NCT02089009

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
214

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Dec 2013

Typical duration for not_applicable

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 1, 2013

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

March 11, 2014

Completed
6 days until next milestone

First Posted

Study publicly available on registry

March 17, 2014

Completed
1.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2016

Completed
Last Updated

July 19, 2016

Status Verified

July 1, 2016

Enrollment Period

2.2 years

First QC Date

March 11, 2014

Last Update Submit

July 17, 2016

Conditions

Eye DiseasesRetina; LesionOptic Disc Structural Anomaly

Outcome Measures

Primary Outcomes (1)

  • Image Quality

    Visit 1 and Visit 2 (for group 2) Evaluating of image quality for each camera-system

    12 to 16 month

Secondary Outcomes (2)

  • Retinal Pathologies

    12 to 16 month

  • Differences Perinatal

    12 to 16 month

Study Arms (2)

Group 1 Standard Population

OTHER

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

Other: Retinal imagingOther: Vessel measurementsOther: Change in vessel diameters

Group 2 Pregnant Population

OTHER

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

Other: Retinal imagingOther: Vessel measurementsOther: Change in vessel diameters

Interventions

Retinal imagingOTHER

Retinal imaging by using non-mydriatic camera devices

Group 1 Standard PopulationGroup 2 Pregnant Population
Vessel measurementsOTHER

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

Group 1 Standard PopulationGroup 2 Pregnant Population
Change in vessel diametersOTHER

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

Group 1 Standard PopulationGroup 2 Pregnant Population

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • written informed consent
  • age \>18 years
  • pregnancy (only group 2)

You may not qualify if:

  • limited ability for agreement
  • heavy tremble
  • reduced general condition
  • known epilepsy

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Female Health Hospital Reutlingen

Reutlingen, Baden-Wurttemberg, 72764, Germany

Location

University Eye Hospital

Tübingen, Baden-Wurttemberg, 72076, Germany

Location

MeSH Terms

Conditions

Eye Diseases

Study Officials

  • Martin A Leitritz, M.D.

    University Hospital Tuebingen

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Dr. med. Martin A. Leitritz

Study Record Dates

First Submitted

March 11, 2014

First Posted

March 17, 2014

Study Start

December 1, 2013

Primary Completion

February 1, 2016

Study Completion

February 1, 2016

Last Updated

July 19, 2016

Record last verified: 2016-07

Locations

DE(2)