Trial document




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  DRKS00013908

Trial Description

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Title

Influence of physiological parameters on intraocular pressure in patients with glaucoma (ARGOS FU EGRET +)

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Trial Acronym

ARGOS FU EGRET+

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URL of the Trial

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Brief Summary in Lay Language

In the context of the ARGOS-02 study, more than a year ago, patients were implanted with an intraocular pressure sensor (the so-called EYEMATE). This one is able to independently measure their intraocular pressure at any time. This measurement method is completely non-contact and also works with a distance of a few centimeters between the hand-held reader and the implant. It is now possible to test the intraocular pressure not only while sitting or lying, but also during physical activity.
In addition, with the help of an external antenna for the hand-held reader, the sensor not only allows measurements which can be initiated by itself, but also automatic measurements, e.g. every 10 minutes. Using this external antenna, which can be placed in front of the eye like an eye patch, it is therefore possible to monitor the pressure of the eye for an extended period of time (e.g., 24 hours) without the action of the patient.
A third possible application is the so-called online measurement, in which the eye pressure can be monitored in real time with a measuring frequency of 10 measurements per second via a computer connected to the handheld reader.
With the help of these measuring methods, it is now possible for the first time to determine the influence of various physiological parameters (for example blood pressure, heart rate, respiratory rate, physical activity, body position and much more) on the intraocular pressure. These examinations are not possible with conventional methods for measuring intraocular pressure, but only with the pressure sensor implanted in the ARGOS-02 study.

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Brief Summary in Scientific Language

As part of the ARGOS-02 study, an intraocular pressure sensor (the so-called EYEMATE-IO) was implanted in 22 patients between 2014 and 2016. This permanent, battery-free implant enables patients to measure their intraocular pressure independently and without contact at any time using a handheld reader (so-called mesograph). The ARGOS-02 study mentioned above has verified the safety and performance of the system (consisting of the implantable sensor and the handheld reader) and led to its CE marking. The sensors implanted as part of the ARGOS-02 study (like artificial lenses of a cataract operation) remain in the eye of the study patients for life, so they can be used at any time without further intervention.
Using this unique telemetric, non-contact measurement method, it is possible to test intraocular pressure not only when sitting or lying down, but also during physical activity. This possibility does not exist in the standard methods for eye pressure measurement.
In addition, the sensor, by means of an external antenna for the handheld reader, allows not only measurements which the patient himself triggers, but also automatic measurements, e.g. every 10 minutes. Therefore, with the help of this external antenna, which can be placed in front of the patient's eye like an eye patch, it is possible to track the eye pressure over an extended period of time (e.g., 24 hours).
A third possible application is the so-called online measurement, in which the eye pressure can be monitored in real time with a measuring frequency of 10 measurements per second via a computer connected to the handheld reader.
With the help of these measuring methods, it is now possible for the first time to determine the influence of various physiological parameters (for example blood pressure, heart rate, respiratory rate, physical activity, body position and much more) on the intraocular pressure. These examinations are not possible with conventional methods for measuring intraocular pressure, but only with the pressure sensor implanted in the ARGOS-02 study.
This follow-up project is set up as a monocentric study. The study patients are recruited from the patients of the ARGOS-02 study.

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Organizational Data

  •   DRKS00013908
  •   2018/01/24
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  •   yes
  •   Approved
  •   209/17, Ethikkommission der Medizinischen Fakultät der Otto-von-Guericke-Universität Magdeburg
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Secondary IDs

  •   U1111-1208-0457 
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Health Condition or Problem studied

  •   H40.1 -  Primary open-angle glaucoma
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Interventions/Observational Groups

  •   Methodology and implementation
    1. Duration of the investigation
    The duration of the examinations depends on the number of partial examinations carried out and is therefore individually different. Only the partial examinations to which the patient is physically capable and which do not exceed the daily workload of the patient are carried out. In an effort to make these examinations as non-invasive as possible for the patient, each individual examination day will not exceed a duration of 4 hours with pauses. The patients will spend a maximum of one week at the study center. The order of the individual examination days is determined individually and is based on the willingness and ability of the patient to carry out each partial examination.
    1. Arrival, accommodation, detailed information about the purpose of the study and the study, obtaining the final declaration of consent
    2. Influence of Respiration / Physical Activity / Eye Movements / Comparison DCT vs. Eyemate
    3. Influence of Body Position on IOP Intraocular pressure) and ICP (Intracranial Pressure) (Tilt Table Test) / Comparison GAT Vs. Eyemate
    4. Electrophysiology / Comparison Rebound tonometer vs. airpump tonometer vs. Eyemate
    5. 24h monitor (blood pressure / pulse oximeter / ECG) + 24h measurement of intraocular pressure
    6. Evaluation and debriefing, departure (if necessary departure only on the following day).

