Ocular Pulse Amplitude And Choroidal Laser Doppler Flowmetry - Tabular View

Tracking Information

First Received Date ^ICMJE

December 7, 2006

Last Updated Date

November 17, 2009

Start Date ^ICMJE

January 2006

Estimated Primary Completion Date

April 2010 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

An association of OPA with the LDF pulsatility index [ Time Frame: 30 seconds ] [ Designated as safety issue: No ]

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

Complete list of historical versions of study NCT00409110 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

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 ]

Original Secondary Outcome Measures ^ICMJE

Same as current

Descriptive Information

Brief Title ^ICMJE

Ocular Pulse Amplitude And Choroidal Laser Doppler Flowmetry

Official Title ^ICMJE

Relationship Between Ocular Pulse Amplitude And Choroidal Laser Doppler Flowmetry In Healthy Subjects

Brief Summary

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 Phase

Study Type ^ICMJE

Observational

Study Design ^ICMJE

Case-Only, Prospective

Condition ^ICMJE

Healthy

Intervention ^ICMJE

Study Arms / Comparison Groups

Publications *

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Recruiting

Estimated Enrollment ^ICMJE

Estimated Completion Date

April 2010

Estimated Primary Completion Date

April 2010 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

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.

Gender

Both

Ages

45 Years to 80 Years

Accepts Healthy Volunteers

Yes

Contacts ^ICMJE

Contact: Robert Katamay, MD

+41-61-58629

rkatamay@uhbs.ch

Location Countries ^ICMJE

Switzerland

Administrative Information

NCT ID ^ICMJE

NCT00409110

Responsible Party

Selim Orgul, University Hospital, Basel, Switzerland

Study ID Numbers ^ICMJE

082-KAR-2006-001

Study Sponsor ^ICMJE

University Hospital, Basel, Switzerland

Collaborators ^ICMJE

Investigators ^ICMJE

Study Director:

Selim Orguel, MD

University Eye Clinic Basel

Information Provided By

University Hospital, Basel, Switzerland

Verification Date

November 2009

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP