Back to resultsComparison of Non-mydriatic Camera Systems in a Female Health Hospital
Primary Purpose
Eye Diseases, Retina; Lesion, Optic Disc Structural Anomaly
Status
Completed
Phase
Not Applicable
Locations
Germany
Study Type
Interventional
Intervention
Retinal imaging
Vessel measurements
Change in vessel diameters
Sponsored by
About this trial
This is an interventional diagnostic trial for Eye Diseases
Eligibility Criteria
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
Sites / Locations
- Female Health Hospital Reutlingen
- University Eye Hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
Other
Other
Arm Label
Group 1 Standard Population
Group 2 Pregnant Population
Arm Description
Retinal Imaging, vessel measurements, vessel changes of a population of a female health hospital
Change in vessel diameter at perinatal visits with retinal imaging (Retinal Imaging, vessel measurements, vessel changes)
Outcomes
Primary Outcome Measures
Image Quality
Visit 1 and Visit 2 (for group 2) Evaluating of image quality for each camera-system
Secondary Outcome Measures
Retinal Pathologies
Visit 1 and Visit 2 (group 2) Which pathologies / diseases can be assessed with the taken images.
Differences Perinatal
Visit 1 and Visit 2 (group 2)
Full Information
NCT ID
NCT02089009
First Posted
March 11, 2014
Last Updated
July 17, 2016
Sponsor
Dr. Martin Leitritz
Collaborators
Optomed
1. Study Identification
Unique Protocol Identification Number
NCT02089009
Brief Title
Comparison of Non-mydriatic Camera Systems in a Female Health Hospital
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
Study Type
Interventional
2. Study Status
Record Verification Date
July 2016
Overall Recruitment Status
Completed
Study Start Date
December 2013 (undefined)
Primary Completion Date
February 2016 (Actual)
Study Completion Date
February 2016 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Dr. Martin Leitritz
Collaborators
Optomed
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
To compare quality and usability of images taken by two different camera-systems without dilating the pupil.
To compare the retinal vessel diameters based on the images of to different camera-systems.
To detect changes in retinal vessel diameters while pregnancy and after delivery.
Detailed Description
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.
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?
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)
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Eye Diseases, Retina; Lesion, Optic Disc Structural Anomaly
7. Study Design
Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
214 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Group 1 Standard Population
Arm Type
Other
Arm Description
Retinal Imaging, vessel measurements, vessel changes of a population of a female health hospital
Arm Title
Group 2 Pregnant Population
Arm Type
Other
Arm Description
Change in vessel diameter at perinatal visits with retinal imaging (Retinal Imaging, vessel measurements, vessel changes)
Intervention Type
Other
Intervention Name(s)
Retinal imaging
Intervention Description
Retinal imaging by using non-mydriatic camera devices
Intervention Type
Other
Intervention Name(s)
Vessel measurements
Intervention Description
Vessel measurements based on the taken images by the use of a specialized software
Intervention Type
Other
Intervention Name(s)
Change in vessel diameters
Intervention Description
Change of vessel diameters before and after delivery based on the taken images by the use of a specialized software
Primary Outcome Measure Information:
Title
Image Quality
Description
Visit 1 and Visit 2 (for group 2) Evaluating of image quality for each camera-system
Time Frame
12 to 16 month
Secondary Outcome Measure Information:
Title
Retinal Pathologies
Description
Visit 1 and Visit 2 (group 2) Which pathologies / diseases can be assessed with the taken images.
Time Frame
12 to 16 month
Title
Differences Perinatal
Description
Visit 1 and Visit 2 (group 2)
Time Frame
12 to 16 month
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Martin A Leitritz, M.D.
Organizational Affiliation
University Hospital Tuebingen
Official's Role
Principal Investigator
Facility Information:
Facility Name
Female Health Hospital Reutlingen
City
Reutlingen
State/Province
BW
ZIP/Postal Code
72764
Country
Germany
Facility Name
University Eye Hospital
City
Tuebingen
State/Province
BW
ZIP/Postal Code
72076
Country
Germany
12. IPD Sharing Statement
Learn more about this trial
Comparison of Non-mydriatic Camera Systems in a Female Health Hospital
We'll reach out to this number within 24 hrs