Trial document




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  DRKS00007654

Trial Description

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Title

Self-measurement of intraocular pressure and using a rebound tonometer (iCare HOME)

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Trial Acronym

[---]*

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URL of the Trial

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Brief Summary in Lay Language

The iCare HOME rebound tonometer is a newly developed device for self-measurement of intraocular pressure. In contrast to the iCare ONE tonometer, the new iCare HOME tonometer is improved for self-measurement by a fixation ring, automatic determination of the right or left eye.
Glaucoma patients as well as patients without glaucoma will be included in the study.

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Brief Summary in Scientific Language

After measurement of spectacles, best-corrected visual acuity, central corneal thickness and visual field, intraocular pressure (IOP) is measured by iCare PRO rebound tonometer by the doctor. Afterwards IOP is measured by the doctor using one of the two self-tonometers (iCare ONE oder HOME). Randomisation is used to determine the order of the instruments. After measurement of IOP using one of the self-tonometers, IOP is measured by the patients themselves using the iCare ONE and HOME. At least IOP is measured by the doctor using the Goldmann applanation tonometry.

Additionally, during hospitalisation and 24-hour IOP profile in case of 50 patients will measure their IOP using the iCare HOME in addition to the Goldmann applanation tonometry.

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Organizational Data

  •   DRKS00007654
  •   2015/01/05
  •   [---]*
  •   yes
  •   Approved
  •   2014-563-f-S, Ethik-Kommission der Ärztekammer Westfalen-Lippe und der med. Fakultät der Westfälischen Wilhelms-Universität Münster
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Secondary IDs

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Health Condition or Problem studied

  •   H40.1 -  Primary open-angle glaucoma
  •   H40.0 -  Glaucoma suspect
  •   H40.2 -  Primary angle-closure glaucoma
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Interventions/Observational Groups

  •   intraocular pressure measured by iCare HOME tonometry by the doctor (glaucoma & non-glaucoma patients)
  •   intraocular pressure measured by iCare HOME tonometry by the patient (glaucoma & non-glaucoma patients)
  •   intraocular pressure measured by iCare ONE tonometry by the doctor (glaucoma & non-glaucoma patients)
  •   intraocular pressure measured by iCare ONE tonometry by the patient (glaucoma & non-glaucoma patients)
  •   intraocular pressure measured by Goldmann applanation tonometry by the doctor (glaucoma & non-glaucoma patients)
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Characteristics

  •   Interventional
  •   [---]*
  •   Randomized controlled trial
  •   Open (masking not used)
  •   [---]*
  •   Active control
  •   Diagnostic
  •   Other
  •   N/A
  •   N/A
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Primary Outcome

intraocular pressure measured with iCare HOME (doctor and patient), iCare ONE (doctor and patient) and Goldmann applanation tonometry (only doctor). All togther 5 measurements

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Secondary Outcome

patient satisfaction measured by a visual analog scale, using a questionnaire

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Countries of Recruitment

  •   Germany
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Locations of Recruitment

  • University Medical Center 
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Recruitment

  •   Planned
  •   2015/01/07
  •   200
  •   Monocenter trial
  •   National
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Inclusion Criteria

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

group A (glaucoma patients)

glaucoma damage

group B (non-glaucoma patients)

patients in ophthalmologic care without glaucoma

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Exclusion Criteria


group A (glaucoma patients)

corneal blurring
pregnancy
lactation period

group B (non-glaucoma patients)

glaucoma damage
pregnacy
lactation period

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Addresses

  • start of 1:1-Block address primary-sponsor
    • Universitätsklinikum Münster
    • Mr.  Priv.-Doz. Dr. med.  André  Rosentreter 
    • Domagkstr. 15
    • 48149  Münster
    • Germany
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    • Universitätsklinikum Münster
    • Mr.  Priv.-Doz. Dr. med.  André  Rosentreter 
    • Domagkstr. 15
    • 48149  Münster
    • Germany
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    • Universitätsklinikum Münster
    • Mr.  Priv.-Doz. Dr. med.  André  Rosentreter 
    • Domagkstr. 15
    • 48149  Münster
    • Germany
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Sources of Monetary or Material Support

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    • Universitätsklinikum Münster
    • Mr.  Priv.-Doz. Dr. med.  André  Rosentreter 
    • Domagkstr. 15
    • 48149  Münster
    • Germany
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Status

  •   Recruiting planned
  •   [---]*
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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.