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OpenTrials
Completed

NCT Number: NCT00431600

The Validity of Retinal Blood Flow Measurements During Hyperoxia in Humans Using Fourier Domain Color Doppler Optical Coherence Tomography (CDOCT)

Noninvasive monitoring of blood flow in retinal circulation may elucidate the progression and treatment of ocular disorders, including diabetic retinopathy, age-related macular degeneration and glaucoma.

Laser Doppler velocimetry (LDV), a noninvasive optical method combined with vessel size determination has been used extensively as a valuable research tool to examine blood flow dynamics in the human retina. However, no information on the velocity profile within the vessel is available. Ophthalmic color Doppler optical coherence tomography (CDOCT) provides laser Doppler information in addition to conventional optical coherence tomography, allowing the observation of blood flow dynamics simultaneously to imaging retinal structure.

We have recently demonstrated the feasibility of Fourier domain CDOCT to assess velocity profiles in human retinal vessels in vivo.

In the present study the validity of Fourier domain CDOCT for retinal blood flow measurements will be tested at baseline and during hyperoxia-induced vasoconstriction in humans by comparison with retinal blood flow measurements using a commercially available LDV system and the Zeiss retinal vessel analyzer (RVA)

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Key information

Conditions

Healthy Hyperoxia Pathological Conditions, Signs and Symptoms Signs and Symptoms Signs and Symptoms, Respiratory

Age range

19 year–35 year

Sex eligibility

Male

Study type

Interventional

Phase

Not applicable

Primary location

Department of Clinical Pharmacology

Vienna, 1090, Austria

Who can participate

Healthy volunteers accepted: Yes

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

Inclusion criteria

  • Men aged between 19 and 35 years, nonsmokers
  • Normal findings in the medical history and physical examination 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
  • Symptoms of a clinically relevant illness in the 3 weeks before the first study day
  • History or presence of gastrointestinal, liver or kidney disease, or other conditions known to interfere with distribution, metabolism or excretion of study drugs
  • Blood donation during the previous 3 weeks
  • Ametropia equal or over 3 dpt

Treatment and study plan

100% Oxygen

Other

100% Oxygen- breathing over 30 minutes

Primary outcomes

  1. Retinal blood flow (LDV, RVA)

    Time frame: 15 minutes

Secondary outcomes

  1. Retinal venous diameters (Zeiss retinal vessel analyzer)

    Time frame: 5 minutes

  2. Retinal blood velocity (laser Doppler velocimetry)

    Time frame: 10 minutes

Sponsors and collaborators

Lead sponsor

Medical University of Vienna

Other

Registry information

Official study title

The Validity of Retinal Blood Flow Measurements During Hyperoxia in Humans Using Fourier Domain CDOCT

Important dates

Study start
2010
Primary completion
2011
Study completion
2012
First posted
Feb 6, 2007
Registry last updated
Jun 11, 2018

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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