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

NCT00914407 | Completed DMC

• 1 other identifier: OPHT-030209
• Study Type: interventional
• Target: 48
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Healthy; Normoxia; Systemic Hypoxia

Keywords

Ocular physiology

Outcome Measures

Primary Outcomes (1)

• Retinal blood velocity Retinal vessel diameters Oxygen saturation of retinal vessels Oxygen extraction as calculated from these parameters

  20 min ocular blood flow measurement on 1 study day

Study Arms (1)

Healthy subjects

EXPERIMENTAL

Drug: Oxygen

Interventions

Oxygen DRUG

100% Oxygen inhalation for 30 minutes

Healthy subjects

Eligibility Criteria

• Age: 18 Years - 35 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

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 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

Sponsors & Collaborators

• Medical University of Vienna: lead

Study Sites (1)

Department of Clinical Pharmacology, Medical University of Vienna

Vienna, 1090, Austria

Location

Related Publications (1)

• Fondi K, Aschinger GC, Bata AM, Wozniak PA, Liao L, Seidel G, Doblhoff-Dier V, Schmidl D, Garhofer G, Werkmeister RM, Schmetterer L. Measurement of Retinal Vascular Caliber From Optical Coherence Tomography Phase Images. Invest Ophthalmol Vis Sci. 2016 Jul 1;57(9):OCT121-9. doi: 10.1167/iovs.15-18476.

  PMID: 27409462 DERIVED

MeSH Terms

Interventions

Oxygen

Intervention Hierarchy (Ancestors)

Chalcogens; Elements; Inorganic Chemicals; Gases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assoc. Prof. Priv.-Doz. Dr

Study Record Dates

• First Submitted: June 4, 2009
• First Posted: June 5, 2009
• Study Start: April 1, 2010
• Primary Completion: December 10, 2016
• Study Completion: March 1, 2017
• Last Updated: March 10, 2017

Record last verified: 2017-03

Locations

AU (1)