Ocular Pulse Amplitude And Choroidal Laser Doppler Flowmetry
This study has been terminated.
(methodological problems)
Sponsor:
University Hospital, Basel, Switzerland
Information provided by:
University Hospital, Basel, Switzerland
ClinicalTrials.gov Identifier:
NCT00409110
First received: December 7, 2006
Last updated: August 8, 2011
Last verified: August 2011
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Purpose
This study intends to investigate the relationship between choroidal blood flow and ocular pulse amplitude (OPA).
| Condition |
|---|
|
Healthy |
| Study Type: | Observational |
| Study Design: | Observational Model: Case-Only Time Perspective: Prospective |
| Official Title: | Relationship Between Ocular Pulse Amplitude And Choroidal Laser Doppler Flowmetry In Healthy Subjects |
Further study details as provided by University Hospital, Basel, Switzerland:
Primary Outcome Measures:
- An association of OPA with the LDF pulsatility index [ Time Frame: 30 seconds ] [ Designated as safety issue: No ]
Secondary Outcome Measures:
- An association of OPA with the systemic blood pressure values [ Time Frame: 30 seconds ] [ Designated as safety issue: No ]
- An association of OPA with mean intraocular pressure [ Time Frame: 30 seconds ] [ Designated as safety issue: No ]
| Enrollment: | 10 |
| Study Start Date: | January 2006 |
| Study Completion Date: | August 2011 |
| Primary Completion Date: | August 2011 (Final data collection date for primary outcome measure) |
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.
Eligibility| Ages Eligible for Study: | 45 Years to 80 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | Yes |
| Sampling Method: | Non-Probability Sample |
Study Population
healthy subjects
Criteria
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.
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00409110
Locations
| Switzerland | |
| University Eye Clinic Basel | |
| Basel, Basel-Stadt, Switzerland, 4031 | |
Sponsors and Collaborators
University Hospital, Basel, Switzerland
Investigators
| Study Director: | Selim Orguel, MD | University Eye Clinic Basel |
More Information
No publications provided
| Responsible Party: | Selim Orguel, University Hospital, Basel, Switzerland |
| ClinicalTrials.gov Identifier: | NCT00409110 History of Changes |
| Other Study ID Numbers: | 082-KAR-2006-001 |
| Study First Received: | December 7, 2006 |
| Last Updated: | August 8, 2011 |
| Health Authority: | Switzerland: Swissmedic |
Keywords provided by University Hospital, Basel, Switzerland:
|
Ocular Pulse Amplitude Dynamic Contour Tonometry Pulsatility Index Choroidal Laser Doppler Flowmetry Finometer |
ClinicalTrials.gov processed this record on May 21, 2013