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CompletedNCT00999024Updated Feb 4, 2013

Reflectometric Measurement of Retinal Oxygen Saturation in Patients With Chronic Obstructive Pulmonary Disease (COPD) Grade IV and Healthy Subjects

An observational study in Retinal Artery and Retinal Veins, sponsored by Medical University of Vienna. Completed at 1 site in Austria. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2013-02-04.

Sponsored by Medical University of Vienna · Observational

Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
40
Ages
18 Years and older
Sex
All
01

Study summary

An adequate oxygenation and retinal perfusion is essential for the function of the inner retina. There is a wide range of autoregulation mechanisms to ensure a sufficient ocular blood and oxygen supply during changes in systemic blood pressure or intraocular pressure (IOP). Nonetheless, various retinopathies such as diabetic retinopathy, which is the leading cause of blindness in people aged 20-65 in the western world, are highly associated with hypoxia (Pemp and Schmetterer 2008). Hence, measurements of oxygen levels in retinal vessels are needed to further our understanding of these ischemic diseases. It is a well known fact and a commonly employed method to measure oxygen saturation of blood through light transmission (Kramer 1934). However, this approach is not feasible in the human eye. Therefore, reflection must be used, meaning the amount of incident light must be estimated based on the amount of light reflected (for a review see Harris 2003). This is a difficult task and investigators in this field have encountered several problems, including optical complexities, nonlinear sensors and eye movement (Beach et al 1999; Delori 1988). Nonetheless considerable progress has been made over the past decades and the development of an reliable oximeter reported (Hardarson et al 2006).

In the present study this technique will be applied in healthy subjects as well as in patients with COPD during room-air conditions. The procedure takes approximately 15 minutes in each subject and will be performed in only one eye.

02

Conditions studied

  • Retinal Artery
  • Retinal Veins
03

In context

Lead sponsor

Medical University of Vienna is the lead sponsor of 1,076 studies on the registry; 177 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
Yes
Sampling method
Non-probability sample

Study population

20 healthy subjects, 20 patients with grade IV COPD

Eligibility criteria

Inclusion Criteria:

Inclusion criteria for healthy subjects:

  • Men and women aged between 18 and 99 years
  • Tiffeneau Index > 70 %
  • Body mass index between 15th and 85th percentile
  • Normal ophthalmic findings, ametropia \< 3 Dpt.

Inclusion criteria for COPD patients:

  • Men and women aged between 18 and 99 years
  • COPD grade IV, oxygen dependent and with a forced expiratory volume in 1 second (FEV1) \< 30 %
  • Body mass index between 15th and 85th percentile
  • Normal ophthalmic findings, ametropia \< 3 Dpt.

Exclusion Criteria:

Healthy subjects:

  • 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 study day
  • Blood donation during the previous 3 weeks

COPD patients:

  • Abuse of alcoholic beverages, participation in a clinical trial in the 3 weeks preceding the study
  • Health status which does interfere with study procedure or their safety
  • Blood donation during the previous 3 weeks
  • Symptoms of a clinically relevant illness other than COPD or COPD related in the 3 weeks before the study day
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Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
40 participants (actual)

Groups and cohorts

  • Healthy subjects

    20 healthy subjects will be included

  • COPD Patients

    20 Patients with Grade IV COPD will be included

06

What researchers measure

Primary outcomes

  1. Blood oxygen saturation measured in retinal vessel

    Time frame: 15 minutes measured with the RVA

Secondary outcomes

  1. Systemic blood pressure

    Time frame: 5 minutes

07

Study locations

1 site
  • Department of Clinical Pharmacology, Medical University of Vienna
    Vienna, 1090, Austria
08

References and documents

Publications

  • Palkovits S, Lasta M, Boltz A, Schmidl D, Kaya S, Hammer M, Marzluf B, Popa-Cherecheanu A, Frantal S, Schmetterer L, Garhofer G. Measurement of retinal oxygen saturation in patients with chronic obstructive pulmonary disease. Invest Ophthalmol Vis Sci. 2013 Feb 5;54(2):1008-13. doi: 10.1167/iovs.12-10504. PubMed 23307953 ↗
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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Feb 4, 2013, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT00999024
Lead sponsor
Medical University of Vienna
First posted
Oct 21, 2009
Start date
Nov 2009
Primary completion
Oct 2012
Completion
Oct 2012
Last update
Feb 4, 2013

Study contacts

Gerhard Garhofer, MD, Priv.Doz.
principal investigator · Medical University of Vienna

Oversight

Data monitoring committee
Yes
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Oct 2009. You cannot join it, but the record below documents what was studied.

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