Clinical Trial: Comparison of Non-mydriatic Camera Systems in a Female Health Hospital

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

Official Title: Comparison of Non-mydriatic Camera Systems for Screening and Follow-up Examinations -Focused on the Retinal Vessel Situation- in the Population of a Female Health Hospital

Brief Summary:

  1. To compare quality and usability of images taken by two different camera-systems without dilating the pupil.
  2. To compare the retinal vessel diameters based on the images of to different camera-systems.
  3. To detect changes in retinal vessel diameters while pregnancy and after delivery.

Detailed Summary:

  1. To compare quality and usability of images taken by two different camera-systems without dilating the pupil.

    Quality means in this content that images cover the planned region of interest and images should be sharp and good illuminated to see details for medical reading of retinal findings.

  2. To compare the retinal vessel diameters based on the images of to different camera-systems.

    The diameters of arteries and veins are planned to be measured with an automated software algorithm. Are there differences in the calculated results between the two used camera devices?

  3. To detect changes in retinal vessel diameters while pregnancy and after delivery.

Are there detectable changes of the retinal findings between the images taken before and after delivery (e.g. bleeding, edema, vessel tortuosity)


Sponsor: Dr. Martin Leitritz

Current Primary Outcome: Image Quality [ Time Frame: 12 to 16 month ]

Visit 1 and Visit 2 (for group 2) Evaluating of image quality for each camera-system


Original Primary Outcome:

  • Image Quality [ Time Frame: 12 to 16 month ]
    Visit 1 and Visit 2 (for group 2) Evaluating of image quality for each camera-system
  • Image Usability [ Time Frame: 12 to 16 month ]
    Visit 1 and Visit 2 (for Group 2) Evaluation of the usability of taken images to perform automated measurements of retinal vessel diameters
  • Differences Perinatal [ Time Frame: 12 to 16 month ]
    Visit 1 and Visit 2 (group 2) Grading of perinatal differences in vessel diameters


Current Secondary Outcome:

  • Retinal Pathologies [ Time Frame: 12 to 16 month ]
    Visit 1 and Visit 2 (group 2) Which pathologies / diseases can be assessed with the taken images.
  • Differences Perinatal [ Time Frame: 12 to 16 month ]
    Visit 1 and Visit 2 (group 2)


Original Secondary Outcome: Retinal Pathologies [ Time Frame: 12 to 16 month ]

Visit 1 and Visit 2 (group 2) Which pathologies / diseases can be assessed with the taken images.


Information By: University Hospital Tuebingen

Dates:
Date Received: March 11, 2014
Date Started: December 2013
Date Completion:
Last Updated: July 17, 2016
Last Verified: July 2016