NCT01692821

Brief Summary

Adequate perfusion and oxygenation is essential for the function of the inner retina. Although it is known that oxygen tension is very well autoregulated in the retina, the physiological mechanisms behind this regulation process are not fully explored. The development of new instruments for the non-invasive measurement of oxygen tension in retinal vessels now allows for the more precise investigation of these physiological processes. The current study seeks to evaluate the retinal oxygen saturation in healthy subjects while breathing different oxygen mixtures to achieve a hypoxic and a hyperoxic state.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
30

participants targeted

Target at below P25 for phase_4

Timeline
Completed

Started Jun 2012

Shorter than P25 for phase_4

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

Study Start

First participant enrolled

June 1, 2012

Completed
13 days until next milestone

First Submitted

Initial submission to the registry

June 14, 2012

Completed
3 months until next milestone

First Posted

Study publicly available on registry

September 25, 2012

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2012

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2013

Completed
Last Updated

January 30, 2013

Status Verified

January 1, 2013

Enrollment Period

6 months

First QC Date

June 14, 2012

Last Update Submit

January 29, 2013

Conditions

Retinal OxygenationRetinal Blood Flow

Keywords

retinal oxygen saturationretinal blood flowhyperoxiahypoxia

Outcome Measures

Primary Outcomes (1)

  • Retinal oxygen saturation

    On the study day - during each breathing period (6 times)

Secondary Outcomes (1)

  • Retinal blood flow

    On the study day - during each breathing period (6 times)

Study Arms (3)

100% oxygen breathing

EXPERIMENTAL
Drug: 100% oxygen breathing

15% oxygen in N2 breathing

EXPERIMENTAL
Drug: 15% oxygen in N2 breathing

12% oxygen in N2 breathing

EXPERIMENTAL
Drug: 12% oxygen in N2 breathing

Interventions

100% oxygen breathingDRUG

100% oxygen breathing - 30 minutes

100% oxygen breathing
15% oxygen in N2 breathingDRUG

15% oxygen in N2 breathing - 30 minutes

15% oxygen in N2 breathing
12% oxygen in N2 breathingDRUG

12% oxygen in N2 breathing - 30 minutes

12% oxygen in N2 breathing

Eligibility Criteria

Age18 Years - 35 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Men and women aged between 18 and 35 years
  • Nonsmokers
  • 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, ametropy \< 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 (except oral contraceptive)
  • Symptoms of a clinically relevant illness in the 3 weeks before the first study day
  • Presence of any form of anemia
  • Blood donation during the previous 3 weeks
  • Pregnancy

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Medical University of Vienna, Department of Clinical Pharmacology

Vienna, Vienna, 1090, Austria

Location

Related Publications (1)

  • Palkovits S, Lasta M, Told R, Schmidl D, Boltz A, Napora KJ, Werkmeister RM, Popa-Cherecheanu A, Garhofer G, Schmetterer L. Retinal oxygen metabolism during normoxia and hyperoxia in healthy subjects. Invest Ophthalmol Vis Sci. 2014 Jul 11;55(8):4707-13. doi: 10.1167/iovs.14-14593.

    PMID: 25015353DERIVED

MeSH Terms

Conditions

HyperoxiaHypoxia

Interventions

Oxygen

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

ChalcogensElementsInorganic ChemicalsGases

Study Officials

  • Gerhard Garhöfer, Assoc. Prof. Priv.-Doz. Dr.

    Department of Clinical Pharmacology, Medical University of Vienna

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
BASIC SCIENCE
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assoc. Prof. Priv.-Doz. Dr.

Study Record Dates

First Submitted

June 14, 2012

First Posted

September 25, 2012

Study Start

June 1, 2012

Primary Completion

December 1, 2012

Study Completion

January 1, 2013

Last Updated

January 30, 2013

Record last verified: 2013-01

Locations

AU(1)