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

July 17, 2016 updated by: Dr. Martin Leitritz

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

  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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

214

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Germany
    • BW
      • Reutlingen, BW, Germany, 72764
        • Female Health Hospital Reutlingen
      • Tuebingen, BW, Germany, 72076
        • University Eye Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Diagnostic
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Other: 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
Other: 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Image Quality
Time Frame: 12 to 16 month
Visit 1 and Visit 2 (for group 2) Evaluating of image quality for each camera-system
12 to 16 month

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
12 to 16 month
Differences Perinatal
Time Frame: 12 to 16 month
Visit 1 and Visit 2 (group 2)
12 to 16 month

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Dr. Martin Leitritz

Collaborators

Optomed

Investigators

  • Principal Investigator: Martin A Leitritz, M.D., University Hospital Tuebingen

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

December 1, 2013

Primary Completion (Actual)

February 1, 2016

Study Completion (Actual)

February 1, 2016

Study Registration Dates

First Submitted

March 11, 2014

First Submitted That Met QC Criteria

March 13, 2014

First Posted (Estimate)

March 17, 2014

Study Record Updates

Last Update Posted (Estimate)

July 19, 2016

Last Update Submitted That Met QC Criteria

July 17, 2016

Last Verified

July 1, 2016

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • NonMydGyn

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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