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

October 20, 2009
February 1, 2013
November 2009
October 2012   (final data collection date for primary outcome measure)
Blood oxygen saturation measured in retinal vessel [ Time Frame: 15 minutes measured with the RVA ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT00999024 on ClinicalTrials.gov Archive Site
Systemic blood pressure [ Time Frame: 5 minutes ] [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
 
Reflectometric Measurement of Retinal Oxygen Saturation in Patients With Chronic Obstructive Pulmonary Disease (COPD) Grade IV and Healthy Subjects
Reflectometric Measurement of Retinal Oxygen Saturation in Patients With COPD Grade IV and Healthy Subjects

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.

Not Provided
Observational
Observational Model: Cohort
Time Perspective: Prospective
Not Provided
Not Provided
Non-Probability Sample

20 healthy subjects, 20 patients with grade IV COPD

  • Retinal Artery
  • Retinal Veins
Not Provided
  • Healthy subjects
    20 healthy subjects will be included
  • COPD Patients
    20 Patients with Grade IV COPD will be included
Palkovits S, Lasta M, Boltz A, Schmidl D, Kaya S, Hammer M, Marzluf B, Popa-Cherecheanu A, Frantal S, Schmetterer L, Garhöfer 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 PMID: 23307953.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
40
October 2012
October 2012   (final data collection date for primary outcome measure)

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
Both
18 Years and older
Yes
Contact information is only displayed when the study is recruiting subjects
Austria
 
NCT00999024
OPHT - 090709
Yes
Gerhard Garhofer, MD, Department of Clinical Pharmacology, Medical University of Vienna
Medical University of Vienna
Not Provided
Principal Investigator: Gerhard Garhofer, MD, Priv.Doz. Medical University of Vienna
Medical University of Vienna
October 2009

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP