HealthyNCT00409110
Ocular Pulse Amplitude And Choroidal Laser Doppler Flowmetry
An observational study of Healthy, run by University Hospital, Basel, Switzerland at 1 site in Switzerland.
Trial summary
This study intends to investigate the relationship between choroidal blood flow and ocular pulse amplitude (OPA). Read more about this study
- Who is it for?
- Ages 45 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy
- How many people
- 10 participants
- Where
- 1 siteSwitzerland
- Study dates
- Jan 2006to Aug 2011
- 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 45 to 80 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: healthy subjects
Who may be able to join
- Healthy subjects should present no history of ocular diseases, of current topical medication, or of drug or alcohol abuse. Furthermore, a best corrected visual acuity above 20/25 in both eyes, lack of pathological findings upon a slit-lamp examination and dilated direct fundoscopy, and an IOP < 21 mmHg in both eyes will be required.
Who cannot join
- History of chronic or recurrent severe inflammatory eye disease such as scleritis or uveitis.
- History of ocular trauma or intraocular surgery. History of infection or inflammation within the past 3 months.
- History and clinical evidence for other retinal disease such as age-related degeneration, or diabetic retinopathy.
Trial locations and contacts
1 site in 1 country.
Switzerland1 site
University Eye Clinic Basel
Basel, Canton of Basel-City, 4031
About this study
Official title: Relationship Between Ocular Pulse Amplitude And Choroidal Laser Doppler Flowmetry In Healthy Subjects
This study intends to investigate the relationship between choroidal blood flow and ocular pulse amplitude (OPA).
Read the detailed description
One eye is randomly selected in 18 healthy subjects. OPA is assessed with Dynamic Contour Tonometry. Submacular choroidal blood flow is measured with Laser Doppler Flowmetry. During both examinations the systemic blood pressure is continuously recorded with Finometer. An average systolic and diastolic LDF parameter flow during 30 seconds are determined and the pulsatility index is calculated according to the formula (LDFsys-LDFdia)/LDFdia. An association of OPA with the LDF pulsatility index, systemic blood pressure values and mean intraocular pressure will be analysed.
- Conditions
- Healthy
- Keywords
- Ocular Pulse Amplitude, Dynamic Contour Tonometry, Pulsatility Index, Choroidal Laser Doppler Flowmetry, Finometer
What is being measured
The primary outcome is the main question the study is designed to answer.
An association of OPA with the LDF pulsatility index
Measured: 30 seconds
Secondary outcomes (2)
An association of OPA with the systemic blood pressure values
Measured: 30 seconds
An association of OPA with mean intraocular pressure
Measured: 30 seconds
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Dec 2006 (estimated)
- Study startJan 2006
- Primary completionAug 2011
- Study completionAug 2011
Why it stopped: methodological problems
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HealthyStudies of the same condition, open and under way.
- More trials run by University Hospital, Basel, SwitzerlandThe 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
- Case only
- Time perspective
- Prospective
- Enrolment
- 10 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Basel, Switzerland
- Sponsor type
- University, hospital or other
- Investigators
- Selim Orguel, MD, Study director, University Eye Clinic Basel
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00409110
- Sponsor's protocol ID
- 082-KAR-2006-001
- Status last verified
- Aug 2011
- First submitted
- 7 Dec 2006
- Last updated
- 9 Aug 2011
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Aug 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Relationship Between Ocular Pulse Amplitude And Choroidal Laser Doppler Flowmetry In Healthy Subjects
- ClinicalTrials.gov ID
- NCT00409110
- Acronym / sponsor ID
- 082-KAR-2006-001
- Conditions
- Healthy
- Keywords
- Ocular Pulse Amplitude, Dynamic Contour Tonometry, Pulsatility Index, Choroidal Laser Doppler Flowmetry, Finometer
- Study type
- Observational
- Recruitment status
- TerminatedReason stopped: methodological problems
- Enrolment
- 10 participants (actual)
- Lead sponsor
- University Hospital, Basel, SwitzerlandUniversity, hospital or other
- Study start
- Jan 2006
- Primary completion
- Aug 2011 (actual)
- Study completion
- Aug 2011 (actual)
- First posted
- 8 Dec 2006 (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.
This study intends to investigate the relationship between choroidal blood flow and ocular pulse amplitude (OPA).
Detailed description
One eye is randomly selected in 18 healthy subjects. OPA is assessed with Dynamic Contour Tonometry. Submacular choroidal blood flow is measured with Laser Doppler Flowmetry. During both examinations the systemic blood pressure is continuously recorded with Finometer. An average systolic and diastolic LDF parameter flow during 30 seconds are determined and the pulsatility index is calculated according to the formula (LDFsys-LDFdia)/LDFdia. An association of OPA with the LDF pulsatility index, systemic blood pressure values and mean intraocular pressure will be analysed.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
Who may qualify
- Ages
- 45 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- healthy subjects
Key inclusion criteria (1 listed)
- Healthy subjects should present no history of ocular diseases, of current topical medication, or of drug or alcohol abuse. Furthermore, a best corrected visual acuity above 20/25 in both eyes, lack of pathological findings upon a slit-lamp examination and dilated direct fundoscopy, and an IOP < 21 mmHg in both eyes will be required.
Key exclusion criteria (3 listed)
- History of chronic or recurrent severe inflammatory eye disease such as scleritis or uveitis.
- History of ocular trauma or intraocular surgery. History of infection or inflammation within the past 3 months.
- History and clinical evidence for other retinal disease such as age-related degeneration, or diabetic retinopathy.
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
An association of OPA with the LDF pulsatility index
Time frame: 30 seconds
2 secondary outcomes
An association of OPA with the systemic blood pressure values
Time frame: 30 seconds
An association of OPA with mean intraocular pressure
Time frame: 30 seconds
Results and safety
The study was stopped early (reason given: methodological problems). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Aug 2011.
Related trials for Healthy
RecruitingObservational study
Survey to Determine Incarcerated Persons' Views on Surrogate Decision Making
Healthy Volunteers
Recruiting
Effects of Urolithin A Supplementation on Glucose Metabolism in Healthy Adults 55 >= Years Old: A Randomized Triple-Masked Controlled Clinical Trial
Healthy Volunteer
Active, not recruitingPhase 3
A Clinical Study to Evaluate the Safety, Tolerability, and Immunogenicity of VAX-31 With Influenza Vaccine in Adults ≥ 50 Years of Age
Pneumococcal Disease
Recruiting
Effect of a Fermented Dairy Protein With Prebiotic Fiber on GI Complaints
Digestive Health, Quality of Life
Not yet recruitingPhase 1
Dynamic Magnetic Resonance Imaging of Human Subarachnoid Space Using Intrathecal Gadolinium Contrast
Healthy Volunteers
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.
Selim Orguel, MD study director
University Eye Clinic Basel
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, run by University Hospital, Basel, Switzerland 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 1 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: stopped early, as of the sponsor's last update on 9 Aug 2011. 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?
The study was stopped early (reason given: methodological problems). Results are not available in the source record.
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?
An association of OPA with the LDF pulsatility index (time frame: 30 seconds). 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 9 Aug 2011.