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Non-invasive Measurement of Hemoglobin in Retinal Arteries

The recruitment status of this study is unknown because the information has not been verified recently.
Verified November 2009 by Triemli Hospital.
Recruitment status was  Recruiting
Sponsor:
Information provided by:
Triemli Hospital
ClinicalTrials.gov Identifier:
NCT01025011
First received: December 2, 2009
Last updated: NA
Last verified: November 2009
History: No changes posted
  Purpose

The purpose of this study is to test a new non-invasive tool to measure hemoglobin in retinal arteries.


Condition Intervention
Healthy Subjects
Anemia
 Device: Fundus photography, cubital blood draw

Study Type: Observational
Official Title: Non- Invasive Measurement of the Absolute Hemoglobin Value in the Retinal Arteries of Anemic and Healthy Subjects Using a New Approach

Resource links provided by NLM:

MedlinePlus related topics: Anemia
U.S. FDA Resources

Further study details as provided by Triemli Hospital:

Primary Outcome Measures:
  • Correlation of hemoglobin concentration measured in a cubital vein and in a non invasive way using hemoglobinometry in the retinal veins [ Time Frame: 2.5 years ] [ Designated as safety issue: No ]

Estimated Enrollment: 100
Study Start Date: March 2008
Estimated Study Completion Date: June 2010
Estimated Primary Completion Date: June 2010 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
healthy volunteers, anemic patients
healthy volunteers from the eye and gynecology department pregnant patients with anemia
 Device: Fundus photography, cubital blood draw
blood draw from a cubital vein to measure hemoglobin concentration taking a fundus photography with a Nidek AFC-230, no pupil dilation needed

Detailed Description:

To our knowledge no tool exists that allows for direct collection of hemoglobin data in the eye. In many eye diseases (especially diabetic and hypertensive retinopathy as well as in retinal vessel occlusions) retinal circulation is modified. Knowing hemoglobin concentration on the site of the pathology will give us further information about the pathogenesis of this diseases and may provide a new possibility in therapy.

The purpose of this study is to test a new non-invasive tool to measure hemoglobin in retinal arteries. Healthy volunteers from the eye clinic and pregnant otherwise healthy patients of the gynecological department of the Triemli Hospital, Zurich, as well as anemic gynecological patients that show up for a check-up are included.

Hemoglobin will be quantified by a blood draw of a cubital vein. Using a Fundus Camera (Nidek AFC-230) pictures of the fundus will be taken from each study patient. Afterwards the study investigator selects a retinal artery of interest which will be used for measuring the hemoglobin concentration. Intensity of the green channel of the camera chip is determined with the aid of the law of Lambert-Beer.

Absolute Hemoglobin concentration is calculated in relation to the vessel volume.

  Eligibility

Ages Eligible for Study:   18 Years to 90 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population

healthy subjects from the eye clinic of Triemli Hospital anemic and pregnant patients from the gynecology department, Triemli Hospital

Criteria

Inclusion Criteria:

  • healthy volunteers
  • pregnant patients from the Triemli Hospital that came for a routine check up
  • anemic patients of the same dept with various gynecological tumors

Exclusion Criteria:

  • any known retinal eye disease
  • poor fundus picture quality due to fixtion problems or too small pupil or media intransparency
  • not willing to participate in a study
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01025011

Contacts
Contact: Yves Robert, Prof MD +41 44 466 ext 3200 yves.robert@triemli.stzh.ch

Locations
Switzerland
Stadtpital Zürich, Triemli Hospital Recruiting
Zürich, Switzerland, 8063
Contact: Yves Robert, Prof MD     +41 44 466 ext 3200     yves.robert@triemli.stzh.ch    
Sponsors and Collaborators
Triemli Hospital
Investigators
Principal Investigator: Yves Robert, Prof MD Triemli Hospital
  More Information

No publications provided

Responsible Party: Prof Yves Robert, Stadtpital Triemli (Triemli Hospital)
ClinicalTrials.gov Identifier: NCT01025011     History of Changes
Other Study ID Numbers: D20028132
Study First Received: December 2, 2009
Last Updated: December 2, 2009
Health Authority: Switzerland: Ethikkommission

Keywords provided by Triemli Hospital:
retinal hemoglobin concentration
non-invasive hemoglobin measurement

Additional relevant MeSH terms:
Anemia
Hematologic Diseases

ClinicalTrials.gov processed this record on May 19, 2013