scholarly journals Continuous 24-hour measurement of intraocular pressure in millimeters of mercury (mmHg) using a novel contact lens sensor: Comparison with pneumatonometry

PLoS ONE ◽  
2021 ◽  
Vol 16 (3) ◽  
pp. e0248211
Author(s):  
Kevin Gillmann ◽  
Robert Wasilewicz ◽  
Kirsten Hoskens ◽  
Sonja Simon-Zoula ◽  
Kaweh Mansouri
Keyword(s):  
Contact Lens ◽  
Open Angle Glaucoma ◽  
Unmet Need ◽  
The Novel ◽  
Open Label ◽  
Fellow Eye ◽  
Corneal Erosion ◽  
Removal Time ◽  
Severe Intensity ◽  
Contact Lens Sensor

Purpose To address the unmet need of continuous IOP monitoring, a Pressure-Measuring Contact Lens (PMCL) was developed to measure IOP in millimeters of mercury (mmHg) continuously over 24 hours. The present study assessed the reliability of the novel PMCL. Methods In this prospective open-label clinical study, healthy and open-angle glaucoma (OAG) subjects were fitted with the PMCL, and pneumatonometry was performed on study eyes (in absence of the PMCL) and on fellow eyes before, during, and after provocative tests. The primary outcome measures were (1) mean IOP difference between same-eye measurements, and (2) percentage of timepoints at which IOP measured by the PMCL was within 5 mmHg of that measured by pneumatonometry in the fellow eye. Results Eight subjects were analysed (4 healthy, 4 OAG). The average difference in successive IOP measurements made by pneumatonometry and with the PMCL was 2.0±4.3mmHg at placement-time, and 6.5±15.2mmHg at removal time. During water drinking test, a significant increase in IOP was detected both by PMCL in the study eye (2.4±2.5mmHg, p = 0.03) and by pneumatonometry in the fellow eye (1.9±1.9mmHg, p = 0.02). Over the 24-hour recording, 88.0% of IOP variations measured by the PMCL were within 5mmHg of that measured with the pneumatonometer in the fellow eye. A transient corneal erosion of severe intensity was observed following removal of the PMCL on one single eye, and may have affected measurement accuracy in that eye. Conclusions This study is a proof-of-concept for this novel PMCL, and its results are encouraging, with a fair accuracy in IOP values measurement and good sensitivity to subtle IOP variations.

scholarly journals Use of Machine Learning on Contact Lens Sensor–Derived Parameters for the Diagnosis of Primary Open-angle Glaucoma

2018 ◽  
Vol 194 ◽  
pp. 46-53 ◽  
Author(s):  
Keith R. Martin ◽  
Kaweh Mansouri ◽  
Robert N. Weinreb ◽  
Robert Wasilewicz ◽  
Christophe Gisler ◽  
...  
Keyword(s):  
Machine Learning ◽  
Contact Lens ◽  
Primary Open Angle Glaucoma ◽  
Open Angle Glaucoma ◽  
Open Angle ◽  
Contact Lens Sensor

scholarly journals The Application of a Contact Lens Sensor in Detecting 24-Hour Intraocular Pressure-Related Patterns

2016 ◽  
Vol 2016 ◽  
pp. 1-8 ◽  
Author(s):  
Sarah C. Xu ◽  
Angela C. Gauthier ◽  
Ji Liu
Keyword(s):  
Intraocular Pressure ◽  
Disease Progression ◽  
Contact Lens ◽  
Open Angle Glaucoma ◽  
Normal Tension Glaucoma ◽  
Angle Closure ◽  
Blink Rate ◽  
Disease States ◽  
Wide Range ◽  
Contact Lens Sensor

Glaucoma is one of the leading causes of blindness worldwide. Recent studies suggest that intraocular pressure (IOP) fluctuations, peaks, and rhythm are important factors in disease advancement. Yet, current glaucoma management remains hinged on single IOP measurements during clinic hours. To overcome this limitation, 24-hour IOP monitoring devices have been employed and include self-tonometry, permanent IOP, and temporary IOP monitoring. This review discusses each IOP measuring strategy and focuses on the recently FDA-approved contact lens sensor (CLS). The CLS records IOP-related ocular patterns for 24 hours continuously. Using the CLS, IOP-related parameters have been found to be associated with the rate of visual field progression in primary open-angle glaucoma, disease progression in primary angle-closure glaucoma, and various clinical variables in ocular hypertension. The CLS has been used to quantify blink rate and limbal strain and measure the circadian rhythm in a variety of disease states including normal-tension glaucoma and thyroid eye disease. The effects of various IOP-lowering interventions were also characterized using the CLS. CLS provides a unique, safe, and well-tolerated way to study IOP-related patterns in a wide range of disease states. IOP-related patterns may help identify patients most at risk for disease progression and assist with the development of tailored treatments.

