Comparison of Retinal Oxygenation and Retinal Vessel Diameters in Healthy Subjects and Patients With Diabetic Retinopathy or Retinal Vein Occlusion Between DVA and Oxymap

Study Overview
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Brief Summary
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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.

Official Title
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Comparison of Retinal Oxygenation and Retinal Vessel Diameters in Healthy Subjects and Patients With Diabetic Retinopathy or Retinal Vein Occlusion Between DVA and Oxymap

Conditions
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Healthy Subjects, Diabetic Retinopathy, Retinal Vein Occlusion

Intervention / Treatment
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* Other: Dynamic Vessel Analyzer
* Other: Oxymap T1


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Other
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Healthy subjects<br>healthy study subjects, age 18-80 years | Other: Dynamic Vessel Analyzer<br> <br> Other: Oxymap T1<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | 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 Outcome Measures

| Outcome Measure | Measure Description | 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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retinal oxygenation, retinal vessel diameters, Dynamic vessel analyzer (DVA), Oxymap T1