Trial document




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  DRKS00015070

Trial Description

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Title

RESCAN 700 – Visualization of anterior and posterior ocular structures at extended OCT Scan depths > 2mm

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Trial Acronym

RESCAN

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URL of the Trial

http:///

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Brief Summary in Lay Language

The study includes an additional investigation as part of the planned surgery on the eye. Optical coherence tomography (OCT) is an investigation method, among others. in medicine, where light is used to represent structures in deeper tissue. In this case, a cross section through different tissue layers can be displayed without contact and decisions for further therapy can be made from this. In addition to OCT devices for diagnostics, the company Carl Zeiss Meditec AG has developed an OCT, which is used during eye operations and is installed in the surgical microscope. There are currently two different software versions of this system on the market, which differ in the depth of the reproducible tissue layers (scanning depth) and, associated therewith, the resolution (= detail sharpness) of the images.
The aim of the present study is to assess the comparability of the two software versions of the RESCAN 700 systems available on the market with regard to the OCT image quality at an extended scan depth> 2 mm and thus to investigate the validity of the images for clinical questions.

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Brief Summary in Scientific Language

Optical coherence tomography (OCT) is an investigation method that uses low coherence length light using an interferometer to measure the distance in scattering materials. Their main field of application is medicine. In addition to OCT devices for diagnostics, Carl Zeiss Meditec AG has developed an OCT, which is used during ophthalmic surgical operations and is implemented in the surgical microscope.

OPMI Lumera 700 incl. RESCAN 700
The Carl Zeiss Meditec developed RESCAN 700 system enables the intraoperative OCT visualization of structures of the anterior and posterior sections of the eye. The RESCAN 700 system consists of an integrated OCT camera (RESCAN 700), the surgical microscope OPMI Lumera 700 and the assistance system CALLISTO eye, which displays the OCT images. Currently two different RESCAN systems with two different software versions and OCT scan depths are available on the market. The aim of the present study is to assess the comparability of the two software versions of the RESCAN 700 systems available on the market with regard to the OCT image quality at an extended scan depth> 2 mm and thus to investigate the validity of the images for clinical questions.

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Organizational Data

  •   DRKS00015070
  •   2018/09/21
  •   [---]*
  •   yes
  •   Approved
  •   132/18, Ethikkommission der Medizinischen Fakultät der Otto-von-Guericke-Universität Magdeburg
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Secondary IDs

  •   U1111-1216-8660 
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Health Condition or Problem studied

  •   H40.1 -  Primary open-angle glaucoma
  •   H18.5 -  Hereditary corneal dystrophies
  •   H35.3 -  Degeneration of macula and posterior pole
  •   H25.9 -  Senile cataract, unspecified
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Interventions/Observational Groups

  •   All 30 patients who are routinely operated on one of the 3 clinical standard indications (corneal, retina or glaucoma) are measured with both Sotware 1 and Software 2.
    Because the two OCT software versions are implemented in two separate (identical) devices, it is necessary for the study during the procedure after taking the OCT images with the primary surgical microscope, its microscope head off and the second device to swing. The change will usually take place within a maximum of two minutes. This is within the normal fluctuations in the temporal course of surgery and will not significantly increase the duration of the procedure. Photo and video recordings belong to the standard procedure of the University Eye Clinic as a quality assurance measure during surgery.
    The time to take the required 3 OCT images is estimated to be about 5 minutes.
    An independent medical expert committee (IMEC) assesses OCT images and their quality accordingly.
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Characteristics

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


1. The image quality of the OCT images at scan depth 2.0 mm (Software 1) with those of 2.9 mm and 5.8 mm (Software 2) for the two RESCAN 700 systems is to be assessed.

2. Evaluation of the quality of distinctness of so-called ghost images and their influence on the interpretability of OCT images in 5.8 mm scan depth by 3 independent medical experts

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Secondary Outcome

There are no secondary endpoints.

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Countries of Recruitment

  •   Germany
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Locations of Recruitment

  • University Medical Center 
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Recruitment

  •   Actual
  •   2018/09/17
  •   30
  •   Monocenter trial
  •   National
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Inclusion Criteria

  •   Both, male and female
  •   21   Years
  •   no maximum age
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Additional Inclusion Criteria

1. The subject is ≥ 21 years and mentally competent to fully understand the aim and conduct of the study
2. The subject has provided written informed consent
3. Subjects are undergoing a corneal, glaucoma and/or retinal surgery, planned independently of this study

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Exclusion Criteria

1. Patients who receive emergency surgical intervention
2. Ocular condition, which prevents the use of the RESCAN System
3. Patients unable to consent to participate in the clinical study

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Addresses

  • start of 1:1-Block address primary-sponsor
    • Universitätsaugenklinik
    • Mr.  Prof. Dr. med.  Hagen  Thieme 
    • Leipziger Str. 44
    • 39120  Magdeburg
    • Germany
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    • Universitätsaugenklinik
    • Mr.  Dr. med.  Lars  Choritz 
    • Leipziger Str. 44
    • 39120  Magdeburg
    • Germany
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    • Universitätsaugenklinik
    • Ms.  Angela  Ehmer 
    • Leipziger Str. 44
    • 39120  Magdeburg
    • Germany
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Sources of Monetary or Material Support

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    • Fa. Carl Zeiss Meditec AGZEISS Gruop
    • Rudolf-Eber-Strasse 11
    • 73447  Oberkochen
    • Germany
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Status

  •   Recruiting complete, follow-up complete
  •   2018/11/19
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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.