ClinicalTrials.gg
CompletedNCT02089009Updated Jul 19, 2016

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

An interventional study of Retinal imaging and Vessel measurements in Eye Diseases, Retina; Lesion and Optic Disc Structural Anomaly, sponsored by Dr. Martin Leitritz. Completed at 2 sites in Germany. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2016-07-19.

Sponsored by Dr. Martin Leitritz · Not applicable, Interventional, and Diagnostic

Phase
Not applicable
Study type
Interventional
Enrollment
214
Allocation
Non-randomized
Ages
18 Years and older
Sex
All
01

Study 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.
Read the 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)

02

Conditions studied

  • Eye Diseases
  • Retina; Lesion
  • Optic Disc Structural Anomaly

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03

In context

Eye Diseases

747 studies on the registry are indexed under Eye Diseases; 118 are open to participants now.

This study's enrollment of 214 is above the median of 69 across 554 interventional studies indexed under Eye Diseases.

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Lead sponsor

This is the only study on the registry with Dr. Martin Leitritz as lead sponsor.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
Yes

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

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

Exclusion criteria

Exclusion Criteria:

  • limited ability for agreement
  • heavy tremble
  • reduced general condition
  • known epilepsy
05

Study design

Phase
Not applicable
Primary purpose
Diagnostic
Allocation
Non-randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
214 participants (actual)

Study arms

  • Other
    Group 1 Standard Population

    Retinal Imaging, vessel measurements, vessel changes of a population of a female health hospital

    Other: Retinal imaging · Other: Vessel measurements · Other: Change in vessel diameters

  • Other
    Group 2 Pregnant Population

    Change in vessel diameter at perinatal visits with retinal imaging (Retinal Imaging, vessel measurements, vessel changes)

    Other: Retinal imaging · Other: Vessel measurements · Other: Change in vessel diameters

Interventions

  • OtherRetinal imaging

    Retinal imaging by using non-mydriatic camera devices

  • OtherVessel measurements

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

  • OtherChange in vessel diameters

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

06

What researchers measure

Primary outcomes

  1. Image Quality

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

    Time frame: 12 to 16 month

Secondary outcomes

  1. Retinal Pathologies

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

    Time frame: 12 to 16 month

  2. Differences Perinatal

    Visit 1 and Visit 2 (group 2)

    Time frame: 12 to 16 month

07

Study locations

2 sites
  • Female Health Hospital Reutlingen
    Reutlingen, Baden-Wurttemberg 72764, Germany
  • University Eye Hospital
    Tübingen, Baden-Wurttemberg 72076, Germany
08

Timeline

Tracking since Sep 25, 2026
Not marked actual or estimatedDates not marked actual or estimated

The record gives a start of Dec 2013, a primary completion of Feb 2016 and a completion of Feb 2016. It does not say whether these dates are actual or estimated.

How these figures are worked out, and which studies are left out of them.

Registered
Mar 11, 2014
First posted
Mar 17, 2014
Start
Dec 2013
Primary completionActual
Feb 2016
CompletionActual
Feb 2016
Last update
Jul 19, 2016
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Jul 19, 2016, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT02089009
Lead sponsor
Dr. Martin Leitritz
Collaborators
Optomed
Responsible party
Dr. Martin Leitritz (Dr. med. Martin A. Leitritz, University Hospital Tuebingen) — Sponsor-investigator
First posted
Mar 17, 2014
Start date
Dec 2013
Primary completion
Feb 2016
Completion
Feb 2016
Last update
Jul 19, 2016

Study contacts

Martin A Leitritz, M.D.
principal investigator · University Hospital Tuebingen

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Jul 2016. You cannot join it, but the record below documents what was studied.

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