Healthy SubjectsNCT01025011
Non-invasive Measurement of Hemoglobin in Retinal Arteries
An observational study of Healthy Subjects and Anemia, run by Triemli Hospital at 1 site in Switzerland.
Trial summary
The purpose of this study is to test a new non-invasive tool to measure hemoglobin in retinal arteries. Read more about this study
- Who is it for?
- Ages 18 to 90 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy Subjects, Anemia
- What is being tested?
- Fundus photography, cubital blood draw
- Type of treatment
- Medical device
- How many people
- 100 participants
- Where
- 1 siteSwitzerland
- Study dates
- Mar 2008to Jun 2010
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 90 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: healthy subjects from the eye clinic of Triemli Hospital anemic and pregnant patients from the gynecology department, Triemli Hospital
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Switzerland1 site, 1 recruiting
- Recruiting
Stadtpital Zürich, Triemli Hospital
Zurich, Canton of Zurich, 8063
Yves Robert, Prof MD, +41 44 466 ext. 3200, yves.robert@triemli.stzh.ch
About this study
Official title: Non- Invasive Measurement of the Absolute Hemoglobin Value in the Retinal Arteries of Anemic and Healthy Subjects Using a New Approach
The purpose of this study is to test a new non-invasive tool to measure hemoglobin in retinal arteries.
Read the 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.
- Conditions
- Healthy Subjects, Anemia
- Being tested
- Fundus photography, cubital blood draw
- Keywords
- retinal hemoglobin concentration, non-invasive hemoglobin measurement
- Medical subject headings
- Anemia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Fundus photography, cubital blood drawDevice
blood draw from a cubital vein to measure hemoglobin concentration taking a fundus photography with a Nidek AFC-230, no pupil dilation needed
| Study group | Role | What they receive |
|---|---|---|
| healthy volunteers, anemic patients | healthy volunteers from the eye and gynecology department pregnant patients with anemia Receives: Device: Fundus photography, cubital blood draw |
What is being measured
The primary outcome is the main question the study is designed to answer.
Correlation of hemoglobin concentration measured in a cubital vein and in a non invasive way using hemoglobinometry in the retinal veins
Measured: 2.5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Dec 2009 (estimated)
- Study startMar 2008
- Primary completionJun 2010 (estimated)
- Study completionJun 2010 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Healthy SubjectsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Triemli Hospital
- Sponsor type
- University, hospital or other
- Investigators
- Yves Robert, Prof MD, Principal investigator, Triemli Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01025011
- Sponsor's protocol ID
- D20028132
- Status last verified
- Nov 2009
- First submitted
- 2 Dec 2009
- Last updated
- 3 Dec 2009
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Dec 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Non- Invasive Measurement of the Absolute Hemoglobin Value in the Retinal Arteries of Anemic and Healthy Subjects Using a New Approach
- ClinicalTrials.gov ID
- NCT01025011
- Acronym / sponsor ID
- D20028132
- Conditions
- Healthy Subjects, Anemia
- Keywords
- retinal hemoglobin concentration, non-invasive hemoglobin measurement
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Triemli HospitalUniversity, hospital or other
- Study start
- Mar 2008
- Primary completion
- Jun 2010 (estimated)
- Study completion
- Jun 2010 (estimated)
- First posted
- 3 Dec 2009 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| healthy volunteers, anemic patients | – | Device: Fundus photography, cubital blood drawhealthy volunteers from the eye and gynecology department pregnant patients with anemia |
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- healthy subjects from the eye clinic of Triemli Hospital anemic and pregnant patients from the gynecology department, Triemli Hospital
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (3 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Fundus photography, cubital blood drawblood draw from a cubital vein to measure hemoglobin concentration taking a fundus photography with a Nidek AFC-230, no pupil dilation needed | Device | healthy volunteers, anemic patients |
Primary outcome
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
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Dec 2009.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Yves Robert, Prof MD principal investigator
Triemli Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Healthy Subjects and Anemia, run by Triemli Hospital at 1 site in Switzerland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 3 Dec 2009. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Switzerland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Yves Robert, Prof MD (+41 44 466 ext. 3200, yves.robert@triemli.stzh.ch), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Dec 2009.