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Non-invasive Measurement of Hemoglobin in Retinal Arteries

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ClinicalTrials.gov Identifier: NCT01025011
Recruitment Status : Unknown
Verified November 2009 by Triemli Hospital.
Recruitment status was:  Recruiting
First Posted : December 3, 2009
Last Update Posted : December 3, 2009
Sponsor:
Information provided by:
Triemli Hospital

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

Condition or disease Intervention/treatment
Healthy Subjects Anemia Device: Fundus photography, cubital blood draw

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.


Study Type : Observational
Estimated Enrollment : 100 participants
Official Title: Non- Invasive Measurement of the Absolute Hemoglobin Value in the Retinal Arteries of Anemic and Healthy Subjects Using a New Approach
Study Start Date : March 2008
Estimated Primary Completion Date : June 2010
Estimated Study Completion Date : June 2010

Group/Cohort Intervention/treatment
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



Primary Outcome Measures :
  1. 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 ]


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Ages Eligible for Study:   18 Years to 90 Years   (Adult, Senior)
Sexes Eligible for Study:   All
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

Responsible Party: Prof Yves Robert, Stadtpital Triemli (Triemli Hospital)
ClinicalTrials.gov Identifier: NCT01025011     History of Changes
Other Study ID Numbers: D20028132
First Posted: December 3, 2009    Key Record Dates
Last Update Posted: December 3, 2009
Last Verified: November 2009

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