EYEMATE-SC Trial: Twelve-Month Safety, Performance, and Accuracy of a Suprachoroidal Sensor for Telemetric Measurement of Intraocular Pressure.

PURPOSE: Measuring and controlling intraocular pressure (IOP) provide the foundation for glaucoma treatment. Self-tonometry has been proposed as an alternative to measure IOP throughout the entire day better. The novel EYEMATE-SC sensor (Implandata) is implanted in the suprachoroidal space to enable contactless continual IOP monitoring. The aim of the present study was to investigate the 1-year safety, performance, and accuracy of the EYEMATE-SC in patients with primary open-angle glaucoma undergoing simultaneous nonpenetrating glaucoma surgery (NPGS). DESIGN: Prospective, multicenter, open-label, single-arm, interventional clinical trial. PARTICIPANTS: Twenty-four eyes of 24 patients with primary open-angle glaucoma who were due to undergo NPGS (canaloplasty or deep sclerectomy). METHODS: An EYEMATE-SC sensor was implanted during NPGS. Goldmann applanation tonometry (GAT) measurements were compared with the sensors' IOP measurements at all postoperative visits through 12 months. MAIN OUTCOME MEASURES: Device position and adverse events. RESULTS: Fifteen eyes underwent canaloplasty, and 9 underwent deep sclerectomy. Successful implantation of the sensor was achieved in all eyes with no reported intraoperative difficulties. Through the 12-month follow-up, no device migration, dislocation, or serious device-related complications were recorded. A total of 536 EYEMATE-SC measurements were pairwise included in the IOP agreement analysis. The overall mean difference between GAT and EYEMATE-SC measurements was 0.8 mmHg (95% confidence interval [CI] of the limits of agreement [LoA], -5.1 to 6.7 mmHg). The agreement gradually improved, and from 3 months after surgery until the end of the follow-up, the mean difference was -0.2 mmHg (95% CI of LoA, -4.6 to 4.2 mmHg) over a total of 264 EYEMATE-SC measurements, and 100% of measurements were within ±5 mmHg of GAT. CONCLUSIONS: The EYEMATE-SC sensor was safe and well tolerated through 12 months. Moreover, it allowed accurate, continuous IOP monitoring. FINANCIAL DISCLOSURE(S): Proprietary or commercial disclosure may be found after the references.

SALUS-a non-inferiority trial to compare self-tonometry in glaucoma patients with regular inpatient intraocular pressure controls: study design and set-up.

PURPOSE: The SALUS study aims to improve the healthcare situation for glaucoma patients in Germany. In order to detect diurnal intraocular pressure (IOP) fluctuations, inpatient monitoring of IOP in an eye hospital for a minimum of 24 h is the current standard. SALUS assesses the benefits of a new form of outpatient care, where IOP can be measured by the patients themselves at home using a self-tonometer. This approach should promote the patient's health competence and empowerment within the healthcare system while reducing treatment costs. METHODS: The SALUS study is a randomized controlled, open non-inferiority trial, alongside an economic analysis, determining whether outpatient monitoring of IOP with self-tonometry is at least as effective as current standard care and would reduce treatment costs. Participants (n = 1980) will be recruited by local ophthalmologists in the area of Westphalia-Lippe, Germany, and randomized to receive 7-day outpatient or 24-h inpatient monitoring. Participants in both study arms will also receive 24-h blood pressure monitoring. Furthermore, patient data from both study groups will be collected in an electronic case file (ECF), accessible to practitioners, hospitals, and the study participants. The primary endpoint is the percentage of patients with IOP peaks, defined as levels 30% above the patient-specific target pressure. Data will also be collected during initial and final examinations, and at 3, 6, and 9 months after the initial examination. RESULTS: The study implementation and trial management are represented below. CONCLUSION: SALUS is a pioneering prospective clinical trial focused on the care of glaucoma patients in Germany. If SALUS is successful, it could improve the healthcare situation and health literacy of the patients through the introduction of various telemedical components. Furthermore, the approach would almost certainly reduce the treatment costs of glaucoma care. TRIAL REGISTRATION: ClinicalTrials.gov ID: NCT04698876, registration date: 11/25/2020. DRKS-ID: DRKS00023676, registration date: 11/26/2020.

