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Effect of Systemic Hypoxia and Hyperoxia on Retinal Oxygen Saturation

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Medical University of Vienna

Status and phase

Completed
Phase 4

Conditions

Retinal Oxygenation
Retinal Blood Flow

Treatments

Drug: 15% oxygen in N2 breathing
Drug: 12% oxygen in N2 breathing
Drug: 100% oxygen breathing

Study type

Interventional

Funder types

Other

Identifiers

NCT01692821
OPHT-180312

Details and patient eligibility

About

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.

Enrollment

30 patients

Sex

All

Ages

18 to 35 years old

Volunteers

Accepts Healthy Volunteers

Inclusion criteria

  • 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.

Exclusion criteria

  • 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

Trial design

Primary purpose

Basic Science

Allocation

Randomized

Interventional model

Crossover Assignment

Masking

Triple Blind

30 participants in 3 patient groups

100% oxygen breathing
Experimental group
Treatment:
Drug: 100% oxygen breathing
15% oxygen in N2 breathing
Experimental group
Treatment:
Drug: 15% oxygen in N2 breathing
12% oxygen in N2 breathing
Experimental group
Treatment:
Drug: 12% oxygen in N2 breathing

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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