Trial document





This trial has been registered retrospectively.
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  DRKS00005778

Trial Description

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Title

Optic coherence tomography, scanning laser polarimetry and topography in retinal nerve fiber layer measurements of glaucoma patients

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Trial Acronym

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URL of the Trial

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Brief Summary in Lay Language

In recent years, more and more non-invasive and non-interventional imaging techniques have become established in the diagnosis of glaucoma. These include optical coherence tomography (eg Zeiss Cirrus HD-OCT, Topcon SD-OCT 2000) , scanning laser polarimetry (Zeiss GDx) and topography (Heidelberg Engineering HRT). Since all of these devices are approved for the measurement of nerve fibers in glaucoma (CE norm) and have become indispensable for glaucoma diagnostics in clinical practice, due to their high costs most practices have only one device, which is often shared with other practices (eg eye diagnostic centers). Larger centers such as University hospitals often have at least 1 or 2 of these modern high-tech devices.
Since glaucoma is a chronic disease that runs over many years and in the course of his life the patient occasionally changes his adress, his doctor and/or the sporadically attendant clinical center or the appropriate practice/clinic occasionally procures a new device. Therefore, we conducted a study with all these non-invasive diagnostic devices in a large, statistically sufficient number of patients (114 eyes of 114 glaucoma patients). The results were statistically analyzed in order to enable doctors and patients for the first time a comparison between the different techniques which is needed in every day clinical practice.

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Brief Summary in Scientific Language

The aim of this study is to determine the correlations and relationships between different imaging systems in analyzing the retinal nerve fiber layer (RNFL) of glaucoma patients: optic coherence tomography (OCT), scanning laser polarimetry (SLP) and topography (SLT). Materials.114 eyes with advanced open angle glaucoma underwent spectral domain OCT, SLP and SLT. The functional relationship between the measured RNFL thickness of the four regions (superior, inferior, nasal, temporal) were evaluated with linear, logarithmic and hyperbolic regression models for the different imaging systems. The highest correlation of the measured RNFL was found between the devices GDx VCC and GDx Pro as well as between Topcon OCT and Cirrus OCT. Our data revealed also a high correlation between the GDx devices (especially GDx Pro) and the OCT devices. In glaucoma patients, high functional relationships were found between RNFL measurements of the two optic coherence tomography devices Topcon OCT 2000 and Cirrus OCT (R² = 0,494) and especially between GDx VCC and Gdx Pro (R² = 0,594). Conclusions. The measurements of the retinal nerve fiber layer in glaucoma patients reveal a high correlation of OCT and GDx devices because OCTs can measure all major retinal layers and SLP can detect nerve fibers. SLT by means of HRT topography, however, can only measure hight values of the retinal surface but it cannot distinguish between different retinal layers. These correlations are important in clinical routine especially when different techniques are used in the follow-up of glaucoma patients.

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Organizational Data

  •   DRKS00005778
  •   2014/03/19
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  •   yes
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Secondary IDs

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

  •   glaucoma
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Interventions/Observational Groups

  •   Glaucoma patients are examined with various, for this purpose approved, non-invasive, and non-interventional imaging devices, optical coherence tomography (Topcon SD-OCT 2000, Zeiss Cirrus HD-OCT), scanning laser polarimetry (Zeiss GDx VCC, Zeiss GDx Pro) and Heidelberg retina topography (HRT III). Results are compared in an anonymous form.
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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

Comparison of retinal nerve fiber layer thickness measurements (temporal - superior - nasal and inferior) with 5 different devices basing on 3 physical different non-invasive imaging techniques

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Secondary Outcome

[---]*

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Countries of Recruitment

  •   Germany
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Locations of Recruitment

  • Medical Center 
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Recruitment

  •   Actual
  •   2011/02/16
  •   114
  •   Monocenter trial
  •   National
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Inclusion Criteria

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

Glaucoma patients with glaucomatous excavation of the optic disc and glaucomatous visual field defects

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Exclusion Criteria

Infectious diseases, trauma, tumors, eye surgery (besides uncomplicated cataract surgery), high ametropia

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Addresses

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    • Augenklinik, Evangelisches Krankenhaus Gelsenkirchen,
    • Mr.  PD Dr.   Stephan   Kremmer,  
    • Munckelstr. 27,
    • 45879   Gelsenkirchen
    • Germany
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    • Department of Ophthalmology, University of Duisburg-Essen,
    • Hufelandstr. 55,
    • 45122  Essen,
    • Germany
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    • Augenklinik, Evangelisches Krankenhaus Gelsenkirchen,
    • Mr.  PD Dr.  Stephan  Kremmer 
    • Munckelstr. 27
    • 45879  Gelsenkirchen
    • Germany
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    • Augenklinik, Evangelisches Krankenhaus Gelsenkirchen,
    • Mr.  PD Dr.  Stephan  Kremmer,  
    • Munckelstr. 27,
    • 45879  Gelsenkirchen,
    • Germany
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Sources of Monetary or Material Support

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    • Augenklinik, Evangelisches Krankenhaus Gelsenkirchen,
    • Mr.  PD Dr.  Stephan  Kremmer,  
    • Munckelstr. 27,
    • 45879  Gelsenkirchen,
    • Germany
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Status

  •   Recruiting complete, follow-up complete
  •   2012/04/10
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* This entry means the parameter is not applicable or has not been set.