Ocular Pulse Amplitude And Choroidal Laser Doppler Flowmetry

This study has been terminated.
(methodological problems)
Sponsor:
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
  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)
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

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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 October 23, 2014