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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT02311504
Other study ID # DCophtaOCTplus14_C
Secondary ID
Status Completed
Phase N/A
First received December 4, 2014
Last updated May 27, 2016
Start date January 2014
Est. completion date September 2015

Study information

Verified date May 2016
Source University Hospital Tuebingen
Contact n/a
Is FDA regulated No
Health authority Germany: Federal Ministry of Education and Research
Study type Observational

Clinical 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. 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).


Recruitment information / eligibility

Status Completed
Enrollment 831
Est. completion date September 2015
Est. primary completion date June 2015
Accepts healthy volunteers No
Gender Both
Age group 18 Years and older
Eligibility Inclusion Criteria:

- diabetes

Exclusion Criteria:

- mental handicap

- in the case of blindness absence of a caregiver

Study Design

Observational Model: Cohort, Time Perspective: Prospective


Related Conditions & MeSH terms


Intervention

Device:
OCT examination


Locations

Country Name City State
Germany University Eye Hospital Tuebingen BW

Sponsors (1)

Lead Sponsor Collaborator
University Hospital Tuebingen

Country where clinical trial is conducted

Germany, 

Outcome

Type Measure Description Time frame Safety issue
Primary presence of diabetic retinopathy day No
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