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Non-invasive Measurement of Hemoglobin in Retinal Arteries

Primary Purpose

Healthy Subjects, Anemia

Status

Unknown status

Phase

Locations

Switzerland

Study Type

Observational

Intervention

Fundus photography, cubital blood draw

About this trial

This is an observational trial for Healthy Subjects focused on measuring retinal hemoglobin concentration, non-invasive hemoglobin measurement

Eligibility Criteria

18 Years - 90 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

Stadtpital Zürich, Triemli HospitalRecruiting

Arms of the Study

Arm 1

Arm Type

Arm Label

healthy volunteers, anemic patients

Arm Description

healthy volunteers from the eye and gynecology department pregnant patients with anemia

Outcomes

Primary Outcome Measures

Correlation of hemoglobin concentration measured in a cubital vein and in a non invasive way using hemoglobinometry in the retinal veins

Secondary Outcome Measures

Full Information

NCT ID

NCT01025011

First Posted

December 2, 2009

Last Updated

December 2, 2009

Sponsor

Triemli Hospital

1. Study Identification

Unique Protocol Identification Number

NCT01025011

Brief Title

Non-invasive Measurement of Hemoglobin in Retinal Arteries

Official Title

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

Study Type

Observational

2. Study Status

Record Verification Date

November 2009

Overall Recruitment Status

Unknown status

Study Start Date

March 2008 (undefined)

Primary Completion Date

June 2010 (Anticipated)

Study Completion Date

June 2010 (Anticipated)

3. Sponsor/Collaborators

Name of the Sponsor

Triemli Hospital

4. Oversight

Data Monitoring Committee

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Healthy Subjects, Anemia

Keywords

retinal hemoglobin concentration, non-invasive hemoglobin measurement

7. Study Design

Enrollment

100 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

healthy volunteers, anemic patients

Arm Description

healthy volunteers from the eye and gynecology department pregnant patients with anemia

Intervention Type

Device

Intervention Name(s)

Fundus photography, cubital blood draw

Intervention Description

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 Measure Information:

Title

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

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

90 Years

Accepts Healthy Volunteers

Eligibility 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

Study Population Description

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

Sampling Method

Non-Probability Sample

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Yves Robert, Prof MD

Phone

+41 44 466

Ext

3200

yves.robert@triemli.stzh.ch

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Yves Robert, Prof MD

Organizational Affiliation

Triemli Hospital

Official's Role

Principal Investigator

Facility Information:

Facility Name

Stadtpital Zürich, Triemli Hospital

City

Zürich

ZIP/Postal Code

8063

Country

Switzerland

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Yves Robert, Prof MD

Phone

+41 44 466

Ext

3200

yves.robert@triemli.stzh.ch

12. IPD Sharing Statement

Learn more about this trial

Non-invasive Measurement of Hemoglobin in Retinal Arteries

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