Ocular Pulse Amplitude And Choroidal Laser Doppler Flowmetry

Healthy Clinical Trial

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00409110
• Other study ID #: 082-KAR-2006-001
• Status: Terminated
• Phase: N/A
• First received: December 7, 2006
• Last updated: August 8, 2011
• Start date: January 2006
• Est. completion date: August 2011

Study information

• Verified date: August 2011
• Source: University Hospital, Basel, Switzerland
• Contact: n/a
• Is FDA regulated: No
• Health authority: Switzerland: Swissmedic
• Study type: Observational

Clinical Trial Summary

This study intends to investigate the relationship between choroidal blood flow and ocular pulse amplitude (OPA).

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 10
• Est. completion date: August 2011
• Est. primary completion date: August 2011
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 45 Years to 80 Years

Eligibility

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 Design

Observational Model: Case-Only, Time Perspective: Prospective

Related Conditions & MeSH terms

• Healthy

Locations

Country	Name	City	State
Switzerland	University Eye Clinic Basel	Basel	Basel-Stadt

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Basel, Switzerland

Country where clinical trial is conducted

Switzerland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	An association of OPA with the LDF pulsatility index		30 seconds	No
Secondary	An association of OPA with the systemic blood pressure values		30 seconds	No
Secondary	An association of OPA with mean intraocular pressure		30 seconds	No