Trial document




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  DRKS00009958

Trial Description

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Title

Prospective study for investigation the development of glaucoma in patients with ventriculo-peritoneal shunt for lowering the intracranial pressure

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Trial Acronym

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URL of the Trial

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Brief Summary in Lay Language

In this prospective study we will examine about 50-100 patients with an age above 40 years old. The examination will take about 2 years and the follow-up about 3 years. The examination contain the morphology of the optic nerve head before the implantation of the shunt and yearly. If a progression will be suspected, there will be an extra 6-month follow up. There will be several examination taken (visual field, intraocular pressure measurement, coherent-based techniques for acquiring information of the damages of the optic nerve head). All these examination are certificated and licensed. These are all non-invasive examinations.

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Brief Summary in Scientific Language

The goal of this study is to evaluate if the implantation of an ventricle-peritoneal shunt for lowering the intracranial pressure can cause the development of glaucoma changes in patient with specific constellation (age/eye pressure/general diseases/blood parameters )

In this prospective study we will examine about 50-100 patients with an age above 40 years old. The examination will take about 2 years and the follow-up about 3 years. The examination contain the morphology of the optic nerve head before the implantation of the shunt and yearly. If a progression will be suspected, there will be an extra 6-month follow up. There will be several examination taken (visual field, intraocular pressure measurement, coherent-based techniques for acquiring information of the damages of the optic nerve head). All these examination are certificated and licensed. These are all non-invasive examinations.

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Forwarding of patient-related data:

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Description IPD sharing plan:

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Organizational Data

  •   DRKS00009958
  •   2016/02/11
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  •   yes
  •   Approved
  •   15-448, Ethik-Kommission der Medizinischen Fakultät der Universität zu Köln
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Secondary IDs

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Health Condition or Problem studied

  •   H40 -  Glaucoma
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Interventions/Observational Groups

  •   In this prospective study we will examine about 50-100 patients with an age above 40 years old. The examination will take about 2 years and the follow-up about 3 years. The examination contain the morphology of the optic nerve head before the implantation of the shunt and yearly. If a progression will be suspected, there will be an extra 6-month follow up. There will be several examination taken (visual field, intraocular pressure measurement, coherent-based techniques for acquiring information of the damages of the optic nerve head) one week before implantation, one week after implantation and yearly. If there is progression to be seen, a extra half-yearly examination will be performed. All these examination are certificated and licensed. These are all non-invasive examinations.

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Characteristics

  •   Non-interventional
  •   Other
  •   Single arm study
  •   Open (masking not used)
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  •   Uncontrolled/Single arm
  •   Diagnostic
  •   Single (group)
  •   N/A
  •   N/A
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Primary Outcome

There is no classic primary outcome

Methods: perimetric data: MD (mean deviation PSD (pattern standard deviation) viele field, intraocular pressure (in mmHg), optic nerve cup (fundocopic view), coherent-based examinations (HRT-Heidelberg Retina Tomograph), optic nerve-OCT ocular coherent tomography

Tho goal of the study is to examine and detect potential damages of the optic nerve after shunt-operation.

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Secondary Outcome

There is no classic secondary outcome

Tho goal of the study is to examine and detect potential damages of the optic nerve after shunt-operation.

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Countries of Recruitment

  •   Germany
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Locations of Recruitment

  • University Medical Center 
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Recruitment

  •   Actual
  •   2016/06/21
  •   100
  •   Monocenter trial
  •   National
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Inclusion Criteria

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

ventriculo-peritoneal shunt

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Exclusion Criteria

younger than 40 years, no ventriculo-peritoneal shunt

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Addresses

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    • Zentrum für Augenheilkunde, Universitätsklinikum Köln
    • Mr.  Prof.  Claus  Cursiefen 
    • Kerpener Str 62
    • 50934  Köln
    • Germany
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    • Zentrum für Augenheilkunde, Universitätsklinikum Köln
    • Mr.  Prof.  Thomas  Dietlein 
    • Kerpener Str 62
    • 50934  Köln
    • Germany
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    • Zentrum für Augenheilkunde, Universitätsklinikum Köln
    • Ms.  Dr. med.  Silvia  Schrittenlocher 
    • Kerpener Str 62
    • 50934  Köln
    • Germany
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Sources of Monetary or Material Support

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    • Zentrum für Augenheilkunde, Universitätsklinikum Köln
    • Kerpener Str 62
    • 50924  Köln
    • Germany
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Status

  •   Recruiting ongoing
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Trial Publications, Results and other Documents

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