Long-term follow-up after implantation of a telemetric intraocular pressure sensor in patients with glaucoma: a safety report.

IMPORTANCE: To investigate the long-term safety of a novel intraocular telemetric pressure sensor. BACKGROUND: Acquisition of accurate intraocular pressure (IOP) data is vital for sufficient medical care of glaucoma patients. Non-invasive self-tonometry with a telemetric IOP sensor can provide important information regarding the individual IOP profile. DESIGN: Retrospective analysis of long-term follow-up data assessed during outpatient visits in a university hospital. PARTICIPANTS: Six patients with open-angle glaucoma were included. Unfortunately, one patient passed away shortly after completion of the original 1-year study. METHODS: Within the scope of a prospective 1-year pilot clinical trial, a telemetric IOP sensor was inserted into the ciliary sulcus after intracapsular lens implantation during planned cataract surgery. Patients were regularly examined as outpatients even beyond the duration of the 1-year study. Data concerning sensor functionality, safety parameters and home self-tonometry were assessed. MAIN OUTCOME MEASURES: Long-term sensor functionality and safety. RESULTS: Sensor measurements were always successful in every patient. Additionally, home self-tonometry was conducted without any problems by every patient. The average follow-up period was 37.5 months (21-50 months). During this period, the average number of IOP measurements performed per patient was 1273 (223-2884 measurements). No severe adverse events were reported. A varying degree of pupillary distortion was observed after 6-12 months in every patient; this remained unchanged thereafter with only one exception. CONCLUSIONS AND RELEVANCE: Telemetric IOP sensors showed good functionality and tolerability during long-term follow-up. Non-invasive self-tonometry with a telemetric IOP sensor can provide useful additional data for future monitoring of patients with glaucoma.

iCare® Home vs Goldmann applanation tonometry: Agreement of methods and comparison of inter-observer variation at a tertiary eye centre.

Purpose: To investigate whether the inter-observer variation is similar between the Goldmann applanation tonometer used by healthcare staff and the iCare® Home tonometer used by glaucoma patients, volunteers and healthcare staff. Methods: Sixty-one participants were recruited to the study, including 24 glaucoma patients. Seven participants were excluded. For each participant, intraocular pressure (IOP) was measured on the same occasion by two different healthcare staff using GAT as well as by a healthcare staff and the participant using the iCare® Home tonometer. Results: Seventy-two per cent of iCare® measurements were within 3 mmHg of the GAT measurements. There was a statistically significant difference between the trainers' measurements made with iCare® Home and those made with GAT (p < 0.001), as well as between the GAT measurements made by trainers and those made by extra personnel (p = 0.017). The strongest correlation was between iCare® Home participants' and trainers' measurements (0.934). The correlation between different users with GAT was lower (0.769). The inter-user agreement was excellent for iCare® Home users (95% CI 0.93, ranging from 0.880 to 0.959) and moderate for GAT users (95% CI 0.741, ranging from 0.558 to 0.849). Conclusion: Our study found that tonometry with iCare® Home has similar or less inter-user variation compared with GAT.

Impact of self-tonometry on glaucoma treatment decision.

PURPOSE: The aim of this study was to examine the impact of self-tonometry on clinicians' decision in glaucoma treatment. MATERIALS AND METHODS: Medical records of 133 patients who had performed self-tonometry using iCare® Home between January and December 2019 were retrospectively reviewed. Inclusion criteria were as follows: age over 18 years, all types of glaucoma, as well as ocular hypertension and glaucoma suspect, compliance with tonometer manufacturer's recommendations and monitoring over at least 2 days. The data consisted of age, gender, diagnosis, visual field index, rate of progression and type of treatment pre- and post-intraocular pressure (IOP) phasing. The following IOP measurements were used to calculate the mean and maximum IOP, and range over each day and consecutive days: Goldmann applanation tonometry (GAT) measurements from referral and training visits and iCare® Home measurements made by the trainers and the patients themselves. A total of 90 patients were included. RESULTS: Clinicians were satisfied with the actual treatment in 54.4% of the cases. There was a statistically significant difference between the clinicians' decision to maintain same treatment or to escalate therapy for all the mean and maximum IOPs measured on each single day and over a 2- or 3-day period (p < 0.002). CONCLUSION: Our results suggest that the presence of high IOP values obtained with self-tonometry supports an intensification of glaucoma treatment. Self-tonometry provides clinicians with an important complement for clinical decision-making, and under- or over-treatment may be avoided for the benefit of patients.

