Healthy Subjects, Diabetic Retinopathy, Retinal Vein Occlusion
Conditions
Keywords
retinal oxygenation, retinal vessel diameters, Dynamic vessel analyzer (DVA), Oxymap T1
Brief summary
To date two different instruments are commercially available to measure retinal oxygen saturation and retinal vessel diameters: Dynamic Vessel Analyzer (DVA) and Oxymap. Retinal oxygen saturation analysis is based on spectroscopic evaluation of retinal fundus images. Up to now no data comparing both instruments for the measurement of retinal oxygen saturation and vessel diameter are available in the literature. Study objectives: To compare retinal oxygenation and retinal vessel diameters in healthy subjects and patients with diabetic retinopathy or retinal vein occlusion between 2 commercially available systems (DVA, Oxymap T1) Study design: Open pilot study Study population: 30 healthy volunteers, age 18-80 years 30 type 2 diabetic patients with mild or moderate non-proliferative diabetic retinopathy, age 18-80 years 30 patients with retinal vein occlusion, age 18-80 years Topically administered medication: Tropicamide (Mydriaticum Agepha®, Agepha, Vienna, Austria), dose: 1-2 drops per study day for dilation of the pupil Oxybuprocainhydrochloride combined with sodium fluorescein (Thilorbin®, Alcon Pharma GmbH, Freiburg, Germany), dose: 1 drop in one eye for measurements of intraocular pressure Nonylacidvanillylamide combined with Nicotinic-acid--ß-butoxyethylester (Finalgon®, Boehringer Ingelheim RCV GmbH & Co KG, Vienna, Austria): topical on the earlobe Methods: Dynamic vessel analyzer Oxymap T1 Blood pressure and pulse rate measurement Applanation tonometry Oxygen and carbon dioxide partial pressure measurement in arterialized blood from earlobe Main outcome variables: Difference of oxygen saturation of retinal vessels between DVA and Oxymap T1 The motive for this investigation is to compare data between 2 commercially available instruments for the measurement of retinal oxygen saturation and retinal vessel diameter in healthy subjects as well as in patients with ocular disease associated with altered retinal oxygenation. Comparative data from both systems are currently not available. Data from this study will allow the comparison of studies performed with different systems. All oxygen measurement procedures are non-invasive and painless. Hence, the risk/benefit ratio appears to be acceptable.
Interventions
OTHEROxymap T1
Sponsors
Medical University of Vienna
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
OTHER
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
Yes
Inclusion criteria
healthy volunteers * normal ophthalmic findings, ametropia \< 3 dpt * men and women aged between 18 and 80 years
Exclusion criteria
Any of the following will exclude a subject from the study: * participation in a clinical trial in the 3 weeks preceding the study * symptoms of a clinically relevant illness in the 3 weeks before the first study day * pregnancy
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Difference of oxygen saturation of retinal vessels between DVA and Oxymap T1 | participants will be followed for the duration of outpatient clinic visit, an expected average of 1 days |
Secondary
| Measure | Time frame |
|---|---|
| Difference of retinal vessel diameter between DVA and Oxymap T1 | participants will be followed for the duration of outpatient clinic visit, an expected average of 1 days |
Countries
Austria
Outcome results
None listed