Non-invasive Measurement of Hemoglobin in Retinal Arteries

• Conditions: Healthy Subjects; Anemia
• Interventions: Device: Fundus photography, cubital blood draw

• Registration Number: NCT01025011
• Lead Sponsor: Triemli Hospital

Brief Summary

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

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 Timeline

• Study Start: 2008-03
• Status Verified: 2009-11
• Study First Submitted: 2009-12-02
• Study First Submitted QC: 2009-12-02
• Last Update Submitted: 2009-12-02
• Study First Posted: 2009-12-03
• Last Update Posted: 2009-12-03
• Primary Completion: 2010-06
• Study Completion: 2010-06

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 100

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

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
healthy volunteers, anemic patients	Fundus photography, cubital blood draw	healthy volunteers from the eye and gynecology department pregnant patients with anemia

Primary Outcome Measures

Name	Time	Method
Correlation of hemoglobin concentration measured in a cubital vein and in a non invasive way using hemoglobinometry in the retinal veins	2.5 years

Trial Locations

Locations (1)

Stadtpital Zürich, Triemli Hospital; 🇨🇭 Zürich, Switzerland