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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03381794
Other study ID # GKR01-16
Secondary ID
Status Completed
Phase N/A
First received December 11, 2017
Last updated December 18, 2017
Start date January 1, 2001
Est. completion date December 31, 2016

Study information

Verified date December 2017
Source Saarland University
Contact n/a
Is FDA regulated No
Health authority
Study type Observational [Patient Registry]

Clinical Trial Summary

Aim of this study is to reflect on the changing trends in absolute numbers, surgical techniques and indications of corneal transplantations being performed in Germany.

In 2017, the Section Cornea of the German Ophthalmological Society provides an interim-assessment about the most up-to-date results of this long-term study over a period of sixteen years between 2001 and 2016.


Recruitment information / eligibility

Status Completed
Enrollment 78165
Est. completion date December 31, 2016
Est. primary completion date December 31, 2016
Accepts healthy volunteers No
Gender All
Age group 1 Year to 100 Years
Eligibility Inclusion Criteria:

All patients in Germany treated with the different types of corneal transplantation from 2001 to 2016.

Exclusion Criteria:

Patients without corneal transplantation.

Study Design


Related Conditions & MeSH terms


Intervention

Procedure:
Corneal transplantation
PKP: Penetrating Keratoplasty DALK: Deep Anterior Lamellar Keratoplasty DMEK: Descemet Membrane Endothelial Keratoplasty DSAEK: Descemet's Stripping Automated Endothelial Keratoplasty

Locations

Country Name City State
Germany Department of Ophthalmology Homburg Saarland

Sponsors (6)

Lead Sponsor Collaborator
Saarland University Charite University, Berlin, Germany, Heinrich-Heine University, Duesseldorf, University Eye Hospital, Freiburg, University of Cologne, University of Erlangen-Nürnberg

Country where clinical trial is conducted

Germany, 

Outcome

Type Measure Description Time frame Safety issue
Primary An overview about absolute numbers of corneal transplantation in Germany from 2001 to 2016. A questionnaire about absolute numbers of corneal transplantation per year was sent to the 111 ophthalmological departments in Germany performing corneal transplantation. Data has been collected annually over a period of sixteen years in Germany between 2001 and 2016. 01/01/2001 to 31/12/2016
Primary An overview about trends in the various types of corneal transplantation in Germany from 2001 to 2016. The questionnaire also records the types of corneal transplantation (i.e. penetrating keratoplasty, deep anterior lamellar keratoplasty, Descemet membrane endothelial keratoplasty (DMEK) and Descemet's stripping automated endothelial keratoplasty DSAEK) allowing a discussion of trends in corneal transplantation. Data has been collected annually over a period of sixteen years in Germany between 2001 and 2016. 01/01/2001 to 31/12/2016
Primary An overview about indications for corneal transplantation in Germany from 2001 to 2016. The questionnaire also records the indications for corneal transplantation (e.g. Fuchs' endothelial corneal dystrophy, pseudophakic corneal decompensation, repeated keratoplasty after graft failure, keratoconus and corneal scarring). Data has been collected annually over a period of sixteen years in Germany between 2001 and 2016. 01/01/2001 to 31/12/2016
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