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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

Tracking Information
First Submitted Date September 7, 2015
First Posted Date March 23, 2016
Last Update Posted Date September 14, 2020
Actual Study Start Date July 2015
Actual Primary Completion Date December 2017   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: March 17, 2016)
retinal vessel diameter [ Time Frame: 5 minutes ]
Original Primary Outcome Measures Same as current
Change History
Current Secondary Outcome Measures
 (submitted: March 17, 2016)
retinal vessel reflectivity [ Time Frame: 5 minutes ]
Original Secondary Outcome Measures Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Multimodal Imaging of Retinal Vessels
Official Title Retinal Vessel Morphology in Multimodal Imaging
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.

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.
Study Type Observational
Study Design Observational Model: Case-Control
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
Sampling Method Probability Sample
Study Population adult patients scheduled for routine retinal assessment
Condition
  • Retinal Blood Vessels
  • Age-Related Macular Degeneration
Intervention
  • 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
Study Groups/Cohorts Not Provided
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Completed
Actual Enrollment
 (submitted: September 11, 2020)
50
Original Estimated Enrollment
 (submitted: March 17, 2016)
120
Actual Study Completion Date January 2018
Actual Primary Completion Date December 2017   (Final data collection date for primary outcome measure)
Eligibility Criteria

Inclusion Criteria:

  • written informed consent, clear media

Exclusion Criteria:

  • any abnormality preventing reliable vessel measurement, pregnancy,
Sex/Gender
Sexes Eligible for Study: All
Ages 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers No
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries Austria
Removed Location Countries  
 
Administrative Information
NCT Number NCT02717026
Other Study ID Numbers 27-262ex14/15
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement
Plan to Share IPD: No
Responsible Party Medical University of Graz
Study Sponsor Medical University of Graz
Collaborators Not Provided
Investigators Not Provided
PRS Account Medical University of Graz
Verification Date September 2020