Retinal ArteryNCT00999024
Reflectometric Measurement of Retinal Oxygen Saturation in Patients With Chronic Obstructive Pulmonary Disease (COPD) Grade IV and Healthy Subjects
An observational study of Retinal Artery and Retinal Veins, run by Medical University of Vienna at 1 site in Austria.
Trial summary
An adequate oxygenation and retinal perfusion is essential for the function of the inner retina. There is a wide range of autoregulation mechanisms to ensure a sufficient ocular blood and oxygen supply during changes in systemic blood pressure or intraocular pressure (IOP). Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Retinal Artery, Retinal Veins
- Type of treatment
- Injection or infusion
- How many people
- 40 participants
- Where
- 1 siteAustria
- Study dates
- Nov 2009to Oct 2012
- 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 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: 20 healthy subjects, 20 patients with grade IV COPD
Who may be able to join
- Men and women aged between 18 and 99 years
- Tiffeneau Index > 70 %
- Body mass index between 15th and 85th percentile
- Normal ophthalmic findings, ametropia < 3 Dpt.
- Men and women aged between 18 and 99 years
- COPD grade IV, oxygen dependent and with a forced expiratory volume in 1 second (FEV1) < 30 %
- Body mass index between 15th and 85th percentile
- Normal ophthalmic findings, ametropia < 3 Dpt.
Who cannot join
- Healthy subjects:
- Regular use of medication, abuse of alcoholic beverages, participation in a clinical trial in the 3 weeks preceding the study
- Treatment in the previous 3 weeks with any drug except oral contraceptives
- Symptoms of a clinically relevant illness in the 3 weeks before the study day
- Blood donation during the previous 3 weeks
- COPD patients:
Show all 10Show fewer
- Abuse of alcoholic beverages, participation in a clinical trial in the 3 weeks preceding the study
- Health status which does interfere with study procedure or their safety
- Blood donation during the previous 3 weeks
- Symptoms of a clinically relevant illness other than COPD or COPD related in the 3 weeks before the study day
Trial locations and contacts
1 site in 1 country.
Austria1 site
Department of Clinical Pharmacology, Medical University of Vienna
Vienna, State of Vienna, 1090
About this study
Official title: Reflectometric Measurement of Retinal Oxygen Saturation in Patients With COPD Grade IV and Healthy Subjects
An adequate oxygenation and retinal perfusion is essential for the function of the inner retina. There is a wide range of autoregulation mechanisms to ensure a sufficient ocular blood and oxygen supply during changes in systemic blood pressure or intraocular pressure (IOP). Nonetheless, various retinopathies such as diabetic retinopathy, which is the leading cause of blindness in people aged 20-65 in the western world, are highly associated with hypoxia (Pemp and Schmetterer 2008). Hence, measurements of oxygen levels in retinal vessels are needed to further our understanding of these ischemic diseases. It is a well known fact and a commonly employed method to measure oxygen saturation of blood through light transmission (Kramer 1934). However, this approach is not feasible in the human eye. Therefore, reflection must be used, meaning the amount of incident light must be estimated based on the amount of light reflected (for a review see Harris 2003). This is a difficult task and investigators in this field have encountered several problems, including optical complexities, nonlinear sensors and eye movement (Beach et al 1999; Delori 1988). Nonetheless considerable progress has been made over the past decades and the development of an reliable oximeter reported (Hardarson et al 2006).
In the present study this technique will be applied in healthy subjects as well as in patients with COPD during room-air conditions. The procedure takes approximately 15 minutes in each subject and will be performed in only one eye.
- Conditions
- Retinal Artery, Retinal Veins
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Healthy subjects | 20 healthy subjects will be included | |
| COPD Patients | 20 Patients with Grade IV COPD will be included |
What is being measured
The primary outcome is the main question the study is designed to answer.
Blood oxygen saturation measured in retinal vessel
Measured: 15 minutes measured with the RVA
Secondary outcomes (1)
Systemic blood pressure
Measured: 5 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Oct 2009 (estimated)
- Study startNov 2009
- Primary completionOct 2012
- Study completionOct 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Retinal ArteryStudies of the same condition, open and under way.
- More trials run by Medical University of ViennaThe sponsor's other registered studies.
