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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT02717026
Other study ID # 27-262ex14/15
Secondary ID
Status Completed
Phase
First received
Last updated
Start date July 2015
Est. completion date January 2018

Study information

Verified date September 2020
Source Medical University of Graz
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

Retinal blood flow measurement is of scientific and clinical value. For this purpose retinal vessel morphology (such as diameter, vessel wall thickness, etc) determination is crucial. Different imaging modalities might provide divergent results. Thus, quantification of such differences is valuable.

The present study aims to reveal and quantify differences in vessel morphology between fundus photography, fundus angiography, and optical coherence tomography in health and disease.


Description:

This is considered a pilot study and will pe performed on patients scheduled for routine fluorescein angiography.

During the study day the following procedures will be performed:

- Medical history and concomitant medication

- Blood pressure and heart rate

- Assessment of visual acuity using Snellen vision charts

- Biomicroscopy

- Intraocular pressure

- Funduscopy

- IOL-Master axial length measurement

- Fundusphotography

- Optical coherence tomography

- Fluorescein Angiography Fundus photography analysis will be performed with an automated software and analysis of both angiography and optical coherence tomography will be performed via the devices inbuilt software.


Recruitment information / eligibility

Status Completed
Enrollment 50
Est. completion date January 2018
Est. primary completion date December 2017
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria:

- written informed consent, clear media

Exclusion Criteria:

- any abnormality preventing reliable vessel measurement, pregnancy,

Study Design


Intervention

Device:
Optical coherence tomography
Sections including the retinal vasculature will be taken.
Fluorescein angiography
Video fluorescein angiography from one eye of each subject will be performed
Fundus photography
30 and 50 degree fundus images

Locations

Country Name City State
Austria Department of Ophthalmology, Medical University of Graz Graz Styria

Sponsors (1)

Lead Sponsor Collaborator
Medical University of Graz

Country where clinical trial is conducted

Austria, 

Outcome

Type Measure Description Time frame Safety issue
Primary retinal vessel diameter 5 minutes
Secondary retinal vessel reflectivity 5 minutes
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