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

Not Applicable

Completed

• Conditions: Retina; Lesion; Optic Disc Structural Anomaly; Eye Diseases
• Interventions: Other: Retinal imaging; Other: Vessel measurements; Other: Change in vessel diameters

• Registration Number: NCT02089009
• Lead Sponsor: Dr. Martin Leitritz

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)

Study Timeline

• Study Start: 2013-12
• Study First Submitted: 2014-03-11
• Study First Submitted QC: 2014-03-13
• Study First Posted: 2014-03-17
• Primary Completion: 2016-02
• Study Completion: 2016-02
• Status Verified: 2016-07
• Last Update Submitted: 2016-07-17
• Last Update Posted: 2016-07-19

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 214

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Group 2 Pregnant Population	Retinal imaging	Change in vessel diameter at perinatal visits with retinal imaging (Retinal Imaging, vessel measurements, vessel changes)
Group 1 Standard Population	Retinal imaging	Retinal Imaging, vessel measurements, vessel changes of a population of a female health hospital
Group 1 Standard Population	Vessel measurements	Retinal Imaging, vessel measurements, vessel changes of a population of a female health hospital
Group 1 Standard Population	Change in vessel diameters	Retinal Imaging, vessel measurements, vessel changes of a population of a female health hospital
Group 2 Pregnant Population	Vessel measurements	Change in vessel diameter at perinatal visits with retinal imaging (Retinal Imaging, vessel measurements, vessel changes)
Group 2 Pregnant Population	Change in vessel diameters	Change in vessel diameter at perinatal visits with retinal imaging (Retinal Imaging, vessel measurements, vessel changes)

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
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)

Trial Locations

Locations (2)

University Eye Hospital; 🇩🇪 Tuebingen, BW, Germany

Female Health Hospital Reutlingen; 🇩🇪 Reutlingen, BW, Germany