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

Dr. Martin Leitritz

Status: Completed

Conditions: Retina; Lesion; Optic Disc Structural Anomaly; Eye Diseases

Treatments: Other: Retinal imaging; Other: Change in vessel diameters; Other: Vessel measurements

Study type: Interventional

Funder types: Other

Identifiers

NCT02089009

NonMydGyn

Details and patient eligibility

About

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.

Full 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)

Enrollment: 214 patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Diagnostic

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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214 participants in 2 patient groups

Group 1 Standard Population

Other group

Description:

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

Treatment:

Other: Change in vessel diameters

Other: Vessel measurements

Other: Retinal imaging

Group 2 Pregnant Population

Other group

Description:

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

Treatment:

Other: Change in vessel diameters

Other: Vessel measurements

Other: Retinal imaging