Healthy Subjects Clinical Trial
Official title:
Comparison of Retinal Oxygenation and Retinal Vessel Diameters in Healthy Subjects and Patients With Diabetic Retinopathy or Retinal Vein Occlusion Between DVA and Oxymap
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.
n/a
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