    2. Description of the data to be collected

    2.1 IOP with various measuring techniques,
    Comparative measurements of the IOP between Eyemate and the following conventional pressure measurement methods are to be carried out:
    a) Goldmann applanation tonometry
    b) Dynamic contour tonometry (Pascal tonometer)
    c) non-contact tonometer (Corvis ST or Ocular Response Analyzer)
    d) Rebound tonometer (iCare)

    Each measurement takes about 1-2 minutes, the measurements are repeated four times at intervals of one hour, in order to also detect fluctuations in the IOP level during the day. Using the external antenna of the mesograph handheld reader, the eye pressure is recorded "live" parallel to the comparison measurement.

    2.2. IOP during eye movements, blinking and pinching,
    For this purpose, the patients are asked to direct the view at a distance of two meters to a measuring system attached to the wall (so-called harms wall) several times for every 10 seconds to certain points to the left, right, up, or down, the eyes open or keep closed, blink or pinch your eyes together. During these eye movements or in the different eye positions, the intraocular pressure is tracked live. This part of the examination takes about 20 minutes for every three repetitions.

    2.3 IOP during deep or shallow breathing,
    To quantify this effect, the eye pressure is recorded by means of online measurement, while the patient inhales and exhales for about 5-8 breaths either slowly and shallowly, very deeply, or against a resistance or stops the air for a short time (Valsalva maneuver ). In addition, the patient should cough or laugh when requested, again, the IOP is continuously recorded. All experiments are repeated three times, in total, this test part takes about 30 minutes.

    2.4 IOP during physical activity,
    Another part of the experiment deals with the influence of physical activity on the IOP. In order to simulate normal physical activity, patients who still ride a bicycle privately should be examined with low to moderate horsepower on a stationary bicycle. The plan is to gradually increase the power by 10 watts to a maximum of 60 watts and a subsequent rest phase. The patient should stay for 2 minutes at each performance level and be supervised by the study doctor the entire time. Unless the patient's ability to perform and willingness to do so does not militate against it, this attempt should be repeated once every 15 minutes
    Alternatively, if the patient is no longer actively cycling, the physician considers that a stationary ergometer is out of the question, or if the patient refuses the examination, IOP may be used while climbing a staircase (15 steps) or while walking at the patient's normal walking pace ( 30 meters). Parallel to eye pressure measurement, blood pressure, heart rate and ECG are also monitored. Patients who historically exceed NYHA Class II (definition: mild restriction of exercise tolerance, freedom from pain at rest, and light exertion, onset of symptoms of increased exercise) are excluded from this sub-study. This part of the experiment takes a maximum of 1 hour with repetition.

    2.5 Natural IOP during the night,
    During their stay in Magdeburg, patients should therefore wear the external antenna described above for at least two nights in order to repeatedly receive automatic measurements of the nocturnal IOP without disrupting sleep.

    2.6 IOP at different positions of the body,
    For this purpose, a medical tilting table, as it is also used for orthostatic experiments, are used. Measurements of 2 minutes duration in 4 defined positions are planned: Upright (90 °), in medium inclined position (45 °), in horizontal position (0 °) and in slight head-down position (-10 °) Microgravity simulated. The changes in position between the individual positions take place slowly and in a controlled manner. The change between lying and standing takes e.g. 14 seconds. In addition to the "online" measurement of the IOP during the tilt table trial, changes in ICP will be estimated using otoacoustic emissions. The measurement of the changes of the ICP shall be carried out by means of the Elios system of Echodia.

    3. IOP and electrophysiological examinations,
    The electrophysiological measurements should be carried out once in a sitting position and once in a lying position. Overall, these measurements will take about 4 hours to complete.

    3.1Visually Evoked Potentials (VEP),
    For the discharge, a total of 7 electrodes are glued to the forehead and the back of the head.

    3.2 pattern electroretinogram (PERG),
    (English: pattern ERG, therefore: P-ERG)
    The study will be standardized according to the guidelines of the International Society for Clinical Electrophysiology of Vision (ISCEV). With the help of an alternating checkerboard pattern, white and black areas in constant light conditions provide the human eye with a constantly changing pattern stimulus on a computer monitor.

    3.3 Photopic negative response (PhNR),
    should be measured while sitting and lying down, while using the EYEMATE-IO sensor, the IOP is registered to investigate an influence of the IOP on the functioning of the ganglion cells.

