- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00409110
Ocular Pulse Amplitude And Choroidal Laser Doppler Flowmetry
August 8, 2011 updated by: University Hospital, Basel, Switzerland
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).
Study Overview
Status
Terminated
Conditions
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 Type
Observational
Enrollment (Actual)
10
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Basel-Stadt
-
Basel, Basel-Stadt, Switzerland, 4031
- University Eye Clinic Basel
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
45 years to 80 years (ADULT, OLDER_ADULT)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
All
Sampling Method
Non-Probability Sample
Study Population
healthy subjects
Description
Inclusion Criteria:
- 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.
Exclusion Criteria:
- 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.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
An association of OPA with the LDF pulsatility index
Time Frame: 30 seconds
|
30 seconds
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
An association of OPA with the systemic blood pressure values
Time Frame: 30 seconds
|
30 seconds
|
An association of OPA with mean intraocular pressure
Time Frame: 30 seconds
|
30 seconds
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Investigators
- Study Director: Selim Orguel, MD, University Eye Clinic Basel
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
January 1, 2006
Primary Completion (ACTUAL)
August 1, 2011
Study Completion (ACTUAL)
August 1, 2011
Study Registration Dates
First Submitted
December 7, 2006
First Submitted That Met QC Criteria
December 7, 2006
First Posted (ESTIMATE)
December 8, 2006
Study Record Updates
Last Update Posted (ESTIMATE)
August 9, 2011
Last Update Submitted That Met QC Criteria
August 8, 2011
Last Verified
August 1, 2011
More Information
Terms related to this study
Keywords
Other Study ID Numbers
- 082-KAR-2006-001
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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