Trial document





This trial has been registered retrospectively.
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  DRKS00013212

Trial Description

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Title

DMEK Replacement of Peribulbar Anaesthesia (DROP) Trial: a controlled, observerblinded, non-inferiority trial

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Trial Acronym

DROP (Dmek Replacement Of Peribulbar anaesthesia )

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URL of the Trial

[---]*

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Brief Summary in Lay Language


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Brief Summary in Scientific Language

From cataract surgery it is known that peribulbar anaesthesia (PBA) and topical anaesthesia (TA) can achieve similar levels of pain control during surgery. We are assuming that TA can also be used in DMEK surgery, without increase in pain sensation or complications. Our Primary outcome is the mean intraoperative pain sensatoin measured by a blinded observed using a visual analogue scale (VAS). We will assume non-inferioty if the mean pain sensation in the TA group is on average not higher than 1 Point on the VAS campared to the PBA group. We are recruiting patients with a planned DMEK surgery and will compare those who receive the surgery due to medical reasons in TA to those receiving the surgery in PBA. We will analyse our primary outcome as the difference in mean VAS scores with 95% confidence interval (95% CI). Non-inferiority will be assumed if the upper limit of the 95% CI excludes one (the non-inferiority limit).

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Organizational Data

  •   DRKS00013212
  •   2017/12/18
  •   [---]*
  •   yes
  •   Approved
  •   EA4/167/16, Ethik-Kommission der Charité -Universitätsmedizin Berlin-
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Secondary IDs

  • [---]*
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Health Condition or Problem studied

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

  •   30 DMEK (Descemet Membrane Endothelial Keratoplasty) patients in topical anaesthesia (Oxybuprocain 0,4% Drops and Lidocainhydrochlorid-gel 2%)
  •   30 DMEK patients in peribulbar anesthesia (6ml Prilocainhdydrochlorid 2%)
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Characteristics

  •   Interventional
  •   [---]*
  •   Non-randomized controlled trial
  •   Blinded
  •   investigator/therapist, assessor
  •   Active control (effective treament of control group)
  •   Other
  •   Parallel
  •   N/A
  •   N/A
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Primary Outcome

Pain sensation during surgery measured on a visual analogue scale

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Secondary Outcome

Pain sensation during anaesthesia, duration of surgery, intra and post-surgical complications, endothelial density, visual acuity, transplant rejection rate

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Countries of Recruitment

  •   Germany
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Locations of Recruitment

  • University Medical Center 
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Recruitment

  •   Actual
  •   2017/10/17
  •   60
  •   Monocenter trial
  •   National
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Inclusion Criteria

  •   Both, male and female
  •   18   Years
  •   no maximum age
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Additional Inclusion Criteria

Patients requiring a DMEK surgery who are willing to participate in the study.

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Exclusion Criteria

- Physical or mental conditions which would impair a regular follow up visit
- excessive fear of surgical pain
- ocular conditions interfering with the surgery such as aphakia, anterior chamber IOL, defects due to trauma, corneal scars or post pars plana vitrectomy

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Addresses

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    • Charité Campus Virchow-Klinikum
    • Augustenburger Platz 1
    • 13353  Berlin
    • Germany
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    • Charité Campus Virchow-Klinikum, Klinik für Augenheilkunde
    • Mr.  Dr. med.  Daniel  Pilger 
    • Augustenburger Platz 1
    • 13353  Berlin
    • Germany
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    • Charité Campus Virchow-Klinikum
    • Mr.  Dr. med.  Daniel  Pilger 
    • Augustenburger Platz 1
    • 13353  Berlin
    • Germany
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Sources of Monetary or Material Support

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    • Charité Campus Virchow-Klinikum
    • Augustenburger Platz 1
    • 13353  Berlin
    • Germany
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Status

  •   Recruiting complete, follow-up complete
  •   2019/04/01
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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.