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Ocular Pulse Amplitude And Choroidal Laser Doppler Flowmetry

This study has been terminated.
(methodological problems)
Sponsor:
ClinicalTrials.gov Identifier:
NCT00409110
First Posted: December 8, 2006
Last Update Posted: August 9, 2011
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
University Hospital, Basel, Switzerland
  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

Resource links provided by NLM:


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 ]

Secondary Outcome Measures:
  • 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 ]

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)
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.
  Eligibility

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Ages Eligible for Study:   45 Years to 80 Years   (Adult, Senior)
Sexes Eligible for Study:   All
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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

Responsible Party: Selim Orguel, University Hospital, Basel, Switzerland
ClinicalTrials.gov Identifier: NCT00409110     History of Changes
Other Study ID Numbers: 082-KAR-2006-001
First Submitted: December 7, 2006
First Posted: December 8, 2006
Last Update Posted: August 9, 2011
Last Verified: August 2011

Keywords provided by University Hospital, Basel, Switzerland:
Ocular Pulse Amplitude
Dynamic Contour Tonometry
Pulsatility Index
Choroidal Laser Doppler Flowmetry
Finometer