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Multimodal Imaging of Retinal Vessels (MIR)

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.
 
ClinicalTrials.gov Identifier: NCT02717026
Recruitment Status : Completed
First Posted : March 23, 2016
Last Update Posted : September 14, 2020
Sponsor:
Information provided by (Responsible Party):
Medical University of Graz

Brief 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.


Condition or disease Intervention/treatment
Retinal Blood Vessels Age-Related Macular Degeneration Device: Optical coherence tomography Device: Fluorescein angiography Device: Fundus photography

Detailed 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.

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Study Type : Observational
Actual Enrollment : 50 participants
Observational Model: Case-Control
Time Perspective: Prospective
Official Title: Retinal Vessel Morphology in Multimodal Imaging
Actual Study Start Date : July 2015
Actual Primary Completion Date : December 2017
Actual Study Completion Date : January 2018

Resource links provided by the National Library of Medicine



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


Primary Outcome Measures :
  1. retinal vessel diameter [ Time Frame: 5 minutes ]

Secondary Outcome Measures :
  1. retinal vessel reflectivity [ Time Frame: 5 minutes ]


Information from the National Library of Medicine

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, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
adult patients scheduled for routine retinal assessment
Criteria

Inclusion Criteria:

  • written informed consent, clear media

Exclusion Criteria:

  • any abnormality preventing reliable vessel measurement, pregnancy,

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): NCT02717026


Locations
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Austria
Department of Ophthalmology, Medical University of Graz
Graz, Styria, Austria, 8036
Sponsors and Collaborators
Medical University of Graz
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Responsible Party: Medical University of Graz
ClinicalTrials.gov Identifier: NCT02717026    
Other Study ID Numbers: 27-262ex14/15
First Posted: March 23, 2016    Key Record Dates
Last Update Posted: September 14, 2020
Last Verified: September 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Additional relevant MeSH terms:
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Macular Degeneration
Retinal Degeneration
Retinal Diseases
Eye Diseases