    3.4Internal pressure measurements in the long-term test,
    24-hour intraocular pressure measurements in combination with long-term blood pressure measurements and long-term ECG are performed. No further trials are planned for this trial day. After applying the measuring devices, the patient is free to design the day according to his wishes and, for example, to explore the city. The patient is merely prompted to record his activities in a provided journal, as is customary in long-term ECG or blood pressure measurements.

    3.5 Self-measurements in everyday life
    After completing the examinations in Magdeburg, IOP self-measurements by the patient in his home environment should be carried out as frequently as possible / practicable for two weeks and any activities performed should be recorded. Patients are encouraged to perform an IOP measurement as soon as possible before, during and immediately after an activity. For example: before / during and after meals, before / during and after shopping, before and after sports, climbing stairs, bath, television, etc.

    3.6 medication changes,
    asked patients to record any drug changes prescribed by their supervising ophthalmologist in their patient diary
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Characteristics

  •   Non-interventional
  •   Other
  •   Single arm study
  •   Open (masking not used)
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  •   Uncontrolled/Single arm
  •   Basic research/physiological study
  •   Single (group)
  •   N/A
  •   N/A
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Primary Outcome

In the context of the observational study, the influence of physiological parameters on intraocular pressure in simulated everyday situations will be investigated.

It is a purely explorative study, which should for the first time use the possibilities of the EYEMATE-IO under (simulated) everyday conditions. The collected data should form the basis for subsequent confirmatory studies, which are planned for a larger number of future patients with sensors still to be implanted. The purpose of the study is solely to explore the potential applications of the EYEMATE-IO sensor and to find first indications of the interactions between normal physiology (blood pressure, heart and respiratory rate, body position) and intraocular pressure, and which parameters may provide information on disease progression in the future.

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Secondary Outcome

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Countries of Recruitment

  •   Germany
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Locations of Recruitment

  • University Medical Center 
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Recruitment

  •   Actual
  •   2018/08/06
  •   21
  •   Monocenter trial
  •   National
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Inclusion Criteria

  •   Both, male and female
  •   50   Years
  •   85   Years
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Additional Inclusion Criteria

This study project will only include patients who have been treated with the EYEMATE pressure sensor as part of the ARGOS-02 study.
1. Compulsory patients who have been provided with a permanent intraocular pressure sensor as part of the ARGOS-02 study in 2014-2016 and who agree to participate in the study described here.
2. Age 50 - 85 years
3. Male or female gender
4. Efficient EYEMATE-IO pressure sensor

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Exclusion Criteria

- Absolute exclusion criteria
1. Functionlessness or defectiveness of the EYEMATE-IO pressure sensor
2. Serious general conditions that, according to the study doctor, make it impossible to travel to the study center or participate in the majority of examinations.
- Relative exclusion criteria (which prevent participation in individual sub-examinations, but not the majority of examinations).
3. ocular diseases preventing the comparison of IOP measurements between EYEMATE-IO and established standard procedures (e.g., corneal ulcer, corneal scar, keratoconus, severe irregular astigmatism)
4. Paralysis of the outer eye muscles, which prevent the measurement of the IOP in different directions.
5. Disorders of the inner ear or organ of balance that prevent a noninvasive measurement of changes in intracranial pressure by means of otoacoustic emissions.
6. Cardiovascular disease greater than grade II NYHA, immobility or musculo-skeletal system disorders that prevent running 30 meters straight or climbing 15 steps.
7. Pulmonary diseases that prevent normal breathing, short-term deep or shallow inspiration, or expiration against resistance (e.g., severe restrictive or obstructive airways disease)
8. Known seizure disorder or epilepsy. This leads to the exclusion of the electrophysiological examinations.

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Addresses

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    • Universitätsaugenklinik
    • Mr.  Prof. Dr. med.  Hagen  Thieme 
    • Leipziger Str. 44
    • 39120  Magdeburg
    • Germany
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    • Universitätsaugenklinik
    • Mr.  Dr. med.  Lars  Choritz 
    • Leipziger Str. 44
    • 39120  Magdeburg
    • Germany
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    • Universitätsaugenklinik
    • Ms.  Angela  Ehmer 
    • Leipziger Str. 44
    • 39120  Magdeburg
    • Germany
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Sources of Monetary or Material Support

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    • EGRET+ (European Glaucoma Research Training Program Plus - European Union’s Horizon 2020 research and innovation programme under the Marie SkÅ‚odowska-Curie grant agreement No. 675033
    • Hanzeplain 1
    • 9713 GZ  Groningen
    • Netherlands
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Status

  •   Recruiting ongoing
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Trial Publications, Results and other Documents

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* This entry means the parameter is not applicable or has not been set.