Trial document




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  DRKS00028581

Trial Description

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Title

Temperature-controlled continous wave (cw)-laser treatment for CSR patients (TempLaser)

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Trial Acronym

TempLaser

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URL of the Trial

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Brief Summary in Lay Language

Patients with chronic central serous retinopathy receive a temperature-controlled laser treatment that is based on real-time measurement and control and is intended to prevent unnecessary damage to the retina. The study aims to show that the new laser system works safely and reliably and that the disease improves after treatment. The new laser system is faster, more independent and cheaper than photodynamic therapy, which is currently not covered by health insurance.

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Brief Summary in Scientific Language

phase II clinical trial

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Do you plan to share individual participant data with other researchers?

No

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Description IPD sharing plan:

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Organizational Data

  •   DRKS00028581
  •   2022/03/22
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  •   no
  •   Approved
  •   D 484/21, Ethikkommission der Christian-Albrechts-Universität zu Kiel
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Secondary IDs

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Health Condition or Problem studied

  •   H35.7 -  Separation of retinal layers
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Interventions/Observational Groups

  •   Patients with chronic retinopathy centralis serosa are treated with a CE-certified cw laser. One laser treatment (approx. 10-15min) was carried out in this study. A new module is coupled between the laser and the patient. It measures the real-time temperature on the retina and attenuates the energy to maintain a preset target temperature. The module can only throttle power.
    Temperature data and power curves can then be extracted and analyzed. Using image diagnostics (OCT, FAG, fundus photo), microperimetry and electrophysiology, therapy safety and success are checked in a 3-month follow-up.
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Characteristics

  •   Interventional
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  •   Single arm study
  •   Open (masking not used)
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  •   Uncontrolled/Single arm
  •   Other
  •   Single (group)
  •   II
  •   N/A
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Primary Outcome

Therapy safety controlled by:
- Microperimetry
- mERG
- Optical coherence tomography
- Fluorescence angiography
- Fundus photography

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Secondary Outcome

Therapy success controlled by:
- Optical coherence tomography
- Subjective improvement (analogue scale)

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Countries of Recruitment

  •   Germany
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Locations of Recruitment

  • University Medical Center 
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Recruitment

  •   Actual
  •   2022/03/29
  •   10
  •   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

- of legal age
- central serous retinopathy for more than 3 months
- Leackage point at least 500µm outside the fovea

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Exclusion Criteria

- underage
- Initial RCS diagnosis less than 3 months
- Leackage point <500µm away from the fovea

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Addresses

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    • Klinik für Ophthalmologie Universitätsklinikum Schleswig-Holstein Campus Kiel
    • Mr.  Prof. Dr.  Johann B.  Roider 
    • Haus B2, Arnold-Heller-Straße 3
    • 24105  Kiel
    • Germany
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    • Klinik für Ophthalmologie Universitätsklinikum Schleswig-Holstein Campus Kiel
    • Mr.  Dr. med.  Claus  von der Burchard 
    • Haus B2, Arnold-Heller-Straße 3
    • 24105  Kiel
    • Germany
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    • Klinik für Ophthalmologie Universitätsklinikum Schleswig-Holstein Campus Kiel
    • Mr.  Dr. med.  Claus  von der Burchard 
    • Haus B2, Arnold-Heller-Straße 3
    • 24105  Kiel
    • Germany
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Sources of Monetary or Material Support

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    • Bundesministerium für Bildung und Forschung Dienstsitz Berlin
    • Friedrichstraße 130 B
    • 10117  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.