Trial document
DRKS00013755
Trial Description
Title
Evaluation of innovative OCT techniques in comparison to conventional OCT
Trial Acronym
Evokon
URL of the Trial
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Brief Summary in Lay Language
Optical coherence tomography (OCT) is a safe, non-invasive method for high-resolution imaging of the human retina. It uses reflection of light beams projected on the retina to calculate tomographic images.
OCT as an examination entity has been standard of care in retinal diagnostics for over 10 years. In this study, we want to test a new OCT device on top of routine OCT examination. The new OCT device uses the same basic principle, but differs in the mode of light projection and image calculation. This offers the potential for self-examination and possible future home-application of the device by the patient. Whereas established OCT devices rely on attention of a physician or a medical assistant, the new device was designed to be fully operated by the patient alone.
Aim of this study is to test the possibility of self-examination.
Brief Summary in Scientific Language
Aim of this study is to examine Full-Field-OCT as a retinal diagnostic tool in comparison to conventional SD-OCT. FF-OCT is a possible candidate for the construction of low-cost easy-to-use OCT devices that can be administered by the patient himself at home. Our study aims to test imaging quality as well as sensitivity and specificity of detection of pathological findings. We want to evaluate the reliability of OCT self-examination as well as to gather patient feedback.
The target sample size was elevated from 51 to 102 patients by two amendments (15.3.2019 and 23.10.2019).
Do you plan to share individual participant data with other researchers?
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Description IPD sharing plan:
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Organizational Data
- DRKS00013755
- 2018/03/14
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- yes
- Approved
- A 139/17, Ethikkommission der Christian-Albrechts-Universität zu Kiel
Secondary IDs
- CIV-17-12-022384
Health Condition or Problem studied
- H35.3 - Degeneration of macula and posterior pole
Interventions/Observational Groups
- Examination of the retina of patients with (suspected) retinal disease with standard OCT and new Full-Field-OCT
Characteristics
- Interventional
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- Single arm study
- Blinded
- assessor, data analyst
- Uncontrolled/Single arm
- Diagnostic
- Single (group)
- N/A
- N/A
Primary Outcome
Rate of successful self-measurement after prior instruction from the physician
Secondary Outcome
Grading of OCT images of both devices. The images will be presented in a randomized order without patient identification.
- Grading of image quality
- Sensitivity and specificity in the detection of retinal pathologies, above all intraretinal fluid (IRF), subretinal fluid (SRF), pigment epithelium detachments (PED)
Countries of Recruitment
- Germany
Locations of Recruitment
- University Medical Center
Recruitment
- Actual
- 2018/03/19
- 102
- Monocenter trial
- National
Inclusion Criteria
- Both, male and female
- 18 Years
- no maximum age
Additional Inclusion Criteria
Persons during ophthalmologic examination requiring myriatic eye drop installation and OCT examination
Exclusion Criteria
Inability to give informed consent, mental disability, under 18 years of age, pregnancy/breast-feeding
Addresses
-
start of 1:1-Block address primary-sponsor
- Medizinisches Laserzentrum Lübeck
- Mr. Dr. Ralf Brinkmann
- Peter-Monnik-Weg 4
- 23562 Lübeck
- Germany
end of 1:1-Block address primary-sponsorstart of 1:1-Block address contact primary-sponsor- [---]*
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- https://www.mll-luebeck.de/
end of 1:1-Block address contact primary-sponsor -
start of 1:1-Block address other
- Universitätsaugenklinik Kiel
- Mr. Dr. Claus von der Burchard
- Hegewischstr. 25
- 24105 Kiel
- Germany
end of 1:1-Block address otherstart of 1:1-Block address contact other- +49 431 500 24201
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- claus.vonderburchard at uksh.de
- https://www.uksh.de/augenklinik-kiel
end of 1:1-Block address contact other -
start of 1:1-Block address scientific-contact
- Universitätsaugenklinik Kiel
- Mr. Dr. Claus von der Burchard
- Hegewischstr. 25
- 24105 Kiel
- Germany
end of 1:1-Block address scientific-contactstart of 1:1-Block address contact scientific-contact- +49 431 500 24201
- [---]*
- claus.vonderburchard at uksh.de
- https://www.uksh.de/augenklinik-kiel
end of 1:1-Block address contact scientific-contact -
start of 1:1-Block address public-contact
- Universitätsaugenklinik Kiel
- Mr. Dr. Claus von der Burchard
- Hegewischstr. 25
- 24105 Kiel
- Germany
end of 1:1-Block address public-contactstart of 1:1-Block address contact public-contact- +49 431 500 24201
- [---]*
- claus.vonderburchard at uksh.de
- https://www.uksh.de/augenklinik-kiel
end of 1:1-Block address contact public-contact
Sources of Monetary or Material Support
-
start of 1:1-Block address materialSupport
- Bundesministerium für Bildung und Forschung Dienstsitz Berlin
- Friedrichstraße 130 B
- 10117 Berlin
- Germany
end of 1:1-Block address materialSupportstart of 1:1-Block address contact materialSupport- [---]*
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- http://www.bmbf.de
end of 1:1-Block address contact materialSupport
Status
- Recruiting complete, follow-up complete
- 2020/03/12
Trial Publications, Results and other Documents
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