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OpenTrials
Completed

NCT Number: NCT02089009

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

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.

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Key information

Conditions

Eye Diseases Optic Disc Structural Anomaly Retina; Lesion

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Female Health Hospital Reutlingen, Reutlingen, Baden-Wurttemberg, Germany

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About this study

  • 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.

  • 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?

  • 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)

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Retinal imaging

Other

Retinal imaging by using non-mydriatic camera devices

Vessel measurements

Other

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

Change in vessel diameters

Other

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

Primary outcomes

  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 outcomes

  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)

Sponsors and collaborators

Lead sponsor

Dr. Martin Leitritz

Other

Collaborators

  • Optomed

Registry information

Official study 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

Important dates

Study start
2013
Primary completion
2016
Study completion
2016
First posted
Mar 17, 2014
Registry last updated
Jul 19, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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