Initial experience in self-monitoring of intraocular pressure.

BACKGROUND/AIMS: Diurnal variation in intraocular pressure (IOP) is a routine assessment in glaucoma management. Providing patients the opportunity to perform self-tonometry might empower them and free hospital resource. We previously demonstrated that 74% of patients can use the Icare® HOME tonometer. This study further explores Icare® HOME patient self-monitoring. METHODS: Patients were trained by standard protocol to use the Icare® HOME rebound tonometer. Patient self-tonometry was compared to Goldmann applanation tonometry (GAT) over one clinical day. Following this, each patient was instructed to undertake further data collection that evening and over the subsequent two days. RESULTS: Eighteen patients (35 eyes) participated. Good agreement was demonstrated between GAT and Icare® HOME for IOPs up to 15 mm Hg. Above this IOP the Icare® tended to over-read, largely explained by 2 patients with corneal thickness >600 um. The mean peak IOP during 'clinic hours' phasing was 16.7 mm Hg and 18.5 mm Hg (p = 0.24) over three days. An average range of 5.0, 7.0 and 9.8 mm Hg was shown during single day clinic, single day home and three day home phasing respectively (p =<0.001). The range of IOP was lower in eyes with prior trabeculectomy (6.1 mm Hg vs 12.2 mm Hg). All patients undertook one reading in the early morning at home with an average of 4.8 readings during, and 3.1 readings after office hours. CONCLUSIONS: This small study shows that self-tonometry is feasible. The findings from home phasing demonstrated higher peak and trough IOPs, providing additional clinical information. Home phasing is a viable alternative. The cost-effectiveness of this approach has yet to be addressed.

Self-measurement with Icare HOME tonometer, patients' feasibility and acceptability.

PURPOSE: To evaluate and compare the accuracy of self-measurement of intraocular pressure using Icare Home rebound tonometer with Goldmann applanation tonometer and assess acceptability of self-tonometry in patients with glaucoma and ocular hypertension. METHODS: In the study, 117 subjects were trained to use Icare Home for self-measurement. Icare Home tonometer readings were compared with Goldmann applanation tonometer, including one eye per patient. Agreement between the two methods of measurement was evaluated by Bland and Altmann analysis. Questionnaire was used to evaluate patients' perception of self-tonometry. RESULTS: One hundred and three out of 117 patients (88%) were able to measure their own intraocular pressure and 96 (82%) fulfilled the requirements for certification. The mean (SD) difference Goldmann applanation tonometer minus Icare Home was 1.2 (2.4) mmHg (95% limits of agreement, -3.4 to 5.9 mmHg). The magnitude of bias between the two methods depended on central corneal thickness, with greater bias at central corneal thickness <500 µm. In 65 out of 96 subjects (67.7%), Icare Home results were within 2 mmHg of the Goldmann applanation tonometer. Seventy-three out of 93 (78.5%) felt that self-tonometry was easy to use and 75 patients (80.6%) responded that they would use the device at home. CONCLUSION: Icare Home tonometry tends to slightly underestimate intraocular pressure compared to Goldmann applanation tonometer. Most patients were able to perform self-tonometry and found it acceptable for home use. Measurements using rebound self-tonometry could improve the quality of intraocular pressure data and optimize treatment regimen.

Icare Home Tonometer: A Review of Characteristics and Clinical Utility.

