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

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ClinicalTrials.gov Identifier: NCT02089009
Recruitment Status : Completed
First Posted : March 17, 2014
Last Update Posted : July 19, 2016
Sponsor:
Collaborator:
Optomed
Information provided by (Responsible Party):
Dr. Martin Leitritz, University Hospital Tuebingen

Study Description
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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.

Condition or disease Intervention/treatment Phase
Eye Diseases Retina; Lesion Optic Disc Structural Anomaly Other: Retinal imaging Other: Vessel measurements Other: Change in vessel diameters Not Applicable

Detailed Description:

  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)

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 214 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
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
Study Start Date : December 2013
Actual Primary Completion Date : February 2016
Actual Study Completion Date : February 2016

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
Group 1 Standard Population
Retinal Imaging, vessel measurements, vessel changes of a population of a female health hospital
 Other: Retinal imaging
Retinal imaging by using non-mydriatic camera devices

Other: Vessel measurements
Vessel measurements based on the taken images by the use of a specialized software

Other: Change in vessel diameters
Change of vessel diameters before and after delivery based on the taken images by the use of a specialized software
Group 2 Pregnant Population
Change in vessel diameter at perinatal visits with retinal imaging (Retinal Imaging, vessel measurements, vessel changes)
 Other: Retinal imaging
Retinal imaging by using non-mydriatic camera devices

Other: Vessel measurements
Vessel measurements based on the taken images by the use of a specialized software

Other: Change in vessel diameters
Change of vessel diameters before and after delivery based on the taken images by the use of a specialized software


Outcome Measures
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Primary Outcome Measures :
  1. Image Quality [ Time Frame: 12 to 16 month ]
    Visit 1 and Visit 2 (for group 2) Evaluating of image quality for each camera-system


Secondary Outcome Measures :
  1. 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.

  2. Differences Perinatal [ Time Frame: 12 to 16 month ]
    Visit 1 and Visit 2 (group 2)


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • written informed consent
  • age >18 years
  • pregnancy (only group 2)

Exclusion Criteria:

  • limited ability for agreement
  • heavy tremble
  • reduced general condition
  • known epilepsy
Contacts and Locations
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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): NCT02089009


Locations
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Germany
Female Health Hospital Reutlingen
Reutlingen, BW, Germany, 72764
University Eye Hospital
Tuebingen, BW, Germany, 72076
Sponsors and Collaborators
Dr. Martin Leitritz
Optomed
Investigators
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Principal Investigator: Martin A Leitritz, M.D. University Hospital Tuebingen
More Information
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Responsible Party: Dr. Martin Leitritz, Dr. med. Martin A. Leitritz, University Hospital Tuebingen
ClinicalTrials.gov Identifier: NCT02089009    
Other Study ID Numbers: NonMydGyn
First Posted: March 17, 2014    Key Record Dates
Last Update Posted: July 19, 2016
Last Verified: July 2016
Additional relevant MeSH terms:
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Eye Diseases