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The German Keratoplasty Registry of the German Ophthalmological Society (DOG)

Sponsor
Universität des Saarlandes (Other)
Overall Status
Completed
CT.gov ID
NCT03381794
Collaborator
University Eye Hospital, Freiburg (Other), University of Erlangen-Nürnberg (Other), University of Cologne (Other), Heinrich-Heine University, Duesseldorf (Other), Charite University, Berlin, Germany (Other)
78,165
Enrollment
1
Location
192
Actual Duration (Months)
407.2
Patients Per Site Per Month

Study Details

Study Description

Brief 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.

Condition or Disease Intervention/Treatment Phase
  • Procedure: Corneal transplantation

Study Design

Study Type:
Observational [Patient Registry]
Actual Enrollment :
78165 participants
Observational Model:
Cohort
Time Perspective:
Other
Official Title:
Trends in Corneal Transplantation From 2001 to 2016 in Germany: A Report of the DOG-Section Cornea and Its Keratoplasty Registry
Actual Study Start Date :
Jan 1, 2001
Actual Primary Completion Date :
Dec 31, 2016
Actual Study Completion Date :
Dec 31, 2016

Arms and Interventions

Arm Intervention/Treatment
Patients with corneal transplantation

Aim is to include all patients in Germany treated with the different types of corneal transplantation with an interim-assessment of the period between 2001 and 2016.

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

    		•

    Outcome Measures

    Primary Outcome Measures

    1. An overview about absolute numbers of corneal transplantation in Germany from 2001 to 2016. [01/01/2001 to 31/12/2016]

      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.

    2. An overview about trends in the various types of corneal transplantation in Germany from 2001 to 2016. [01/01/2001 to 31/12/2016]

      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.

    3. An overview about indications for corneal transplantation in Germany from 2001 to 2016. [01/01/2001 to 31/12/2016]

      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.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    1 Year to 100 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:

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

    Exclusion Criteria:

    Patients without corneal transplantation.

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Department of Ophthalmology Homburg Saarland Germany 66421

    Sponsors and Collaborators

    • Universität des Saarlandes
    • University Eye Hospital, Freiburg
    • University of Erlangen-Nürnberg
    • University of Cologne
    • Heinrich-Heine University, Duesseldorf
    • Charite University, Berlin, Germany

    Investigators

    • Study Director: Berthold Seitz, Prof.Dr.med., Universität des Saarlandes

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Elias Flockerzi, Principal Investigator, Resident of Ophthalmology, Universität des Saarlandes
    ClinicalTrials.gov Identifier:
    NCT03381794
    Other Study ID Numbers:
    • GKR01-16
    First Posted:
    Dec 22, 2017
    Last Update Posted:
    Dec 22, 2017
    Last Verified:
    Dec 1, 2017
    Individual Participant Data (IPD) Sharing Statement:
    Undecided
    Plan to Share IPD:
    Undecided
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Keywords provided by Elias Flockerzi, Principal Investigator, Resident of Ophthalmology, Universität des Saarlandes
    Keratoplasty Registry, PKP, DSAEK, DMEK, DALK

    Study Results

    No Results Posted as of Dec 22, 2017