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

NCT ID: NCT02089009

Last Updated: 2016-07-19

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

214 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-12-31

Study Completion Date

2016-02-29

Brief Summary

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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

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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)

Conditions

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Eye Diseases Retina; Lesion Optic Disc Structural Anomaly

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

Study Groups

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Group 1 Standard Population

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

Group Type OTHER

Retinal imaging

Intervention Type OTHER

Retinal imaging by using non-mydriatic camera devices

Vessel measurements

Intervention Type OTHER

Vessel measurements based on the taken images by the use of a specialized software

Change in vessel diameters

Intervention Type OTHER

Change of vessel diameters before and after delivery based on the taken images by the use of a specialized software

Group 2 Pregnant Population

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

Group Type OTHER

Retinal imaging

Intervention Type OTHER

Retinal imaging by using non-mydriatic camera devices

Vessel measurements

Intervention Type OTHER

Vessel measurements based on the taken images by the use of a specialized software

Change in vessel diameters

Intervention Type OTHER

Change of vessel diameters before and after delivery based on the taken images by the use of a specialized software

Interventions

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Retinal imaging

Retinal imaging by using non-mydriatic camera devices

Intervention Type OTHER

Vessel measurements

Vessel measurements based on the taken images by the use of a specialized software

Intervention Type OTHER

Change in vessel diameters

Change of vessel diameters before and after delivery based on the taken images by the use of a specialized software

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Optomed

UNKNOWN

Sponsor Role collaborator

Dr. Martin Leitritz

OTHER

Sponsor Role lead

Responsible Party

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Dr. Martin Leitritz

Dr. med. Martin A. Leitritz

Responsibility Role SPONSOR_INVESTIGATOR

Principal Investigators

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Martin A Leitritz, M.D.

Role: PRINCIPAL_INVESTIGATOR

University Hospital Tuebingen

Locations

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Female Health Hospital Reutlingen

Reutlingen, Baden-Wurttemberg, Germany

Site Status

University Eye Hospital

Tübingen, Baden-Wurttemberg, Germany

Site Status

Countries

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Germany

Other Identifiers

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NonMydGyn

Identifier Type: -

Identifier Source: org_study_id

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