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

Eye Diseases Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02089009
• Other study ID #: NonMydGyn
• Status: Completed
• Phase: N/A
• First received: March 11, 2014
• Last updated: July 17, 2016
• Start date: December 2013
• Est. completion date: February 2016

Study information

• Verified date: July 2016
• Source: University Hospital Tuebingen
• Contact: n/a
• Is FDA regulated: No
• Health authority: Germany: Ethics Commission
• Study type: Interventional

Clinical Trial 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.

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)

Recruitment information / eligibility

• Status: Completed
• Enrollment: 214
• Est. completion date: February 2016
• Est. primary completion date: February 2016
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Allocation: Non-Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Diagnostic

Related Conditions & MeSH terms

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

Intervention

Other:
• Retinal imaging
Retinal imaging by using non-mydriatic camera devices
• Vessel measurements
Vessel measurements based on the taken images by the use of a specialized software
• Change in vessel diameters
Change of vessel diameters before and after delivery based on the taken images by the use of a specialized software

Locations

Country	Name	City	State
Germany	Female Health Hospital Reutlingen	Reutlingen	BW
Germany	University Eye Hospital	Tuebingen	BW

Sponsors (2)

Lead Sponsor	Collaborator
Dr. Martin Leitritz	Optomed

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Image Quality	Visit 1 and Visit 2 (for group 2) Evaluating of image quality for each camera-system	12 to 16 month	No
Secondary	Retinal Pathologies	Visit 1 and Visit 2 (group 2) Which pathologies / diseases can be assessed with the taken images.	12 to 16 month	No
Secondary	Differences Perinatal	Visit 1 and Visit 2 (group 2)	12 to 16 month	No