Outcome After Descemet Membrane Endothelial Keratoplasty (DMEK) and Ultra-thin Descemet Stripping Automated Endothelial Keratoplasty (DSAEK)

December 18, 2013 updated by: Necip Torun, Charite University, Berlin, Germany

Prospective Clinical Study on Postoperative Outcome After Descemet Membrane Endothelial Keratoplasty (DMEK) and Ultra-thin Descemet Stripping Automated Endothelial Keratoplasty (DSAEK)

The purpose of this study is evaluate the outcome after posterior lamellar keratoplasty (DMEK and Ultra-thin DSAEK) for corneal transplantation.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

200

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Germany
      • Berlin, Germany, 13353
        • Recruiting
        • Department of Ophthalmology, Charité - Universitätsmedizin Berlin
        • Contact:
        • Principal Investigator:
          • Anna-Karina Maier, MD
        • Principal Investigator:
          • Necip Torun, MD
        • Sub-Investigator:
          • Johannes Gonnermann, MD
        • Sub-Investigator:
          • Mathias KJ Klamann, MD
        • Sub-Investigator:
          • Tobias Brockmann, MD
        • Sub-Investigator:
          • Enken Gundlach, MD
        • Sub-Investigator:
          • Christian Eulufi, MD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Male or female aged 18 or older
  • Scheduled to undergo endothelial keratoplasty
  • Able to provide written informed consent.

Exclusion Criteria:

  • Age less than 18 years

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Other: Endothelial Keratoplasty
Descemet membrane endothelial keratoplasty DMEK Ultra-thin Descemet stripping automated endothelial keratoplasty Ultra-thin DSAEK
Other: Endothelial Keratoplasty
Other Names:
  • DMEK
  • Descemet Membrane Endothelial Keratoplasty
  • Ultra-thin Descemet stripping automated endothelial keratoplasty
  • Ultra-thin DSAEK

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Visual acuity (change from baseline)
Time Frame: 1, 3, 6, and 12 months and annually
1, 3, 6, and 12 months and annually

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Endothelial cell density (change from baseline)
Time Frame: 1, 3, 6, and 12 months and annually
1, 3, 6, and 12 months and annually
Intraocular pressure (change from baseline)
Time Frame: 1, 3, 6, and 12 months and annually
1, 3, 6, and 12 months and annually
Manifest refraction (change from baseline)
Time Frame: 1, 3, 6, 12 months and annually
1, 3, 6, 12 months and annually
corneal pachymetry (change from baseline)
Time Frame: 1, 3, 6, 12 months and annually
1, 3, 6, 12 months and annually
Quality of Life, NEI-VFQ 25 (change from baseline)
Time Frame: 3, 12 months, annualy
Questionnaire
3, 12 months, annualy
corneal topography (change from baseline)
Time Frame: 1, 3, 6, and 12 months and annually
1, 3, 6, and 12 months and annually
Anterior Segment OCT of cornea and anterior chamber angle (change from baseline)
Time Frame: 1, 3, 6, and 12 months and annually
1, 3, 6, and 12 months and annually
postoperative Medication (change from baseline)
Time Frame: 1,3,6 and 12 months and annually
1,3,6 and 12 months and annually
Histological Sample of Recipient's Descemet Membrane
Time Frame: intraoperative
Recipient's Descemet Membrane
intraoperative

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Charite University, Berlin, Germany

Investigators

  • Study Director: Necip Torun, MD, Department of Ophthalmology, Charité - Unviersitätsmedizin Berlin

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

September 1, 2012

Primary Completion (Anticipated)

December 1, 2015

Study Registration Dates

First Submitted

December 11, 2013

First Submitted That Met QC Criteria

December 18, 2013

First Posted (Estimate)

December 24, 2013

Study Record Updates

Last Update Posted (Estimate)

December 24, 2013

Last Update Submitted That Met QC Criteria

December 18, 2013

Last Verified

December 1, 2013

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • EA2/108/12

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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