Comparison of intraocular pressure fluctuation before and after cataract surgeries in normal-tension glaucoma patients

2018 ◽  
Vol 29 (5) ◽  
pp. 516-523 ◽  
Author(s):  
Naoki Tojo ◽  
Mitsuya Otsuka ◽  
Atsushi Hayashi
Keyword(s):  
Regression Analysis ◽  
Intraocular Pressure ◽  
Cataract Surgery ◽  
Contact Lens ◽  
Pressure Fluctuations ◽  
Normal Tension Glaucoma ◽  
Open Label ◽  
Before And After ◽  
Contact Lens Sensor ◽  
Harmonic Regression

Purpose: Cataract surgeries have been shown to reduce intraocular pressure. We used a Sensimed Triggerfish® contact lens sensor to compare intraocular pressure levels and their fluctuation between before and after cataract surgeries in patients with normal-tension glaucoma. Methods: This was a prospective open-label study. Thirteen patients with normal-tension glaucoma were included. All patients underwent a 1-month washout and discontinued glaucoma medications during this study. In each eye, intraocular pressure fluctuations over 24 h were measured with the contact lens sensor before and at 3 months after the cataract surgery. We compared intraocular pressure levels and their fluctuation between before and after cataract surgeries. We used two approaches to evaluate the amplitude of intraocular pressure fluctuations: dual-harmonic regression analysis, and measurement of the difference between the maximum and the minimum value. Results: The mean pre-operative intraocular pressure was 14.7 ± 2.2 mm Hg and mean post-operative intraocular pressure was 11.4 ± 2.2 mm Hg. Cataract surgery significantly decreased intraocular pressure (p = 0.0005). In both methods, the post-operative fluctuations in intraocular pressure over 24 h were significantly smaller than their pre-operative counterparts (dual-harmonic regression analysis: p = 0.0171; difference between the maximum and the minimum: p = 0.0398). Conclusion: Cataract surgery decreased both intraocular pressure values and intraocular pressure fluctuations in normal-tension glaucoma patients.

scholarly journals Twenty-Four-Hour Contact Lens Sensor Monitoring of Aqueous Humor Dynamics in Surgically or Medically Treated Glaucoma Patients

2019 ◽  
Vol 2019 ◽  
pp. 1-10 ◽  
Author(s):  
Chiara Posarelli ◽  
Pierluigi Ortenzio ◽  
Antonio Ferreras ◽  
Mario Damiano Toro ◽  
Andrea Passani ◽  
...  
Keyword(s):  
Circadian Rhythm ◽  
Contact Lens ◽  
Open Angle Glaucoma ◽  
Therapy Group ◽  
Open Angle ◽  
Aqueous Humor Dynamics ◽  
Contact Lens Sensor ◽  
Group 3 ◽  
Group 2 ◽  
Group 1

Aim. This study assessed the 24 h circadian rhythm of intraocular pressure (IOP) using a contact lens sensor in three groups of patients with open-angle glaucoma. Methods. This study was a monocentric, cross-sectional, nonrandomized, prospective, pilot study. Eighty-nine patients were enrolled: 29 patients previously underwent an Ex-PRESS mini glaucoma device procedure (Group 1), 28 patients previously underwent Hydrus microstent implantation (Group 2), and 32 patients were currently being treated medically for primary open-angle glaucoma (Group 3). Circadian rhythm patterns were considered with five circadian indicators: fluctuation ranges, maximum, minimum, acrophase (time of peak value), and bathyphase (time of trough value). A two-tailed Mann–Whitney U-test was used to evaluate differences between groups. Results. All subjects exhibited a circadian rhythm and a nocturnal pattern. The signal fluctuation range was significantly smaller in the surgical groups than in the medically treated group (Group 1 vs. Group 3, p=0.003; Group 2 vs. Group 3, p=0.010). Subjects who underwent the Ex-PRESS procedure (Group 1) exhibited significant differences compared with the drug therapy group (Group 3) with regard to the minimum value (p=0.015), acrophase (p=0.009), and bathyphase (p=0.002). The other circadian indicators were not significantly different among groups. Conclusions. Patients who underwent IOP-lowering surgery had an intrinsic nyctohemeral rhythm. Both surgical procedures, Ex-PRESS and Hydrus, were associated with smaller signal fluctuations compared with medical treatment.