- 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
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Medical University of Vienna
- Sponsor type
- University, hospital or other
- Investigators
- Gerhard Garhofer, MD, Priv.Doz., Principal investigator, Medical University of Vienna
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00999024
- Sponsor's protocol ID
- OPHT - 090709
- Status last verified
- Oct 2009
- First submitted
- 20 Oct 2009
- Last updated
- 4 Feb 2013
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Palkovits S, Lasta M, Boltz A, Schmidl D, Kaya S, Hammer M, Marzluf B, Popa-Cherecheanu A, Frantal S, Schmetterer L, Garhofer G. Measurement of retinal oxygen saturation in patients with chronic obstructive pulmonary disease. Invest Ophthalmol Vis Sci. 2013 Feb 5;54(2):1008-13. doi: 10.1167/iovs.12-10504.
PubMed 23307953
Study at a glance
From the registry record, last updated by the sponsor on 4 Feb 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Reflectometric Measurement of Retinal Oxygen Saturation in Patients With COPD Grade IV and Healthy Subjects
- ClinicalTrials.gov ID
- NCT00999024
- Acronym / sponsor ID
- OPHT - 090709
- Conditions
- Retinal Artery, Retinal Veins
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Medical University of ViennaUniversity, hospital or other
- Study start
- Nov 2009
- Primary completion
- Oct 2012 (actual)
- Study completion
- Oct 2012 (actual)
- First posted
- 21 Oct 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.
An adequate oxygenation and retinal perfusion is essential for the function of the inner retina. There is a wide range of autoregulation mechanisms to ensure a sufficient ocular blood and oxygen supply during changes in systemic blood pressure or intraocular pressure (IOP). Nonetheless, various retinopathies such as diabetic retinopathy, which is the leading cause of blindness in people aged 20-65 in the western world, are highly associated with hypoxia (Pemp and Schmetterer 2008). Hence, measurements of oxygen levels in retinal vessels are needed to further our understanding of these ischemic diseases. It is a well known fact and a commonly employed method to measure oxygen saturation of blood through light transmission (Kramer 1934). However, this approach is not feasible in the human eye. Therefore, reflection must be used, meaning the amount of incident light must be estimated based on the amount of light reflected (for a review see Harris 2003). This is a difficult task and investigators in this field have encountered several problems, including optical complexities, nonlinear sensors and eye movement (Beach et al 1999; Delori 1988). Nonetheless considerable progress has been made over the past decades and the development of an reliable oximeter reported (Hardarson et al 2006).
In the present study this technique will be applied in healthy subjects as well as in patients with COPD during room-air conditions. The procedure takes approximately 15 minutes in each subject and will be performed in only one eye.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Healthy subjects | – | –20 healthy subjects will be included |
| COPD Patients | – | –20 Patients with Grade IV COPD will be included |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- 20 healthy subjects, 20 patients with grade IV COPD
Key inclusion criteria (8 listed)
- Men and women aged between 18 and 99 years
- Tiffeneau Index > 70 %
- Body mass index between 15th and 85th percentile
- Normal ophthalmic findings, ametropia < 3 Dpt.
- Men and women aged between 18 and 99 years
Key exclusion criteria (10 listed)
- Regular use of medication, abuse of alcoholic beverages, participation in a clinical trial in the 3 weeks preceding the study
- Treatment in the previous 3 weeks with any drug except oral contraceptives
- Symptoms of a clinically relevant illness in the 3 weeks before the study day
- Blood donation during the previous 3 weeks
- Abuse of alcoholic beverages, participation in a clinical trial in the 3 weeks preceding the study
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Blood oxygen saturation measured in retinal vessel
Time frame: 15 minutes measured with the RVA
1 secondary outcome
Systemic blood pressure
Time frame: 5 minutes
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Feb 2013.
- Derived from this study: PubMed 23307953Palkovits S, Lasta M, Boltz A, Schmidl D, Kaya S, Hammer M, Marzluf B, Popa-Cherecheanu A, Frantal S, Schmetterer L, Garhofer G. Measurement of retinal oxygen saturation in patients with chronic obstructive pulmonary disease. Invest Ophthalmol Vis Sci. 2013 Feb 5;54(2):1008-13. doi: 10.1167/iovs.12-10504.
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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.
Gerhard Garhofer, MD, Priv.Doz. principal investigator
Medical University of Vienna
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 Retinal Artery and Retinal Veins, run by Medical University of Vienna at 1 site in Austria.
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 8 inclusion and 10 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: finished, as of the sponsor's last update on 4 Feb 2013. 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 Austria. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Blood oxygen saturation measured in retinal vessel (time frame: 15 minutes measured with the RVA). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00999024, which also lists 1 linked publication.
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 4 Feb 2013.