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OpenTrials
Completed

NCT Number: NCT00914407

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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Key information

Conditions

Healthy Normoxia Systemic Hypoxia

Age range

18 year–35 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Department of Clinical Pharmacology, Medical University of Vienna

Vienna, 1090, Austria

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Oxygen

Drug

100% Oxygen inhalation for 30 minutes

Primary outcomes

  1. 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

Sponsors and collaborators

Lead sponsor

Medical University of Vienna

Other

Registry information

Important dates

Study start
2010
Primary completion
2016
Study completion
2017
First posted
Jun 5, 2009
Registry last updated
Mar 10, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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