Trial document





This trial has been registered retrospectively.
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  DRKS00009627

Trial Description

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Title

Evaluation of the Glycerin-eye-bath as a predicitve marker for the success after Descemetmembrane endothelial keratoplasty (DMEK)

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Trial Acronym

[---]*

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URL of the Trial

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Brief Summary in Lay Language

A Descement membrane endothelial keratoplasty (DMEK) is a method to replace the dysfunctional innermost layer of the cornea. In case of a dysfunctional innermost layer corneal hydration will be disturbed eventually leading to water retentions, meaning a thicker cornea, and corneal scars. With a Descement membrane endothelial keratoplasty it is possible to generate a long-term decrease in corneal thickness along with an increase in visual acuity. Glycerin containing eyedrops applicated before DMEK show a deswelling effect and therefore can be used to reduce corneal thickness for a short term. In order to find out how corneal thickness, visual acuity and endothelial cell density changes, corresponding examinations were performed before and after the application of glycerin containing eyedrops as well as six weeks after DMEK. The purpose of collecting and analysing all data is finding out how the application of glycerin containing eyedrops before DMEK can predict and be used as a prognostic parameter concerning the outcome of DMEK surgery.

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Brief Summary in Scientific Language

A Descement membrane endothelial keratoplasty (DMEK) is a method to replace the dysfunctional corneal endothelium. In case of endothelial damage corneal hydration will be disturbed eventually leading to corneal stromal edema, an increase in pachymetry, and stromal scars. With a Descement membrane endothelial keratoplasty it is possible to generate a long-term decrease in pachytmetry along with an increase in visual acuity. Glycerin containing eyedrops applicated before DMEK show a deswelling effect and therefore can be used to reduce corneal pachymetry for a short term. In order to find out how pachymetry, visual acuity and endothelial cell density changes, corresponding examinations were performed before and after the application of glycerin containing eyedrops as well as six weeks after DMEK. The purpose of collecting and analysing all data is finding out how the application of glycerin containing eyedrops before DMEK can predict and be used as a prognostic Parameter concerning the outcome of DMEK surgery.

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Organizational Data

  •   DRKS00009627
  •   2015/11/24
  •   [---]*
  •   no
  •   Approved
  •   4908R, Ethik-Kommission an der Medizinischen Fakultät der Heinrich-Heine-Universität Düsseldorf
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Secondary IDs

  •   U1111-1176-7846 
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Health Condition or Problem studied

  •   H18.5 -  Hereditary corneal dystrophies
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Interventions/Observational Groups

  •   - visual acuity, measured by autorefraction and best corrected subjective visual acuity
    - pachymetry measured by Pentacam (Oculus, Wetzlar, Germany)
    - endothelial cell density (Topcon, Hamburg, Germany)
    All parameters are evaluated preoperatively and six weeks / six months postoperatively in a standardized manner for each DMEK-patient.
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Characteristics

  •   Non-interventional
  •   Observational study
  •   Single arm study
  •   Open (masking not used)
  •   [---]*
  •   Uncontrolled/Single arm
  •   Prognosis
  •   Single (group)
  •   N/A
  •   N/A
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Primary Outcome

- visual acuity, measured by autorefraction and best corrected subjective visual acuity
- pachymetry measured by Pentacam (Oculus, Wetzlar, Germany)
Both parameters are evaluated preoperatively and six weeks / six months postoperatively.

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Secondary Outcome

endothelial cell density (Topcon, Hamburg, Germany) measured preoperatively and 6 weeks / six months postoperatively.

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Countries of Recruitment

  •   Germany
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Locations of Recruitment

  • Medical Center 
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Recruitment

  •   Actual
  •   2015/04/01
  •   50
  •   Monocenter trial
  •   National
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Inclusion Criteria

  •   Both, male and female
  •   18   Years
  •   100   Years
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Additional Inclusion Criteria

The patients are able and willing to participate in the investigations required for the study.

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Exclusion Criteria

Any physical disabilities which enable the patients to participate in the investigations.

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Addresses

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    • Augenklnik Universität Düsseldorf
    • Mr.  Prof. Dr. med.  Gerd  Geerling 
    • Moorenstraße 5
    • 40225  Düsseldorf
    • Germany
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    • Universitätsaugenklinik Düsseldorf
    • Ms.  Dr. med.  Kristina  Spaniol 
    • Moorenstraße 5
    • 40225  Düsseldorf
    • Germany
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    • Universitätsaugenklinik Düsseldorf
    • Ms.  Dr. med.  Kristina  Spaniol 
    • Moorenstraße 5
    • 40225  Düsseldorf
    • Germany
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Sources of Monetary or Material Support

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Status

  •   Recruiting ongoing
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Trial Publications, Results and other Documents

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* This entry means the parameter is not applicable or has not been set.