Evaluation of innovative OCT techniques in comparison to conventional OCT
Organizational Data
- DRKS-ID:
- DRKS00013755
- Recruitment Status:
- Recruiting complete, study complete
- Date of registration in DRKS:
- 2018-03-14
- Last update in DRKS:
- 2023-12-29
- Registration type:
- Prospective
Acronym/abbreviation of the study
Evokon
URL of the study
No Entry
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).
Health condition or problem studied
- ICD10:
- H35.3 - Degeneration of macula and posterior pole
- Healthy volunteers:
- No Entry
Interventions, Observational Groups
- Arm 1:
- Examination of the retina of patients with (suspected) retinal disease with standard OCT and new Full-Field-OCT
Endpoints
- 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)
Study Design
- Purpose:
- Diagnostic
- Allocation:
- N/A (single arm study)
- Control:
-
- Uncontrolled/single arm
- Phase:
- N/A
- Study type:
- Interventional
- Mechanism of allocation concealment:
- No Entry
- Blinding:
- No
- Assignment:
- Single (group)
- Sequence generation:
- No Entry
- Who is blinded:
- No Entry
Recruitment
- Recruitment Status:
- Recruiting complete, study complete
- Reason if recruiting stopped or withdrawn:
- No Entry
Recruitment Locations
- Recruitment countries:
-
- Germany
- Number of study centers:
- Monocenter study
- Recruitment location(s):
-
- University medical center Klinik für Ophthalmologie Kiel
Recruitment period and number of participants
- Planned study start date:
- 2018-03-19
- Actual study start date:
- 2018-03-19
- Planned study completion date:
- No Entry
- Actual Study Completion Date:
- 2020-03-12
- Target Sample Size:
- 102
- Final Sample Size:
- 97
Inclusion Criteria
- Sex:
- All
- Minimum Age:
- 18 Years
- Maximum Age:
- 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
Primary Sponsor
- Address:
- Medizinisches Laserzentrum LübeckDr. Ralf BrinkmannPeter-Monnik-Weg 423562 LübeckGermany
- Telephone:
- No Entry
- Fax:
- No Entry
- Contact per E-Mail:
- Contact per E-Mail
- URL:
- https://www.mll-luebeck.de/
- Investigator Sponsored/Initiated Trial (IST/IIT):
- Yes
Contact for Scientific Queries
- Address:
- Universitätsaugenklinik KielDr. Claus von der BurchardHegewischstr. 2524105 KielGermany
- Telephone:
- +49 431 500 24201
- Fax:
- No Entry
- Contact per E-Mail:
- Contact per E-Mail
- URL:
- https://www.uksh.de/augenklinik-kiel
Contact for Public Queries
- Address:
- Universitätsaugenklinik KielDr. Claus von der BurchardHegewischstr. 2524105 KielGermany
- Telephone:
- +49 431 500 24201
- Fax:
- No Entry
- Contact per E-Mail:
- Contact per E-Mail
- URL:
- https://www.uksh.de/augenklinik-kiel
Principal Investigator
- Address:
- Universitätsaugenklinik KielDr. Claus von der BurchardHegewischstr. 2524105 KielGermany
- Telephone:
- +49 431 500 24201
- Fax:
- No Entry
- Contact per E-Mail:
- Contact per E-Mail
- URL:
- https://www.uksh.de/augenklinik-kiel
Sources of Monetary or Material Support
Public funding institutions financed by tax money/Government funding body (German Research Foundation (DFG), Federal Ministry of Education and Research (BMBF), etc.)
- Address:
- Bundesministerium für Bildung und Forschung Dienstsitz BerlinFriedrichstraße 130 B10117 BerlinGermany
- Telephone:
- No Entry
- Fax:
- No Entry
- Contact per E-Mail:
- Contact per E-Mail
- URL:
- http://www.bmbf.de
Ethics Committee
Address Ethics Committee
- Address:
- Ethik-Kommission der Medizinischen Fakultät der Christian-Albrechts-Universität zu KielSchwanenweg 2024105 KielGermany
- Telephone:
- +49-431-50014191
- Fax:
- +49-431-50014195
- Contact per E-Mail:
- Contact per E-Mail
- URL:
- No Entry
Vote of leading Ethics Committee
- Vote of leading Ethics Committee
- Date of ethics committee application:
- 2017-12-11
- Ethics committee number:
- A 139/17
- Vote of the Ethics Committee:
- Approved
- Date of the vote:
- 2018-02-27
Further identification numbers
- Other primary registry ID:
- No Entry
- EudraCT Number:
- No Entry
IPD - Individual Participant Data
- Do you plan to make participant-related data (IPD) available to other researchers in an anonymized form?:
- No
- IPD Sharing Plan:
- No Entry
Study protocol and other study documents
- Study protocols:
- No Entry
- Study abstract:
- No Entry
- Other study documents:
- No Entry
- Background literature:
- No Entry
- Related DRKS studies:
- No Entry
Publication of study results
- Planned publication:
- No Entry
- Publikationen/Studienergebnisse:
- von der Burchard C, Moltmann M, Tode J, Ehlken C, Sudkamp H, Theisen-Kunde D, König I, Hüttmann G, Roider J. Self-examination low-cost full-field OCT (SELFF-OCT) for patients with various macular diseases. Graefes Arch Clin Exp Ophthalmol. 2021 Jun;259(6):1503-1511. doi: 10.1007/s00417-020-05035-6. Epub 2020 Dec 21. PMID: 33346888; PMCID: PMC8166739.
- von der Burchard C, Sudkamp H, Tode J, Ehlken C, Purtskhvanidze K, Moltmann M, Heimes B, Koch P, Münst M, Vom Endt M, Kepp T, Theisen-Kunde D, König I, Hüttmann G, Roider J. Self-Examination Low-Cost Full-Field Optical Coherence Tomography (SELFF-OCT) for neovascular age-related macular degeneration: a cross-sectional diagnostic accuracy study. BMJ Open. 2022 Jun 27;12(6):e055082. doi: 10.1136/bmjopen-2021-055082. PMID: 35760534; PMCID: PMC9237881.
- Date of first publication of study results:
- 2020-12-21
- DRKS entry published for the first time with results:
- 2023-12-29
Basic reporting
- Basic Reporting / Results tables:
- No Entry
- Brief summary of results:
- No Entry