Eye DiseasesNCT02089009
Comparison of Non-mydriatic Camera Systems in a Female Health Hospital
A study testing Retinal imaging, Vessel measurements and Change in vessel diameters in people with Eye Diseases and Retina; Lesion, run by Dr. Martin Leitritz at 2 sites in Germany.
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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Eye Diseases, Retina; Lesion, Optic Disc Structural Anomaly
- What is being tested?
- Retinal imaging, Vessel measurements and Change in vessel diameters
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 214 participants
- Where
- 2 sitesGermany
- Study dates
- Dec 2013to Feb 2016
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- written informed consent
- age >18 years
- pregnancy (only group 2)
Who cannot join
- limited ability for agreement
- heavy tremble
- reduced general condition
- known epilepsy
Trial locations and contacts
2 sites in 1 country.
Germany2 sites
Female Health Hospital Reutlingen
Reutlingen, Baden-Wurttemberg, 72764
University Eye Hospital
Tübingen, Baden-Wurttemberg, 72076
About this study
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
- 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.
Read the 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)
- Conditions
- Eye Diseases, Retina; Lesion, Optic Disc Structural Anomaly
- Being tested
- Retinal imaging, Vessel measurements, Change in vessel diameters
- Medical subject headings
- Eye Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Retinal imagingOther
Retinal imaging by using non-mydriatic camera devices
Vessel measurementsOther
Vessel measurements based on the taken images by the use of a specialized software
Change in vessel diametersOther
Change of vessel diameters before and after delivery based on the taken images by the use of a specialized software
| Study group | Role | What they receive |
|---|---|---|
| Group 1 Standard Population | Other | Retinal Imaging, vessel measurements, vessel changes of a population of a female health hospital Receives: Other: Retinal imaging; Other: Vessel measurements; Other: 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) Receives: Other: Retinal imaging; Other: Vessel measurements; Other: Change in vessel diameters |
What is being measured
The primary outcome is the main question the study is designed to answer.
Image Quality
Visit 1 and Visit 2 (for group 2) Evaluating of image quality for each camera-system
Measured: 12 to 16 month
Secondary outcomes (2)
Retinal Pathologies
Visit 1 and Visit 2 (group 2) Which pathologies / diseases can be assessed with the taken images.
Measured: 12 to 16 month
Differences Perinatal
Visit 1 and Visit 2 (group 2)
Measured: 12 to 16 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Mar 2014 (estimated)
- Study startDec 2013
- Primary completionFeb 2016
- Study completionFeb 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Eye DiseasesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 214 participants (actual)
Sponsor and investigators
- Lead sponsor
- Dr. Martin Leitritz
- Sponsor type
- University, hospital or other
- Collaborators
- Optomed
- Responsible party
- Sponsor-investigator, Dr. Martin Leitritz, University Hospital Tuebingen
- Investigators
- Martin A Leitritz, M.D., Principal investigator, University Hospital Tuebingen
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02089009
- Sponsor's protocol ID
- NonMydGyn
- Status last verified
- Jul 2016
- First submitted
- 11 Mar 2014
- Last updated
- 19 Jul 2016
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Jul 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT02089009
- Acronym / sponsor ID
- NonMydGyn
- Conditions
- Eye Diseases, Retina; Lesion, Optic Disc Structural Anomaly
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 214 participants (actual)
- Lead sponsor
- Dr. Martin LeitritzUniversity, hospital or other
- Collaborators
- Optomed
- Study start
- Dec 2013
- Primary completion
- Feb 2016 (actual)
- Study completion
- Feb 2016 (actual)
- First posted
- 17 Mar 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
- 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)
Study design
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group 1 Standard Population | Other | Other: Retinal imaging, Other: Vessel measurements, Other: Change in vessel diametersRetinal Imaging, vessel measurements, vessel changes of a population of a female health hospital |
| Group 2 Pregnant Population | Other | Other: Retinal imaging, Other: Vessel measurements, Other: Change in vessel diametersChange in vessel diameter at perinatal visits with retinal imaging (Retinal Imaging, vessel measurements, vessel changes) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- written informed consent
- age >18 years
- pregnancy (only group 2)
Key exclusion criteria (4 listed)
- limited ability for agreement
- heavy tremble
- reduced general condition
- known epilepsy
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Retinal imagingRetinal imaging by using non-mydriatic camera devices | Other | Group 1 Standard Population, Group 2 Pregnant Population |
| Vessel measurementsVessel measurements based on the taken images by the use of a specialized software | Other | Group 1 Standard Population, Group 2 Pregnant Population |
| Change in vessel diametersChange of vessel diameters before and after delivery based on the taken images by the use of a specialized software | Other | Group 1 Standard Population, Group 2 Pregnant Population |
Primary outcome
Image Quality
Time frame: 12 to 16 month
Visit 1 and Visit 2 (for group 2) Evaluating of image quality for each camera-system
2 secondary outcomes
Retinal Pathologies
Time frame: 12 to 16 month
Differences Perinatal
Time frame: 12 to 16 month
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Jul 2016.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Martin A Leitritz, M.D. principal investigator
University Hospital Tuebingen
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Retinal imaging, Vessel measurements and Change in vessel diameters in people with Eye Diseases and Retina; Lesion, run by Dr. Martin Leitritz at 2 sites in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 19 Jul 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Image Quality (time frame: 12 to 16 month). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Jul 2016.