Non-invasive Measurement of Hemoglobin in Retinal Arteries

Anemia Clinical Trial

Official title:

Non- Invasive Measurement of the Absolute Hemoglobin Value in the Retinal Arteries of Anemic and Healthy Subjects Using a New Approach

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01025011
• Other study ID #: D20028132
• Status: Recruiting
• Phase: N/A
• First received: December 2, 2009
• Last updated: December 2, 2009
• Start date: March 2008
• Est. completion date: June 2010

Study information

• Verified date: November 2009
• Source: Triemli Hospital
• Contact: Yves Robert, Prof MD
• Phone: +41 44 466
• Email: yves.robert[@]triemli.stzh.ch
• Is FDA regulated: No
• Health authority: Switzerland: Ethikkommission
• Study type: Observational

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 100
• Est. completion date: June 2010
• Est. primary completion date: June 2010
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 90 Years

Eligibility

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

Study Design

N/A

Related Conditions & MeSH terms

• Anemia
• Healthy Subjects

Intervention

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

Locations

Country	Name	City	State
Switzerland	Stadtpital Zürich, Triemli Hospital	Zürich

Sponsors (1)

Lead Sponsor	Collaborator
Triemli Hospital

Country where clinical trial is conducted

Switzerland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Correlation of hemoglobin concentration measured in a cubital vein and in a non invasive way using hemoglobinometry in the retinal veins		2.5 years	No