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

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

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT02089009

Enrollment

214

Registered

2014-03-17

Start date

2013-12-31

Completion date

2016-02-29

Last updated

2016-07-19

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Eye Diseases, Retina; Lesion, Optic Disc Structural Anomaly

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 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)

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

Study design

Allocation

NON_RANDOMIZED

Intervention model

PARALLEL

Primary purpose

DIAGNOSTIC

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

Yes

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

Design outcomes

Primary

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

Secondary

Measure	Time frame	Description
Retinal Pathologies	12 to 16 month	Visit 1 and Visit 2 (group 2) Which pathologies / diseases can be assessed with the taken images.
Differences Perinatal	12 to 16 month	Visit 1 and Visit 2 (group 2)

Countries

Germany

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026