NCT00431600

Brief Summary

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)

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
12

participants targeted

Target at below P25 for not_applicable healthy

Timeline
Completed

Started Sep 2010

Typical duration for not_applicable healthy

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

February 5, 2007

Completed
1 day until next milestone

First Posted

Study publicly available on registry

February 6, 2007

Completed
3.6 years until next milestone

Study Start

First participant enrolled

September 1, 2010

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2011

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2012

Completed
Last Updated

June 11, 2018

Status Verified

June 1, 2018

Enrollment Period

1.2 years

First QC Date

February 5, 2007

Last Update Submit

June 7, 2018

Conditions

Healthy

Keywords

Regional Blood FlowColor Doppler Optical Coherence TomographyCDOCTRetinal Blood FlowHyperoxiaVasoconstrictionLaser Doppler VelocimetryRetinal Vessel Analyzer

Outcome Measures

Primary Outcomes (1)

  • Retinal blood flow (LDV, RVA)

    15 minutes

Secondary Outcomes (2)

  • Retinal venous diameters (Zeiss retinal vessel analyzer)

    5 minutes

  • Retinal blood velocity (laser Doppler velocimetry)

    10 minutes

Study Arms (1)

1

EXPERIMENTAL

12 healthy male subjects

Other: 100% Oxygen

Interventions

100% OxygenOTHER

100% Oxygen- breathing over 30 minutes

1

Eligibility Criteria

Age19 Years - 35 Years
Sexmale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Department of Clinical Pharmacology

Vienna, 1090, Austria

Location

MeSH Terms

Conditions

Hyperoxia

Interventions

Oxygen

Condition Hierarchy (Ancestors)

Signs and Symptoms, RespiratorySigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

ChalcogensElementsInorganic ChemicalsGases

Study Officials

  • Gerhard Garhoefer, MD

    Department of Clinical Pharmacology Medical University of Vienna

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assoc. Prof. PD Dr.

Study Record Dates

First Submitted

February 5, 2007

First Posted

February 6, 2007

Study Start

September 1, 2010

Primary Completion

December 1, 2011

Study Completion

January 1, 2012

Last Updated

June 11, 2018

Record last verified: 2018-06

Locations

AU(1)