scholarly journals Direct antivirals working against the novel coronavirus: azithromycin (DAWn-AZITHRO), a randomized, multicenter, open-label, adaptive, proof-of-concept clinical trial of new antivirals working against SARS-CoV-2—azithromycin trial

Trials ◽  
2021 ◽  
Vol 22 (1) ◽  
Author(s):  
Iwein Gyselinck ◽  
◽  
Laurens Liesenborghs ◽  
Ewout Landeloos ◽  
Ann Belmans ◽  
...  
Keyword(s):  
Clinical Trial ◽  
Standard Of Care ◽  
Ordinal Scale ◽  
Cytokine Signaling ◽  
Nasopharyngeal Swab ◽  
The Novel ◽  
Proof Of Concept ◽  
Open Label ◽  
Novel Coronavirus

Abstract Background The rapid emergence and the high disease burden of the novel coronavirus SARS-CoV-2 have created a medical need for readily available drugs that can decrease viral replication or blunt the hyperinflammatory state leading to severe COVID-19 disease. Azithromycin is a macrolide antibiotic, known for its immunomodulatory properties. It has shown antiviral effect specifically against SARS-CoV-2 in vitro and acts on cytokine signaling pathways that have been implicated in COVID-19. Methods DAWn-AZITHRO is a randomized, open-label, phase 2 proof-of-concept, multicenter clinical trial, evaluating the safety and efficacy of azithromycin for treating hospitalized patients with COVID-19. It is part of a series of trials testing promising interventions for COVID-19, running in parallel and grouped under the name DAWn-studies. Patients hospitalized on dedicated COVID wards are eligible for study inclusion when they are symptomatic (i.e., clinical or radiological signs) and have been diagnosed with COVID-19 within the last 72 h through PCR (nasopharyngeal swab or bronchoalveolar lavage) or chest CT scan showing typical features of COVID-19 and without alternate diagnosis. Patients are block-randomized (9 patients) with a 2:1 allocation to receive azithromycin plus standard of care versus standard of care alone. Standard of care is mostly supportive, but may comprise hydroxychloroquine, up to the treating physician’s discretion and depending on local policy and national health regulations. The treatment group receives azithromycin qd 500 mg during the first 5 consecutive days after inclusion. The trial will include 284 patients and recruits from 15 centers across Belgium. The primary outcome is time from admission (day 0) to life discharge or to sustained clinical improvement, defined as an improvement of two points on the WHO 7-category ordinal scale sustained for at least 3 days. Discussion The trial investigates the urgent and still unmet global need for drugs that may impact the disease course of COVID-19. It will either provide support or else justify the discouragement of the current widespread, uncontrolled use of azithromycin in patients with COVID-19. The analogous design of other parallel trials of the DAWN consortium will amplify the chance of identifying successful treatment strategies and allow comparison of treatment effects within an identical clinical context. Trial registration EU Clinical trials register EudraCT Nb 2020-001614-38. Registered on 22 April 2020

EVALUATION OF A DIET AND ANTIBIOTICS TARGETING THE MICROBIOTA FOR TREATMENT OF MILD TO MODETARE ACTIVE PEDIARTIC ULCERATIVE COLITIS: AN OPEN LABEL PILOT STUDY

2021 ◽  
Vol 27 (Supplement_1) ◽  
pp. S38-S38
Author(s):  
Chen Sarbagili-Shabat ◽  
Lindsey Albenberg ◽  
Johan Van Limbergen ◽  
Dror Weiner ◽  
Michal Yaakov ◽  
...  
Keyword(s):  
Ulcerative Colitis ◽  
Pilot Study ◽  
Dietary Intervention ◽  
Activity Index ◽  
Fecal Calprotectin ◽  
Dietary Therapy ◽  
The Novel ◽  
Open Label ◽  
Intention To Treat ◽  
Stable Maintenance

