Trial document





This trial has been registered retrospectively.
drksid header

  DRKS00020800

Trial Description

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Title

Comparing effectiveness of different surgical techniques for the Treatment of Primary Open Angle Glaucoma

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Trial Acronym

[---]*

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URL of the Trial

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Brief Summary in Lay Language

The Gold Standard in surgical glaucoma Treatment is trabeculectomy. Comparing the effectivity of different new minimal invasive surgical techniques with trabeculectomy is the main Goal of this Research.

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Brief Summary in Scientific Language

For more than 50 years trabeculectomy is the gold Standard in surgical glaucoma Treatment. To compare the effectiveness to lower eye pressure and necessary medication of newer less invasive surgical techniques with trabeculectomy is the main Goal of this study.

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Do you plan to share individual participant data with other researchers?

Yes

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Description IPD sharing plan:

The complied data will be analyzed and published in anonymized form. Used statistical raw patient data will remain saved on computers of the Leipzig University.

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Organizational Data

  •   DRKS00020800
  •   2020/02/25
  •   [---]*
  •   yes
  •   Approved
  •   209-18-ek, Ethikkommission an der Medizinischen Fakultät der Universität Leipzig
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Secondary IDs

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

  •   H40.1 -  Primary open-angle glaucoma
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Interventions/Observational Groups

  •   trabeculectomy
  •   XEN microstent Implantation
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Characteristics

  •   Interventional
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  •   Non-randomized controlled trial
  •   Open (masking not used)
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  •   Active control (effective treament of control group)
  •   Treatment
  •   Parallel
  •   IV
  •   N/A
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Primary Outcome

intraocular pressure, medication

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Secondary Outcome

visual acuity, occuring complications

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Countries of Recruitment

  •   Germany
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Locations of Recruitment

  • University Medical Center 
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Recruitment

  •   Actual
  •   2018/10/01
  •   200
  •   Monocenter trial
  •   National
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Inclusion Criteria

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

Primary open angle glaucoma with necessity for surgical intervention

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Exclusion Criteria

glaucoma different from Primary open angle glaucoma

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Addresses

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    • Klinik und Poliklinik für AugenheilkundeUniversitätsklinikum Leipzig
    • Mr.  Prof. Dr. med.  Peter  Wiedemann 
    • Liebigstrasse 10-14
    • 04103  Leipzig
    • Germany
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    •   0341 97 21650
    •   [---]*
    •   [---]*
    •   [---]*
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    • Klinik und Poliklinik für Augenheilkunde
    • Mr.  Dr.  Jan Darius  Unterlauft 
    • Liebigstrasse 10-14
    • 04103  Leipzig
    • Germany
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    • Klinik und Poliklinik für Augenheilkunde
    • Mr.  Dr.  Jan Darius  Unterlauft 
    • Liebigstrasse 10-14
    • 04103  Leipzig
    • Germany
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Sources of Monetary or Material Support

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    • Universitätsklinikum LeipzigKlinik und Poliklinik für Augenheilkunde
    • Liebigstrasse 10-14
    • 04103  Leipzig
    • Germany
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    •   [---]*
    •   [---]*
    •   [---]*
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Status

  •   Recruiting complete, follow-up continuing
  •   2019/12/31
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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.