typically measured by hand with a tonometer, so data are sparse and sporadic and round-the-clock variations are not well characterized. Here we present a novel system for continuous wireless IOP and temperature measurement in small animals. The system consists of a cannula implanted in the anterior chamber of the eye connected to pressure sensing electronics that can be worn by rats or implanted in larger mammals. The system can record IOP with 0.3 mmHg accuracy and negligible drift at a rate of 0.25 Hz for 1-2 months on a regulated battery or indefinitely at rates up to 250 Hz via RF energy harvesting. Chronic recordings from conscious rats showed that IOP follows a diurnal rhythm, averaging 16.5 mmHg during the day and 21.7 mmHg at night, and that the IOP rhythm lags a diurnal rhythm in body temperature by 2.1 h. IOP and body temperature fluctuations were positively correlated from moment-to-moment as well. This technology allows researchers to monitor for the first time the precise IOP history of rat eyes, a popular model for glaucoma studies.
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Project description:Glaucoma, the most common cause of irreversible blindness worldwide, usually causes characteristic optic nerve damage. Pathological intraocular pressure (IOP) elevation is a major risk factor. Drug reduction of IOP is the preferred treatment for clinicians because it can delay the progression of disease. However, the traditional IOP-lowering drugs currently used by patients may be poorly tolerated. Therefore, in recent years, some new drugs have been put into clinical application or in clinical phase I-III studies. They have a better IOP-lowering effect and fewer adverse reactions. Because glaucoma is a chronic disease, drugs need to be administered continuously for a long time. For patients, good compliance and high drug bioavailability have a positive effect on the prognosis of the disease. Therefore, clinicians and scientists have developed drug delivery systems to solve this complex problem. In addition, natural compounds and dietary supplements have a good effect of reducing IOP, and they can also protect the optic nerve through antioxidant action. We summarize the current traditional drugs, new drugs, sustained-release drug delivery systems, and complementary drugs and outline the mechanism of action and clinical effects of these drugs on glaucoma and their recent advances.
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