H40.1
Conditions
Interventions
Group 1: 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 differ
Sponsors
Universitätsaugenklinik
Eligibility
Sex/Gender
All
Age
50 Years to 85 Years
Inclusion criteria
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
Exclusion criteria
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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. | — |
Countries
Germany
Contacts
Public ContactAngela Ehmer
Universitätsaugenklinik
Outcome results
None listed