Trial document





This trial has been registered retrospectively.
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  DRKS00009350

Trial Description

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Title

Immediate Registration of photocoagulation lesions by slit-lamp adapted optical coherence tomography

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Trial Acronym

SoPhoS

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URL of the Trial

[---]*

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Brief Summary in Lay Language

The SoPhoS study investigates fine tissue effects of retinal photocoagulation. It applies a customized machine for optical coherence tomography (OCT). In retinal photocoagulation, 1/50 - 1/5 s short, very intense laser irradations generate fine retinal burns, which are helpful in ischemic retinal diseases such as diabetic retinopathy to protect the eye from consecutive secondary diseases. The customized OCT-machine can record highly resolved sectional images of the coagulating retina in high speed, with hundreds of Frames per second. It also allows conclusions about temperature profiles and Perfusion within the tissue. We can recrute Patient eyes that receive panretinal laser photocoagulation for the first time and that are legally capable to give informed consent (above 18 years old, no prisoners), that are not pregnant and are physically without obstacles for the Treatment. Follow up examinations with clinical Standard Imaging will be necessary after 1 day, 1 and 3 months.

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Brief Summary in Scientific Language

The SoPhoS study applies Phase sensitive high-speed OCT to record representative Images of retina and choroid under laser irradatiation. It does not only generate morphological Information via OCT reflecitivity, but also allows conclusions about retinal and choroidal Perfusion, tissue displacement and temperature profiles. Functionality of the method in humans is to be tested, and first conclusions about the clinical potential of the method are to be drawn.

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Organizational Data

  •   DRKS00009350
  •   2015/10/21
  •   [---]*
  •   yes
  •   Approved
  •   D470/15, Ethikkommission der Christian-Albrechts-Universität zu Kiel
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Secondary IDs

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

  •   H36.0 -  Diabetic retinopathy
  •   H34.8 -  Other retinal vascular occlusions
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Interventions/Observational Groups

  •   Patients with indication for first session of panretinal laserphotocoagulation: Recording with high-speed OCT during application of 40 photocoagulation lesions, afterward clinical imaging of these lesions with OCT and color fundus photo over 3 months.
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Characteristics

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

Histologic tissue changes under retinal photocoagulation

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Secondary Outcome

data quality of custom made high-speed OCT

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Countries of Recruitment

  •   Germany
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Locations of Recruitment

  • University Medical Center 
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Recruitment

  •   Actual
  •   2015/09/15
  •   20
  •   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

indication for panretinal photocoagulation, first treatment session

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Exclusion Criteria

pregnancy
disseases that hamper photocoagulation (Tremor, Nystagmus, spine Deformation), corneal diseases

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Addresses

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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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