The Icare HOME (TA022, Icare Oy, Vanda, Finland) is rebound tonometer recently approved by the US Food and Drug Administration in March 2017 designed for self-measurement of intraocular pressure (IOP). IOP remains a major modifiable risk factor for glaucoma progression; however, IOP measurements typically occur through single office measurements on Goldmann applanation tonometry (GAT) and do not always reveal the complete picture of patient's IOP patterns and daily fluctuations, which are important for accurate diagnosis and evaluation. Numerous studies have now compared the efficacy of the Icare HOME to that of GAT. The objective of this article is to review the existing literature surrounding the Icare HOME tonometer and its efficacy as a self-tonometer in comparison to GAT. The available literature has shown promising results in its accuracy of measuring IOP but suggests cautious usage in patients with central corneal thicknesses or IOP ranges that are outside of a certain range. This article will also provide details and example cases for when the Icare HOME may be most clinically useful.

Self-monitoring of intraocular pressure using Icare HOME tonometry in clinical practice.

Purpose: To determine the value of self-monitoring of diurnal intraocular pressure (IOP) by Icare Home rebound tonometer in patients with glaucoma and ocular hypertension. Methods: Patients with open-angle glaucoma or ocular hypertension, controlled IOP at office visits, and at least 3 years of follow-up in the glaucoma clinic were included. Progression of glaucoma was based on medical records and defined by documented structural and/or visual field change. Patients were trained to correctly perform self-tonometry and instructed to measure diurnal IOP in a home setting for 3 days. IOP characteristics (mean, peak IOP, fluctuation of IOP as range, and SD of IOP) were documented and compared between the progressive and stable eyes. Results: Ninety-four patients (50 females) with a mean (SD) age of 57.1 (14.7) years were included. Among the 94 eyes from 94 subjects, 72 (76.6%) eyes had primary open-angle glaucoma, ten (10.6%) had pigmentary glaucoma, four (4.3%) had exfoliative glaucoma, and eight (8.5%) eyes had ocular hypertension. Thirty-six eyes showed progression and 58 eyes were stable. Patients with progression were older than those with stable disease (mean (SD) 65.8 (8.4) years vs 51.7 (15.3) years, P<0.001). The progression group had higher average IOP (mean (SD) 15.8 (4.0) mmHg vs 13.3 (3.7) mmHg, P=0.002), peak IOP (mean (SD) 21.8 (5.8) mmHg vs 18.6 (4.8) mmHg, P=0.01), and greater IOP fluctuation range (mean (SD) 11.6 (4.8) vs 9.1 (3.5) mmHg, P=0.011) compared to non-progression group. Conclusion: Self-monitoring of IOP using Icare Home tonometry provides more complete data on variability of IOP to assist in the management of glaucoma.

[Application of rebound self-tonometry for measurements in a supine position]. / Einsatzmöglichkeit von Rebound-Selbsttonometrie zur Liegendmessung.

BACKGROUND: Diurnal or nocturnal fluctuations of intraocular pressure (IOP), which are especially common in glaucoma patients, often require hospitalization of the patient in order to be detected. This is often inconvenient for the patient. Therefore, this study evaluated the usefulness of a rebound tonometer (RT) designed for IOP self-tonometry (RT-Home) in an outpatient department, especially in the supine position and out of office hours. METHODS: Over a period of 6 months unselected open-angle glaucoma patients were equipped with a RT-home device for one night each. At the beginning IOP values measured by medical personnel (RT-Home(o)) were compared with IOP measured by the patient (RT-Home(p)), as well as measured by applanation tonometry according to Goldmann (GAT). Patients also completed a questionnaire regarding subjective comfort during use of the RT-Home. RESULTS: The RT-Home(o) showed a bias of -1.1 mm Hg (-7.9 to 5.7 mm Hg) compared to GAT and RT-Home(p) showed a bias of -1.6 mm Hg (-8.9 to 5.9 mm Hg) compared to GAT. The measurement differences between GAT and RT-Home(o) as well as RT-Home(p) showed a stong correlation with the IOP and the central corneal thickness (IOP: r = 0.481, P > 0.0001, RT-Home(o) vs. GAT; corneal thickness: r = 0.612, P < 0.0001, RT-Home(o) vs. GAT). The RT-Home(p) in a supine position showed significantly elevated IOP levels than during the day (P < 0.0001). The RT-Home showed no qualitative differences between measurements in supine and sitting positions. DISCUSSION: The RT-Home is effective and precise for use in an outpatient department to gain a general overview over patients' IOP out of office hours and also in the supine position. In the long term it seems possible that RT-Home can avoid hospitalization for diurnal and nocturnal IOP evaluation especially of young, mobile patients; however, interpretation of the data always requires professional knowledge.

