Eye Screening in German Secondary Diabetes Care Centers (DiabCheckophta)

May 27, 2016 updated by: University Hospital Tuebingen

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).

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

831

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Germany
    • BW
      • Tuebingen, BW, Germany, 72076
        • University Eye Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

patients with diabetes in secondary care diabetes centers

Description

Inclusion Criteria:

- diabetes

Exclusion Criteria:

  • mental handicap
  • in the case of blindness absence of a caregiver

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
DiabCheck ophta OCTplus
persons with diabetes undergoing OCT examination
Device: OCT examination

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
presence of diabetic retinopathy
Time Frame: day
day

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University Hospital Tuebingen

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2014

Primary Completion (Actual)

June 1, 2015

Study Completion (Actual)

September 1, 2015

Study Registration Dates

First Submitted

December 4, 2014

First Submitted That Met QC Criteria

December 4, 2014

First Posted (Estimate)

December 8, 2014

Study Record Updates

Last Update Posted (Estimate)

May 30, 2016

Last Update Submitted That Met QC Criteria

May 27, 2016

Last Verified

May 1, 2016

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • DCophtaOCTplus14_C

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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