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

Sponsor
Charite University, Berlin, Germany (Other)
Overall Status
Unknown status
CT.gov ID
NCT02020044
Collaborator
(none)
200
Enrollment
1
Location
1
Arm

Study Details

Study Description

Brief Summary

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

Condition or Disease Intervention/Treatment Phase
  • Other: Endothelial Keratoplasty
 N/A

Study Design

Study Type:
Interventional
Anticipated Enrollment :
200 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
Prospective Clinical Study on Postoperative Outcome After Descemet Membrane Endothelial Keratoplasty (DMEK) and Ultra-thin Descemet Stripping Automated Endothelial Keratoplasty (DSAEK)
Study Start Date :
Sep 1, 2012
Anticipated Primary Completion Date :
Dec 1, 2015

Arms and Interventions

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

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Visual acuity (change from baseline) [1, 3, 6, and 12 months and annually]

    Secondary Outcome Measures

    1. Endothelial cell density (change from baseline) [1, 3, 6, and 12 months and annually]

    2. Intraocular pressure (change from baseline) [1, 3, 6, and 12 months and annually]

    3. Manifest refraction (change from baseline) [1, 3, 6, 12 months and annually]

    4. corneal pachymetry (change from baseline) [1, 3, 6, 12 months and annually]

    5. Quality of Life, NEI-VFQ 25 (change from baseline) [3, 12 months, annualy]

      Questionnaire

    6. corneal topography (change from baseline) [1, 3, 6, and 12 months and annually]

    7. Anterior Segment OCT of cornea and anterior chamber angle (change from baseline) [1, 3, 6, and 12 months and annually]

    8. postoperative Medication (change from baseline) [1,3,6 and 12 months and annually]

    9. Histological Sample of Recipient's Descemet Membrane [intraoperative]

      Recipient's Descemet Membrane

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Department of Ophthalmology, Charité - Universitätsmedizin Berlin Berlin Germany 13353

    Sponsors and Collaborators

    • Charite University, Berlin, Germany

    Investigators

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

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    Responsible Party:
    Necip Torun, Necip, Torun, MD, Charite University, Berlin, Germany
    ClinicalTrials.gov Identifier:
    NCT02020044
    Other Study ID Numbers:
    • EA2/108/12
    First Posted:
    Dec 24, 2013
    Last Update Posted:
    Dec 24, 2013
    Last Verified:
    Dec 1, 2013
    Additional relevant MeSH terms:
    Corneal Dystrophies, Hereditary
    Fuchs' Endothelial Dystrophy
    Iridocorneal Endothelial Syndrome

    Study Results

    No Results Posted as of Dec 24, 2013