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

This study has been completed.
Sponsor:
Information provided by:
Medical University of Vienna
ClinicalTrials.gov Identifier:
NCT00999024
First received: October 20, 2009
Last updated: February 1, 2013
Last verified: October 2009
History of Changes
  Purpose

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.


Condition
Retinal Artery
Retinal Veins

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Reflectometric Measurement of Retinal Oxygen Saturation in Patients With COPD Grade IV and Healthy Subjects

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Medical University of Vienna:

Primary Outcome Measures:
  • Blood oxygen saturation measured in retinal vessel [ Time Frame: 15 minutes measured with the RVA ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Systemic blood pressure [ Time Frame: 5 minutes ] [ Designated as safety issue: No ]

Enrollment: 40
Study Start Date: November 2009
Study Completion Date: October 2012
Primary Completion Date: October 2012 (Final data collection date for primary outcome measure)
Groups/Cohorts
Healthy subjects
20 healthy subjects will be included
COPD Patients
20 Patients with Grade IV COPD will be included

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population

20 healthy subjects, 20 patients with grade IV COPD

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00999024

Locations
Austria
Department of Clinical Pharmacology, Medical University of Vienna
Vienna, Austria, 1090
Sponsors and Collaborators
Medical University of Vienna
Investigators
Principal Investigator: Gerhard Garhofer, MD, Priv.Doz. Medical University of Vienna
  More Information

No publications provided by Medical University of Vienna

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Responsible Party: Gerhard Garhofer, MD, Department of Clinical Pharmacology, Medical University of Vienna
ClinicalTrials.gov Identifier: NCT00999024     History of Changes
Other Study ID Numbers: OPHT - 090709
Study First Received: October 20, 2009
Last Updated: February 1, 2013
Health Authority: Austria: Agency for Health and Food Safety

Additional relevant MeSH terms:
Pulmonary Disease, Chronic Obstructive
Lung Diseases, Obstructive
Lung Diseases
Respiratory Tract Diseases

ClinicalTrials.gov processed this record on May 16, 2013