Eye Screening in German Secondary Diabetes Care Centers | NCT02311504

Studies
Eye Screening in German Secondary Diabetes Care Centers

NCT02311504

Sponsor

University Hospital Tuebingen

Status

Completed

Last Update Posted

May 30, 2016Estimated

Enrollment

831Actual

Phase

Not provided

Conditions

Diabetic Retinopathy

Interventions

OCT examination

Countries

Germany

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

May 2016

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jan 2014

Primary Completion Date

Jun 2015Actual

Completion Date

Sep 2015Actual

First Submitted Date

Dec 4, 2014

First Submission Date that Met QC Criteria

Dec 4, 2014

First Posted Date

Dec 8, 2014Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

May 27, 2016

Last Update Posted Date

May 30, 2016Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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).

Detailed Description

Not provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

831Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
DiabCheck ophta OCTplus		persons with diabetes undergoing OCT examination	Device: OCT examination

Interventions

Name	Type	Description	Arm Group Labels	Other Names
OCT examination	Device		DiabCheck ophta OCTplus

Measure	Description	Time Frame
presence of diabetic retinopathy		day

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

- diabetes

Exclusion Criteria:

mental handicap
in the case of blindness absence of a caregiver

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

patients with diabetes in secondary care diabetes centers

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
University Eye Hospital		Tübingen	Baden-Wurttemberg	72076	Germany

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
27701169	Derived	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.

ID	Term
D012164	Retinal Diseases
D005128	Eye Diseases
D003925	Diabetic Angiopathies
D014652	Vascular Diseases