Abstract Background Newer strategies that target the microbiome may offer an alternative therapeutic approach for Ulcerative Colitis (UC). We developed a novel diet that targets changes in the microbiome and barrier function that have been reported in UC. The goal of the current study was to evaluate the efficacy of two sequential induction of remission strategies that target the microbiota: the novel diet termed the ulcerative colitis diet (UCD) and an antibiotics cocktail combination in dietary non responders. Methods This was a prospective, single arm, open label, pilot study in patients aged 8–19, with a pediatric UC activity index (PUCAI) scores >10 and ≤45 on stable maintenance therapy (5ASA or thiopurines). PUCAI score was assessed at week 3 and 6. Patients failing to enter remission or intolerant to dietary therapy could receive an open label 14-day course of Amoxycillin, Metronidazole and Doxycycline (AMD), and had PUCAI scored at day 21. Response was defined a decline in PUCAI ≥ 10 points, remission as PUCAI< 10. The primary endpoint was intention to treat (ITT) remission at week 6 with diet as the sole intervention. Results Twenty-three children mean age of 15.1±2.9 years were enrolled. Two patients (1 responder, 1 remission) withdrew by 3 weeks, four required additional therapy by week 3, all were considered failures by ITT. Mean PUCAI decreased at week 3 and 6 from 34.5±9.8 to 21.7±14.9 and 17.6±17.2 respectively (P=0.005, P=0.001) at ITT analysis including all patients. Sixteen out of twenty-three patients (69.6%) responded by week 6. Ten of twenty-three (43.5%) achieved remission by week 6, and nine (39.1%) had clinical remission at week 6. The median fecal calprotectin (FC) level decreased in patients (n=5) who achieved remission from 630 (IQR, 332–1586) μg/g at week 0 to 230 (75–1298) μg/g at week 6. Eight patients received treatment with antibiotics after failing diet, 4/8 (50.0%) subsequently entered remission. Conclusion A dietary intervention called the UC Diet appears to be effective for induction of remission in children with mild to moderate UC. Sequential use of diet, followed by antibiotic therapy in dietary non responders, needs further evaluation as a microbiome directed steroid sparing therapy in patient’s refractory to 5ASA and thiopurines.

scholarly journals Convalescent Plasma Therapy in Critically Ill COVID-19 Patients: An Open Label Trial

2021 ◽  
Vol 36 (5) ◽  
pp. e296-e296
Author(s):  
Faryal Khamis ◽  
Zainab Al Arimi ◽  
Hamed Al Naamani ◽  
Maher Al Bahrani ◽  
Nenad Pandak ◽  
...  
Keyword(s):  
Distress Syndrome ◽  
The Novel ◽  
Open Label ◽  
Plasma Therapy ◽  
Royal Hospital ◽  
Protective Antibodies ◽  
Univariate Statistics ◽  
Study Power ◽  
Open Label Trial ◽  
Overall Mortality

Objectives: The novel severe acute respiratory syndrome coronavirus 2 pandemic continues to spread globally without an effective treatment. In search of the cure, convalescent plasma (CP) containing protective antibodies from survivors of coronavirus disease 2019 (COVID-19) infection has shown potential benefit in a non-intensive care unit setting. We sought to evaluate the effectiveness of CP therapy for patients with COVID-19 on mechanical ventilation (MV) and/or acute respiratory distress syndrome (ARDS). Methods: We conducted an open-label trial in a single center, Royal Hospital, in Oman. The study was conducted from 17 April to 20 June 2020. The trial included 94 participants with laboratory-confirmed COVID-19. The primary outcomes included extubation rates, discharges from the hospital and overall mortality, while secondary outcomes were the length of stay and improvement in respiratory and laboratory parameters. Analyses were performed using univariate statistics. Results: The overall mean age of the cohort was 50.0±15.0 years, and 90.4% (n = 85) were males. A total of 77.7% (n = 73) of patients received CP. Those on CP were associated with a higher extubation rate (35.6% vs. 76.2%; p < 0.001), higher extubation/home discharges rate (64.4% vs. 23.8%; p =0.001), and tendency towards lower overall mortality (19.2% vs. 28.6%; p =0.354; study power = 11.0%) when compared to COVID-19 patients that did not receive CP. Conclusions: CP was associated with higher extubation/home discharges and a tendency towards lower overall mortality when compared to those that did not receive CP in COVID-19 patients on MV or in those with ARDS. Further studies are warranted to corroborate our findings.

Sign in / Sign up

Export Citation Format

Share Document