Monitoring daily intraocular pressure fluctuations with self-tonometry in healthy subjects.

PURPOSE: To evaluate the accuracy of the intraocular pressure (IOP) measured by healthy subjects with icare® Home and to observe the IOP fluctuation and pattern of IOP fluctuation in healthy subjects over three consecutive days. METHODS: Sixty healthy subjects were recruited to the study. IOP was measured by the subjects themselves and by study staff using icare® Home tonometers on visits 1 and 2, as well as by study staff using Goldmann applanation tonometry (GAT). Furthermore, the subjects measured their IOP at home for three consecutive days. RESULTS: Twenty-three per cent of the study eyes were excluded in the statistical analysis due to dropout or non-compliance to the schedule. Approximately 70% of the icare® Home measurements were within 3 mmHg of the GAT measurements. Ten to 16% of the study eyes had IOP peaks outside office hours. Sixty-three per cent of the study eyes had different IOP patterns on consecutive days. CONCLUSION: Rebound self-tonometry appears to be accurate and could be used to monitor short- and long-term IOP variations. The difference between IOP patterns on consecutive days raises questions as to the certainty of a single IOP measurement as a measure of treatment effect.

[Reliability and reproducibility of introcular pressure (IOP) measurement with the Icare® Home rebound tonometer (model TA022) and comparison with Goldmann applanation tonometer in glaucoma patients]. / Fiabilité et reproductibilité des mesures de la pression intraoculaire par le tonomètre Icare® Home (modèle TA022) et comparaison avec les mesures au tonomètre à aplanation de Goldmann chez des patients glaucomateux.

PURPOSE: The Icare® Home tonometer is a new rebound tonometer, developed for intraocular pressure (IOP) self-monitoring. The main objective of our study was to evaluate the reliability and reproducibility of measurements taken with the Icare® Home tonometer in glaucoma patients compared to the Goldmann applanation tonometer. A secondary objective was to investigate factors that could influence the reproducibility of these measurements. MATERIALS AND METHODS: Fifty-two glaucoma patients were included in this prospective, non-randomized, monocentric study. IOP measurements were performed on the right eye and then on the left eye in the following order (3 measurements of IOP for each method): air tonometer (T-Air), Icare® Home tonometer by the patient (RT-P), Icare® Home tonometer by an ophthalmologist (RT-O), Goldmann applanation tonometer (GAT). RESULTS: Forty-four patients (85%) managed to take their IOP on both eyes with the Icare® Home tonometer. Mean IOPs were 14.35±3.93mmHg (T-Air), 13.43±4.65mmHg (RT-P), 14.13±4.29mmHg (RT-O), 14.74±3.84mmHg (GAT). The intraclass correlation indices (ICC) on the 3 repeated IOP measurements were 0.924, 0.872, 0.947 and 0.957, respectively. Bland-Altman analysis found a mean difference (bias) between GAT and RT-P, between GAT and RT-O, and between RT-O and RT-P, respectively, of 1.31, 0.61 and 0.70mmHg, with a 95% confidence interval of -3.34 to 5.96, -3.91 to 5.14 and -3.44 to 4.84mmHg, respectively. The reproducibility of the measurements taken with the Icare® Home tonometer did not vary according to corneal thickness or age of the patients. CONCLUSION: The Icare® Home tonometer provides reliable and reproducible IOP values in glaucoma patients, although it appears to slightly underestimate the IOP measurements compared to the Goldmann applanation tonometer.

Self-tonometry as a complement in the investigation of glaucoma patients.

