The effect of hyperbaric oxygen exposure on the eye and the blood-retinal barrier
- Conditions
- E14.3
- Registration Number
- DRKS00026986
- Lead Sponsor
- HBO-Zentrum Euregio Aachen
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- All
- Target Recruitment
- 40
Informed consent to participate
Age 18-70 years
Sufficient knowledge of the German language
Diabetic collective:
additional: confirmed diabetic retinopathy
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.
Study & Design
- Study Type
- interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 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). <br><br>In the collective of healthy subjects, leakage is expected to occur at the exposure examination that does not occur at the baseline examination.<br><br>In the diabetic collective with retinopathy it is expected that a reduced leakage is visible in the exposure examination, compared to the baseline examination.
- Secondary Outcome Measures
Name Time Method 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). <br><br>- Fluorescein angiography: <br>Same findings in the recovery examination as in the baseline examination.<br>Arm retinal time and arteriovenous passage time are altered by intervention.<br><br><br>- Optical coherence tomography: <br>Changes in morphology of various structures of the eye: retina, retinal blood vessels, lens, iridocorneal angle, and cornea.<br><br>- Clinical examination:<br>No changes after intervention in Amsler, Snellen and Ishihara test.<br>