NCT03381794

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. The Section Cornea of the German Ophthalmological Society provides interim-assessments on a regular basis about the most up-to-date results of this long-term study.

Trial Health

77
On Track

Trial Health Score

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

Enrollment
100,000

participants targeted

Target at P75+ for all trials

Timeline
117mo left

Started Jan 2001

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
recruiting

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 Progress72%
Jan 2001Jan 2036

Study Start

First participant enrolled

January 1, 2001

Completed
17 years until next milestone

First Submitted

Initial submission to the registry

December 11, 2017

Completed
11 days until next milestone

First Posted

Study publicly available on registry

December 22, 2017

Completed
18 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2036

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2036

Last Updated

April 27, 2026

Status Verified

April 1, 2026

Enrollment Period

35 years

First QC Date

December 11, 2017

Last Update Submit

April 22, 2026

Conditions

Corneal Transplantation

Keywords

Keratoplasty Registry, PKP, DSAEK, DMEK, DALK

Outcome Measures

Primary Outcomes (3)

  • An overview about absolute numbers of corneal transplantation in Germany.

    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 and is collected annually since 2001.

    01/01/2001 to 31/12/2031

  • An overview about trends in the various types of corneal transplantation in Germany.

    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 and is collected annually since 2001.

    01/01/2001 to 31/12/2031

  • An overview about indications for corneal transplantation in Germany.

    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 and is collected annually since 2001.

    01/01/2001 to 31/12/2031

Study Arms (1)

Patients with corneal transplantation

Aim is to include all patients in Germany treated with the different types of corneal transplantation.

Procedure: Corneal transplantation

Interventions

Corneal transplantationPROCEDURE

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

Also known as: PKP, DALK, DMEK, DSAEK
Patients with corneal transplantation

Eligibility Criteria

Age1 Year - 100 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

All patients in Germany treated with the different types of corneal transplantation since 2001.

You may qualify if:

  • All patients in Germany treated with the different types of corneal transplantation since 2001.

You may not qualify if:

  • Patients without corneal transplantation.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Department of Ophthalmology

Homburg, Saarland, 66421, Germany

RECRUITING

Related Publications (2)

  • Flockerzi E, Turner C, Seitz B, Collaborators GSG; GeKeR Study Group. Descemet's membrane endothelial keratoplasty is the predominant keratoplasty procedure in Germany since 2016: a report of the DOG-section cornea and its keratoplasty registry. Br J Ophthalmol. 2024 May 21;108(5):646-653. doi: 10.1136/bjo-2022-323162.

    PMID: 37586835RESULT

  • Flockerzi E, Maier P, Bohringer D, Reinshagen H, Kruse F, Cursiefen C, Reinhard T, Geerling G, Torun N, Seitz B; all German Keratoplasty Registry Contributors. Trends in Corneal Transplantation from 2001 to 2016 in Germany: A Report of the DOG-Section Cornea and its Keratoplasty Registry. Am J Ophthalmol. 2018 Apr;188:91-98. doi: 10.1016/j.ajo.2018.01.018. Epub 2018 Feb 2.

    PMID: 29410297RESULT

MeSH Terms

Interventions

Corneal Transplantation

Intervention Hierarchy (Ancestors)

Tissue TransplantationCell- and Tissue-Based TherapyBiological TherapyTherapeuticsRefractive Surgical ProceduresOphthalmologic Surgical ProceduresSurgical Procedures, OperativeTransplantation

Study Officials

  • Berthold Seitz, Prof.Dr.med.

    Universität des Saarlandes

    STUDY DIRECTOR

Central Study Contacts

Elias Flockerzi, PD Dr.med.

CONTACT

0049-6841-16-22302elias.flockerzi@uks.eu

Berthold Seitz, Prof.Dr.med.

CONTACT

0049-6841-16-22387berthold.seitz@uks.eu

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
OTHER
Target Duration
16 Years
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator, Resident of Ophthalmology

Study Record Dates

First Submitted

December 11, 2017

First Posted

December 22, 2017

Study Start

January 1, 2001

Primary Completion (Estimated)

January 1, 2036

Study Completion (Estimated)

January 1, 2036

Last Updated

April 27, 2026

Record last verified: 2026-04

Locations

DE(1)