PURPOSE: To evaluate the reliability of intraocular pressure measured by patients with glaucoma themselves using a new hand-held tonometer and to observe whether the intraocular pressure (IOP) variations have the same pattern on different days while glaucoma treatment is constant. METHODS: Eighty-seven patients diagnosed with open-angle glaucoma or ocular hypertension were recruited to the study. Intraocular pressure measured using Goldmann applanation tonometry (GAT) was compared with IOP measured using tonometry at baseline and on the second visit. Patients measured their IOP at home using the hand-held tonometers. RESULTS: The mean difference between GAT and iCare® values varies from 0 to 1 mmHg. Seventy-eight per cent of iCare® measurements were within 3 mmHg of the GAT measurements. Approximately 64% of the study eyes had higher IOP in the morning than in the afternoon/evening. Circadian patterns differed between consecutive days in 47% of the study eyes. There were IOP peaks outside office hours in up to 16% of the study eyes. CONCLUSION: Measurements made using rebound self-tonometry are accurate and could be used to complement the investigation of patients with glaucoma. Intraocular pressure curves provide valuable data usable when adapting glaucoma treatment.

Systematic Review of Current Devices for 24-h Intraocular Pressure Monitoring.

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 peak IOP levels. There is an unmet need for a reliable and accurate device for 24-h IOP monitoring. The 24-h IOP monitoring devices that are currently available and in development fall into three main categories: self-monitoring, temporary continuous monitoring, and permanent continuous monitoring. This article is a systematic review of current and future technologies for measuring IOP over a 24-h period.

Noninvasive intraocular pressure monitoring: current insights.

Glaucoma is the second leading cause of blindness worldwide and intraocular pressure (IOP) is currently its only modifiable risk factor. Peak IOP has for a long time been considered as a major contributor to glaucoma progression, but its effects may depend not only on its magnitude, but also on its time course. The IOP is nowadays considered to be a dynamic parameter with a circadian rhythm and spontaneous changes. The current practice of punctual measuring the IOP during office hours is therefore a suboptimal approach, which does not take into account the natural fluctuation of IOP. Because of its static nature a single IOP measurement in sitting position fails to document the true range of an individual's IOP, peak IOP, or variation throughout the day. Phasing means monitoring a patient's IOP during the daytime or over a 24-hour period. This can provide additional information in the management of glaucoma patients. This review focuses on the current insight of non-invasive IOP monitoring as a method of obtaining more complete IOP profiles. Invasive techniques using an implantable sensor are beyond the scope of this review.

Implantation of a novel telemetric intraocular pressure sensor in patients with glaucoma (ARGOS study): 1-year results.

PURPOSE: We investigated the safety of a telemetric IOP sensor and the accuracy of its IOP measurements in six patients with open-angle glaucoma and cataract. METHODS: The study design was a prospective, single-center clinical trial. Here we present 1-year follow-up data. A ring-shaped telemetric IOP sensor was implanted in the ciliary sulcus after implantation of the intracapsular lens, during planned cataract surgery. The sensor is encapsulated in silicone rubber and consists of a miniature device with eight pressure-sensitive capacitors and a circular microcoil antenna. IOP measurements are performed with a reader unit held in front of the eye. IOP is calculated as the differences between the absolute pressure inside the eye (pressure sensor) and that outside the eye (reader unit). RESULTS: The sensor was successfully implanted in all patients. Four patients developed sterile anterior chamber inflammation that resolved completely within 9 days after surgery with anti-inflammatory treatment. All patients showed mild to moderate pupillary distortion and pigment dispersion after surgery. Telemetric IOP measurement was performed in all patients at all visits, and the patients successfully performed self-tonometry at home after receiving instructions. Telemetric IOP values showed similar profiles compared to those of Goldmann applanation tonometry (GAT). Three patients showed a relevant IOP step during follow-up, and in one patient, negative values were obtained throughout the study. CONCLUSIONS: Despite early postoperative anterior chamber inflammation, the IOP sensor was well tolerated by all patients. We describe the first prospective clinical study of a noncontact IOP sensor that potentially enables continuous IOP monitoring in patients with glaucoma. The sensor shape and size needs to be adapted to avoid pupillary distortion and to confirm that IOP measurements are accurately recorded in comparison to those of GAT. ( www.germanctr.de; number DRKS00003335.).