Measurement of Retinal Blood Flow, Retinal Oxygenation and Retinal Oxygen Extraction in Healthy Subjects During Normoxia and Systemic Hyperoxia

The recruitment status of this study is unknown because the information has not been verified recently.
Verified June 2009 by Medical University of Vienna.
Recruitment status was  Recruiting
Sponsor:
Information provided by:
Medical University of Vienna
ClinicalTrials.gov Identifier:
NCT00914407
First received: June 4, 2009
Last updated: June 15, 2011
Last verified: June 2009

June 4, 2009
June 15, 2011
September 2009
October 2011   (final data collection date for primary outcome measure)
Retinal blood velocity Retinal vessel diameters Oxygen saturation of retinal vessels Oxygen extraction as calculated from these parameters [ Time Frame: 20 min ocular blood flow measurement on 1 study day ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT00914407 on ClinicalTrials.gov Archive Site
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Measurement of Retinal Blood Flow, Retinal Oxygenation and Retinal Oxygen Extraction in Healthy Subjects During Normoxia and Systemic Hyperoxia
Measurement of Retinal Blood Flow, Retinal Oxygenation and Retinal Oxygen Extraction in Healthy Subjects During Normoxia and Systemic Hyperoxia

The inner retina is crucially dependent on an adequate retinal blood supply. When the retina becomes ischemic and hypoxic this results in severe vision loss due to retinal neovascularization. Measurement of retinal blood flow and retinal oxygenation is, however, still a difficult task. Information on retinal oxygenation is almost unavailable from human studies. In the present protocol the investigators propose a procedure allowing for the measurement of retinal blood flow, retinal oxygenation and retinal oxygen extraction by combining a number of innovative techniques. Specifically, retinal vessel diameters will be measured with a Retinal Vessel Analyzer, retinal blood velocities with bi-directional laser Doppler velocimetry and retinal oxygenation with spectroscopic evaluation of retinal fundus images. This will allow for the calculation of retinal oxygen extraction, a fundamental parameter of retinal function. Up to now, no data for retinal oxygen extraction are available in the literature.

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Interventional
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Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Basic Science
  • Healthy
  • Normoxia
  • Systemic Hypoxia
Drug: Oxygen
100% Oxygen inhalation for 30 minutes
Experimental: Healthy subjects
Intervention: Drug: Oxygen
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
48
October 2011
October 2011   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Men and women aged between 18 and 35 years
  • Nonsmokers
  • Body mass index between 15th and 85th percentile
  • Normal findings in the medical history and physical examination unless the investigator considers an abnormality to be clinically irrelevant
  • Normal laboratory values unless the investigator considers an abnormality to be clinically irrelevant
  • Normal ophthalmic findings, ametropia < 3 Dpt

Exclusion Criteria:

  • Regular use of medication, abuse of alcoholic beverages, participation in a clinical trial in the 3 weeks preceding the study
  • Treatment in the previous 3 weeks with any drug except oral contraceptives
  • Symptoms of a clinically relevant illness in the 3 weeks before the first study day
  • Blood donation during the previous 3 weeks
  • Pregnancy
Both
18 Years to 35 Years
Yes
Contact: Gerhard Garhofer, MD 00431 40400 ext 2981 gerhard.garhoefer@meduniwien.ac.at
Austria
 
NCT00914407
OPHT-030209
Yes
Gerhard Garhofer, Department of Clinical Pharmacology, Medical University of Vienna
Medical University of Vienna
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Not Provided
Medical University of Vienna
June 2009

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP