E14.3
Conditions
Interventions
Group 1: In the healthy collective, a single pressure chamber exposure is performed according to the TS-240-90 scheme. In the diabetic collective, a single pressure chamber exposure is performed accor
Sponsors
HBO-Zentrum Euregio Aachen
Eligibility
Sex/Gender
All
Age
18 Years to 70 Years
Inclusion criteria
Inclusion criteria: Informed consent to participate Age 18-70 years Sufficient knowledge of the German language Diabetic collective: additional: confirmed diabetic retinopathy
Exclusion criteria
Exclusion criteria: Psychological pre-existing conditions Acute and chronic cataract Acute and chronic glaucoma Diseases with increased vascular permeability (e.g. vasculitides) Known intolerance to elevated ambient pressure Acute and chronic diseases of the middle or inner ear Claustrophobia Pulmonary changes (bronchial asthma, emphysema, pneumothorax, current infections) Non-removable implants Pregnancy and lactation Severe cardiovascular diseases Kidney failure requiring dialysis Sickle cell disease Seizure disorders or the use of drugs that lower the seizure threshold Known intolerance or allergy to fluorescein sodium or tropicamide Persistent foramen ovale (PFO). Collective of healthy subjects: Additional: underlying disease with use of permanent medication additional: disturbance of the blood-retinal barrier Collective with diabetic retinopathy: additional: increased risk for hypoglycemic decompensation.
Design outcomes
Secondary
| Measure | Time frame |
|---|---|
| Secondary outcome will be measured with fluorescein angiography, optical coherence tomography, and clinical tests. Assessments are performed before intervention (baseline), after intervention (exposure), and during follow-up (recovery). - Fluorescein angiography: Same findings in the recovery examination as in the baseline examination. Arm retinal time and arteriovenous passage time are altered by intervention. - Optical coherence tomography: Changes in morphology of various structures of the eye: retina, retinal blood vessels, lens, iridocorneal angle, and cornea. - Clinical examination: No changes after intervention in Amsler, Snellen and Ishihara test. | — |
Primary
| Measure | Time frame |
|---|---|
| The primary outcome is measured by fluorescein angiography. The examinations will be performed before the intervention (baseline), after the intervention (exposure) and during the following time period (recovery). In the collective of healthy subjects, leakage is expected to occur at the exposure examination that does not occur at the baseline examination. In the diabetic collective with retinopathy it is expected that a reduced leakage is visible in the exposure examination, compared to the baseline examination. | — |
Countries
Germany
Contacts
Public ContactUllrich Siekmann
HBO-Zentrum Euregio Aachen
Outcome results
None listed