Diabetic RetinopathyDiabCheckophtaNCT02311504
Eye Screening in German Secondary Diabetes Care Centers
An observational study of Diabetic Retinopathy, run by University Hospital Tuebingen at 1 site in Germany.
Trial summary
In patients with confirmed diagnosis of diabetes, an eye examination and a comprehensive survey are conducted after recruitment in secondary diabetes care centers. All patients undergo a comprehensive eye examination including wide-angle fundus photograph and ocular cohaerence tomography. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Diabetic Retinopathy
- What is being tested?
- OCT examination
- Type of treatment
- Medical device
- How many people
- 831 participants
- Where
- 1 siteGermany
- Study dates
- Jan 2014to Sep 2015
- Phase
- Observational
- 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
- No healthy volunteers
- Adult, Older adult
Study population: patients with diabetes in secondary care diabetes centers
Who may be able to join
- diabetes
Who cannot join
- mental handicap
- in the case of blindness absence of a caregiver
Trial locations and contacts
1 site in 1 country.
About this study
Official title: OCT Screening of Diabetes Patients: Health Care Research in Secondary Diabetes Care Centers
In patients with confirmed diagnosis of diabetes, an eye examination and a comprehensive survey are conducted after recruitment in secondary diabetes care centers. All patients undergo a comprehensive eye examination including wide-angle fundus photograph and ocular cohaerence tomography. A questionnaire assesses the characteristics (history: diabetes duration, type of treatment), knowledge and personal attitudes of the persons affected. The relevant lab findings were collected from the electronic files.
Main focus of the study is the concordance to the national screening recommendations (last eye exam, presence of retinopathy).
- Conditions
- Diabetic Retinopathy
- Being tested
- OCT examination
- Medical subject headings
- Diabetic Retinopathy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
OCT examinationDevice
| Study group | Role | What they receive |
|---|---|---|
| DiabCheck ophta OCTplus | persons with diabetes undergoing OCT examination Receives: Device: OCT examination |
What is being measured
The primary outcome is the main question the study is designed to answer.
presence of diabetic retinopathy
Measured: day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Dec 2014 (estimated)
- Study startJan 2014
- Primary completionJun 2015
- Study completionSep 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Diabetic RetinopathyStudies of the same condition, open and under way.
- More trials run by University Hospital TuebingenThe sponsor's other registered studies.
- 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 831 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital Tuebingen
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02311504
- Sponsor's protocol ID
- DCophtaOCTplus14_C
- Acronym
- DiabCheckophta
- Status last verified
- May 2016
- First submitted
- 4 Dec 2014
- Last updated
- 30 May 2016
- Results posted
- No
- Data monitoring committee
- No
Publications
Marahrens L, Ziemssen F, Fritsche A, Ziemssen T, Kern R, Martus P, Roeck D. Limited Time from the Diabetes Patients' Perspective: Need for Conversation with the Eye Specialist. Ophthalmologica. 2016;236(3):154-158. doi: 10.1159/000450708. Epub 2016 Oct 5.
PubMed 27701169
Study at a glance
From the registry record, last updated by the sponsor on 30 May 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- OCT Screening of Diabetes Patients: Health Care Research in Secondary Diabetes Care Centers
- ClinicalTrials.gov ID
- NCT02311504
- Acronym / sponsor ID
- DiabCheckophta / DCophtaOCTplus14_C
- Conditions
- Diabetic Retinopathy
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 831 participants (actual)
- Lead sponsor
- University Hospital TuebingenUniversity, hospital or other
- Study start
- Jan 2014
- Primary completion
- Jun 2015 (actual)
- Study completion
- Sep 2015 (actual)
- First posted
- 8 Dec 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.
In patients with confirmed diagnosis of diabetes, an eye examination and a comprehensive survey are conducted after recruitment in secondary diabetes care centers. All patients undergo a comprehensive eye examination including wide-angle fundus photograph and ocular cohaerence tomography. A questionnaire assesses the characteristics (history: diabetes duration, type of treatment), knowledge and personal attitudes of the persons affected. The relevant lab findings were collected from the electronic files.
Main focus of the study is the concordance to the national screening recommendations (last eye exam, presence of retinopathy).
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| DiabCheck ophta OCTplus | – | Device: OCT examinationpersons with diabetes undergoing OCT examination |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- patients with diabetes in secondary care diabetes centers
Key inclusion criteria (1 listed)
- diabetes
Key exclusion criteria (2 listed)
- mental handicap
- in the case of blindness absence of a caregiver
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 |
|---|---|---|
| OCT examination | Device | DiabCheck ophta OCTplus |
Primary outcome
presence of diabetic retinopathy
Time frame: day
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 30 May 2016.
- Derived from this study: PubMed 27701169Marahrens L, Ziemssen F, Fritsche A, Ziemssen T, Kern R, Martus P, Roeck D. Limited Time from the Diabetes Patients' Perspective: Need for Conversation with the Eye Specialist. Ophthalmologica. 2016;236(3):154-158. doi: 10.1159/000450708. Epub 2016 Oct 5.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Diabetic Retinopathy, run by University Hospital Tuebingen at 1 site 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 1 inclusion and 2 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 30 May 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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?
presence of diabetic retinopathy (time frame: day). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02311504, which also lists 1 linked publication.
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 30 May 2016.