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

Study Overview
=================
Brief Summary
-----------------
To compare quality and usability of images taken by two different camera-systems without dilating the pupil. To compare the retinal vessel diameters based on the images of to different camera-systems. To detect changes in retinal vessel diameters while pregnancy and after delivery.

Detailed Description
-----------------
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)

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

Conditions
-----------------
Eye Diseases, Retina; Lesion, Optic Disc Structural Anomaly

Intervention / Treatment
-----------------
* Other: Retinal imaging
* Other: Vessel measurements
* Other: Change in vessel diameters


Participation Criteria
=================
Eligibility 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

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
Accepts Healthy Volunteers

Study Plan
=================
How is the study designed?
-----------------

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Group 1 Standard Population<br>Retinal Imaging, vessel measurements, vessel changes of a population of a female health hospital | Other: Retinal imaging<br>* Retinal imaging by using non-mydriatic camera devices<br>Other: Vessel measurements<br>* Vessel measurements based on the taken images by the use of a specialized software<br>Other: Change in vessel diameters<br>* Change of vessel diameters before and after delivery based on the taken images by the use of a specialized software<br>|
| Other: Group 2 Pregnant Population<br>Change in vessel diameter at perinatal visits with retinal imaging (Retinal Imaging, vessel measurements, vessel changes) | Other: Retinal imaging<br>* Retinal imaging by using non-mydriatic camera devices<br>Other: Vessel measurements<br>* Vessel measurements based on the taken images by the use of a specialized software<br>Other: Change in vessel diameters<br>* Change of vessel diameters before and after delivery based on the taken images by the use of a specialized software<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Image Quality | 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 | Visit 1 and Visit 2 (group 2) Which pathologies / diseases can be assessed with the taken images. | 12 to 16 month | 
| Differences Perinatal | Visit 1 and Visit 2 (group 2) | 12 to 16 month |