NCT02311504

Brief 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).

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
831

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jan 2014

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2014

Completed
11 months until next milestone

First Submitted

Initial submission to the registry

December 4, 2014

Completed
4 days until next milestone

First Posted

Study publicly available on registry

December 8, 2014

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2015

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2015

Completed
Last Updated

May 30, 2016

Status Verified

May 1, 2016

Enrollment Period

1.4 years

First QC Date

December 4, 2014

Last Update Submit

May 27, 2016

Conditions

Diabetic Retinopathy

Outcome Measures

Primary Outcomes (1)

  • presence of diabetic retinopathy

    day

Study Arms (1)

DiabCheck ophta OCTplus

persons with diabetes undergoing OCT examination

Device: OCT examination

Interventions

OCT examinationDEVICE
DiabCheck ophta OCTplus

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

patients with diabetes in secondary care diabetes centers

You may qualify if:

  • \- diabetes

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University Eye Hospital

Tübingen, Baden-Wurttemberg, 72076, Germany

Location

Related Publications (1)

  • 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.

    PMID: 27701169DERIVED

MeSH Terms

Conditions

Diabetic Retinopathy

Condition Hierarchy (Ancestors)

Retinal DiseasesEye DiseasesDiabetic AngiopathiesVascular DiseasesCardiovascular DiseasesDiabetes ComplicationsDiabetes MellitusEndocrine System Diseases

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 4, 2014

First Posted

December 8, 2014

Study Start

January 1, 2014

Primary Completion

June 1, 2015

Study Completion

September 1, 2015

Last Updated

May 30, 2016

Record last verified: 2016-05

Locations

DE(1)