Trial document




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  DRKS00005173

Trial Description

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Title

MHz-OCT

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Trial Acronym

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URL of the Trial

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Brief Summary in Lay Language

The diagnostic device „Megahertz-OCT“ (MHz-OCT) allows high speed imaging based on a novel, fast laser source. The device allows to scan the complete posterior part of the eye (vitreous, retina, choroid) over a large field of view with one single scan. Patients, who require an examination by optical coherence tomography (OCT) based on clinical criteria are elegible to be included in the study. In the study imaging with the novel, fast MHz-OCT is performed in addition to standard OCT imaging.

Goal of the study is to investigate, if fast MHz-OCT imaging offers advantages compared to standard imaging. Analysis of data sets is performed off-line after the imaging session, evaluation of image quality is masked to image source.

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Brief Summary in Scientific Language

Optical coherence tomography (OCT) is a key diagnostic imaging modality in ophthalmology today. However, currently available devices are limited by speed of image acquisition. The current study investigates a novel OCT device, „MHz-OCT“, which has been developed at the Institute for Biomolecular Optics (LMU München) based on a novel laser source. MHz-OCT allows a considerably faster image acquisition compared to conventional OCT devices.

Primary goal of the study is to investigate, if the fast MHz-OCT image set after appropriate software processing provides equal or better information compared to standard OCT. Therefore conventional OCT images are compared with additional MHz-OCT images generated from the full 3D datasets. Analysis of MHz-OCTs and masked grading is performed „off-line“, i.e. after the patient visit.

Ths study is performed monocentric at the Department of Ophthalmology, LMU Muenchen Germany. It is scheduled to include a total of 85 patients in the study. Patients are elegible to be included, for whom a conventional OCT examination of the retina is necessary. In the study in addition to standard OCT an one-time additional non-touch examination is performed by MHz-OCT. Clinical management and follow-up is performed by standard clinical practice and is not altered by the study.

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Organizational Data

  •   DRKS00005173
  •   2013/07/26
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  •   yes
  •   Approved
  •   192/13, Ethik-Kommission der Medizinischen Fakultät der Ludwig-Maximilians-Universität München
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Secondary IDs

  •   CIV-13-02-009703 
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Health Condition or Problem studied

  •   H30-H36 -  Disorders of choroid and retina
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Interventions/Observational Groups

  •   In patients, who are imaged by standard OCT for retinal changes, additionally MHz OCT is applied.
  •   Current generation standard OCT
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Characteristics

  •   Non-interventional
  •   Other
  •   Non-randomized controlled trial
  •   Single blind
  •   assessor
  •   Other
  •   Diagnostic
  •   Parallel
  •   N/A
  •   N/A
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Primary Outcome

Primary endpoint is based on the comparison of OCT images, which are obtained by image analysis from MHz-OCT datasets, with OCT images from current generation OCT systems (e.g. Heidelberg Spectralis SD-OCT). The question to be answered is, if diagnostic quality of images from the fast 3D MHz-data set are equal or better than current standard SD-OCT technology for diseases of the vitreoretinal interface, within the retina and the choroid. Primary endpoint is defined as no difference in diagnostic clinical quality grading (Grading of "clinical diagnostic value") between MHz-OCT and standard OCT.

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Secondary Outcome

Sekundary outcomes are the effects of different recording and analysis protocols with MHz OCT for different diseases. Also as an explantory endpoint, potential requirements for the usability of the device are investigated.

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Countries of Recruitment

  •   Germany
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Locations of Recruitment

  • University Medical Center 
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Recruitment

  •   Planned
  •   2013/09/01
  •   85
  •   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 can be included, who need for diagnosis or follow-up a standard OCT
• Men and women >18 years
• Informed written consent

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Exclusion Criteria

General:
• No written informed consent;
• age<18 years;
• pregnancy of breast feeding;
• patients with severely reduced health status;
• patients unable to comply and in whom conventional OCT cannot be performed;
• neurologic disease within the face/affecting the eye (e. g. facial palsy);
• allergy against Polymethylmethacrylate (PMMA);
Concomitant eye disease:
• active inflammation and infections of the eye;
• uncontrolled glaucoma;

Previous therapies of the eye (e.g. laser or surgery) are no exclusion criteria.

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Addresses

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    • Augenklinik der Ludwig-Maximilians-Universität
    • Mr.  Prof. Dr. med.  Aljoscha S  Neubauer 
    • Mathildenstr. 8
    • 80336  München
    • Germany
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    • Augenklinik der Ludwig-Maximilians Universität
    • Mr.  Prof. Dr. med.  Aljoscha S  Neubauer 
    • Mathildenstr. 8
    • 80336  München
    • Germany
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    • Augenklinik der Ludwig-Maximilians Universität
    • Mr.  PD Dr.  Marcus  Kernt 
    • Mathildenstr. 8
    • 80336  München
    • Germany
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Sources of Monetary or Material Support

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    • Gesellschaft der Freunde und Förderer der Augenklinik München e.V.
    • Mathildenstr. 8
    • 80336  München
    • Germany
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    • Bundesministerium für Wirtschaft und Technologie - Projektträger Jülich (PTJ) Forschungszentrum Jülich GmbH Geschäftsstelle Berlin
    • Zimmerstraße 26-27
    • 10969  Berlin
    • Germany
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Status

  •   Recruiting ongoing
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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.