Trial document





This trial has been registered retrospectively.
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  DRKS00006156

Trial Description

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Title

Variability of retinal laser photocoagulation effects

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Trial Acronym

VARILAS

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URL of the Trial

http://www.uni-kiel.de/uak/forsch_studie_varilas.html

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Brief Summary in Lay Language

Several eye diseases, such as diabetic retinopathy or thrombosis of retinal vessels, may require a ablative retinal therapy with laser. This therapy is called retinal laser photocoagulation.

During a panretinal photocoagulation therapy, up to 2000 single laser lesions are created on the ocular fundus. Each lesion's diameter is about half a millimeter. Having applied a laser lesion, the physician has to assure that it has achieved the desired degree of white discoloration on the retina. If necessary, power of the treatment laser is adapted after every single shot.

Judgement of retinal whitening is observer-dependent, and the resulting lesions are a little variable between treating physicians. In this study, we examine with a modern, high-resolution photographic imaging device, so called „OCT“, some of the created lesion very exactly over time. Furthermore, we check retinal light sensitivity on selected photocoagulation sites. We do this with a technique called microperimetry. It is the goal of this study to detect and quantify the effect variation from one patient to the next and from one physician to the next. We would like to conduct these examinations on patients that need retinal photocoagulation anyway and that have never been treated with photocoagulation before.

Study participants will not need to take additional appointsments in the clinic apart from those necessary for routine treatment and follow-up. All additional examinations are innocuous and painless for the patient, but they do require some extra time on study days. Our professional study team comprises a study nurse and several experienced doctors, who take care of every study participants' personal needs and undertakes every effort to keep waiting times as short as possible.

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Brief Summary in Scientific Language

This study aims to quantify effect variation of panretinal photocoagulation lesions within a treatment session, between different patients and different physicians. We want to recruite patients with an indication for panretinal photocoagulation and examine two study areas on the retina with detailed imaging. Before the treatment and after 1 hour, 1 day, 1 and 3 months, we take fundus color images and OCT-scans of all study lesions. Influence variables of our analysis will be physician, patient and laser power. Outcome measure are visibility of the lesion, lesion diameter in fundus images and OCT-scans and lesion intensity as graded on a 6 step, OCT-based lesion classification. Every participant will receive approx. 2x20 study lesions at the temporal vessel arcades (irradiation diameter 300 µm, irradiation time 20 ms or 200 ms, lesion intensitiy as required by clinical routine according to ETDRS standard). These lesions are required according to the clinical treatment indication anyway and their creation is not related to the study.

A second endpoint will examine functional retinal impairment at the site of every laser burn. Selected lesion of the same patients – approx. 8 lesions per patient – will be examined by microperimetry prior to the treatment, after 1 day, 1 and 3 months (Nidek MP1). On and around every lesions, several stimuli of Goldmann III size will be examined. At every timepoint, we will examine presence of an absolute scotoma (sensitivity at worst stimulus = 0 dB), sensitivity at worst stimulus in the area and mean sensitivity over the area.

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Organizational Data

  •   DRKS00006156
  •   2014/05/12
  •   [---]*
  •   yes
  •   Approved
  •   D 449/12, 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

  •   Observation group 1: A selection of retinal photocoagulation lesions will be clinically examined by MP1 microperimetry, fundus color photography and OCT at the time points baseline, 1 hour, 1 day, 1 and 3 months after treatment
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Characteristics

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

The intensity of selected photocoagulation lesions will be examined after 3 months morphologically (OCT) and functionally (MP1 microperimetry)

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Secondary Outcome

none

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Countries of Recruitment

  •   Germany
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Locations of Recruitment

  • University Medical Center 
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Recruitment

  •   Actual
  •   2012/09/17
  •   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 for diabetic retinopathy or retinal vein occlusion, no prior panretinal photocoagulation, ability to give legal consent, sufficient cooperativity for microperimetry (sufficient clarity of optical media, no major tremor, fixation ability of study eye)

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Exclusion Criteria

pregnancy

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Addresses

  • start of 1:1-Block address primary-sponsor
    • Klinik für AugenheilkundeUniversitätsklinikum Schleswig-HolsteinCampus Kiel
    • Mr.  Dr. med.  Stefan  Koinzer 
    • Arnold-Heller-Str. 3, Haus 25
    • 24105  Kiel
    • Germany
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    • Klinik für AugenheilkundeUniversitätsklinikum Schleswig-HolsteinCampus Kiel
    • Mr.  Dr. med.  Stefan  Koinzer 
    • Arnold-Heller-Str. 3, Haus 25
    • 24105  Kiel
    • Germany
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    • Klinik für AugenheilkundeUniversitätsklinikum Schleswig-HolsteinCampus Kiel
    • Mr.  Dr. med.  Stefan  Koinzer 
    • Arnold-Heller-Str. 3, Haus 25
    • 24105  Kiel
    • Germany
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Sources of Monetary or Material Support

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    • Universitätsklinikum Schleswig-Holstein Campus Kiel
    • Arnold-Heller-Str. 3
    • 24105  Kiel
    • Germany
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Status

  •   Recruiting complete, follow-up complete
  •   2014/04/03
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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.